StemCell Therapy

Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the right price. For example, biotech and mining exploration companies often lose money for years before finding success with a new treatment or mineral discovery. Nonetheless, only a fool would ignore the risk that a loss making company burns through its cash too quickly.

So should PDS Biotechnology (NASDAQ:PDSB) shareholders be worried about its cash burn? For the purpose of this article, we'll define cash burn as the amount of cash the company is spending each year to fund its growth (also called its negative free cash flow). The first step is to compare its cash burn with its cash reserves, to give us its 'cash runway'.

View our latest analysis for PDS Biotechnology

A company's cash runway is the amount of time it would take to burn through its cash reserves at its current cash burn rate. As at September 2019, PDS Biotechnology had cash of US$17m and such minimal debt that we can ignore it for the purposes of this analysis. Looking at the last year, the company burnt through US$12m. So it had a cash runway of approximately 17 months from September 2019. That's not too bad, but it's fair to say the end of the cash runway is in sight, unless cash burn reduces drastically. The image below shows how its cash balance has been changing over the last few years.

NasdaqCM:PDSB Historical Debt, November 12th 2019

Because PDS Biotechnology isn't currently generating revenue, we consider it an early-stage business. So while we can't look to sales to understand growth, we can look at how the cash burn is changing to understand how expenditure is trending over time. Remarkably, it actually increased its cash burn by 673% in the last year. With that kind of spending growth its cash runway will shorten quickly, as it simultaneously uses its cash while increasing the burn rate. Clearly, however, the crucial factor is whether the company will grow its business going forward. So you might want to take a peek at how much the company is expected to grow in the next few years.

While PDS Biotechnology does have a solid cash runway, its cash burn trajectory may have some shareholders thinking ahead to when the company may need to raise more cash. Generally speaking, a listed business can raise new cash through issuing shares or taking on debt. Commonly, a business will sell new shares in itself to raise cash to drive growth. We can compare a company's cash burn to its market capitalisation to get a sense for how many new shares a company would have to issue to fund one year's operations.

PDS Biotechnology has a market capitalisation of US$15m and burnt through US$12m last year, which is 85% of the company's market value. That suggests the company may have some funding difficulties, and we'd be very wary of the stock.

Even though its cash burn relative to its market cap makes us a little nervous, we are compelled to mention that we thought PDS Biotechnology's cash runway was relatively promising. Considering all the measures mentioned in this report, we reckon that its cash burn is fairly risky, and if we held shares we'd be watching like a hawk for any deterioration. For us, it's always important to consider risks around cash burn rates. But investors should look at a whole range of factors when researching a new stock. For example, it could be interesting to see how much the PDS Biotechnology CEO receives in total remuneration.

Story continues

Of course, you might find a fantastic investment by looking elsewhere. So take a peek at this free list of interesting companies, and this list of stocks growth stocks (according to analyst forecasts)

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned. Thank you for reading.

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PDS Biotechnology (NASDAQ:PDSB) Will Have To Spend Its Cash Wisely - Yahoo Finance

The 59 rating InvestorsObserver gives to Forty Seven Inc (FTSV) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 81 percent of stocks in the Biotechnology industry, FTSVs 59 overall rating means the stock scores better than 59 percent of all stocks.

Click Here to get the full Stock Score Report on Forty Seven Inc (FTSV) Stock.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Forty Seven Inc (FTSV) stock is trading at $10.31 as of 10:05 AM on Thursday, Nov 14, a rise of $0.12, or 1.18% from the previous closing price of $10.19. The stock has traded between $10.28 and $10.57 so far today. Volume today is below average. So far 51,681 shares have traded compared to average volume of 211,996 shares.

To see InvestorsObservers Sentiment Score for Forty Seven Inc click here.

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Where Does FTSV Stock Rank in the Biotechnology Industry? - InvestorsObserver

Looking for broad exposure to the Healthcare - Biotech segment of the equity market? You should consider the Invesco Dynamic Biotechnology & Genome ETF (PBE), a passively managed exchange traded fund launched on 06/23/2005.

Passively managed ETFs are becoming increasingly popular with institutional as well as retail investors due to their low cost, transparency, flexibility and tax efficiency. They are excellent vehicles for long term investors.

Sector ETFs also provide investors access to a broad group of companies in particular sectors that offer low risk and diversified exposure. Healthcare - Biotech is one of the 16 broad Zacks sectors within the Zacks Industry classification. It is currently ranked 2, placing it in top 13%.

Index Details

The fund is sponsored by Invesco. It has amassed assets over $227.92 M, making it one of the average sized ETFs attempting to match the performance of the Healthcare - Biotech segment of the equity market. PBE seeks to match the performance of the Dynamic Biotechnology & Genome Intellidex Index before fees and expenses.

This is comprised of stocks of 30 U.S. biotechnology and genome companies. These are companies that are principally engaged in the research, development, manufacture and marketing and distribution of various biotechnological products, services and processes and companies that benefit significantly from scientific and technological advances in biotechnology and genetic engineering and research.

Costs

Expense ratios are an important factor in the return of an ETF and in the long term, cheaper funds can significantly outperform their more expensive counterparts, other things remaining the same.

Annual operating expenses for this ETF are 0.57%, making it on par with most peer products in the space.

Sector Exposure and Top Holdings

While ETFs offer diversified exposure, which minimizes single stock risk, a deep look into a fund's holdings is a valuable exercise. And, most ETFs are very transparent products that disclose their holdings on a daily basis.

This ETF has heaviest allocation in the Healthcare sector--about 100% of the portfolio.

Looking at individual holdings, Biogen Inc (BIIB) accounts for about 6.52% of total assets, followed by Vertex Pharmaceuticals Inc (VRTX) and Celgene Corp (CELG).

The top 10 holdings account for about 49.20% of total assets under management.

Performance and Risk

The ETF has added roughly 10.04% so far this year and is down about -3.11% in the last one year (as of 11/05/2019). In that past 52-week period, it has traded between $43.44 and $56.26.

The ETF has a beta of 1.43 and standard deviation of 23.63% for the trailing three-year period, making it a high risk choice in the space. With about 30 holdings, it has more concentrated exposure than peers.

Alternatives

Invesco Dynamic Biotechnology & Genome ETF carries a Zacks ETF Rank of 3 (Hold), which is based on expected asset class return, expense ratio, and momentum, among other factors. Thus, PBE is a reasonable option for those seeking exposure to the Health Care ETFs area of the market. Investors might also want to consider some other ETF options in the space.

SPDR S&P Biotech ETF (XBI) tracks S&P Biotechnology Select Industry Index and the iShares Nasdaq Biotechnology ETF (IBB) tracks Nasdaq Biotechnology Index. SPDR S&P Biotech ETF has $3.81 B in assets, iShares Nasdaq Biotechnology ETF has $7.02 B. XBI has an expense ratio of 0.35% and IBB charges 0.47%.

Bottom Line

To learn more about this product and other ETFs, screen for products that match your investment objectives and read articles on latest developments in the ETF investing universe, please visit Zacks ETF Center.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportInvesco Dynamic Biotechnology & Genome ETF (PBE): ETF Research ReportsiShares Nasdaq Biotechnology ETF (IBB): ETF Research ReportsSPDR S&P Biotech ETF (XBI): ETF Research ReportsCelgene Corporation (CELG) : Free Stock Analysis ReportVertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis ReportBiogen Inc. (BIIB) : Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment Research

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Should You Invest in the Invesco Dynamic Biotechnology & Genome ETF (PBE)? - Yahoo Finance

FORT LAUDERDALE, Fla., Nov. 6, 2019 /PRNewswire/ --Goodwin Biotechnology, Inc. announced that it has recently licensed an industry leading electronic content and document management solution to enhance the efficiency and effectiveness of its Quality systems and operations. This improvement continues to ensure that Goodwin Biotechnology remains uniquely positioned as aqualified and flexible biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that offers an integrated Single Source Solution from Cell Line Development, Process Development and cGMP manufacturing including Scale-Up, cGMP Contract Manufacturing, and Aseptic Fill / Finish of mammalian cell-culture derived monoclonal antibodies, recombinant proteins, vaccines, and Antibody Drug Conjugates (ADCs).

"Acquisition and implementation of this sophisticated electronic solution demonstrates Goodwin's commitment to providing top-tier development and manufacturing services for our clients," noted Karl Pinto, Chief Executive Officer at Goodwin Biotechnology. "Goodwin's past successes supporting our clients through their early- and late-stage clinical trials, and regulatory compliant commercial manufacturing, will be strengthened through this recent investment. These strategic steps demonstrate our commitment to effectively support our clients through all stages of product development and cGMP manufacturing to assure conformance to worldwide regulatory standards." added Mr. Pinto.

About Goodwin Biotechnology, Inc.Goodwin Biotechnologyis a uniquely qualified and flexible, US-based CDMO that offers a Single Source Solution to enhance the value of complex biopharmaceuticals for our clients. With over 26 years of experience as an independent integrated contract manufacturer, Goodwin Biotechnology has worked as a strategic partner with companies of all sizes from small university spin-offs to major research institutes, government agencies and large, established and multi-national biopharmaceutical companies. Based on the impressive track record, Goodwin Biotechnology has received numerous industry awards that span from Frost & Sullivan's Customer Value and Leadership Award for Best Practices in Mammalian Contract Manufacturing to the Biologics cGMP Manufacturer of the Year 2018 by Global Health & Pharma News. Click here to view the press releases! Additional information may be found at http://www.GoodwinBio.com.

For more information, please contact:

View original content:http://www.prnewswire.com/news-releases/goodwin-biotechnology-launches-a-digitization-initiative-by-investing-in-a-sophisticated-electronic-quality-solution-300953066.html

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Goodwin Biotechnology Launches a Digitization Initiative by Investing in a Sophisticated Electronic Quality Solution - Yahoo Finance

Biotech stocks extended their gains last week amid earnings news flow and the broader market strength. Large-cap pharma stocks saw particular strength.

Here are the key catalytic event a biotech investor should keep a tab on in the unfolding week.

The FDA is set to rule on Lipocine Inc (NASDAQ: LPCN)'s NDA for Tlando, or LPCN 1021 to treat hypogonadism in adult males. The PDUFA date is set for Saturday, Nov. 9.

Alkermes Plc (NASDAQ: ALKS) Phase 1/2 data for ALKS 4230 in solid tumors and ALKS 4230 in combination with Merck & Co., Inc. (NYSE: MRK)'s Keytruda in solid tumors.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) Phase 1 data for CDX-1140 in solid tumors (Friday, Nov. 8).

Pieris Pharmaceuticals Inc (NASDAQ: PIRS) Phase 1/2 data for PRS-343 in HER2-positive solid tumors.

CELYAD SA/ADR (NASDAQ: CYAD) Phase 1 data for CYAD-01 and FOLFOX in colorectal cancer (Friday, Nov. 8) and Phase 1 data for CYAD-101 in colorectal cancer (Saturday, Nov. 9).

Heat Biologics Inc (NASDAQ: HTBX) Phase 2 data for HS-110 and Bristol-Myers Squibb Co (NYSE: BMY)'s Opdivo in non-small cell lung cancer (Friday).

Oncolytics Biotech, Inc. (NASDAQ: ONCY) - interim Phase 1b data for Pelareorep and Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY)'s Tecentriq in breast cancer (Friday).

Nektar Therapeutics (NASDAQ: NKTR) updated Phase 1/2 data for NKTR-214 + Opdivo in multiple cancers (urothelial carcinoma, melanoma, renal cell carcinoma, and non-small cell lung cancer) (Saturday).

Mirati Therapeutics Inc (NASDAQ: MRTX) initial Phase 2 data for sitravatinib in urothelial carcinoma (Saturday).

Allena Pharmaceuticals Inc (NASDAQ: ALNA) Phase 2 data for reloxaliase, or ALLN-177, in primary hyperoxaluria and Phase 3 data for reloxaliase in enteric hyperoxaluria (Friday).

See Also: BTIG: Crispr Could Be A Takeover Target For Vertex

The earnings list is not comprehensive

Monday

Tuesday

Wednesday

Thursday

Friday

Galera Therapeutics has filed to offer 5 million shares in an IPO, with an estimated price range of $14-$16. The company has applied for listing its shares on the Nasdaq under the ticker symbol "GRTX."

89bio, a biotech company focusing on therapies for NASH and other metabolic disorders, is planning a 4.375-million IPO at an estimated price range of $15-17. The company has applied for listing its shares on the Nasdaq under the ticker symbol "ETNB."

Gene testing company Centogene is proposing to offer 4 million shares in an IPO, which are to be priced between $14 and $16. The company has applied to list the shares on the Nasdaq under the ticker symbol "CNTG."

CNS Pharmaceuticals, which develops therapies for brain cancer and other CNS tumors, has filed for a 2.125-million share IPO. The shares, which are likely to be priced in the range of $4-$5, are to be listed on the Nasdaq under the ticker symbol "CNSP."

Tela Bio, which sells soft tissue implants used in hernia repair and reconstructive surgery, is set to offer 4 million shares in an IPO, with each share to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol "TELA."

BioNTech SE ADR (NASDAQ: BNTX)Vir Biotechnology Inc (NASDAQ: VIR)

2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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The Week Ahead In Biotech: Smid-Cap Earnings Deluge, SITC Conference In The Spotlight - Benzinga

The company provides a detailed analysis of the market and future aspects of the Biotechnology Market. It focuses on critical and critical data that makes it a very important tool for research, experts, analysts, and managers to achieve ready-to-access analysis. The report provides an inclusive analysis of the Biotechnology market size forecast from 2018-2025.

Sample report can be viewed in a PDF form by visiting @ researchunt.com/report/global-biotechnology-market-size-status-and-forecast-2019-2025/#Free-Sample-Report

The report embraces the complete information of the key players involved in the worldwide Biotechnology market. In addition, it provides its market share by various regions with the company and product introduction and their position in the Biotechnology market. In addition, the report takes into account recent marketing developments as well as their marketing strategies along with an overall business overview. In addition, the report covers market growth factors and restraints of this market.

Prominent players of Biotechnology market:

Product Type Coverage (Market Size & Forecast, Major Company of Product Type etc.):

Application Coverage (Market Size & Forecast, Different Demand Market by Region, Main Consumer Profile etc.):

Regional Segmentation for Biotechnology market:

There are 10 chapters to put on view for Biotechnology market:

Chapter 1: Consumption by Regions

Chapter 2: Production, By Types, Revenue and Market share by Types

Chapter 3: Consumption, By Applications, Market share (%) and Growth Rate by Applications

Chapter 4: Complete profiling and analysis of Manufacturers

Chapter 5: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expenses

Chapter 6: Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 7: Marketing Strategy Analysis, Distributors/Traders

Chapter8: Market Effect Factors Analysis

Chapter9: Market Forecast

Chapter 10: Biotechnology Research Findings and Conclusion, Appendix, methodology and data source

Check here for the [emailprotected] researchunt.com/report/global-biotechnology-market-size-status-and-forecast-2019-2025/#Buying-Enquiry

Customization of the Report:This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs.

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Global Biotechnology Market 2019, Trend, CAGR Status, Growth, Analysis and Forecast to 2024 - BoundWatch

Analysts expect that Unity Biotechnology Inc (NASDAQ:UBX) will report earnings of ($0.49) per share for the current fiscal quarter, according to Zacks. Zero analysts have provided estimates for Unity Biotechnologys earnings. Unity Biotechnology posted earnings of ($0.43) per share in the same quarter last year, which indicates a negative year over year growth rate of 14%. The firm is expected to announce its next earnings report after the market closes on Wednesday, November 6th.

On average, analysts expect that Unity Biotechnology will report full year earnings of ($2.02) per share for the current financial year, with EPS estimates ranging from ($2.07) to ($1.96). For the next year, analysts expect that the company will post earnings of ($2.09) per share, with EPS estimates ranging from ($2.25) to ($1.93). Zacks Investment Researchs earnings per share averages are an average based on a survey of research firms that follow Unity Biotechnology.

Unity Biotechnology (NASDAQ:UBX) last released its earnings results on Wednesday, August 7th. The company reported ($0.54) earnings per share (EPS) for the quarter, missing analysts consensus estimates of ($0.44) by ($0.10).

Institutional investors and hedge funds have recently made changes to their positions in the company. Aperio Group LLC acquired a new position in shares of Unity Biotechnology during the 2nd quarter worth $50,000. Citadel Advisors LLC grew its stake in Unity Biotechnology by 449.0% in the 2nd quarter. Citadel Advisors LLC now owns 238,386 shares of the companys stock valued at $2,265,000 after buying an additional 194,965 shares during the last quarter. Ellington Management Group LLC acquired a new position in Unity Biotechnology in the 2nd quarter valued at $103,000. BlackRock Inc. grew its stake in Unity Biotechnology by 5.0% in the 2nd quarter. BlackRock Inc. now owns 1,992,613 shares of the companys stock valued at $18,929,000 after buying an additional 94,183 shares during the last quarter. Finally, Virtus ETF Advisers LLC grew its stake in Unity Biotechnology by 84.8% in the 2nd quarter. Virtus ETF Advisers LLC now owns 30,554 shares of the companys stock valued at $290,000 after buying an additional 14,021 shares during the last quarter. Institutional investors own 38.32% of the companys stock.

UBX stock opened at $6.88 on Friday. Unity Biotechnology has a 12-month low of $5.61 and a 12-month high of $17.46. The company has a market cap of $295.51 million, a price-to-earnings ratio of -2.71 and a beta of -0.19. The company has a 50 day moving average of $6.81 and a two-hundred day moving average of $7.63.

About Unity Biotechnology

Unity Biotechnology, Inc, a biotechnology company, engages in the research and development of therapeutics to extend human health span. The company's lead drug candidates include UBX0101 that is in Phase 1 clinical study for musculoskeletal disease; and UBX1967 for ophthalmologic diseases. It is also developing programs in pulmonary disorders.

Read More: Dollar Cost Averaging

Get a free copy of the Zacks research report on Unity Biotechnology (UBX)

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Brokerages Anticipate Unity Biotechnology Inc (NASDAQ:UBX) Will Announce Earnings of -$0.49 Per Share - Slater Sentinel

LOS ANGELES--(BUSINESS WIRE)--

Puma Biotechnology, Inc. (PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 10:55 a.m. MST (9:55 a.m. PST, 12:55 p.m. EST) on Tuesday, November 12, at the Credit Suisse 28th Annual Healthcare Conference. The conference will be held at The Phoenician Resort in Scottsdale, Arizona.

A live webcast of the presentation will be available on the Companys website at http://www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to three drug candidates PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in September 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191104005169/en/

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Puma Biotechnology to Present at the Credit Suisse Healthcare Conference - Yahoo Finance

MIRAMAR, Fla., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (GNBT) is pleased to announce that its 10k annual report will be filed Tuesday morning within the time afforded to public companies under the standard filing extension. Generex has received many calls in regard to this very important filing, and the company wants to assure everyone that the report has been completed, and the filing is definitive for Tuesday, November 12, 2019.

Joe Moscato, CEO and President commented, I appreciate everyones concern in this important filing as we march towards our NASDAQ listing. This annual report filing was much more complicated than last years report due to the many acquisitions the company made over the last year, which required that the financial audit be reviewed by multiple audit firms. Further, this is the first full audit that our new auditors have had to complete, so understanding all of Generex 23-year history of business, and the complexities of the MSO and healthcare initiatives that the company has initiated was no small task. Now that this first 10K audit has been completed for the NuGenerex family of companies, our financial accounting and auditing work will get easier, having been streamlined for the future with standard operating procedures.

About Generex Biotechnology Corp.

Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets, medical devices, and diagnostics, the Company is focused on an acquisition strategy of strategic businesses that complement existing assets and provide immediate sources of revenue and working capital. Recent acquisitions include a management services organization, a network of pharmacies, clinical laboratory, and medical device companies with new and approved products.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato 646-599-6222

Todd Falls 1-800-391-6755 Extension 222investor@generex.com

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Generex Biotechnology Provides Guidance: Form 10k Annual Report will be filed Tuesday Morning November 12th 2019 - Yahoo Finance

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that its licensing partner in Greater China, CANbridge Pharmaceuticals Inc., has received registration approval from the Department of Health in Hong Kong to market NERLYNX (neratinib) for the extended adjuvant treatment of adult patients with early stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who have completed adjuvant trastuzumab-based therapy less than one year ago.

The rapid and smooth advancement of NERLYNX through the Hong Kong regulatory process to market approval is a testament to the quality of our regulatory expertise, and the CANbridge commitment to bring new treatments to underserved patient populations in greater China, said James Xue, PhD, Founder, Chairman and CEO, CANbridge Pharmaceuticals. With this first targeted therapy approved in our oncology platform, CANbridge is able to provide women in Hong Kong, with HER2-positive breast cancer at risk of recurrence, a new and vital treatment option shortly after approval in the West.

Alan H. Auerbach, Puma Biotechnologys Chairman, Chief Executive Officer and President, added, This registration approval through our partnership with CANbridge represents an important market entry for us as we execute on our global commercial strategy. CANbridge has the commercial infrastructure and resources to provide NERLYNX to patients in the region.

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

About CANbridge Pharmaceuticals

CANbridge Pharmaceuticals Inc. is a China-based biopharmaceutical company accelerating development and commercialization of specialty healthcare products for orphan diseases and targeted cancers, focusing on products that are unavailable or address medical needs that are underserved in the region. CANbridge has been widely recognized as a leader in orphan diseases in China. It has a global partnership with WuXi Biologics to develop and commercialize proprietary therapeutics for the treatment of rare genetic diseases. In addition, it has an exclusive licensing agreement to commercialize Hunterase, an enzyme replacement therapy for the treatment of Hunter syndrome, developed by GC Pharma and marketed in more than ten countries worldwide. CANbridge also has an oncology portfolio, which includes exclusive rights to develop and commercialize Puma Biotechnologys NERLYNX (neratinib), approved in the United States, and rights to other novel candidates.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. NERLYNX was granted marketing authorization by the European Commission in August 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at http://www.pumabiotechnology.com.

Important Safety Information Regarding NERLYNX (neratinib) U.S. Indication

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS: The most common adverse reactions ( 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight decreased and urinary tract infection.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) and http://www.NERLYNX.com or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Please see Full Prescribing Information for additional safety information.

The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given orally once daily with food, continuously for one year. Antidiarrheal prophylaxis should be initiated with the first dose of NERLYNX and continued during the first 2 months (56 days) of treatment and as needed thereafter.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the worldwide expansion of NERLYNX. All forward-looking statements involve risks and uncertainties that could cause Pumas actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Pumas Annual Report on Form 10-K for the year ended December 31, 2018. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

Continued here:
Puma Biotechnology Licensing Partner CANbridge Pharmaceuticals Receives Registration Approval in Hong Kong for NERLYNX (neratinib) for Extended...

Dr. Lauren V. Wood, M.D. to present data from the companys phase 1 PDS0101 human trial demonstrating potent antigen-specific CD8+ T-cell responses in-vivo

PRINCETON, N.J., Nov. 06, 2019 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (PDSB), a clinical-stage immuno-oncology company developing multiple therapies based on the companys proprietary Versamune T-cell activating technology , today announced that Lauren V. Wood, M.D., Chief Medical Officer of PDS Biotechnology, has been selected to make an oral presentation reporting on the study design and clinical data from its previously announced Phase 1 study of PDS0101 at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting, taking place on November 7-10, 2019 in National Harbor, Maryland.

In addition to the immunogenicity and safety data from the Phase 1 study of PDS0101, we are very pleased to highlight follow-up data, demonstrating the translation of our Versamune-induced immunological mechanisms from animal to human studies in an oral presentation at the 34th annual SITC meeting, commented Lauren V. Wood, M.D., PDS Biotechnologys Chief Medical Officer. Based on this encouraging data, we are now focused on initiating three Phase 2 studies in the first quarter of 2020. These include our previously announced combination study to evaluate PDS0101 in combination with KEYTRUDA in the treatment of HPV16 positive head and neck cancer, a study to evaluate PDS0101 in combination with two immunotherapies in advanced HPV-associated cancers with the National Cancer Institute and a study, the details of which are included in our supplemental corporate presentation filed on October 29, 2019, to evaluate the combination of PDS0101 and chemoradiotherapy in patients with locally advanced cervical cancer.

Details for the oral presentation are below:

Abstract 017: A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens Induces Potent Antigen-Specific CD8+ T Cell Responses In-Vivo in Subjects with CIN and High-Risk Human Papilloma Virus InfectionPresenter: Dr. Lauren V. Wood, M.D., Chief Medical Officer, PDS BiotechnologySession Title: Session 209: Virus Driven CancersDate: Friday, November 8th, 2019Time: 6:00 6:10pm ET

Full data from the Phase 1 study can be found in the supplemental corporate presentation filed on October 29, 2019.

About PDS Biotechnology

PDS Biotechnology is a clinical-stage immuno-oncology company developing multiple therapies based on the companys proprietary Versamune T-cell activating technology platform. The Versamune platform effectively delivers tumor-specific antigens for in-vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune, PDS Biotechnology is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotechnologys pipeline combines the Versamune technology with tumor-specific antigens across several cancer types. To learn more, please visit http://www.pdsbiotech.com.

About PDS0101

PDS Biotechnologys lead candidate, PDS0101, combines the utility of the Versamune platform with targeted antigens in HPV-expressing cancers. In partnership with Merck and the National Cancer Institute (NCI), PDS Biotechnology is advancing PD0101 to Phase 2 studies in head and neck cancer and in HPV-related advanced cancer.

Forward Looking StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the Company) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Companys management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as may, will, should, would, expect, anticipate, plan, likely,believe,estimate,project,intend,and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability of the Company to integrate Edge and PDS Biotechnology following the merger; the Companys ability to protect its intellectual property rights; competitive responses to the completion of the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger;the Companys anticipated capital requirements, including the Companys anticipated cash runway and the Companys current expectations regarding its plans for future equity financings; the timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Companys interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or the future success of such trials;the successful implementation of the Companys research and development programs and collaborations; the acceptance by the market of the Companys product candidates, if approved;the timing of and the Companys ability to obtain and maintainU.S. Food and Drug Administrationor other regulatory authority approval of, or other action with respect to, the Companys product candidates;and other factors, including legislative, regulatory, political and economic developmentsnot within the Companys control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Companys annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

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PDS Biotechnology Accepted for Oral Presentation at the 34th Annual Society for Immunotherapy of Cancer Annual Meeting - Yahoo Finance

Green advocacy groups, mostly based in Europe, are the single biggest impediment to sustainable agriculture, said GLP executive director Jon Entine in an interview with Marcel Bruins, editorial director of European Seed magazine and website.

CRISPR and other gene-editing and New Breeding Techniques are fast being adopted around the world, although many environmental activist groups are doing their best to frighten the public and intimidate legislators into erecting insurmountable regulatory barriers. Theyve been largely successful in Europe, which is blocking gene-edited crops under legislation passed in the pre-CRISPR era in 2001, Entine said, but the rest of the world is more open to the innovations.

Entine was interviewed in mid-October at the annual Euroseeds Congress 2019, held in Stockholm.

The GLP founder raised a range of challenges facing agriculture in the face of what can only be called a determined anti-technology faction. Africa appears to be emerging as a central battleground. Europe has strong historical trade and cultural ties to the continent. It has long used those connections to push its anti-GMO policies. Africa is now rebelling, Entine noted, and is pursuing biotechnology innovation led by African scientists, particularly focusing on animal biotech, in an attempt to shed Europes yoke.

Its an uphill battle for Europe and Africa, Entine noted. Activist groups, mostly from European nations, are going door-to-door, telling Africans deliberate falsehoods about biotechnology, claiming that genetically engineered crops cause cancer and sterility.

Entine went on to offer a communications strategy to give the science a chance, so crop biotechnology has an opportunity to succeed on its merits, without being tangled in Europes ideological web.

Jon Entine is the founder and executive director of the Genetic Literacy Project. Twitter: @jonentine.

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Video: 'Blood on their hands'Greens' resistance to biotechnology blocks sustainable agriculture, climate change innovation, says GLP's Jon Entine -...

In attendance at the Park Hyatt Hotel in Midtown Manhattan, were approximately 140 guests, predominately from the US, but also from across Europe, the Middle East, Asia as well as Australia. Partners Capital's client base of investment professionals, institutional clients and family offices were all represented. This included investment committee members from New York University School of Law, the Los Angeles Museum of Contemporary Art, Singapore educational endowments and INSEAD Business School.

The afternoon started with Stan Miranda, Chief Executive Officer of Partners Capital, describing the overarching theme of the Client Workshop being de-globalization, with four underlying sub-themes - geopolitics, China, biotechnology and impact investing. "While Globalization has been a strong force in the past, lifting people out of poverty and bringing the world closer together, there are serious headwinds. Given these headwinds, we face a question of whether investors should concentrate their investments more domestically or seek opportunities out of new economic alliances that are likely to form?" The afternoon provided arguments on multiple sides.

Internal speakers were joined by three experts:

Matthew Gertken, Geopolitical Strategist at BCA Researchspoke on geopolitics' impact on investment strategy going forward. BCA research concludes that the US will be in at least a decade-long economic "cold war" with China. Any trade deals between now and Trump's re-election will be temporary stop-gaps distracting investors from the real changes in the form of deeper alliances between China and its historical and new allies; and between the US and its historical allies.

Jason Tan, Chief Investment Officer from Jeneration Capitallaid out the facts surrounding the technology arms race between China and the US, highlighting the very different strategies Chinese tech leaders are following versus US tech leaders. These companies initially start with one online business and subsequently expand into additional segments (e.g., content & media, social & messaging, mobile payments), funding start-ups to create new innovations so they do not have to themselves. The integrated ecosystem approach is highlighted by the fact that China is home to a disproportionate number of the "super" unicorns ($15B+ valued companies).

Behzad Aghazadeh, Managing Partner at Avoro Capitalspoke on the future biotechnology breakthroughs saying that "today we are benefitting from the groundwork of decades of research that can now be widely applied to medicine.breakthroughs in cancer are accelerating as we continue to see advances in treatments for previously uncurable indications. Today there are 16,000 ongoing pipeline projects, up from 6,000 in 2001, which provides a strong platform of ongoing innovation in the sector".Stan Miranda added his own comments on investing in the public biotech sector - "There are 1,200 public biotech companies today, only 5% of which have revenue and 75% have not yet reached phase III drug trials. By investing with firms like Avoro, we expect to see venture capital like returns from this liquid public sector of the public equity markets."

Partners Capital presentations included two four-person panel sessions featuring the Partners Capital CIO's and Asset Class Heads, addressing Client Portfolio Strategy Choices and Asset Class Strategies going forward, respectively.

- Will Fox, Partner, Head of North America, Boston - spoke on the right illiquidity budget

- John Collis, Partner, Head of Europe, London spoke on tactical asset allocation

- Elizabeth Trotta, Managing Director, New York covered our recession playbook

- David Shushan, Partner, Boston discussed technology sector over-weights

- Alex Band, Managing Director, Head of Public Equities, Boston

- Rich Scarinci, Partner, Absolute Return & Credit, Boston

- Suzanne Streeter, Partner, Head of Private Markets, Boston

- Emma Bewley, Principal, Private Debt, London

The audience responded most to Elizabeth Trotta's run-through of the "Partners Capital Recession Playbook", which is already in place in most client portfolios. But the key message of the internal presentations was how Partners Capital believes that a highly diversified, risk-managed multi-asset class portfolio is the best long term defense against an economic downturn.

The afternoon's final session, Impact Investing, featured a short video of Sir Ronald Cohen, filmed specifically for the event, addressing the importance of social impact investing and why investors should be focusing not only on risk and return but also on optimizing the impact of their investments on society and the environment. Euan Finlay, Partner and Chair of Partners Capital's Responsible Investing Committee, then went on to discuss the firm's responsible investing framework for implementing and reporting on responsible investing in client portfolios.

Paul Dimitruk, Chairman of Partners Capital, closed the day focusing on the firm's desire to be not just an advisor, but a "thought-partner" on each client's investment journey. He implored each client to continue to challenge and push Partners Capital to be the best it can be. "Our mission is to do go beyond just asset allocation and manager selection, but to help discern where risk and return are, and where value is created or destroyed."

About Partners Capital

Founded in 2001, Partners Capital is a wholly independent Outsourced Investment Office (OCIO) primarily serving sophisticated institutions and senior investment professionals inEurope,North AmericaandAsia. With offices inBoston,New York,San Francisco, London, Singapore and Paris, the firm is one of the few truly global OCIOs, employing 175 people worldwide and covering all major asset classes. The firm oversees assets of more than$27 billion. Its institutional clients include a number of Oxford and Cambridge Colleges,Eton College, INSEAD business school, the Research Foundation for theState of New York'sUniversity System, the Royal Academy of Arts, Milton Academy, the Hong Kong Cancer Fund and the Cancer Research Institute. Additional information on Partners Capital may be found athttp://www.partners-cap.com.

Photo: https://mma.prnewswire.com/media/1019263/Partners_Capital_AIW_Image.jpg Logo: https://mma.prnewswire.com/media/817400/Partners_Capital_Logo.jpg

SOURCE Partners Capital

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Partners Capital Shines the Spotlight on Geopolitics, China, Biotechnology and Impact Investing at Its Fourth Annual Investor Workshop - PRNewswire

Biotechnology Market will expand at +9.9% CAGR to hit $775 Billion by 2025

Biotechnology For example, growth in this area is expected to accelerate as the proliferation of conditions such as hepatitis B disease and other problems increases. The growing population in the United States, China, and India is expected to increase the importance of these products due to growing interest in livelihood and horticultural items such as wheat, rice, sugar cane, and soybeans. In addition, factors such as water shortages, low yields, insect attacks and limited access to farmland require scientists to participate in extensive R & D.

The organization has partnered with members of the industry to focus on strengthening and using the unique system. In conjunction with the Government Grants Foundation and various self-governing communities, significant associations will improve funding to support R & D and new product improvement attempts for biotechnology funding.

U.S. biotechnology market dominated North America region in 2017 and will continue to project similar trend with +11.1% CAGR during analysis timeframe.

Ask for sample copy of this report at:

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Top key player profiled in this report:Agilent Technologies, BioGen Medical Instruments, Danaher, F. Hoffmann-La Roche, Abbott Laboratories Illumina, Merck, PerkinElmer, Qiagen and Thermo Fisher Scientific, Amgen, Bio-Rad Laboratories.

The analysis further includes a thorough description based on the dominant competitors that illuminate plant location, capacity, technology development, price structure, value chain, manufacturing methodology, sales / distribution network, raw materials and import and export activities. It also reveals participants financial stability and provides a detailed assessment of their revenue model, sales volume, profit margin and annual growth rate.

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Today, North America leads the market for Biotechnology, followed by Europe due to the potential of Biotechnology. Emerging economies in Asia Pacific, Latin America, the Middle East and Africa are also expected to grow rapidly in these developing countries as the need for Biotechnology grows.

Technology Outlook (Revenue, USD Billion; 2014 2025)

DNA Sequencing

Nanobiotechnology

Tissue engineering and Regeneration

Fermentation

Cell Based Assay

PCR Technology

Chromatography Market

Others

Application Outlook (Revenue, USD Billion; 2014 2025)

Health

Food & Agriculture

Natural Resources & Environment

Industrial Processing

Bioinformatics

Others

Major factors covered in the report:

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Astonishing Growth in Biotechnology Market 2019: Insights of the Industry & Rising Demand by Top Companies like Agilent Technologies, BioGen...

The market study on the global Biotechnology Reagent market will encompass the entire ecosystem of the industry, covering five major regions namely North America, Europe, Asia Pacific, Latin America and Middle East & Africa, and the major countries falling under those regions. The study will feature estimates in terms of sales revenue and consumption from 2019 to 2025, at the global level and across the major regions mentioned above. The study has been created using a unique research methodology specifically designed for this market.

(Halloween Special Discount Offer for Limited Period)Add this report toCART and Use Coupon Code HALLOWEEN40 to avail 40% Instant Discounthttps://inforgrowth.com/report/5610186/biotechnology-reagent-market

Quantitative information includes Biotechnology Reagent Market estimates & forecast for a upcoming years, at the global level, split across the key segments covered under the scope of the study, and the major regions and countries. Sales revenue and consumption estimates, year-on-year growth analysis, price estimation and trend analysis, etc. will be a part of quantitative information for the mentioned segments and regions/countries. Qualitative information will discuss the key factors driving the restraining the growth of the market, and the possible growth opportunities of the market, regulatory scenario, value chain & supply chain analysis, export & import analysis, attractive investment proposition, and Porters 5 Forces analysis among others will be a part of qualitative information. Further, justification for the estimates for each segments, and regions will also be provided in qualitative form.

Request a Sample of Biotechnology Reagent Market Research Report and Analysis of Key Players at https://inforgrowth.com/sample-request/5610186/biotechnology-reagent-market

Major players profiled in the report are Abbott Laboratories, Agilent Technologies, Beckman Coulter, BD Medical, Roche Diagnostics, Thermo Fisher Scientific, Merck Millipore, GE Healthcare, Perkinelmer, Tosoh Corporation, Siemens Healthcare, Biomerieux, Sigma Aldrich, Lonza Group, Life Technologies, Quality Biological, Bio-Rad Laboratories, Hoefer.

On the basis of products, report split into, Biotechnology Reagent.

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including Protein Synthesis & Purification, Gene Expression, DNA & RNA Analysis, Drug Testing, Other.

The study will also feature the key companies operating in the industry, their product/business portfolio, market share, financial status, regional share, segment revenue, SWOT analysis, key strategies including mergers & acquisitions, product developments, joint ventures & partnerships an expansions among others, and their latest news as well. The study will also provide a list of emerging players in the Biotechnology Reagent market.

The global Biotechnology Reagent market is bifurcated on the basis of types and on the basis of distribution channel.

Based on regions, the market is classified into North America, Europe, Asia Pacific, Middle East & Africa and Latin America. The study will provide detailed qualitative and quantitative information on the above mentioned segments for every region and country covered under the scope of the study.

Furthermore, this study will help our clients solve the following issues:

This study will address some of the most critical questions which are listed below:

Ask Your Queries or Requirements at https://inforgrowth.com/enquiry/5610186/biotechnology-reagent-market

About InForGrowth:

We are a market-intelligence company formed with the objective of providing clients access to the most relevant and accurate research content for their growth needs. At InForGrowth, we understand Research requirements and help a client in taking informed business critical decisions. Given the complexities and interdependencies of market-intelligence, there is always more than one source to explore and arrive at the right answer. Through our smart search feature and our reliable & trusted publishing partners, we are paving way for a more simplified and relevant research.

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News Live 2019: Global Biotechnology Reagents Market Rise to High Globally In Next Five Years - Maxi Wire

How far can we go with DNA? The scientific community does not yet have the answer, as the potential of this molecule seems infinite. But to study the possibilities offered in this field, laboratories must still have enough material for researchers to continue their work.

However, for the past forty years, DNA has been manufactured by chemical synthesis. A particularly long and costly process, with an error rate that increases as the sequence lengthens.

In this context, researchers are looking to develop alternatives to synthesize DNA more easily, with more convincing results. Among the solutions considered, one that particularly appealed to the scientific community: enzymatic synthesis. This process, which is faster and more efficient, and for which it is no longer necessary to be a chemist, is now used for the production of medicines, perfumes, cosmetics and biofuels.

The synthetic DNA market is estimated at $1.5 billion, with a growth of 10% per year. The French start-up DNA Script is developing a printer based on genetically modified enzymes to generate a personalized DNA sequence in a few hours. To make synthetic DNA a lever for predictive medicine, but not only, the company raised 11 million in September 2017. And also, an additional 35 million in May.

Founded in 2014 by Thomas Ybert, Sylvain Gariel and Xavier Godron, DNA Script has developed a printer capable of synthesizing high-quality DNA to foster innovation in science and technology. Through this technology, DNA Script intends to give a second wind to the writing of genetic codes.

The new process developed by the company makes it possible to produce better quality and longer DNA molecules. This process is donde in a much shorter time frame than usual production methods. And provides an opportunity for researchers in molecular biology to accelerate their experiments to achieve faster results.

These advances should eventually make it possible to develop new therapeutic products, such as medicines or vaccines. But also to move towards more ecological production of chemicals or to propose a new way of storing data.

DNA Scripts printer could even take on a new dimension with Crispr-Cas9. A genome transformation technique that allows DNA modification by targeting a gene with unparalleled accuracy. To understand better, FrenchWeb went to meet Xavier Godron and Sylvain Gariel. Two of the three founders of the French start-up, in their laboratory at the Kremlin-Bictre, south of Paris.

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(Featured Image bymadartzgraphics)

First published infrenchweb, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. B2I assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. B2I is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

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How synthetic DNA is revolutionizing research in biotechnology - Born2Invest

DUBLIN, Oct. 25, 2019 /PRNewswire/ -- The "Improving Processes and CAPA (Corrective and Preventative Action)" conference has been added to ResearchAndMarkets.com's offering.

The course has been specifically designed for the Pharma, Biotechnology, Devices and Veterinary industries and particularly if you are involved in process improvement, corrective and preventative action, problem solving and managing inspections and documenting how to deal with these.

This meeting will cover CAPA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and planning and implementation in practice of improvements and CAPA

With this one-day course you will learn how to use the most efficient processes and ensure compliance with Corrective and Preventative Action (CAPA) within the pharmaceutical, medical device and animal health industries.

Regulatory inspectors are increasing reviewing responses to findings dealt with by the CAPA approach and process improvement. It is highly likely that organisations who have already been inspected will be assessed at their next inspection in terms of whether the corrective and preventative actions have been implemented. If previous major findings have not been addressed then a critical finding may be given. This course will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system.

Why you should attend

It is highly likely that organisations who have already been inspected will be assessed at their next inspection in terms of whether the corrective and preventative actions have been implemented - has the organisation done what they said they would? If previous major findings have not been addressed then a critical finding may be given. This couse will be ideal for you to learn how to improve industry procedures and processes and how to implement and document an effective CAPA quality system.

Topics to be covered include:

Agenda:

Why is CAPA important?

CAPA Methodology and Documentation

Diagnosing Process Improvement

Developing Options for Process Improvement and CAPA

Planning and Implementation in Practice of Improvements and CAPA

Final Discussion

For more information about this conference visit https://www.researchandmarkets.com/r/qcawr8

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

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One Day Improving Processes and CAPA (Corrective and Preventative Action) Course Designed for the Pharma, Biotechnology, Devices and Veterinary...

The French Plant Biotechnology Association (AFBV in French) wants to categorize each published plant. AFBV wants to do this according to the genetic modifications made to their genetic heritage. And not according to the technology used to obtain them, as is currently the case in Europe under Directive 2001/18.

According to the Court of Justice of the European Union (decision of 25 July 2018), plants created through mutagenesis are comparable to genetically modified plants. But only if the technique used existed before the publication of Directive 2001/18 on the deliberate release into the environment of genetically modified organisms. This is why genomic publishing is one of these technologies.

In other words, the decision of the European Court of Justice makes no distinction between the different genetic modifications made to plant genomes. The hazardous insertion, in the genome of a plant, of a gene of another species, is not comparable to genomic editing.

Genome editing consists of simply and precisely modifying the site of the genome of these same plants. Moreover, the decision of the Court of Justice does not take into account the evolution of the technologies used.

If the European Union does not quickly adopt appropriate regulations for these precision biotechnologies, our crops will be in danger. Also, the EUs food security will come under threat. And the competitiveness of European agriculture will suffer a serious handicap, said Georges Freyssinet, President of the Association franaise des biotechnologies vgtales (AFBV).

As farmers have fewer and fewer products available to effectively treat their crops, orchards and vegetables, they need new varieties of plants. Ones that can naturally defend themselves against predators (insects) and parasites (fungi). For example, by emitting volatile repellent substances.

Rapeseed cultivation is already at risk. Cereal growers no longer have the means to effectively eradicate flea beetles. Because the authorities banned the use of neonicotinoids.

At the same time, however, the European Union imports products treated with substances banned on its territory.

The AFBV wants to enable European research to continue its plant breeding work. In this regard, the AFBV and other European associations propose to categorize genetically modified plants according to the nature of the transformation carried out on their genome.

And then, to prepare a dossier to confirm on a case-by-case basis, before release or marketing, whether or not the published plants are excluded from Directive 2001/18.

According to the genetic modifications made, the AFBV distinguishes four categories of published plants.

The first category includes plants with a known allele. The one present in the genetic heritage of the species to which they belong. This first category of plants is different from the second. That would include plants published according to a known allele model but present in the plant kingdom in general.

If the introduced allele is new, of the type obtained through mutagenesis, then the plants would be in category 3. And if the insertion concerns several genes of a plant of the same species, then the published plants would constitute the fourth category.

The AFBV will submit this proposal to the European Commission for an update of the European Directive 2001/18 on GMOs during its next mandate. The directive must also cover imported products.

As the European market is no longer profitable, countries that export these commodities in the near future could deliberately turn away from them by no longer producing the authorized commodities.

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(Featured Image byStephen Radford via Unsplash)

First published inwikiagri, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

Although we made reasonable efforts to provide accurate translations, some parts may be incorrect. Born2Invest assumes no responsibility for errors, omissions or ambiguities in the translations provided on this website. Any person or entity relying on translated content does so at their own risk. Born2Invest is not responsible for losses caused by such reliance on the accuracy or reliability of translated information. If you wish to report an error or inaccuracy in the translation, we encourage you to contact us.

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The AFBV moves ahead with new categorization for plants - Born2Invest

Swiss biotech company BioVersys AG has received a 8m grant by US-based non-profit organisation CARB-Xto develop novel anti-virulence antibiotics to treat severe bacterial infections.

Privately-owned BioVersys AG, headquartered in Basel, is focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications to fight antimicrobial resistance (AMR) and targeted microbiome modulation. The most advanced R&D programmes are in preclinical development for nosocomial infections (hospital infections), and tuberculosis in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille. In 2020, BioVersys plans to launch its first Phase I clinical trials, for its two leading programmes, which focus on Acinetobacter baumannii and Mycobacterium tuberculosis (TB) infections. The TB programme runs within the recently started TRIC-TB consortium and is financed with a total 6.9m under the umbrella of the new European AMR accelerator initiated by the Innovative Medicines Initiative (IMI).

This new CARB-X grant will help to further advance a third asset from the companys R&D pipeline towards clinical stages. It provides the company with non-dilutive funding of 3.5m upfront and up to an extra 4.5m if certain milestones are met. BioVersys will use the money to push forward its BV200 series of molecules that has been developed using the companys TRIC technology (Transcriptional Regulator Inhibitory Compounds). These are not direct acting antibiotics, but rather a new class of molecules, capable of disarming bacteria such as Staphylococcus aureus including MRSA of their harmful virulence factors including toxins, that cause serious skin infections that can spread to muscles, lungs and other body parts. According to the company, they have the potential to be used as stand-alone therapy as well as in combination with antibiotics, thus improving many available antibiotic therapies and supporting stewardship. The most advanced compounds are in Lead Optimisation.

We are delighted that CARB-X recognises the immense potential of BioVersys anti-virulence programme (BV200) through this funding award, said Marc Gitzinger, CEO and Co-Founder of BioVersys. The diversity in the challenge of AMR diseases requires us to broaden our approach beyond classical antibiotics, and further R&D investment in novel paradigm shifting approaches such as anti-virulence is vitally important.

Molecules of the BV200 class inhibit the transcriptional regulator AgrA which controls the production of harmful virulence factors including -toxin, phenol-soluble-modulin (PSM) and Panton-Valentine leukocidin (PVL) toxins that are directly linked to the severity of S. aureus-mediated skin and skin structure infections (SSSIs) and pneumonia. By preventing the expression of the toxins, the molecules have the potential to reduce tissue damage, disease progression and, consequently, reduce infection severity and mortality rates in patients. The BV200 series will initially be developed for skin and skin structure infections (SSSI) and pneumonia caused by S. aureus, including Methicillin-resistant S. aureus (MRSA).

Drug-resistant bacteria represent one of the greatest threats to public health globally. New approaches, like the BioVersys project, are urgently needed to help save lives and to curb the spread of drug-resistant bacteria, said Kevin Outterson, Executive Director of CARB-X, which is based at the Boston University School of Law. This project is in early stages of development but if successful and approved for use in patients, it would represent tremendous progress in the fight against drug resistance, by offering an alternative therapy to traditional antibiotics and also restoring the effectiveness of existing antibiotics.

The new investment adds another European company to the CARB-X portfolio, the worlds largest antibacterial development portfolio. Currently, it includes 30 projects in five countries. Since its inception in 2016, CARB-X has announced 49 awards exceeding US$155m, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, Germanys Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Cares Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID).

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BioVersys receives up to 8m from CARB-X - European Biotechnology

The Herald

Sifelani Tsiko Agric, Environment & Innovations EditorThe mere mention of genetically modified foods (GMOs) has stirred emotions and popular consternation around the issue of altered foods, with concerns over health and its effects on the environment. So much has been said about GMOs, with various people on opposing sides making various claims substantiated and unsubstantiated.

The result has been fear, confusion and meaningless propaganda.

Fear of new technology has generated mixed feelings marked by initial scepticism followed with embrace and adoption after noting the benefits.

Despite a blanket ban on GMOs in Zimbabwe, scientists have been doing research on GMO crops for years benefiting other countries which they have been sharing their findings with.

Darlington Mutetwa, a Quton plant breeder, has spearheaded efforts to promote the growing genetically modified cotton in Nigeria, Malawi and other African countries.

Renowned University of Zimbabwe biochemist Prof Idah Sithole-Niang has also been at the forefront of promoting the growing of GM crops from maize, cowpeas, Bt cotton and others globally without much recognition back home.

The same goes for a number of top Zimbabwean academics who are working in various top global companies using biotechnology to promote the development of various agricultural and medical products.

All this has been going on without Zimbabwe benefiting from its talent and the emerging technology, simply because the country is not willing to adopt the new technologies.

Zimbabwe, for long has been a hostile place for researchers testing genetically modified crops.

Through a combination of regulations, bureaucracy, mistrust and fear, the Government has barred the commercial planting of a transgenic crops.

Anti-GM activists have also added to the woes, but under the new dispensation, things are changing.

Higher and Tertiary Education, Science and Technology Development Minister Professor Amon Murwira has been bold and aggressive in terms of re-orienting the education system under five terms of reference which includes teaching, research, community engagement, innovation and industrialisation.

He has come out strongly and supported science and technology development to promote the new products, platforms and solutions that embed best practice to support the countrys industrial and technological development.

The space is opening up for scientists who are keen on GM crop development.

And, recently, the National Biotechnology Authority of Zimbabwe organised the biosafety sensitisation and consultative workshop to demystify biotechnology and GMOs for parliamentarians and other stakeholders.

The hosting of the event was supported by the African Union Development Agency-New Partnership for Africas Development/African Biosafety Network of Expertise (AUDA-NEPAD/ABNE), an African Union (AU) organisation responsible for supporting the building of functional biosafety regulatory systems in African Union member states.

All this demonstrates the opening up of space for scientists and the international research community to play their part in creating an enabling environment for Zimbabwe to adopt new technologies that can enhance agricultural productivity.

Years of unnecessary anti-GMO debate in Zimbabwe has missed the mark.

We should not just single out GMOs for criticism, but also look at the impact of the vast amount of chemicals nitrogen fertilisers and synthetic pesticides used in our conventional agricultural system.

These also have serious implications on health and the environment. Our scientists are quite clear about GM technology that it is not a silver bullet solution, but one crop strategy we can employ to enhance our crop yields and reduce our costs.

Our own biochemists, Prof Christopher Chetsanga and Prof Sithole-Niang, have spoken out eloquently on the subject and outlining the potential benefits of GM crops.

They have said that Zimbabwe should go step by step and start with GM cotton as plunging into GM food crops totally may be too risky and controversial.

They are saying Zimbabwe should at least move to do trials for Bt cotton to boost cotton production.

Government wants to prioritise digitisation and technology and innovation in order to achieve meaningful development in the country and the region.

To meet the Fourth Industrial Revolution in Zimbabwe and the SADC region, our country has pledged to promote emerging technologies in a number of fields such as robotics, artificial intelligence, nanotechnology, quantum computing, big data, biotechnology, fifth generation wireless technology and 3D printing.

Prof Sithole-Niang says if the growing of genetically modified cotton is allowed in Zimbabwe it could be a boon for the State.

She says if we adopt GM cotton we can save up to US$90 million a year in terms of reduced production cost.

The country, she argues, could also get $40 million in incremental revenue every year through improved crop yields and reduced cost of production.

Zimbabwe was the first country in Africa to conduct confined field trials for GM cotton and maize around 2000 before the country put a blanket ban on GM crop trials and food by 2005.

And as a result, biotechnology experts say the country has lost out on the potential benefits of new agricultural technologies that can significantly boost yields, incomes and improve livelihoods.

Zimbabwe has not adopted GMO crop technologies, but established the National Biotechnology Authority in 2006 to regulate research, transport, import, manufacture, safe handling and use of organisms and products of modern biotechnology.

In its Second Science, Technology and Innovation Policy released in March 2012, the country identified biotechnology as one of the most promising tools that can help increase food productivity, enhance the health and wellness of society and boost manufacturing output.

While Zimbabwe is delaying the adoption of GM crops, other countries such as South Africa have been growing GM maize, soyabean and cotton for nearly two decades with latest statistics indicating plant hectarage of some 2,7 million hectares.

There has been a massive spread of GMO products in Zimbabwe and across the entire SADC region which include maize, cotton and soyabean, livestock feed, tobacco, bananas, potatoes, poultry products and vegetables.

South Africa has embraced GMOs and as the regions strongest economy it has been impossible to stop the penetration of GMO foods.

Worse still, with drought ravaging Zimbabwe and most other SADC countries, food aid has come from the US and China, which are now among the biggest producers of GM maize.

No matter what we do, Zimbabwe cannot stop the emergence and movement of new technologies. We only have to adopt the new technologies and take the necessary biosafety measures to minimise the potential risks.

We are legging behind.

In 2018, Sudan cultivated 243 000 ha of Bt cotton, eSwatini 250ha, while in 2019 Ethiopia planted Bt cotton on more than 500 000ha, according to the International Service for the Acquisition of Agri-biotech Applications (ISAAA) 2018 report.

Nigeria, Malawi and Kenya have given cultivation approvals for Bt cotton. More than 70 percent of cotton traded global is GM cotton.

India and China are among some of the biggest producers of Bt cotton where Zimbabwe imports some of its clothing materials from.

As a country we are consuming GMO products and it only makes sense to get on the train and start growing GM cotton for a start.

We have the technical expertise and what we need are resources and the political will.

Debate on GMOs is quite controversial and anyone who touches GMOs gets burned. People are so worked up on both sides that no matter what you say, someone will criticise you. We should raise concerns using facts. We should utilise scientists to drive our own biotechnology agenda.

We should not lose ourselves to fear and confusion.

Biotechnology is big business and as a country we should harness it for our benefit. Cuba, South Africa, China, US, Sudan, Egypt and many other countries are using biotechnology for their benefit.

Zimbabwe should allow our scientists to conduct confined field trials for genetically modified crops as part of efforts to find innovative solutions to some of the pressing problems facing the countrys agricultural sector.

We have the capacity to do it. Our universities are training biotechnology students who are being taken outside and benefiting other countries.

Why should we waste our resources and fail to tap on the benefits of this technology when we have the capacity to harness it?

See the article here:
Why Zim must harness benefits of biotechnology - The Herald