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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 · 5mo 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 · 5mo agoRegulatoryPositive↗ source
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  • 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo agoDealPositive↗ 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 · 5mo 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 · 5mo agoRegulatoryPositive↗ 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 · 5mo 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 · 5mo agoRegulatoryNegative↗ 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 · 5mo agoDealPositive↗ 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 · 5mo agoRegulatoryNeutral↗ source
  • Acting FDA chief vows to shield rare-disease discussions from political influence
    Acting FDA Commissioner Kyle Diamantas met with executives from fifteen rare‑disease nonprofit groups and senior agency staff. During the gathering he emphasized a new approach that differs from th…
    Endpoints · 5mo agoRegulatoryPositive↗ source
  • Elevance Health’s chief digital officer discusses practical AI applications for insurers
    Elevance Health interviewed its chief digital information officer, Ratnakar Lavu, about how health insurers are adopting artificial intelligence. Lavu, who previously held digital roles at Kohl’s,…
    Endpoints · 5mo agoNeutral↗ source
  • Axsome secures settlement to keep Sunosi exclusive until 2040
    Axsome Therapeutics announced it has reached a settlement that pushes back the entry of generic versions of its narcolepsy medication Sunosi until 2040. The agreement was reached with the last rem…
    Endpoints · 5mo agoRegulatoryPositive↗ source
  • Regeneron expands partnership with CytomX as other pharma partners exit
    Regeneron announced it will deepen its collaboration with CytomX Therapeutics, a Bay Area biotech. The decision follows CytomX losing several partnership agreements with other large pharmaceutical…
    Endpoints · 5mo agoDealPositive↗ source
  • Eli Lilly signs up to $1.9B deal with Ascidian Therapeutics for RNA editing in kidney disease
    Ascidian Therapeutics recently presented early data indicating that its novel RNA‑editing approach to repair faulty genes appears safe in humans, focusing on kidney disease applications. Eli Lilly…
    Endpoints · 5mo agoDealPositive↗ source
  • Alnylam commits $30 million upfront to AI startup Inceptive for RNA research collaboration
    Alnylam Pharmaceuticals announced a new collaboration with Inceptive, a Silicon Valley biotech startup that focuses on RNA. The agreement includes an upfront payment of $30 million and is intended…
    Endpoints · 5mo agoDealPositive↗ source
  • Eli Lilly says its GLP-1 weight loss shot and pill now covered for millions of Americans
    Eli Lilly announced that its GLP-1 based weight-loss injection and oral medication have been added to the formularies of the three largest pharmacy benefit managers. The company said this move make…
    Endpoints · 5mo agoPositive↗ source
  • Mineralys Therapeutics raises funds ahead of pending lorundrostat hypertension approval
    Mineralys Therapeutics first came to market attention in 2021 when it licensed a novel hypertension candidate, lorundrostat, from Japan’s Tanabe Pharma, agreeing to a modest $1 million upfront paym…
    Endpoints · 5mo agoDealNeutral↗ source
  • FDA issues new guidance for pharma on discussing unapproved drugs with payors
    The FDA has released guidance aimed at biopharma companies that are preparing to launch new therapies before they receive formal approval. The advice focuses on how companies can inform health-pla…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
  • Bristol Myers Squibb assesses AI spending after deploying tools to thousands of staff
    Bristol Myers Squibb has recently provided artificial intelligence applications to a large portion of its workforce. The company is now turning its attention to measuring the cost of these tools a…
    Endpoints · 5mo agoNeutral↗ source
  • FDA releases draft guidance to speed cell and gene therapy approvals
    The FDA announced a draft guidance aimed at helping developers bring gene therapies to patients more quickly. It encourages use of publicly available scientific data and existing platform knowledge…
    fda press · 5mo agoRegulatoryNeutral↗ source
  • Roche reports narrow failure of breast cancer pill in Phase 3 trial at ASCO
    Roche updated investors and the oncology community that its experimental breast cancer oral therapy did not meet its primary endpoint in a pivotal Phase 3 study. The data, presented at the America…
    Endpoints · 5mo agoNegative readoutNegative↗ source
  • Allen Institute launches multi-hundred-million-dollar effort to turn brain atlas data into neurodegenerative drug candidates
    The Allen Institute, a Seattle nonprofit known for basic brain research, announced a major new effort to move its brain‑atlas knowledge toward drug development. The program will invest several hun…
    Endpoints · 5mo agoPositive↗ source