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  • Biotech firms must adopt global regulatory strategies to commercialize drugs independently
    Biotech developers are increasingly able to fund the pursuit of regulatory approval and commercial launch on their own, rather than selling their assets early. This new option is driven by a reboun…
    BioSpace · 12d agoRegulatoryPositive↗ source
  • Formation Bio raises $600 million fund to expand AI-driven drug licensing and testing model
    Formation Bio, an AI-focused biotech that builds value by acquiring external drug assets, developing them and then transferring them to partners, announced a new financing round. The company secur…
    Endpoints · 12d agoDealPositive↗ source
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  • Analysts Question Biogen's Lupus Drug Litifilimab Ahead of Key Phase 3 Readouts
    Analysts pressed Biogen CEO Chris Viehbacher during a recent call, focusing on the company's late‑stage pipeline. The discussion centered on litifilimab, Biogen’s experimental lupus therapy, with…
    Endpoints · 12d agoNeutral↗ source
  • Chinese biotech BioGeometry secures over $100 million Series A for AI-driven protein design
    BioGeometry, a four-year-old biotech startup based in Beijing, announced it has closed a Series A financing round of more than $100 million. The capital will be used to expand its artificial-intel…
    Endpoints · 12d agoDealPositive↗ source
  • Merck and Moderna vaccine data leak ahead of ESMO, Merck's sac-TMT cuts endometrial cancer deaths, BMS reports CAR-T death
    A data leak of the highly anticipated personalized cancer vaccine being developed by Merck and Moderna surfaced online before the European Society for Medical Oncology (ESMO) meeting. The premature…
    BioSpace · 12d agoNeutral↗ source
  • Former Novo and Sanofi staff describe mixed layoff experiences, citing severance benefits and poor communication
    Three former employees of large pharmaceutical companies, including Novo and Sanofi, spoke to BioSpace about how they were let go. Their accounts form part of a broader survey that collects layoff…
    BioSpace · 12d agoLayoffsNegative↗ source
  • Zocdoc pushes AI personal agents into healthcare as other sectors restrict their use
    Zocdoc is positioning AI personal agents to take on patient‑focused tasks, signaling a new direction for health‑tech services. While Amazon, Delta Air Lines and several major U.S. banks have block…
    Endpoints · 12d agoPositive↗ source
  • Survey finds 78% of scientists expect AI to accelerate drug discovery this year
    Endpoints Signal surveyed roughly 1,500 biopharma insiders about AI's near-term impact on drug discovery. The respondents included a broad mix of industry roles. While scientists had been the most…
    Endpoints · 12d agoPositive↗ source
  • Astellas secures exclusive option on Audax Biosciences preclinical IL-12 cancer drug
    Astellas has taken an exclusive option to license a preclinical immuno-oncology asset from Audax Biosciences, an Australian biotech company. The asset is an IL-12 based cancer therapeutic that is…
    Endpoints · 12d agoDealNeutral↗ source
  • GSK vaccine sales miss expectations amid falling demand from adults
    With pressure on GSK’s vaccine business, analysts predict the U.K. pharma will face challenges as it prepares for the loss of exclusivity on a key product.
    BioSpace · 12d agoRegulatoryNeutral↗ source
  • HHS pauses enforcement of ban on compounding wellness peptides as FDA drafts new rules
    HHS announced it will temporarily stop enforcing the existing prohibition on the compounding of certain peptides marketed for wellness. The agency said the move is intended to protect consumer saf…
    Endpoints · 12d agoRegulatoryNeutral↗ source
  • Biopharma leader urged to prioritize own job search after team layoffs
    A biopharma executive recently had to announce a downsizing of her team, and she described feeling guilt and grief for the impact on her direct reports. She said she would wait until every person…
    BioSpace · 12d agoLayoffsNeutral↗ source
  • Genmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
    Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
    BioSpace · 12d ago↗ source
  • Lilly’s retatrutide trounces Novo’s Ozempic in diabetes, weight loss
    Eli Lilly’s next-gen weight loss drug retatrutide soundly beat Novo’s approved medicine Ozempic in weight loss and blood sugar reduction, padding the case for a regulatory application that’s expect…
    BioSpace · 12d ago↗ source
  • Lilly's triple-G drug retatrutide outshines Novo's Ozempic in diabetes
    Eli Lilly’s retatrutide, the incretin shot that has already proven its effectiveness against other assets on a cross-trial basis, has cemented its utility in a head-to-head trial, albeit in diabete…
    Endpoints · 12d ago↗ source
  • Incyte's KRAS G12D inhibitor shows 89% response rate in early pancreatic cancer trial
    In a Phase 1 study, Incyte tested its KRAS G12D inhibitor together with standard chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma carrying the G12D mutation. The combinati…
    BioSpace · 13d agoPositive readoutPositive↗ source
  • Novartis takes $1.9B write-down after Avidity's del-desiran fails Phase 3 but reaffirms confidence in $12B acquisition
    Novartis announced a $1.9 billion partial impairment after the Phase 3 HARBOR study of del-desiran, an antibody‑oligonucleotide conjugate from its Avidity Biosciences acquisition, did not meet its…
    BioSpace · 13d agoNegative readoutNeutral↗ source
  • Novartis reaffirms $12 billion Avidity acquisition despite $1.9 billion impairment loss
    Novartis said its $12 billion purchase of Avidity Biosciences remains on track, according to CEO Vas Narasimhan. The comment followed the company's disclosure of a $1.9 billion impairment charge t…
    Endpoints · 13d agoDealNeutral↗ source
  • US Treasury draft COINS rules could sharply limit China biotech partnerships
    US Treasury released a draft set of regulations known as the COINS rule that targets cross-border biotech transactions. The proposal would bar certain US-China deals and tighten oversight of collab…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Ferring agrees to buy fertility startup Gameto in deal up to $1.38 billion
    Ferring Pharmaceuticals announced it has signed an agreement to acquire Gameto, a biotech company developing an ovary-in-a-dish platform for fertility treatments. The transaction is structured as…
    Endpoints · 13d agoDealNeutral↗ source
  • Novartis weighs private-pay launches in Europe as MFN rules pressure government pricing
    Novartis CEO Vas Narasimhan said the company is exploring the option of introducing new medicines directly to private or self‑pay patients in Europe. The discussion is driven by the European Union…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Artiva Biotherapeutics to cease operations after two deaths in autoimmune cell therapy trials
    Artiva Biotherapeutics announced it will wind down and lay off nearly all staff following two patient fatalities in its autoimmune cell therapy trials. The deaths occurred during clinical testing…
    Endpoints · 13d agoNegative↗ source
  • Biopharma optimism climbs after FDA commissioner Makary's exit, survey finds
    Endpoints Signal released its Q3 Biopharma Sentiment Index, showing the highest level of industry optimism in years, according to a survey of 569 insiders. The index’s regulatory score rose sharpl…
    Endpoints · 13d agoRegulatoryPositive↗ source
  • Alphabet’s GV tops biotech corporate investors with $5.23 billion in deals since 2025
    Alphabet’s venture arm GV has become the largest corporate spender in biotech, investing a cumulative $5.23 billion across 20 deals since the start of 2025. The total outlay exceeds the combined v…
    BioSpace · 13d agoNeutral↗ source
  • Gubra aims to expand beyond obesity drugs, targets first portfolio partner this year
    Copenhagen‑based biotech Gubra is currently known for its obesity drug candidates, but the company says its long‑term growth will depend on a broader pipeline beyond metabolism. The firm’s existin…
    Endpoints · 13d agoNeutral↗ source