– Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics to present on Tuesday, February 14th at 4:20 PM ET – – Russ Trenary, President and Chief Executive Officer of Outlook Therapeutics to present on Tuesday, February 14th at 4:20 PM ET –
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Outlook Therapeutics® to Present at the SVB Securities Global Biopharma Conference
XIAN, China, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Bon Natural Life Limited (Nasdaq: BON) ("BON" or the "Company"), one of the leading bio-ingredient solutions providers in the natural, health and personal care industries, will issue its FY2022 earnings release for the fiscal year ended September 30, 2021 before the market open on Friday, February 10, 2023.
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Bon Natural Life Limited Announces FY2022 Earnings Release Date and Webcast
VLN®, a cigarette with 95% less nicotine than conventional cigarettes, is now available for the 75% of Colorado smokers that are willing to switch brands to help them cut back
New Agreement Enhances High-Parameter Panels on Cytek Cell Analysis Systems New Agreement Enhances High-Parameter Panels on Cytek Cell Analysis Systems
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Cytek® Biosciences Partners with Bio-Rad to Expand Reagent Portfolios
VANCOUVER, British Columbia, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Derm-Biome Pharmaceuticals, Inc, a Vancouver based biopharmaceutical company focused on skin health, is pleased to announce that it has been invited to present at the 2023 OBIO Investment Summit (OIS) in Toronto on Friday, February 10th at 11:51am EST. The Summit is Canada’s premier health science investment event, a forum that connects global investors with Canada’s best technology innovators. Since 2018 summit companies have raised $1.3 billion.
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Derm-Biome Pharmaceuticals to Present at the 2023 OBIO Investment Summit on February 10, 2023
Collaboration will establish a platform cGMP line to support Elektrofi’s planned clinical trials of injectable biologics Collaboration will establish a platform cGMP line to support Elektrofi’s planned clinical trials of injectable biologics
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Elektrofi Announces Collaboration with Thermo Fisher Scientific to Strengthen Manufacturing Capabilities for Future Clinical Trials
The second Phase 2 clinical trial known as APEX-2 will augment the VT-X7 safety and efficacy data collected in the APEX trial. The second Phase 2 clinical trial known as APEX-2 will augment the VT-X7 safety and efficacy data collected in the APEX trial.
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Osteal Therapeutics Announces First Subject Enrollment in Second Phase 2 Clinical Trial of VT-X7 Combination Product for Treatment of Periprosthetic...
SANTA MONICA, Calif., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals Inc. (NASDAQ: OPNT) announced today that the Committee on Foreign Investment in the United States (CFIUS) approved the previously announced Merger Agreement (the Agreement) for Opiant to be acquired by Indivior PLC (LSE: INDV).
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Opiant Pharmaceuticals Announces CFIUS Approval for Proposed Acquisition by Indivior PLC
YAVNE, Israel, Feb. 07, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced the closing of its previously announced registered direct offering. The gross proceeds to the Company from the offering were $27.5 million, before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering primarily for the acceleration of the development of EscharEx®, establishing a U.S. commercial presence, supporting business development activities, and for general corporate purposes. The Company may also use a portion of the net proceeds to in-license, invest in or acquire businesses, technologies, products or assets that it believes are complementary to its own, although it has no current plans, commitments or agreements with respect to any acquisitions or in-licenses at this time.
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MediWound Announces Closing of $27.5 Million Registered Direct Offering of Ordinary Shares
SEATTLE, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that Chinook management is scheduled to participate in a virtual fireside chat at the SVB Securities Global Biopharma Conference on Tuesday, February 14, 2023 at 11:20 am ET, as well as 1x1 meetings.
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Chinook Therapeutics to Present at SVB Securities Global Biopharma Conference
FREMONT, Calif., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Cytek Biosciences, Inc. (“Cytek Biosciences” or “Cytek”) (Nasdaq: CTKB), today announced it will report financial results for the fourth quarter and full year 2022 after market close on Tuesday, February 28th, 2023. The company’s management will webcast a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time to discuss its results, business developments and outlook.
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Cytek Biosciences to Report Fourth Quarter and Full Year 2022 Financial Results on February 28, 2023
BALA CYNWYD, Pa., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the appointment of Gopi Shankar, PhD, MBA, FAAPS, to the newly created position of Chief Development Officer (CDO). Dr. Shankar will report directly to Chief Executive Officer Carole Ben-Maimon, MD, and will be responsible for the strategic development of the Company’s clinical and R&D programs, including additional applications of the Company’s platform technology.
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Larimar Therapeutics Appoints Dr. Gopi Shankar as Chief Development Officer
SAN CARLOS, Calif., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced that Company management will participate in a fireside chat at the SVB Securities Global Biopharma Conference on Tuesday, February 14, 2023, at 3:00 p.m. ET / 12:00 p.m. PT.
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Vaxcyte to Present at the SVB Securities Global Biopharma Conference
SAN DIEGO, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that Mark Rothera, its President and Chief Executive Officer, is scheduled to present at the virtual 2023 SVB Securities Global Biopharma Conference on Tuesday, February 14, 2023, at 1:00 p.m. ET.
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Viracta Therapeutics to Present at the 2023 SVB Securities Global Biopharma Conference
Proceeds to be used for debt paydown Proceeds to be used for debt paydown
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Lifecore Biomedical Announces Sale of Curation Foods’ Avocado Products Business
SOUTH SAN FRANCISCO, Calif., Feb. 07, 2023 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that company management will participate in the SVB Securities Global Biopharma Conference and Cowen’s 43rd Annual Health Care Conference. Details of participation are as follows:
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Tenaya Therapeutics to Participate in Upcoming Investor Conferences
NEW YORK, Feb. 07, 2023 (GLOBE NEWSWIRE) -- Cellectis S.A. (“Cellectis” or the “Company”) (Euronext Growth: ALCLS - NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, announced today:
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Cellectis Announces Closing of Global Offering and Exercise of Underwriters’ Option to Purchase Additional Shares
Basel, 23 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Lunsumio® (mosunetuzumab-axgb) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody, represents a new class of fixed-duration cancer immunotherapy, which is off-the-shelf and readily available, so that patients do not have to wait to start treatment. Lunsumio will be available in the United States in the coming weeks. “This approval is a significant milestone for people with relapsed or refractory follicular lymphoma, who have had limited treatment options until now,” said Elizabeth Budde, M.D., Ph.D., Haematologic Oncologist and Associate Professor, City of Hope Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation, and Lunsumio clinical trial investigator. “As a first-in-class T-cell engaging bispecific antibody that can be initiated in an outpatient setting, Lunsumio’s high response rates and fixed-duration could change the way advanced follicular lymphoma is treated.”“Despite treatment advances, follicular lymphoma remains incurable and relapse is common, with outcomes worsening following each consecutive treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Lunsumio represents our first approved T-cell engaging bispecific antibody and builds on our legacy of more than 20 years of innovation in blood cancer.”The FDA approval is based on positive results from the phase II GO29781 study of Lunsumio in people with heavily pre-treated FL, including those who were at high risk of disease progression or whose disease was refractory to prior therapies. Results from the study showed high and durable response rates. An objective response was seen in 80% (72/90 [95% confidence interval (CI): 70-88]) of patients treated with Lunsumio, with a majority maintaining responses for at least 18 months (57% [95% CI: 44-70]). The objective response rate is the combination of complete response (CR) rate (a disappearance of all signs and symptoms of cancer) and partial response rate (a decrease in the amount of cancer in the body). The median duration of response among those who responded was almost two years (22.8 months [95% CI: 10-not reached]). A CR was achieved in 60% of patients (54/90 [95% CI: 49-70]). Among 218 patients with haematologic malignancies who received Lunsumio at the recommended dose, the most common adverse event (AE) was cytokine release syndrome (CRS; 39%), which can be severe and life-threatening. The median duration of CRS events was three days (range: 1-29). Other common AEs (?20%) included fatigue, rash, pyrexia and headache.Lunsumio is administered as an intravenous infusion for a fixed-duration, which allows for time off therapy, and can be infused in an outpatient setting. Hospitalisation may be needed to manage select AEs, should be considered for subsequent infusions following a Grade 2 CRS event, and is recommended for subsequent infusions following a Grade 3 CRS event.Lunsumio was developed based on the Roche Group's broad expertise in creating bispecific antibodies. Lunsumio is designed to address the diverse needs of people with blood cancer, physicians, and practice settings, and is part of the company’s robust bispecific antibody clinical programme in lymphoma. Lunsumio is being further investigated as a subcutaneous formulation (i.e., administered under the skin) and in phase III studies that will expand the understanding of its impact in earlier lines of treatment in people with non-Hodgkin lymphoma.About the GO29781 studyThe GO29781 study [NCT02500407] is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab-axgb) in people with relapsed or refractory B-cell non-Hodgkin lymphoma. Outcome measures include complete response rate (best response) by independent review facility (primary endpoint), objective response rate, duration of response, progression-free survival, safety, and tolerability (secondary endpoints).About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.1 It typically responds well to treatment but is often characterised by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2022 and more than 100,000 people are diagnosed with FL each year worldwide.1,2About Lunsumio® (mosunetuzumab-axgb)Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. This dual targeting activates and redirects a patient’s existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab) and Lunsumio® (mosunetuzumab-axgb). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
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FDA approves Roche’s Lunsumio, a first-in-class bispecific antibody, to treat people with relapsed or refractory follicular lymphoma
Mechelen, Belgium; 23 December 2022, 22.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) received a transparency notification from FMR LLC.
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Galapagos receives transparency notification from FMR LLC
- FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA -