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  • Vera Therapeutics receives accelerated approval for Trutakna to treat IgA nephropathy
    Vera Therapeutics announced that its fusion protein atacicept, branded as Trutakna, has been granted accelerated approval by the FDA for the treatment of immunoglobulin A nephropathy, a chronic aut…
    Endpoints · 1mo agoApprovalPositive↗ source
  • FDA greenlights Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has approved a new therapy from Vera Therapeutics aimed at treating IgA nephropathy, a chronic autoimmune kidney disorder. The drug, called Trutakna, is intended for patients with this con…
    STAT · 1mo agoApprovalPositive↗ source
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  • Oberland invests up to $400M in MeiraGTx eye gene‑therapy pipeline
    Oberland Capital Management announced a financing package that could total $400 million to support MeiraGTx's development of gene therapies for inherited eye disorders. The arrangement includes up…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Kailera's oral GLP-1 pill shows ~10% weight loss in Chinese Phase 3 trial
    Kailera Therapeutics reported that its oral GLP-1 candidate HRS-7535 achieved about 10% average weight loss over 44 weeks in a Phase 3 study in China. The highest daily dose led to a mean 9.8% red…
    BioPharma Dive · 1mo agoPositive readoutNeutral↗ source
  • Tampa General Hospital sues Eli Lilly over 340B discount halt
    Tampa General Hospital filed a lawsuit against Eli Lilly, alleging the drugmaker stopped providing 340B program discounts to the hospital. The dispute centers on Lilly's new requirement that hospi…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • STAT+: The crumbling employer-based health insurance system
    Today's D.C. Diagnosis newsletter covers maintaining diversity in drug trials and troubling trends in employer-based health insurance.
    STAT · 1mo ago↗ source
  • Compass Pathways touts durability data for psilocybin drug in depression ahead of year-end filing
    Compass Pathways said Tuesday that patients in the second of its two pivotal psilocybin trials maintained their response to treatment for at least six months, keeping the company on track to comple…
    Endpoints · 1mo ago↗ source
  • Hengrui, Kailera's GLP-1 pill posts encouraging efficacy but high side effect rates in late-stage China trials
    The GLP-1 pill being developed by Hengrui Pharma and Kailera Therapeutics posted decent results in two late-stage China-based trials — one in obesity and the other in diabetes. But the safety profi…
    Endpoints · 1mo ago↗ source
  • STAT+: Compass says depression drug has long-lasting benefits
    Vertex makes its largest-ever deal, skyrocketing health insurance costs, and more biotech news from The Readout
    STAT · 1mo ago↗ source
  • STAT+: America’s employer health insurance is decaying
    STAT's Bob Herman examines the under-the-radar crisis brewing in employer-based health insurance.
    STAT · 1mo ago↗ source
  • Novartis, Vertex and Ipsen extend pharma M&A spree from 2026's first half
    Biopharma's M&A engine is revved up and shows no signs of cooling off. Four companies have announced acquisitions in the first six days of July, forging deals that could pay out as much as $12.6 ...
    Endpoints · 1mo ago↗ source
  • MeiraGTx strikes royalty deal; Fore's 2023 Series D continues
    Plus, news about Kalohexis, Teva and Agios: 👑 MeiraGTx makes royalty deal with Oberland Capital: The gene therapy maker will get an initial $135 million via a $10 million equity investment ...
    Endpoints · 1mo ago↗ source
  • STAT+: ‘Secret shopper’ study probes GLP-1 telehealth sites
    In this edition of STAT Health Tech: A 'secret shopper' study of telehealth sites prescribing GLP-1s, news about Epic, Anthropic, and brain implants.
    STAT · 1mo ago↗ source
  • Conquering Medicare's ACCESS program
    There was so much excitement when CMS announced the ACCESS program. Finally, a way for digital health companies to make their mark on Medicare! A program that pays only if patients get better! But…
    Endpoints · 1mo ago↗ source
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    BioPharma Dive · 1mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about a $10 billion Vertex deal, the pace of FDA drug approvals, and more
    Vertex Pharmaceuticals will spend $10 billion to acquire Crinetics Pharmaceuticals and its drug for a rare endocrine disorder
    STAT · 1mo ago↗ source
  • How digital health companies are planning to conquer CMS ACCESS
    A new Medicare experiment to manage seniors’ chronic diseases will pay some digital health companies only about as much in a year as they might earn for a couple of patient visits from commercial i…
    Endpoints · 1mo ago↗ source
  • Ebola outbreak exposes a fractured outbreak response system
    The costly threat to employer-based health care, Gen Z doctors, and more health news
    STAT · 1mo ago↗ source
  • Vera Therapeutics wins FDA nod for closely watched kidney disease drug
    The clearance marks another step forward in treatment for IgA nephropathy and sets up a commercial battle with Otsuka, which brought a similar medication to market last year.
    BioPharma Dive · 1mo ago↗ source
  • STAT+: For a Georgia entrepreneur, health coverage has never been affordable
    Amy Bielawski is one of the 30 million people who run their own businesses. She's gone most of her life without health insurance.
    STAT · 1mo ago↗ source
  • STAT+: America’s small businesses are giving up on health insurance
    America's employer-based health insurance system is crumbling. STAT investigates why, in our new series, “Out of Pocket, Out of Reach.”
    STAT · 1mo ago↗ source
  • STAT+: This whistleblower took on a health insurance giant and a political machine. She’s not stopping there
    America’s employers must stop acting helpless in the face of health care industry profiteering, Chris Deacon says.
    STAT · 1mo ago↗ source
  • Opinion: What if this Ebola outbreak can’t be stopped?
    In the past, the possibility of endemic Ebola was unthinkable. This time is different, write Ivan Buendia Gayton and Eric D. Perakslis.
    STAT · 1mo ago↗ source
  • 5 takeaways from STAT’s series on the soaring cost of health insurance
    Read the 5 key takeaways from STAT's series "Out of Pocket, Out of Reach," an examination of workplace health insurance.
    STAT · 1mo ago↗ source
  • French gene therapy biotech gets €33M to follow Krystal's blueprint
    A small French-US biotech has gathered more funds to see if it can follow in the footsteps of Krystal Biotech in the HSV-based gene therapy field, but in a different therapeutic area. Cyllene Thera…
    Endpoints · 1mo ago↗ source