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668 stories matching this filter · ← front page

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  • Opinion: STAT+: China’s strict new supply chain regulations could create massive problems for Western biopharma companies
    China is now a peer competitor in drug innovation — and it intends to stay that way on its own terms, writes Dennis Kwok.
    STAT · 4mo ago↗ source
  • Federal appeals court blocks mailing of abortion pill mifepristone
    Mifepristone, involved in most abortions in the U.S., can now be distributed only in person and at clinics.
    STAT · 4mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about obesity drugs and a compounding list, an AstraZeneca setback, and more
    The FDA proposed excluding the active ingredients in popular obesity and diabetes drugs from a list of substances that can be used for compounded versions
    STAT · 4mo ago
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  • STAT+: Her daughter Mila got a bespoke medicine. Now she’s starting a new biotech to make more
    Efforts to make customized medicines at scale have hit commercial and regulatory roadblocks. Julia Vintarello is trying again.
    STAT · 4mo ago↗ source
  • Two biotechs raise a combined $556M in latest spurt of IPOs
    Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center
    Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.
    STAT · 4mo ago↗ source
  • UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy
    News of the submission, which would be the first for UniQure’s closely watched treatment, comes as the therapy faces an uncertain future in the U.S.
    BioPharma Dive · 4mo ago↗ source
  • Avalyn, in pursuit of better lung drugs, banks $300M in an IPO
    The biotech will use the proceeds to develop inhalable versions of therapies already on the market for the “idiopathic” and “progressive” forms of pulmonary fibrosis.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: Supreme Court justices appear to signal ‘skinny labeling’ can survive
    At Wednesday's argument, the justices did not appear to question whether skinny labeling is valid.
    STAT · 4mo ago↗ source
  • Chiesi to buy KalVista in $1.9B deal for rare disease drug
    The acquisition is the fifth of a biotech company so far this week and, according to some Wall Street analysts, proves pharma’s interest in new and emerging oral therapies for hereditary angioedema.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: A patent win for Pfizer and BridgeBio
    A change to FDA clinical trial data review, Rocket sells its priority review voucher, and more biotech news from The Readout
    STAT · 4mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about the FDA speeding up trials, a Supreme Court hearing on ‘skinny labels,’ and more
    The FDA announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen
    STAT · 4mo ago↗ source
  • Opinion: The medical school nutrition blues
    “I don’t think anyone has the answers. But the conversation needs to start”: medical students on bringing a preventive mindset to medical education.
    STAT · 4mo ago↗ source
  • Opinion: STAT+: Did Kennedy just stack the deck on FDA oversight of peptides?
    RFK Jr. had long signaled that he was going to do something big on peptides. Now the moment has arrived.
    STAT · 4mo ago↗ source
  • In first meeting, federal autism committee focuses on ‘profound autism’
    The committee met for the first time since Kennedy fired most of the committee’s scientific experts and replaced them with activists and advocates.
    STAT · 4mo ago↗ source
  • STAT+: Health system CEOs get off easy at Congressional hearing on affordability
    Committee members largely blamed the other party’s health care policies for driving U.S. health care prices to levels inaccessible to many Americans.
    STAT · 4mo ago↗ source
  • STAT+: AIDS group sues Trump administration over undisclosed agreement with Gilead
    The AIDS advocacy group PrEP4All has sued the Trump administration over an undisclosed agreement with Gilead.
    STAT · 4mo ago↗ source
  • Opinion: Healthcare or health care? Help STAT decide
    Should STAT use “healthcare” or “health care”? We want to hear from you.
    STAT · 4mo ago↗ source
  • Opinion: FDA commissioner: ‘Smarter,’ real-time clinical trials could transform drug development
    “For the first time, FDA regulators will be able to see what’s happening in a clinical trial, looking at endpoints in the cloud as they occur,” writes FDA commissioner.
    STAT · 4mo ago↗ source
  • Pfizer deals extend patent life for a top-selling rare disease drug
    Settlements delaying the arrival of generic versions of tafamidis will protect billions in Pfizer revenue and have implications for others, including BridgeBio Pharma and Alnylam.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: Supreme Court to hear case about ‘skinny labeling’ and generic access
    The Supreme Court Wednesday will hear oral arguments about a simmering controversy over so-called skinny labels, with implications for the availability of generics.
    STAT · 4mo ago↗ source
  • Rocket's PRV goes for $180M; Oruka targets $500M offering
    Rocket sells PRV for $180M: The New Jersey gene therapy maker sold the rare pediatric disease priority review voucher to an undisclosed buyer. Rocket Pharmaceuticals got the PRV after securing FDA ...
    Endpoints · 4mo ago↗ source
  • FDA claims Amgen drug data were ‘manipulated’; Erasca slides despite ‘home run’ results
    Tavneos’ original developer hid a study analysis and then altered data, the FDA alleged. Elsewhere, Erasca’s RAS drug was met with skepticism and Rocket Pharma sold a voucher.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: Boehringer’s obesity drug shows 16.6% weight loss; more data needed
    Eli Lilly's deal with Profluent, Erasca's RAS-targeting cancer pill, and more biotech news today
    STAT · 4mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about warnings over Trump’s MFN plan, Purdue Pharma sentencing, and more
    The Novartis CEO warned that Trump's drug pricing policy poses a “very difficult situation” and the reality will soon catch up with drugmakers and patients
    STAT · 4mo ago↗ source