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India can lead the One Earth, One Health vision with holistic policy-making environment: Mansukh Manda.. – ETHealthWorld

March 21st, 2023 12:07 am

India can lead the One Earth, One Health vision with holistic policy-making environment: Mansukh Manda..  ETHealthWorld

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Advancing Safe and Effective Regenerative Medicine Products

March 21st, 2023 12:05 am

By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative medical products. Products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.

The FDAs November 2017 regenerative medicine policy framework was developed to help facilitate and support innovation in the area of regenerative medicine therapies. As part of this framework, we encourage sponsors to take advantage of ongoing expedited programs that might be available to them, including Regenerative Medicine Advanced Therapy, breakthrough therapy, and fast track designations, to support product development and licensure.

The framework also outlines the agencys intent to exercise enforcement discretion with respect to the FDAs investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products until November 2020, which was later extended through May 2021. This compliance and enforcement discretion policy gives manufacturers time to determine if certain requirements apply to their products, and if an application is needed, to prepare and submit the appropriate application to the FDA.

We are now reaffirming the timing of the end of the compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies. The period during which the FDA intends to exercise enforcement discretion with respect to the IND and premarket approval requirements for certain HCT/Ps ends on May 31, 2021, and will not be extended further.

Since November 2017, the FDA has worked with product developers to help them determine if they need to submit an IND or marketing application and, if so, how they should submit their application to the FDA. The FDA developed programs that provide opportunities for engagement between HCT/P manufacturers and the agency, including the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP). TRIP helped manufacturers of HCT/Ps, including stakeholders that market HCT/Ps to physicians or patients, obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated. TRIP was a temporary program of the TRG. The TRIP began in June 2019 and was extended twice. It recently ended on March 31, 2021.

Despite all of the FDAs efforts to engage industry, there continues to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions. Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements. The wide extent of the marketing of such unapproved products is evidenced by their inappropriate advertisement in various media and by the number of consumer complaints about them submitted to the FDA.

These regenerative medicine products are not without risk and are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they havent been adequately studied in clinical trials. Weve said previously and want to reiterate here there is no room for manufacturers, clinics, or health care practitioners to place patients at risk through products that violate the law, including by not having an IND in effect or an approved biologics license. We will continue to take action regarding unlawfully marketed products. Our oversight of cellular and related products has included taking compliance actions, including numerous warning and untitled letters, and pursuing enforcement action for serious violations of the law.

Since December 2019, the agency has issued more than 350 letters to manufacturers, clinics, and health care providers, noting that it has come to our attention that they may be offering unapproved regenerative medicine products and reiterating the FDAs compliance and enforcement policy.

We encourage the public and patients who are considering treatment with regenerative medicine products to work with their health care providers to learn about the treatment being offered. Ask questions and understand the potential risks of treatment with unapproved products. It is critical to only seek treatment using legally marketed products, or, for unapproved products, to enroll in clinical trials under FDA oversight. The public can visit the FDAs website to find out if a particular regenerative medicine product is approved.

The FDA remains committed to helping advance the development of safe and effective regenerative medicine products, including stem cell-based products, to benefit individuals in need. We look forward to working with those who share this goal.

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Active Wound Care Market Rising demand for Skin Substitutes to boost the industry (2023-2033) | CAGR of 5.5% – EIN News

March 21st, 2023 12:04 am

Active Wound Care Market Rising demand for Skin Substitutes to boost the industry (2023-2033) | CAGR of 5.5%  EIN News

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Active Wound Care Market Rising demand for Skin Substitutes to boost the industry (2023-2033) | CAGR of 5.5% - EIN News

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Veterinary Orthopedic Implants Market is estimated to be 421.3 Million by 2029 with a CAGR of 5.3% – By PMI – EIN News

March 21st, 2023 12:04 am

Veterinary Orthopedic Implants Market is estimated to be 421.3 Million by 2029 with a CAGR of 5.3% - By PMI  EIN News

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Diabetes: What It Is, Causes, Symptoms, Treatment & Types

March 13th, 2023 12:20 am

OverviewWhat is Diabetes?What is diabetes?

Diabetes is a condition that happens when your blood sugar (glucose) is too high. It develops when your pancreas doesnt make enough insulin or any at all, or when your body isnt responding to the effects of insulin properly. Diabetes affects people of all ages. Most forms of diabetes are chronic (lifelong), and all forms are manageable with medications and/or lifestyle changes.

Glucose (sugar) mainly comes from carbohydrates in your food and drinks. Its your bodys go-to source of energy. Your blood carries glucose to all your bodys cells to use for energy.

When glucose is in your bloodstream, it needs help a key to reach its final destination. This key is insulin (a hormone). If your pancreas isnt making enough insulin or your body isnt using it properly, glucose builds up in your bloodstream, causing high blood sugar (hyperglycemia).

Over time, having consistently high blood glucose can cause health problems, such as heart disease, nerve damage and eye issues.

The technical name for diabetes is diabetes mellitus. Another condition shares the term diabetes diabetes insipidus but theyre distinct. They share the name diabetes because they both cause increased thirst and frequent urination. Diabetes insipidus is much rarer than diabetes mellitus.

There are several types of diabetes. The most common forms include:

Other types of diabetes include:

Diabetes is common. Approximately 37.3 million people in the United States have diabetes, which is about 11% of the population. Type 2 diabetes is the most common form, representing 90% to 95% of all diabetes cases.

About 537 million adults across the world have diabetes. Experts predict this number will rise to 643 million by 2030 and 783 million by 2045.

Symptoms of diabetes include:

Its important to talk to your healthcare provider if you or your child has these symptoms.

Additional details about symptoms per type of diabetes include:

Too much glucose circulating in your bloodstream causes diabetes, regardless of the type. However, the reason why your blood glucose levels are high differs depending on the type of diabetes.

Causes of diabetes include:

Long-term use of certain medications can also lead to Type 2 diabetes, including HIV/AIDS medications and corticosteroids.

Diabetes can lead to acute (sudden and severe) and long-term complications mainly due to extreme or prolonged high blood sugar levels.

Acute diabetes complications that can be life-threatening include:

Blood glucose levels that remain high for too long can damage your bodys tissues and organs. This is mainly due to damage to your blood vessels and nerves, which support your bodys tissues.

Cardiovascular (heart and blood vessel) issues are the most common type of long-term diabetes complication. They include:

Other diabetes complications include:

Living with diabetes can also affect your mental health. People with diabetes are two to three times more likely to have depression than people without diabetes.

Healthcare providers diagnose diabetes by checking your glucose level in a blood test. Three tests can measure your blood glucose level:

To screen for and diagnose gestational diabetes, providers order an oral glucose tolerance test.

The following test results typically indicate if you dont have diabetes, have prediabetes or have diabetes. These values may vary slightly. In addition, healthcare providers rely on more than one test to diagnose diabetes.

Diabetes is a complex condition, so its management involves several strategies. In addition, diabetes affects everyone differently, so management plans are highly individualized.

The four main aspects of managing diabetes include:

Due to the increased risk for heart disease, its also important to maintain a healthy:

You cant prevent autoimmune and genetic forms of diabetes. But there are some steps you can take to lower your risk for developing prediabetes, Type 2 diabetes and gestational diabetes, including:

Its important to note that there are some diabetes risk factors you cant change, such as your genetics/family history, age and race. Know that Type 2 diabetes is a complex condition that involves many contributing factors.

The prognosis (outlook) for diabetes varies greatly depending on several factors, including:

Chronic high blood sugar can cause severe complications, which are usually irreversible. Several studies have shown that untreated chronic high blood sugar shortens your lifespan and worsens your quality of life.

In the United States, diabetes is the eighth leading cause of death. A large number of people with diabetes will die from a heart attack or stroke.

However, its important to know that you can live a healthy life with diabetes. The following are key to a better prognosis:

Studies show that people with diabetes may be able to reduce their risk of complications by consistently keeping their A1c levels below 7%.

If you havent been diagnosed with diabetes, you should see a healthcare provider if you have any symptoms of diabetes, such as increased thirst and frequent urination.

If you have diabetes, you should see your provider who helps you manage diabetes (such as an endocrinologist) regularly.

A note from Cleveland Clinic

Being diagnosed with diabetes is a life-changing event, but it doesnt mean you cant live a happy and healthy life. Managing diabetes involves consistent care and diligence. While itll likely be very overwhelming at first, over time youll get a better grasp on managing the condition and being in tune with your body.

Be sure to see your healthcare provider(s) regularly. Managing diabetes involves a team effort youll want medical professionals, friends and family on your side. Dont be afraid to reach out to them if you need help.

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Diabetes: What It Is, Causes, Symptoms, Treatment & Types

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A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors – Economic Times

March 13th, 2023 12:20 am

A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors  Economic Times

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Regenerative Therapies Market is Set to Grow at a CAGR of 8.7% by 2033, Propelled by Advancements in – EIN News

March 13th, 2023 12:17 am

Regenerative Therapies Market is Set to Grow at a CAGR of 8.7% by 2033, Propelled by Advancements in  EIN News

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Regenerative Therapies Market is Set to Grow at a CAGR of 8.7% by 2033, Propelled by Advancements in - EIN News

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Gene Therapy Market Size (USD 46.5 Bn by 2030): A Growing Industry and Its Impact on Healthcare Systems – EIN News

March 13th, 2023 12:17 am

Gene Therapy Market Size (USD 46.5 Bn by 2030): A Growing Industry and Its Impact on Healthcare Systems  EIN News

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Genetic Engineering – Meaning, Applications, Advantages and Challenges …

March 13th, 2023 12:16 am

Genetic engineering, also calledgenetic modification, is the direct manipulation of an organismsgenomeusing biotechnology. It is a set of technologies used to change the genetic makeup of cells, including the transfer of genes within and across species boundaries to produce improved or novelorganisms. Read important facts about Genetic Engineering in this article for the IAS Exam.

NewDNAmay be inserted in the host genome by first isolating and copying the genetic material of interest usingmolecular cloningmethods to generate a DNA sequence, or by synthesizing the DNA and then inserting this construct into the host organism.Genesmay be removed, or knocked out, using anuclease.Gene targetingis a different technique that useshomologous recombinationto change an endogenous gene and can be used to delete a gene, removeexons, add a gene, or introducepoint mutations.

Aspirants reading, GEAC can also refer to topics lined below:

Medicine, research, industry and agriculture are a few sectors where genetic engineering applies. It can be used on various plants, animals and microorganisms. The first microorganism to be genetically modified is bacteria.

Genetic Engineering Appraisal Committee (GEAC) is the biotech regulator in India. It is created under the Ministry of Environment and Forests. Read more about GEAC in the linked article.

There are five bodies that are authorized to handle rules noted underEnvironment Protection Act 1986 Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989. These are:

Soybean-Herbicide tolerance,Canola-Altered fatty acid composition,Plum-Virus resistance,Corn-Insect resistance

Pros:Tackling and Defeating Diseases,Getting Rid of All Illnesses in Young and Unborn Children,Potential to Live Longer,Produce New Foods,Faster Growth in Animals and Plants,Pest and Disease Resistance.Cons:May Lead to Genetic Defects,Limits Genetic Diversity,Reduced Nutritional Value,Risky Pathogens,Negative Side Effects

UPSC Preparation:

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Sometimes 15 Minutes Are More Than Enough To Improve Immune System, Sleep Quality And Depression – Revyuh

March 13th, 2023 12:14 am

Sometimes 15 Minutes Are More Than Enough To Improve Immune System, Sleep Quality And Depression  Revyuh

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Where Does Revance Therapeutics Inc (RVNC) Stock Fall in the Biotechnology Field After It Is Lower By -2.17% This Week? – InvestorsObserver

March 5th, 2023 12:13 am

Where Does Revance Therapeutics Inc (RVNC) Stock Fall in the Biotechnology Field After It Is Lower By -2.17% This Week?  InvestorsObserver

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Is TG Therapeutics Inc common stock (TGTX) Stock at the Top of the Biotechnology Industry? – InvestorsObserver

March 5th, 2023 12:13 am

Is TG Therapeutics Inc common stock (TGTX) Stock at the Top of the Biotechnology Industry?  InvestorsObserver

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Where Does GT Biopharma Inc (GTBP) Stock Fall in the Biotechnology Field After It Is Down -20.73% This Week? – InvestorsObserver

March 5th, 2023 12:13 am

Where Does GT Biopharma Inc (GTBP) Stock Fall in the Biotechnology Field After It Is Down -20.73% This Week?  InvestorsObserver

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Where Does GT Biopharma Inc (GTBP) Stock Fall in the Biotechnology Field After It Is Down -20.73% This Week? - InvestorsObserver

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Where Does Dyne Therapeutics Inc (DYN) Stock Fall in the Biotechnology Field After It Is Lower By -2.35% This Week? – InvestorsObserver

March 5th, 2023 12:12 am

Where Does Dyne Therapeutics Inc (DYN) Stock Fall in the Biotechnology Field After It Is Lower By -2.35% This Week?  InvestorsObserver

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Tampa doctor who lost brother to diabetes calls insulin price cut a ‘game changer’ – ABC Action News Tampa Bay

March 5th, 2023 12:10 am

Tampa doctor who lost brother to diabetes calls insulin price cut a 'game changer'  ABC Action News Tampa Bay

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Revolutionary Specialty Enzymes Transform Industries, Projected to Reach $2.2 Billion by 2031 – Billion-Dollar – EIN News

March 5th, 2023 12:08 am

Revolutionary Specialty Enzymes Transform Industries, Projected to Reach $2.2 Billion by 2031 - Billion-Dollar  EIN News

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A Career in Veterinary Medicine – AAVMC

February 24th, 2023 12:33 am

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The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.

The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.

The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.

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Building the next generation of veterinary professionals (FCL Feb. 22, 2023) – FirstCoastNews.com WTLV-WJXX

February 24th, 2023 12:33 am

Building the next generation of veterinary professionals (FCL Feb. 22, 2023)  FirstCoastNews.com WTLV-WJXX

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Peripheral neuropathy: Symptoms, causes, and treatment – Medical News Today

February 24th, 2023 12:32 am

Peripheral neuropathy is a disorder of the peripheral nerves. These nerves send messages between the central nervous system, the brain and the spinal cord, and the rest of the body.

Peripheral neuropathy is a general term that describes many conditions caused by damage to the peripheral nervous system, which is responsible for sending sensory information to and from the central nervous system. For example, the peripheral nerves can tell the body when the hands are cold.

Peripheral neuropathy affects more than 20 million people in the United States. In general, the condition can cause a loss of normal nerve signals, or cause inappropriate or distorted signals.

The condition can affect a range of different nerves, so it can impact a variety of locations in different ways. It can affect a single nerve or several nerves at the same time.

Examples of peripheral neuropathy include:

Symptoms of peripheral neuropathy may vary according to the type of neuropathy. Researchers have identified 100 different types of neuropathy.

Generally, the types are classified into three categories, each with its own set of symptoms. They are:

This affects the sensory nerves, which impact the sensations of pain, touch, and temperature.

The person may have:

Especially in cases when the cause is diabetes, sensory neuropathy can also lead to foot and leg ulcers, infection, and gangrene.

This affects the muscles that the brain controls consciously.

Symptoms include:

The affects body processes that the brain controls involuntarily. Symptoms may include:

Treatment either targets the underlying cause, or it aims to provide symptomatic pain relief and prevent further damage. Treatments may include:

Medications that may help relieve symptoms, but do not cure the problem, include:

A persons choice of treatment should take into account any medications that person is taking for other conditions in order to avoid unwanted interactions.

When a persons neuropathy happens as a result of compression of a single nerve, treatment is similar regardless of which nerve is involved. The approach depends on whether the compression is fixed or transient.

A palsy of the ulnar, radial, or peroneal nerve may be temporary and reversible if a person simply avoids the cause of the nerve compression. For example, a person with ulnar nerve palsy should not lean on the affected elbow.

The person may need to rest, use heat, or take a limited course of drugs to reduce inflammation.

In carpal tunnel syndrome, conservative therapy includes splinting the wrist and taking oral or injected corticosteroid drugs.

If a single-nerve neuropathy does not respond to these measures, surgery may be an option in rare cases. Surgery may also be necessary if the nerve compression is fixed, for example when the cause is a tumor.

A doctor should consider referring a person to pain specialist or a relevant clinical specialty at any stage if:

Non-drug measures for peripheral neuropathy can include using warm or cold packs, unless heat or cold makes the symptoms worse.

Stress relief and other complementary therapies include meditation, relaxation techniques, massage, and acupuncture. These may help a person cope with pain from the condition.

Some people find that using a transcutaneous electrical nerve stimulation (TENS) machine helps. This device interrupts nerve messages by delivering a small electric current. Research has not confirmed the effectiveness of this treatment.

Many types of neuropathy are idiopathic, or of unknown cause, but a number of conditions can trigger the problem. These include:

Other causes can include:

Disorders of the small blood vessels can reduce blood supply to the nerves, resulting in nerve tissue damage. Certain benign tumors can also affect nerve tissue and lead to neuropathic pain.

Diabetes is the most common cause of chronic peripheral neuropathy in the U.S. About 60-70 percent of people with diabetes will have some form of damage to their sensory, motor, or autonomic nerves. Many will have foot problems and ulcers.

High blood sugar levels cause damage to the walls of the tiny blood vessels that supply oxygen and nutrients to the nerves in the ends of the hands and feet, and the essential organs in the body, such as the eyes, kidneys, and heart. Whenever skin becomes damaged, the loss of sensation further increases the risk of damage.

Peripheral neuropathy causes a variety of symptoms with many possible causes.

A doctor will usually begin by taking a persons medical history. This includes gathering information about all the symptoms, but also details about a persons life, potential environmental exposures, and any risks of infectious or neurological diseases.

The next step should be a physical and neurological exam that will help the doctor identify any nerve damage. Potential tests a doctor may perform include nerve conduction velocity (NCV) and electromyography (EMG). These tests measure nerve signal strength and electrical activity.

A doctor may also do a nerve biopsy. In cases of suspected autonomic peripheral neuropathy, a person can get a QSART test, which measures their ability to sweat.

For some types of neuropathies, like nerve compression, a person can also get a magnetic resonance imaging (MRI) scan or a computed tomography (CT) scan. Another option is a muscle and nerve ultrasound, but this is not common.

If the doctor confirms that neuropathy is present, the doctor will look for the cause. The doctor may then send the person to get blood tests in order to check for diabetes and other potential underlying conditions.

The doctor may check for vitamin deficiencies, liver or kidney dysfunction, infections, metabolic disorders, or any immune cells that may indicate an immune disorder. In some cases, the doctor may order a test to rule out a genetic disorder.

If none of these tests can point to a cause, a doctor may conduct additional tests.

The outlook for peripheral neuropathy varies depending on the underlying cause, and which nerves have been damaged.

Some cases may improve with time if the underlying cause is treated, but in others, the damage may be permanent or gradually worsen over time.

Peripheral neuropathy describes many different conditions that damage the peripheral nervous system. Many underlying conditions can cause neuropathies, which result in impairments to a persons nerve signals.

A persons symptoms will vary depending on the affected nerves and the type of neuropathy. The condition affects more than 20 million people in the U.S.

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Different Types of Peripheral Neuropathy | Paid Content – Local 5 – weareiowa.com

February 24th, 2023 12:32 am

Different Types of Peripheral Neuropathy | Paid Content  Local 5 - weareiowa.com

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