Day: July 29, 2021

Biden wants $100 rewards for those who get vaccinated against Covid-19 — but there’s little he can do to make it happen

WASHINGTON – President Biden wants states to give $100 to people who get vaccinated against Covid-19. He wants to require federal workers to get immunized. He wants the same for members of the military, too. It remains entirely unclear, however, whether he has the power to achieve those goals. Read the rest…

Listen: The quest for a Covid pill, a microbiome gut-check, & CRISPR on the big screen

How long do vaccines last? Is the microbiome overhyped? And who should play Jennifer Doudna in a movie? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss the CDC’s about-face on mask wearing, the debate over vaccine booster shots, and the slow but steady race to […]

Opinion: Clinical research doesn’t reflect the Alzheimer’s population. That needs to change

New data from the National Institute on Aging (NIA), part of the National Institutes of Health, show that our nation needs a fundamental shift in how Alzheimer’s research and clinical trials are designed and funded to overcome urgent health equity challenges. Alzheimer’s — a progressive brain disease that slowly erodes memory and executive function over […]

STAT+: FDA threatens to fine another drug maker for failing to report clinical trial results

For only the second time, the Food and Drug Administration is threatening to fine a drug maker for failing to submit required information about a clinical trial to a U.S. government registry. In a July 26 letter, the agency noted results of Phase 2 clinical test of a drug for treating acne rosacea had not […]

STAT+: Congress presses the FDA to move faster on ALS drugs

WASHINGTON — Lawmakers pressed a top Food and Drug Administration official Thursday for answers on why the agency has balked at approving medicines to treat the fatal neurodegenerative condition ALS. Two key politicians even called out specific drug candidates by name, a rare congressional boost for the biotechs behind them. The questions came during a […]

Opinion: The FDA just broke the logjam on interchangeable biologics. Here’s what that decision means

The Food and Drug Administration’s decision on Wednesday to approve a long-acting insulin called Semglee (insulin glargine-yfgn) as the first interchangeable biologic licensed for the U.S. market represents a major step forward to greater competition and access for patients. What it means in practice, however, depends on where you sit. The term “interchangeable” sounds simple […]

STAT+: New research exploring centenarians’ gut microbiomes reveals a potential clue to their longevity

New research into the microbiomes of centenarians reveals a potential clue to their longevity, adding to the scientific understanding that bacteria in the gut have major implications for our ability to fight disease. People who live past their 100th birthday are more likely to carry certain bacteria in their gut that produce powerful antimicrobial compounds, […]

STAT+: Pharmalittle: Emergent to resume Covid-19 vaccine production; FDA OKs first interchangeable biosimilar insulin

Hello, everyone, and how are you today? We are just fine, thank you, despite gray skies hovering over the Pharmalot campus. Despite the looming rain, our spirits remain sunny. As the Morning Mayor taught us long ago: Every new day should be unwrapped like a precious gift. So while you tug on the ribbon, we […]

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