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  • Innovent Biologics reports Phase 3 success for stomach cancer ADC, now under priority review in China
    Innovent Biologics announced that its antibody‑drug conjugate (ADC) candidate has met the primary endpoint in a Phase 3 trial for advanced stomach cancer. The positive outcome has placed the produ…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Fulcrum Therapeutics cuts workforce, retaining only nine employees as layoffs hit 48 staff
    Fulcrum Therapeutics announced a dramatic reduction in its staff, letting go of 48 of its 57 full‑time employees. The move leaves the company with just nine remaining workers, effectively turning i…
    Endpoints · 3mo agoLayoffsNegative↗ source
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  • Analysts warn that PD-1/VEGF bispecific drugs may be better suited for liver cancer than lung cancer
    Many drugmakers have poured billions into PD-1/VEGF bispecific antibodies after ivonescimab beat Keytruda in a 2024 lung‑cancer trial, sparking a wave of deals and development programs. A recent C…
    BioPharma Dive · 3mo agoNeutral↗ source
  • Biotech lobby groups in Washington push to keep Chinese low-cost drug pipeline open amid rising anti-China proposals
    Washington biotech lobby groups are working to ensure a steady flow of affordable medicines that originate from Chinese manufacturers. These groups have become aware that they are encountering voc…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Industry and rare disease groups call for more transparency in FDA voucher pilot
    The pharmaceutical industry and rare‑disease advocacy groups have voiced concerns about the Commissioner's National Priority Voucher pilot program. Stakeholders say the program lacks transparency…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • House Appropriations Committee urges FDA to accelerate IND approvals for clinical trials
    The House Appropriations Committee issued a directive to the Food and Drug Administration, calling for reforms to speed up the Investigational New Drug (IND) sign-off process for new clinical trial…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Uli Stilz joins Flagship while Revolution Medicines adds Alex Hoffman as commercial lead
    On June 5, 2026, biotech veteran Uli Stilz announced his new position at Flagship, marking a notable personnel shift in the industry. Stilz has spent much of the year traveling internationally, in…
    Endpoints · 3mo agoNeutral↗ source
  • ADC Therapeutics shares plunge as Phase 3 trial of Zynlonta shows high death rate despite efficacy gain
    ADC Therapeutics reported Phase 3 data for Zynlonta combined with rituximab in a hard-to-treat blood cancer. The trial met its primary endpoint by extending progression-free survival versus standar…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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 · 3mo agoRegulatoryPositive↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 3mo agoDealNeutral↗ 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 · 3mo agoNeutral↗ source