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Bio Roundup: NASH News, Merck Strikes, Digital Tokens & More

The growing epidemic of the fatty liver disease known as NASH, which has no FDA-approved treatment, has led to a frenzied race among drug companies. This week, one company, Intercept Pharmaceuticals, solidified its lead. But how much will being first to the finish line mean when all is said and done?Intercept (NASDAQ: ICPT) reported interim data from a Phase 3 study showing its drug, obeticholic acid (OCA), reduced liver scarring in NASH patients. The results should be enough to support an appr...
Tags: Deals, Startups, Drugs, Cancer, Trends, Investing, Merck, Leukemia, Acne, Inflammatory Bowel Disease, Xerox, Astrazeneca, Fda, National, Pfizer, Abbvie


FDA’s new proposed rule would update regulatory requirements for sunscreen products in the U.S

The U.S. Food and Drug Administration today issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.
Tags: Health, Fda, U S Food and Drug Administration


Alcoholics may benefit from multimillion-dollar grant for opioid-blocking implant, says Anaheim company

It’s a well-known and lethal problem: About 90 percent of recovering addicts relapse and use drugs such as heroin again. The overwhelming majority of these falls from grace occur within one month of successfully completing treatment, and the results can be deadly, according to several studies. BioCorRX, a small Anaheim company, believes it can help break this vicious cycle, and the National Institute on Drug Abuse is inclined to agree. The institute — part of the National Institutes of Health — ...
Tags: Health, Business, News, Australia, California, Russia, California News, Sport, Soccer, United States, Addiction, SEC, National Institutes of Health, Fda, Nih, Ucla


Spravato: New Ketamine Treatment to be Approved by FDA

Last week a committee of the U.S. Food and Drug Administration (FDA) recommended in a 14-2 vote that the agency approve the use of a nasal spray form of esketamine (a specific type of ketamine) for the treatment of treatment-resistant depression and certain other types of depression. Treatment-resistant depression is when clinical depression fails to respond to multiple (at least two) attempts to treat it with at least two different types of medications or psychotherapy over the course of a year...
Tags: Psychology, General, Suicide, Disorders, Depression, Treatment, Fda, Ketamine, Ketamine For Depression, Medications, U S Food and Drug Administration FDA, Janssen, Trd, Treatment Resistant Depression, Treatment-resistant, Esketamine


FDA warning brings controversial young blood transfusion company to a halt

On Tuesday, the FDA issued a warning to anyone who might be inclined to give their old bones a jolt with fresh blood harvested from the young. The idea is pretty far from mainstream, even in Silicon Valley, where the ultra-wealthy have a keen interest in the cutting edge of life extension science. Still, there’s apparently enough buzz around the practice that the FDA is warning consumers of “unscrupulous actors” who tout the benefits of infusing patients with plasma extracted from youthful donor...
Tags: Health, TC, Tech, Food And Drug Administration, Silicon Valley, Fda, Plasma, Blood, Ambrosia, Ambrosia Medical


Will the public be able to resist the pitch from 23andMe?

Just because something is legal, doesn’t make it right. Just because we enjoy a right of free speech, doesn’t mean we should be verbally insulting people. Just because the Food and Drug Administration (FDA) approves a treatment or a test, doesn’t mean we should pursue it. The FDA has given approval to 23andMe, a private […] Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more.
Tags: Health, Genetics, Fda, Food and Drug Administration FDA, Primary Care, Conditions, PA NP, CRNA


FDA warns consumers against ‘young blood’ plasma infusions for dementia, PTSD and other conditions

WASHINGTON — Federal health regulators on Tuesday warned consumers against controversial “young blood” treatments — plasma infusions from young donors marketed for conditions such as Parkinson’s, Alzheimer’s, multiple sclerosis and post-traumatic stress disorder. “There is no proven clinical benefit of infusion of plasma from young donors to cure, mitigate, treat or prevent these conditions and […]
Tags: Health, News, Washington, Nation, Fda, Nation & World


FDA authorizes new interoperable insulin pump for children, adults with diabetes

The U.S. Food and Drug Administration today permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes.
Tags: Health, Fda, U S Food and Drug Administration


FDA warns doctor for illegally marketing unapproved implantable device

Today, the U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue.
Tags: Health, Fda, U S Food and Drug Administration, Berman, Beverly Hills California, Mark Berman


Biotech AI startup Sight Diagnostics gets $27.8M to speed up blood tests

Sight Diagnostics, an Israeli medical devices startup that’s using AI technology to speed up blood testing, has closed a  $27.8 million Series C funding round. The company has built a desktop machine, called OLO, that analyzes cartridges manually loaded with drops of the patient’s blood — performing blood counts in situ. The new funding is led by VC firm Longliv Ventures, also based in Israel, and a member of the multinational conglomerate CK Hutchison Group. Sight Diagnostics said it was aft...
Tags: Health, Fundings & Exits, Startups, TC, Asia, Europe, UK, Israel, US, Tech, Artificial Intelligence, Leukemia, Italy, Food And Drug Administration, Machine Learning, Fda


Medicinal Mushrooms: Turkey Tail (Trametes versicolor), Reishi (Ganoderma lucidum) and Lion's mane (Hericium erinaceus)

There some evidence in PubMed than medicinal mushrooms may play a role in treatment of some cancers. Most of the claims of medical benefits are bot backed up by high quality studies as of 2019. References are below.---What is turkey tail?Turkey tail is a type of mushroom that grows on dead logs worldwide. It's named turkey tail because its rings of brown and tan look like the tail feathers of a turkey. Its scientific name is Trametes versicolor or Coriolus versicolor. In traditional Chinese medi...
Tags: Health, Facebook, Japan, China, Turkey, Fda, Mushroom, Oncology, U S Food and Drug Administration FDA, PSK, Paul Stamets, Medicinal Mushrooms, Yun Zhi, K PSK, In Japan PSK, Chizhi


Ketamine-like depression treatment on track for FDA approval

A ketamine-like drug for treatment-resistant depression was backed by a US Food and Drug Administration advisory committee on Tuesday. If it is then approved by the FDA, the drug -- called esketamine -- may provide a new option for patients with major depressive disorder who have tried at least two other antidepressants without success.
Tags: Health, Fda, US Food and Drug Administration advisory committee


What the FDA’s actions mean for dietary supplements

NEW YORK (AP) — The Food and Drug Administration announced plans Monday to step up its policing of dietary supplements, which it said has mushroomed into a $40 billion industry with more than 50,000 products. The agency warned 17 companies for illegally making claims about their products’ ability to treat diseases. Here’s a look at […]
Tags: Health, Business, New York, News, Nation, Fda, The Food and Drug Administration


7 Ways to Manage High Blood Pressure

High blood pressure is a problem that many people deal with today. According to the FDA, almost 65 million adults in the US are affected by it. Needless to say, it can be rather scary. With symptoms like Severe headaches, shortness of breath, and nosebleeds, it’s no wonder it’s a popular topic. When left untreated, it can lead to a lot more serious problems like a heart attack or kidney damage. Luckily, most cases can be managed or even prevented with a few lifestyle changes that -let’s be hon...
Tags: Health, Hollywood, US, Jazz, Fda, Mayo Clinic, Heart Association, Daddy Talk


FDA wants new meetings with Juul, Altria on teen vaping

WASHINGTON (AP) — The head of the Food and Drug Administration is questioning whether electronic cigarette maker Juul and its new partner Altria are following through on pledges to help stop underage vaping. FDA commissioner Scott Gottlieb on Friday posted letters he sent to Juul and Altria, the maker of Marlboro cigarettes and other tobacco […]
Tags: Health, Business, News, Washington, Ap, Nation, Food And Drug Administration, Fda, Juul, Altria, Scott Gottlieb, JUUL Altria


FDA takes initiative to adopt modern technologies for enhancing security of the drug supply chain

A key element of the U.S. Food and Drug Administration's mission is focused on helping to ensure that all products we regulate, including drugs available to consumers, are safe and of high quality. This means working to ensure greater accountability in our nation's drug supply chain.
Tags: Health, Fda, U S Food and Drug Administration


Honest Company co-founder Christopher Gavigan has a new, and newly funded, CBD startup called Prima

Christopher Gavigan, sitting in a crisp white shirt inside a small TechCrunch conference room, radiates energy, even in a late-day interview just hours before he’s scheduled to fly home from San Francisco to L.A. We’re meeting to talk about Prima, a new startup that Gavigan began developing seven months ago with two co-founders. One of them is a former beauty and marketing executive, Jessica Assaf, who was until recently running a company called Cannabis Feminist to sell marijuana wellness pr...
Tags: Health, Startups, TC, California, Oregon, New York City, San Francisco, Tech, Atlantic, United States, Fda, Honest Company, Greycroft, Ucla, Southern California, Mount Sinai


Trump administration salutes parade of generic drug approvals, but hundreds aren’t for sale

The Trump administration has been trumpeting a huge increase in FDA generic drug approvals the past two years, the result of its actions to streamline a cumbersome process and combat anti-competitive practices.
Tags: Health, Fda, Trump


First therapy indicated for treating adults with rare blood clotting disorder receives FDA approval

The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting.
Tags: Health, Fda, U S Food and Drug Administration


FDA warns that some home-use test strips may provide inaccurate results

The U.S. Food and Drug Administration today is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage.
Tags: Health, Fda, U S Food and Drug Administration


Juul Labs hires former Apple employee to lead the fight against counterfeits

Juul Labs, the e-cig company under fire for its product’s popularity with young people, has brought on a new VP of Intellectual Property Protection with Adrian Punderson, formerly of PwC and Apple. Punderson’s job is all about working alongside government agencies, as well as Juul Labs Intellectual Property VP Wayne Sobon, to combat the sale of counterfeit and infringing products. These can range from copycat vapes and pods that are actually marketed as Juul products all the way to products that...
Tags: Apple, Health, Startups, TC, Gadgets, Facebook, Tech, Fda, Juul, Altria Group, Wayne Sobon, Intellectual Property Protection, Juul Labs, Adrian Punderson, Punderson, Juul Labs Intellectual Property VP


Dadi brings in $2M to democratize sperm storage

The founders of Dadi — pronounced daddy — think men are in need of a wake-up call. “Men [have] a biological clock just like women, which is something that people don’t talk about,” Dadi co-founder and chief executive officer Tom Smith told TechCrunch. “Infertility isn’t a women’s issue; It’s both a men’s and women’s issue.” Smith believes Dadi, the provider of a temperature-controlled at-home fertility test and sperm collection kit, will encourage men to contribute to family planning conversat...
Tags: Health, Startups, New York, London, Instagram, Berlin, Funding, Tech, Venture Capital, Fda, Smith, New England, Felix Capital, Fedex, Mackey, Tom Smith


Will tech companies change the way we manage our health?

Cyrus Radfar Contributor Cyrus Radfar is the founding partner at V1 Worldwide. More posts by this contributor Amazon isn’t to blame for the Postal Service’s woes, but it will need to innovate to survive Dear United: Autonomous cars will pull you out of your seat As of September 2018, the top 10 tech companies in the U.S. had spent a total of $4.7 billion on healthcare acquisitions since 2012. The number of healthcare deals undertak...
Tags: Apple, Health, Google, Amazon, Column, Utah, California, Washington, White House, Tech, Canada, Healthcare, Oscar, Jp Morgan, Health Insurance, Berkshire Hathaway


FDA approves first generic version of commonly prescribed asthma inhaler

The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease.
Tags: Health, Fda, U S Food and Drug Administration


FDA OKs 1st generic version of popular Advair asthma inhaler

The first generic version of the popular Advair asthma inhaler has been approved by U.S. regulators. The Food and Drug Administration on Wednesday approved Mylan’s version in three strengths for ages 4 and up. The inhalers are used twice daily to keep airways open and prevent flare-ups of wheezing, shortness of breath and other symptoms […]
Tags: Health, Business, News, Nation, Fda, Mylan, The Food and Drug Administration, Advair


Is personalized medicine mostly marketing and hype?

“Personalized” medicine sounds appealing. Rather than just guessing at what medication to try, a genetic test can figure out, in advance, which medications will be effective and which medications are more likely to make you sicker. Except it doesn’t work. It’s mostly marketing and hype. The FDA has officially warned consumers and physicians that genetic tests sold […] Find jobs at Careers by KevinMD.com. Search thousands of physician, PA, NP, and CRNA jobs now. Learn more.
Tags: Health, Genetics, Fda, Conditions, PA NP, CRNA


Wellness startup Hims enters the unicorn club with $100M investment

Hims, known by many for its phallic New York subway advertisements, has raised an additional $100 million in venture capital funding on a pre-money valuation of $1 billion. The round was first reported by Recode and confirmed to TechCrunch by sources with knowledge of the deal. A growth-stage investor has led the round, which is ongoing, with participation from existing investors. Our source declined to name the lead investor but did say it was a “super big fund” that isn’t SoftBank and th...
Tags: Health, Startups, TC, New York, Softbank, Funding, San Francisco, Tech, Venture Capital, Fda, IVP, Forerunner Ventures, Founders Fund, Hims


Lack of transparency in healthcare startups risks another Theranos implosion

Are more Theranos -style scandals looming for investors in healthcare startups? A team of researchers associated with the Meta Research Innovation Center at Stanford thinks so. They’ve  published a paper warning investors in life sciences startups that a systemic lack of transparency exists in their portfolio companies — creating the possibility for more multi-billion dollar implosions and scandals like the one that toppled Theranos and its charismatic founder, Elizabeth Holmes. Indeed, one of...
Tags: TC, Entrepreneurship, Stanford, Cancer, Articles, Tech, Companies, Diabetes, University, Healthcare, Food And Drug Administration, Astrazeneca, Fda, Cancer Treatment, Device, Abbvie


How CBD Has Improved the Medical Industry

A lot of people live their daily lives in severe pain. Most of them rely on strong painkillers to achieve comfort, even if it’s temporary. Unfortunately, being pain-free comes at a cost. As soon as you stop taking those painkillers, you’ll experience their nasty side effects. Hot and cold spells, trouble sleeping, constipation, nausea, vomiting, and drowsiness- the list of side effects can be scary. It may feel like it’s a situation wherein you have to choose between going through pain or those ...
Tags: Health, Europe, Featured, Cdc, Brazil, Fda, Lifehacks, Centers for Disease Control Prevention, Mechoulam, Raphael Mechoulam He


New therapy turns cancer cells into fat to stop it from spreading

In 2018, an estimated 627,000 women died from breast cancer worldwide. Researchers recently discovered a drug combination that turned cancer cells into fat cells, preventing its proliferation. The drug therapy could be used to halt metastasis, the leading cause of death from cancer.It may be a family member, a friend, a coworker, or even yourself, but chances are breast cancer will invade your life at some point. According to the Center for Disease Control and Prevention, 242,476 new cases of fe...
Tags: Health, Medicine, Cancer, Genetics, Medical Research, Innovation, Switzerland, Disease, Fda, Illness, University of Basel, Center for Disease Control and Prevention, Molecular Biology, Human body, Gerhard Christofori



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