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  • FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to rena…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Vertex to buy Crinetics for $10 billion, expanding into endocrine disease drugs
    Vertex announced an agreement to acquire Crinetics Pharmaceuticals for $10 billion in cash, paying $85 per share. The purchase brings two recently launched drugs for a rare hormonal disorder into…
    BioPharma Dive · 3mo agoDealNeutral↗ source
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  • CMS launches ACCESS program to reward Medicare digital health solutions that improve outcomes
    The Centers for Medicare & Medicaid Services introduced the ACCESS program, a new initiative that invites digital health companies to participate in Medicare. The program ties Medicare payments to…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • 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 · 3mo 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 · 3mo agoPositive readoutNeutral↗ source
  • STAT newsletter highlights the decline of employer-based health insurance in the U.S.
    John Wilkerson, a Washington correspondent for STAT, writes the D.C. Diagnosis newsletter that focuses on health policy. In this edition he turns his attention to the weakening of the employer-base…
    STAT · 3mo agoNegative↗ source
  • Hengrui and Kailera's oral GLP-1 pill shows promising efficacy but notable side effects in Chinese obesity and diabetes trials
    Hengrui Pharma and Kailera Therapeutics reported results from two late‑stage trials in China, one targeting obesity and the other diabetes, using their daily oral GLP‑1 pill. The studies demonstrat…
    Endpoints · 3mo agoPositive readoutNeutral↗ source
  • STAT+ warns that employer-sponsored health insurance is deteriorating, leaving workers and businesses exposed
    Bob Herman's latest STAT+ newsletter introduces a new series called Out of Pocket, Out of Reach, which will examine how the employer-based health-insurance system is falling apart. The article not…
    STAT · 3mo agoNegative↗ source
  • Novartis, Vertex and Ipsen announce new acquisitions as M&A activity surges in early July 2026
    Biopharma’s merger and acquisition engine remains robust, with four companies revealing new deals within the first six days of July. The announcements add to a total of 45 acquisitions reported in…
    Endpoints · 3mo agoDealPositive↗ source
  • MeiraGTx secures $135 million royalty deal with Oberland Capital
    MeiraGTx announced a royalty financing agreement with Oberland Capital. The deal provides the gene-therapy company with an initial $135 million, including a $10 million equity investment from Oberl…
    Endpoints · 3mo agoDealPositive↗ source
  • Secret shopper study examines GLP-1 prescribing practices on telehealth platforms
    STAT Health Tech newsletter reports a secret shopper study that evaluated how telehealth sites prescribe GLP-1 drugs. The study involved researchers posing as patients to assess prescribing behavi…
    STAT · 3mo agoNeutral↗ source
  • Ebola outbreak highlights gaps in response system
    The recent Ebola outbreak has underscored serious shortcomings in the global and national mechanisms designed to detect and contain emerging infections. Analysts note that the fragmented response…
    STAT · 3mo agoNegative↗ source
  • Small U.S. Businesses Struggle to Provide Health Insurance as Coverage Rates Slip
    America's employer-based health insurance system is becoming unsustainable for small businesses, which form the backbone of many communities. The share of working-age adults receiving coverage thr…
    STAT · 3mo agoNegative↗ source
  • Ebola outbreak in eastern DRC risks becoming a never-ending crisis, experts warn
    Ivan Buendia Gayton, a technologist and humanitarian adviser, and Eric D. Perakslis, an engineer and former MSF strategic adviser, co‑author an opinion piece on the latest Ebola flare‑up in eastern…
    STAT · 3mo agoNegative↗ source
  • Fresenius Kabi issues correction for Ivenix infusion pumps over battery health software bug
    The U.S. Food and Drug Administration has classified a correction for Fresenius Kabi’s Ivenix Large Volume infusion pump as the most serious type of recall. The action does not require removal of t…
    fda medwatch · 3mo agoCRLNegative↗ 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 · 3mo agoRegulatoryNegative↗ source
  • Compass Pathways reports six-month durability of response in pivotal psilocybin depression trial
    Compass Pathways announced that patients in the second of its two pivotal psilocybin trials for depression continued to show a therapeutic response for at least six months. The durability data sugg…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction
    Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become un…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Digital health firms eye CMS ACCESS Medicare pilot despite modest reimbursement
    A new Medicare initiative called CMS ACCESS is being launched to manage chronic diseases among seniors. The program will contract digital health companies to provide remote monitoring and other se…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • STAT series highlights rising workplace health insurance costs and shrinking coverage at small firms
    STAT's investigative series "Out of Pocket, Out of Reach" examines why employer-provided health insurance is becoming increasingly unaffordable for many American workers. One of the takeaways note…
    STAT · 3mo agoNegative↗ source
  • Cyllene Therapeutics raises €33 million to pursue HSV-based gene therapy after Krystal model
    Cyllene Therapeutics, a French-US biotech, announced it has secured €33 million in financing. The capital will be used to develop HSV-based gene therapy programs, aiming to replicate the approach…
    Endpoints · 3mo agoDealPositive↗ source
  • Whistleblower Chris Deacon helps secure $100 million settlement against Horizon Blue Cross Blue Shield
    Chris Deacon, a former health‑care employee turned whistleblower, spent months reviewing legal and financial records that alleged misconduct by Horizon Blue Cross Blue Shield. The investigation le…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Georgia entrepreneur struggles to afford health insurance after decades of self‑employment
    Amy Bielawski, a 61‑year‑old owner of an entertainment company in Tucker, Georgia, has spent most of her adult life without health insurance. For 32 years she has run a business that provides bounc…
    STAT · 3mo agoNegative↗ source
  • Vertex to buy Crinetics for $10 billion, adding acromegaly drug Palsonify
    Vertex Pharmaceuticals announced a $10 billion acquisition of Crinetics Pharmaceuticals, marking the largest deal in Vertex’s history. The purchase gives Vertex control of Crinetics’ marketed ther…
    STAT · 3mo agoDealPositive↗ source
  • Vertex to acquire Crinetics in $10 billion deal to expand endocrinology portfolio
    Vertex Pharmaceuticals announced it will acquire Crinetics Pharmaceuticals for $10 billion, the largest purchase in the company's history. The transaction is aimed at broadening Vertex's commercia…
    Endpoints · 3mo agoDealPositive↗ source