Should Biotechnology Stock Outlook Therapeutics Inc (OTLK) Be in Your Portfolio Thursday? InvestorsObserver
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Should Biotechnology Stock Outlook Therapeutics Inc (OTLK) Be in Your Portfolio Thursday? - InvestorsObserver
SANA BIOTECHNOLOGY, INC. : Results of Operations and Financial Condition, Financial Statements and Exhibits (form 8-K) Marketscreener.com
Genetic therapies aim to treat or cure conditions by correcting problems in your DNA. Your DNA, including specific genes, contains instructions for making proteins that are essential for good health. Mutations, or changes in your DNA, can lead to proteins that do not work properly or that are missing altogether. These changes can cause genetic, or inherited, disorders such as cystic fibrosis, thalassemia, hemophilia, and sickle cell disease.
Genetic therapies are approaches that treat genetic disorders by providing new DNA to certain cells or correcting the DNA. Gene transfer approaches, also called gene addition, restore the missing function of a faulty or missing gene by adding a new gene to affected cells. The new gene may be a normal version of the faulty gene or a different gene that bypasses the problem and improves the way the cell works.
Genome editing is a newer approach that allows precise correction or other targeted changes to the DNA in cells to restore a cells function. Genome editing can:
Gene transfer or genome editing treatments can directly modify the cells in your body, or your cells can be collected and treated outside of your body and then returned to you. For example, a doctor can remove immune system cells, cells that are part of your bodys natural defense system, or bone marrow cells from your body, modify their DNA, and then re-introduce them to your body.
The only genetic therapies that are currently approved by the U.S. Food and Drug Administration (FDA) are for a rare inherited eye condition, as well as certain types of cancer. Genetic therapies that are in development could treat or cure other inherited disorders; treat other cancers; or treat infections, including HIV.
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Genetic Therapies - What Are Genetic Therapies? | NHLBI, NIH
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The genes in your bodys cells play a key role in your health. Indeed, a defective gene or genes can make you sick.
Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition.
This research is paying off, as advancements in science and technology today are changing the way we define disease, develop drugs, and prescribe treatments.
The U.S. Food and Drug Administration has approved multiple gene therapy products for cancer and rare disease indications.
Genes and cells are intimately related. Within the cells of our bodies, there are thousands of genes that provide the information to produce specific proteins that help make up the cells. Cells are the basic building blocks of all living things; the human body is composed of trillions of them.
The genes provide the information that makes different cells do different things. Groups of many cells make up the tissues and organs of the body, including muscles, bones, and blood. The tissues and organs in turn support all our bodys functions.
Sometimes the whole or part of a gene is defective or missing from birth. This is typically referred to as a genetically inherited mutation.
In addition, healthy genes can change (mutate) over the course of our lives. These acquired mutations can be caused by environmental exposures. The good news is that most of these genetic changes (mutations) do not cause disease. But some inherited and acquired mutations can cause developmental disorders, neurological diseases, and cancer.
Depending on what is wrong, scientists can do one of several things in gene therapy:
To insert new genes directly into cells, scientists use a vehicle called a vector. Vectors are genetically engineered to deliver the necessary genes for treating the disease.
Vectors need to be able to efficiently deliver genetic material into cells, and there are different kinds of vectors. Viruses are currently the most commonly used vectors in gene therapies because they have a natural ability to deliver genetic material into cells. Before a virus can be used to carry therapeutic genes into human cells, it is modified to remove its ability to cause infectious disease.
Gene therapy can be used to modify cells inside or outside the body.When a gene therapy is used to modify cells inside the body, a doctor will inject the vector carrying the gene directly into the patient.
When gene therapy is used to modify cells outside the body, doctors take blood, bone marrow, or another tissue, and separate out specific cell types in the lab. The vector containing the desired gene is introduced into these cells. The cells are later injected into the patient, where the new gene is used to produce the desired effect.
Before a gene therapy can be marketed for use in humans, the product must be tested in clinical studies for safety and effectiveness so FDA scientists can consider whether the risks of the therapy are acceptable considering the potential benefits.
The scientific field for gene therapy products is fast-paced and rapidly evolving ushering in a new approach to the treatment of vision loss, cancer, and other serious and rare diseases. As scientists continue to make great strides in this therapy, the FDA is committed to helping speed up development by interacting with those developing products and through prompt review of groundbreaking treatments that have the potential to save lives.
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How Gene Therapy Can Cure or Treat Diseases | FDA
India can lead the One Earth, One Health vision with holistic policy-making environment: Mansukh Manda.. ETHealthWorld
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India can lead the One Earth, One Health vision with holistic policy-making environment: Mansukh Manda.. - ETHealthWorld
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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Advancing Safe and Effective Regenerative Medicine Products
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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
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
A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors Economic Times
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A number of healthtech startups claim they can reverse Type 2 diabetes. But caveats apply, caution doctors - Economic Times
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
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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Genetic Engineering - Meaning, Applications, Advantages and Challenges ...
Sometimes 15 Minutes Are More Than Enough To Improve Immune System, Sleep Quality And Depression Revyuh
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Sometimes 15 Minutes Are More Than Enough To Improve Immune System, Sleep Quality And Depression - Revyuh
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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Where Does Revance Therapeutics Inc (RVNC) Stock Fall in the Biotechnology Field After It Is Lower By -2.17% This Week? - InvestorsObserver
Is TG Therapeutics Inc common stock (TGTX) Stock at the Top of the Biotechnology Industry? InvestorsObserver
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Is TG Therapeutics Inc common stock (TGTX) Stock at the Top of the Biotechnology Industry? - InvestorsObserver
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
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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Where Does Dyne Therapeutics Inc (DYN) Stock Fall in the Biotechnology Field After It Is Lower By -2.35% This Week? - InvestorsObserver
Tampa doctor who lost brother to diabetes calls insulin price cut a 'game changer' ABC Action News Tampa Bay
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Tampa doctor who lost brother to diabetes calls insulin price cut a 'game changer' - ABC Action News Tampa Bay