Posts filtered by tags: Fda[x]


 

As clinical guidelines shift, heart disease screening startup pulls in $43M Series B

Cleerly Coronary, a company that uses A.I powered imaging to analyze heart scans, announced a $43 million Series B funding this week. The funding comes at a moment when it seems that a new way of screening for heart disease is on its way.  Cleerly was started in 2017 by James K. Min a cardiologist, and the director of the Dalio Institute for Cardiac Imaging at New York Presbyterian Hospital/Weill Cornell Medical College. The company, which uses A.I to analyze detailed CT scans of the heart, h...
Tags: TC, UK, Medicine, Cdc, US, Tech, Cta, Artificial Intelligence, Heart Attack, Disease, Fda, United Healthcare, Radiation, American College of Cardiology, European Society of Cardiology, Imaging


153 workers at Houston Methodist Hospital quit or were fired after they refused a mandatory COVID-19 vaccine

The hospital said in late March that it would mandate COVID-19 vaccines for its 26,000 employees. FREDERIC J. BROWN/AFP via Getty Images Houston Methodist Hospital told The Washington Post that it had fired staff who refused a COVID-19 shot. Some staff quit over the vaccine mandate, too. More than 150 staff had left or were fired, it said. Earlier this month a judge dismissed a lawsuit that said the mandate treated staff like "guinea pigs." See more stories on Insider's business page. ...
Tags: Post, Texas, News, US, Trends, Healthcare, Delta, Goldman Sachs, Fda, Houston, The Washington Post, United Airlines, US Food and Drug Administration, Houston Methodist Hospital, Houston Methodist, Frederic J Brown


A new Alzheimer's drug exposes a 'fundamentally flawed' part of how the US pays for drugs

Hi, Good morning, and welcome back to Insider Healthcare. I'm Andrew Dunn, and today in healthcare news:A new Alzheimer's drug exposes a 'fundamentally flawed' part of how the US pays for drugs;The US will likely miss Biden's July 4 vaccination goal;GlaxoSmithKline faces a critical investor day as activist investor pressure increases.If you're new to this newsletter, sign up here. And let me know what we should be paying attention to going forward: [email protected] On t...
Tags: Europe, White House, US, America, Trends, Getty Images, Alzheimer's Disease, Healthcare, Fda, GlaxoSmithKline, Pfizer, Biden, Fairfax Media, Chadwick Boseman, Elliott, GSK


Behind the historic US vaccine effort is FDA's Peter Marks. The job is 'not for the faint of heart.'

The FDA's Dr. Peter Marks has played a key role in nearly every major vaccine-related decision since the United States' COVID-19 outbreak began.       [Author: USA TODAY]
Tags: Usa, News, US, United States, Fda, Usa Today, Peter Marks


FDA approved Alzheimer's drug over internal objections

FDA gave the drug conditional approval earlier this month, making it the first new Alzheimer’s therapy approved in nearly 20 years.
Tags: Fda


FDA Approved Biogen Alzheimer’s Drug Despite Some Staff Concerns

Statisticians at the Food and Drug Administration said there wasn’t enough evidence to approve the drug from Biogen, and the agency’s...
Tags: Food And Drug Administration, Fda, Biogen


The FDA approved a controversial, $56,000-a-year Alzheimer's drug despite opposition inside the agency, internal memos show

Atthapon Raksthaput/Shutterstock The approval of Biogen's new Alzheimer's drug has been widely debated and led regulatory three advisors to resign. New documents show that FDA experts were divided on the drug. Two of the people involved in reviewing the drug said hadn't been shown to slow down the disease. See more stories on Insider's business page. Regulatory advisors and Alzheimer's disease experts have decried the approval of a controversial new treatment since it...
Tags: America, Trends, Food And Drug Administration, Fda, Alzheimer, Biogen, Massie, Center for Biologics Evaluation and Research, Peter Stein, Peter Marks, Center for Drug Evaluation and Research, Allison DeAngelis, Patrizia Cavazzoni, Aduhelm, Sylva Collins, Tristan Massie


Is it ethical to pay people to get vaccinated?

A financial shot in the arm could be just what is needed for Americans unsure about vaccination.On May 12, 2021, the Republican governor of Ohio, Mike DeWine, announced five US$1 million lottery prizes for those who are vaccinated. Meanwhile, in West Virginia, younger citizens are being enticed to get the shot with $100 savings bonds, and a state university in North Carolina is offering students who get vaccinated a chance to win the cost of housing. Many companies are paying vaccinated employee...
Tags: England, Money, Nigeria, US, West Virginia, Poverty, Public Health, Medical Research, United States, United Kingdom, Innovation, Ohio, Fda, Vaccines, North Carolina, U S Supreme Court


Healthcare startups are driving a takeover boom

Hi, Morning, and welcome to Insider Healthcare. I'm Allison DeAngelis, and today in healthcare news:A top analyst explains what's driving a banner year of healthcare consolidation.Digital therapeutics firm Pear is going public in a $1.6 billion SPAC deal.WHO's top scientist isn't sold on booster shots, yet.If you're new to this newsletter, sign up here. If you've got biotech/pharmaceutical industry tips, email me at [email protected] or tweet @ADeAngelis_bio. Now, le...
Tags: India, Digital, US, Trends, Healthcare, Who, Fda, Nevada, Anthony Fauci, WSJ, Mount Sinai, Pear, Icahn, SPAC, Milton, Hyatt Regency


THE 600-WORD INTERVIEW: The guy who saved Healthcare.gov, and just helped Biden get 150 million Americans vaccinated, explains why we shouldn't just pay people to take the vaccine

Andy Slavitt, the head of President Biden's vaccine rollout and former administrator of the Centers for Medicare and Medicaid Services. Shari L. Gross/Star Tribune/Getty Images Andy Slavitt saved Healthcare.gov, ran Medicare and Medicaid, and headed up Biden's vaccine rollout. He says vaccine-hesitant people don't want to hear from the government. He says we can prevent pandemics if we're less selfish and don't politicize the science. See more stories on Insider's b...
Tags: Politics, Science, Trends, Joe Biden, Healthcare, Medicare, Fda, Vaccines, Biden, Donald Trump, Medicaid, Trump, Centers for Medicare, Medicaid Services, Department of Health and Human Services, Andy Slavitt


A.I. drug discovery platform Insilico Medicine announces $255 million in Series C funding

Insilico Medicine, an A.I-based platform for drug development and discovery announced $255 million in Series C financing on Tuesday. The massive round is reflective of a recent breakthrough for the company: proof that it’s A.I based platform can create a new target for a disease, develop a bespoke molecule to address it, and begin the clinical trial process.  It’s also yet another indicator that A.I and drug discovery continues to be especially attractive for investors.  Insilico Medicine i...
Tags: TC, Hong Kong, Tech, Artificial Intelligence, Machine Learning, Fda, Pfizer, Ai, Johnson, Stanford University, Warburg Pincus, Clinical Trials, InSilico Medicine, Drug Discovery, Nature Biotechnology, Alex Zhavoronkov


AI drug discovery platform Insilico Medicine announces $255 million in Series C funding

Insilico Medicine, an AI-based platform for drug development and discovery announced $255 million in Series C financing on Tuesday. The massive round is reflective of a recent breakthrough for the company: proof that it’s AI based platform can create a new target for a disease, develop a bespoke molecule to address it, and begin the clinical trial process.  It’s also yet another indicator that AI and drug discovery continues to be especially attractive for investors.  Insilico Medicine is a...
Tags: Hong Kong, Tech, Fda, Pfizer, Johnson, Stanford University, Warburg Pincus, InSilico Medicine, Nature Biotechnology, Alex Zhavoronkov, Zhavoronkov, Crunchbase Insilico Medicine, COVID, Insilco, Taisho Pharmaceuticals Today, Teva Branded Pharmaceutical Products R D Inc Teva


Undocumented immigrants are turning to unproven black market COVID-19 remedies, including a drug for deworming horses, because they don't have proper healthcare access, according to a report

The medicine comes in several varieties, including transparent yellow gel. Hollis Johnson/INSIDER Undocumented immigrants are turning to unproven coronavirus treatments, The New York Times reported. They don't have access to proper healthcare and some are sceptical of healthcare workers, it reported. The treatments include antimalarial drugs or herbal remedies sold at markets or "wellness" clinics. See more stories on Insider's business page. Everyone living in the US can get a fre...
Tags: Mexico, US, Fresno, Trends, New York Times, The Times, Fda, Times, Donald Trump, Department Of Homeland Security, Baltimore, Central America, Federal Trade Commission, Trump, Fresno California, Johns Hopkins University School of Medicine


Kids are more likely to be vectors for fast-spreading new coronavirus strains like the Delta variant, former FDA chief says

A girl wearing gloves and a face mask before going to the park in Turkey. Not related to this story. Aykut Unlupinar/Anadolu Agency/Getty Images Officials are warning about the spread of the Delta variant, which is currently dominant in the UK. Scott Gottlieb said such contagious variants mean "kids are becoming more likely to be vectors." He predicted that children and schools could "become more of a focal point of spread." See more stories on Insider's business page. The former head ...
Tags: UK, Science, New York City, US, Trends, Turkey, Joe Biden, News UK, Delta, Bill De Blasio, Fda, Cnbc, US Food and Drug Administration, Squawk Box, US Centers for Disease Control and Prevention, Gottlieb


FDA approves oral pellets to treat children with venous thromboembolism

Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins) directly after they have been treated with a blood thinner given by injection for at least five days.
Tags: Health, Fda, U S Food and Drug Administration, Pradaxa


Bizarre Outbreak of Tuberculosis Linked to Donated Bone Grafts, CDC and FDA Officials Say

A contaminated batch of donated bone tissue is the likely source behind a strange outbreak of tuberculosis, according to federal health officials at the Centers for Disease Control and Prevention as well as the Food and Drug Administration. As many as 113 people who went in for spinal repair surgery are thought to…Read more...
Tags: Science, Medicine, Surgery, Food And Drug Administration, Fda, Centers For Disease Control And Prevention, Tuberculosis, Batch, Lot, Antimicrobial resistance, Aziyo Biologics, Clinical Medicine, Medical Specialties, Health Medical Pharma, Mycobacterium Tuberculosis, J I P James


The 20 fastest-growing, highest-paying biotechs

Hello,Welcome to Insider Healthcare. I'm Lydia Ramsey Pflanzer, and today in healthcare news:We rounded up the 20 fastest growing drugmakers that pay the most;The recently approved Alzheimer's treatment could change the way we pay for drugs;5 questions facing GlaxoSmithKline ahead of a big investor meeting.If you're new to this newsletter, sign up here. Comments, tips? Email me at [email protected] or tweet @lydiaramsey125. Let's get to it... FILE PHOTO: A technician works...
Tags: Texas, Obama, US, Trends, Compensation, Healthcare, Delta, Medicare, Fda, GlaxoSmithKline, Biotech, Humana, GSK, William Burke, Biogen, Newsletters


United States: FDA Withdraws Notice Of Proposed Rulemaking For Premium Cigars - Troutman Pepper Hamilton Sanders

On June 11, 2021, the U.S. Food and Drug Administration (FDA) withdrew an advanced notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018 as part of the Spring 2021...
Tags: News, United States, Fda, U S Food and Drug Administration FDA, Premium Cigars Troutman Pepper Hamilton Sanders


Former FDA Chief Says COVID-19 Variant May Cause Surge In States With Low Vaccination

The warnings echo those of Dr. Anthony Fauci, who urged Americans earlier this month to get their vaccinations.
Tags: News, Fda, Anthony Fauci, COVID


Bill would require doctors to disclose payments from drug, device manufacturers

New legislation inspired by a Studio City woman’s failed breast reconstruction surgery would force doctors in California to tell their patients annually about any money or gifts they receive from drug and medical device companies. The federal Physician Payments Sunshine Act, a law signed in 2010, already requires the companies to report such payments to a public “Open Payments” database run by the Centers for Medicare and Medicaid Services. But proponents of Assembly Bill 1278 say the federal ac...
Tags: News, Congress, California, Senate, California News, Legislation, Sport, Soccer, Fda, Bill, Local News, Cma, Nazarian, U S Food and Drug Administration, Assembly, South Bay


How Pfizer and BioNTech made history with their vaccine

Wondering how Pfizer and partner BioNTech developed a COVID-19 vaccine in record time without compromising safety? Dr Bill Gruber, SVP of Pfizer Vaccine Clinical Research and Development, explains the process from start to finish."I told my team, at first we were inspired by hope and now we're inspired by reality," Dr Gruber said. "If you bring critical science together, talented team members together, government, academia, industry, public health officials—you can achieve what was previously th...
Tags: Health, Science, Technology, Innovation, Fda, Pfizer, Vaccines, Gruber, Food and Drug Administration FDA, EUA, BioNtech, Bill Gruber, Pfizer Vaccine Clinical Research and Development


Danessa Myricks Mermaid & Parade Colorfix Foils Reviews & Swatches

Mermaid Danessa Myricks Mermaid Colorfix FoilsDanessa Myricks Mermaid Colorfix Foils ($18.00 for 0.34 fl. oz.) is a brighter, medium blue with subtle, cool undertones and a sparkling, metallic finish. It had semi-opaque, buildable pigmentation that was best applied in thinner layers. I’d highly recommend squeezing out a little product onto the back of your hand or onto a metal palette, then picking up product with a fluffy brush to ...
Tags: Beauty, Sydney, Fda, Christine, Stila, Eye Products, Cream Eyeshadow, Pigmentation, Temptalia, BH Cosmetics Foil Eyes, Danessa Myricks, Becca Abalone LE, Summer 2021, Danessa Myricks Mermaid Parade Colorfix Foils, Hydroxyethylcellulose Carbomer Phenoxyethanol Mica


The US is scrambling to send promised vaccines abroad after the production plant that ruined millions of J&J vaccines may have tainted AstraZeneca shots

A person receives the AstraZeneca vaccine in Bologna, Italy on March 19, 2021. Michele Lapini/Getty Images Emergent BioSolutions in Baltimore ruined at least 15 million Johnson & Johnson vaccines earlier this year. 100 million AstraZeneca and Johnson & Johnson vaccines from the facility are under safety review. The US is scrambling to send vaccines from other manufacturers abroad, The New York Times reported. See more stories on Insider's business page. The US is working to replace ...
Tags: Science, US, Trends, New York Times, The Times, Food And Drug Administration, Astrazeneca, Fda, Pfizer, Biden, Baltimore, Johnson Johnson, Bologna Italy, Moderna, Coronavirus, Sarah Al Arshani


Orphazyme stock plunges after receiving CRL from FDA after review of NPC treatment

Shares of Orphazyme A/S undefined plummeted 54.3% in premarket trading Friday, after the Denmark-based biopharmaceutical company said...
Tags: Denmark, Fda, NPC, CRL


These communities remain at high risk for dangerous Covid-19 variants rapidly increasing in US, expert warns

By Travis Caldwell | CNN The country continued this week on a path to reopening from the Covid-19 pandemic, with major population centers such as New York and California pulling back on restrictions following increased vaccinations and lowered infections. Yet with overall vaccination rates in the US slowing this month when compared to highs in April, health officials are raising awareness about the uneven distribution of vaccines in different parts of the country. “I’m very unconcerned for peop...
Tags: New York, News, California, Cdc, White House, Virginia, India, US, California News, Sport, Cnn, Soccer, United States, Maine, Washington Dc, Delta


Orphazyme provides regulatory update from FDA on arimoclomol for Niemann-Pick disease type C

Orphazyme A/SCompany announcement        No. 16/2021Inside informationCompany Registration No. 32266355   Copenhagen – June 18, 2021...
Tags: Fda, Copenhagen, Niemann Pick


FDA approves antihistamine nasal spray for over-the-counter use

The U.S. Food and Drug Administration today approved a nasal antihistamine for nonprescription use through a process called a partial prescription to nonprescription switch.
Tags: Health, Fda, U S Food and Drug Administration


The 19 best true crime books, from the investigation of the Golden State Killer to a Truman Capote classic

If you buy through our links, we may earn money from affiliate partners. Learn more. Amazon; Alyssa Powell/Insider True crime books are nonfiction accounts of real crimes, such as unsolved murders by serial killers. The books in this list were recommended by true crime fans for their unique take on notable crimes. Want more books? Check out the best thrillers or best books to learn about climate change. True crime - nonfiction accounts of real crimes - is a quickly growing genre in near...
Tags: Amazon, Hollywood, Mississippi, Supreme Court, Australia, California, Steve Jobs, Trends, Ted, Fbi, Chicago, David, Harvey Weinstein, Northern Ireland, Kansas, Fda


Mobile dialysis startup eyes human trials in 2022 following encouraging animal study

This past year, three sheep in Canada have been wearing their kidneys on their sleeves. Or more aptly, in jackets on their fluffy backs.  These three sheep are part of an ongoing animal study run by the Buffalo, New York-based startup Qidni Labs, a company pursuing waterless and mobile blood purification systems. Qidni Labs was founded in 2014, has raised $1.5 million and is currently in the due diligence process leading up to another round of funding. Qidni Labs was also an award winner ...
Tags: Health, TC, Medicine, Cdc, US, Tech, Canada, Medicare, Fda, Buffalo, Biotech, Infection, Davita, Dialysis, Morteza, Fresenius


New Alzheimer's drug sets dangerous precedent

Doctors Reshma Ramachandran and Joe Ross write that normally, FDA approval of a drug means that the agency has done its due diligence in reviewing data from pivotal clinical trials, confirming that the drug has proven benefits that outweigh any known or potential risks. But this was not the case for the newly-approved Alzheimer's drug, Aduhelm.
Tags: Cnn, Fda, Joe Ross, Reshma Ramachandran