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  • Novo Nordisk Indiana plant faces FDA re-inspection after hair found in drugs and roof leaks threaten sterility
    Novo Nordisk's fill‑finish facility in Bloomington, Indiana underwent a follow‑up FDA inspection in April. The agency reported mammalian hair in finished drug containers and identified water leaks…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Otsuka presents new data to bolster full approval bid for Voyxact in IgA nephropathy
    Otsuka Pharmaceutical announced that new clinical evidence has been generated for its monoclonal antibody Voyxact, aimed at treating IgA nephropathy, a chronic autoimmune kidney disease. The data,…
    Endpoints · 3mo agoRegulatoryPositive↗ source
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  • Supreme Court rules generic maker Hikma does not infringe Amarin patents, easing skinny-label lawsuits
    The U.S. Supreme Court issued a unanimous decision that Hikma Pharmaceuticals did not violate patents owned by Amarin. The high court overturned a lower court ruling that had favored the brand name…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Dimension Capital targets up to $750M for third life-sciences fund after strong portfolio performance
    Dimension Capital, a New York and San Francisco-based investment firm that blends machine learning with life-science ventures, announced it is launching its third fund. The firm is seeking up to $…
    Endpoints · 3mo agoDealPositive↗ source
  • FDA reinspects Novo Nordisk's Indiana plant, finds mammalian hair and roof leaks compromising drug sterility
    Novo Nordisk's manufacturing facility in Indiana, acquired from Catalent, has undergone a second FDA reinspection after earlier concerns. The April inspection revealed mammalian hair in finished d…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Hikma invests $267 million in Ohio as Cingulate receives CRL for ADHD candidate
    Hikma Pharmaceuticals, a generic drugmaker, announced a $267 million investment to expand its manufacturing footprint in Ohio. The plan includes $216 million to upgrade its existing Columbus plant…
    Endpoints · 3mo agoDealNeutral↗ source
  • Novo Holdings invests €500 million in Europe-focused fund as Alnylam advances second obesity drug to clinic
    Novo Holdings, the investment arm of the Novo Nordisk Foundation, has committed €500 million to the Scaleup Europe Fund, a vehicle aimed at supporting European biotech scale‑ups. Alnylam Pharmaceu…
    Endpoints · 3mo agoDealPositive↗ source
  • Alnylam partners with Inceptive Nucleics on AI deal that could reach $2 billion
    Alnylam Pharmaceuticals announced a partnership with Inceptive Nucleics to apply artificial‑intelligence tools to its RNA‑based drug discovery program. The agreement provides an upfront $30 millio…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • AI pioneer Jakob Uszkoreit’s Inceptive Nucleics teams with Alnylam as biotech lobby pushes Congress for DNA safeguards
    Jakob Uszkoreit, one of the architects behind the transformer model that powers ChatGPT, has turned his attention to drug development. His new venture, Inceptive Nucleics, is creating biological fo…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Grail’s Galleri multi-cancer early detection trial misses primary endpoint, but oncologists note promising signals
    The first randomized trial of a multi-cancer early detection test enrolled about 143,000 English adults aged 50 to 77. Participants were randomly assigned to receive either standard care or the Gal…
    STAT · 3mo agoNegative readoutNeutral↗ source
  • Promising pancreatic cancer drug daraxonrasib shows near-double survival, patients await expanded access
    Amy Johnston, diagnosed with pancreatic cancer last year, has undergone chemotherapy and surgery and is now in a clinical trial that hopes to delay disease progression. She expects results by the e…
    STAT · 3mo agoPositive readoutNeutral↗ source
  • Lilly and Boehringer cut German investments amid health-spending overhaul
    A proposed overhaul of Germany's health-insurance financing is sparking criticism from industry groups. Eli Lilly and Boehringer Ingelheim announced they will reduce their investment programmes in…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Supreme Court unanimously backs Hikma's skinny label fish oil generic
    The U.S. Supreme Court issued a unanimous decision favoring Hikma Pharmaceuticals in a dispute over its skinny label version of a prescription-strength fish oil product. The court ruled that Hikma…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Eli Lilly cuts German weight-loss syringe investment by half amid new cost-cutting law
    Eli Lilly said it will cut its planned investment in Germany for the production of weight‑loss syringes. The company had originally earmarked $2.67 billion, but will now invest roughly half that a…
    STAT · 3mo agoDealNegative↗ source
  • Parabilis Medicines targets over $400 million in Nasdaq IPO to fund peptide pipeline
    Parabilis Medicines, a peptide-focused biotech led by former Johnson & Johnson R&D head Mathai Mammen, announced plans for a Nasdaq initial public offering. The company aims to raise more than $40…
    Endpoints · 3mo agoDealPositive↗ source
  • ADC Therapeutics' Zynlonta confirmatory trial shows higher death rates, clouding full approval prospects
    ADC Therapeutics is pursuing full FDA approval for its antibody-drug conjugate Zynlonta in patients with relapsed or refractory diffuse large B-cell lymphoma. In the confirmatory study presented,…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Revolution Medicines eyes broader use of daraxonrasib pending FDA submission
    Revolution Medicines' daraxonrasib has not yet been approved for metastatic pancreatic cancer after chemotherapy, but a recent ASCO plenary presentation generated strong interest. Analysts expect…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Lawmakers backtrack on promised Medicaid protections for cancer patients, new CMS rules impose work requirements
    Gwen Nichols, a hematologist/oncologist and chief medical officer of Blood Cancer United, wrote that lawmakers who pledged to protect cancer patients from Medicaid cuts are now backing a policy tha…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Patient-focused AI apps turn smartphones into real-time visit scribes
    More than a quarter of U.S. medical practices now rely on AI-powered ambient scribes that record appointments and draft clinical notes for doctors. The technology, initially deployed for clinicians…
    STAT · 3mo agoDealPositive↗ source
  • ADC biotech Ona Therapeutics raises $86.6M in Series B to move two ADC candidates toward clinic
    Barcelona-based Ona Therapeutics announced a $86.6 million Series B financing round. The capital will be used to move two antibody‑drug conjugate (ADC) programs into early‑stage clinical testing.…
    Endpoints · 3mo agoDealPositive↗ source
  • Spanish biotech Ona Therapeutics secures $86.6 million Series B to advance new ADCs for breast and colorectal cancer
    Ona Therapeutics, a Barcelona‑based biotechnology startup, announced a Series B financing round that raised roughly $86.6 million. The new capital will fund the launch of two antibody‑drug conjuga…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Trump admin moves to politicize NIH grant officials, stripping job protections
    The White House issued an executive order that reclassifies thousands of civil‑service positions as political appointments under the so‑called Schedule F. The change would allow the administration…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Drug makers and patient groups call on FDA to suspend fast‑track voucher program
    The FDA held a town‑hall listening session on its Commissioner’s National Priority Voucher program, hearing from 17 speakers that included patient advocates, pharmaceutical companies and academic r…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Otsuka's Voyxact reduces kidney function decline in IgA nephropathy but falls short of expectations in Phase 3
    Otsuka reported Phase 3 trial results for its drug Voyxact in patients with IgA nephropathy, a chronic autoimmune kidney disease. In the study, patients receiving Voyxact experienced an annualized…
    STAT · 3mo agoNegative readoutNeutral↗ source
  • Acting FDA Commissioner Kyle Diamantas says he will not seek permanent appointment
    Acting FDA Commissioner Kyle Diamantas has indicated that he does not intend to remain in the role on a permanent basis. Sources close to the administration say that the search for a new permanent…
    Endpoints · 3mo agoRegulatoryNeutral↗ source