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  • Sanofi’s tolebrutinib receives EU CHMP endorsement for specific multiple sclerosis patients despite US FDA setback
    Sanofi's BTK inhibitor tolebrutinib is moving toward approval in the European Union for a subset of multiple sclerosis patients. The Committee for Medicinal Products for Human Use (CHMP) of the Eu…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Avalyn Pharma targets $182M IPO as WHO prequalifies Novartis malaria drug
    Avalyn Pharma announced plans for an initial public offering that could raise about $182 million in net proceeds. The company is developing inhaled formulations of drugs already approved for pulmon…
    Endpoints · 4mo agoDealNeutral↗ source
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  • Novartis withdraws EU filing for Pluvicto label expansion into early-stage prostate cancer
    Novartis announced it has pulled its application to the European Medicines Agency to extend the label of its radioligand therapy Pluvicto for use in earlier stages of prostate cancer. The move com…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • Lilly shares slide as Foundayo prescriptions lag expectations, while Novo's Wegovy gains momentum
    Eli Lilly's stock fell nearly 5% after the latest weekly prescription count for its obesity drug Foundayo missed analysts' expectations. IQVIA data showed U.S. prescriptions for Foundayo reached 3…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • FDA grants fast-track vouchers to three psychedelic firms
    The FDA announced it has issued fast-track development vouchers to three companies working on psychedelic therapies. The recipients are R&DCompass, Transcend, and the Usona Institute. The vouchers…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • UC Berkeley spinout explores gene-editing approach to GLP-1 based weight-loss therapy
    UC Berkeley researchers have launched a startup that plans to use jumping genes to deliver GLP-1 gene therapy for obesity treatment. The approach seeks to create a long-lasting source of the hormon…
    Endpoints · 4mo agoNeutral↗ source
  • Daiichi Sankyo delays release of annual results, shares fall
    Daiichi Sankyo announced it will postpone the reporting of its annual results, saying more time is needed to finalize the numbers. The company had planned to unveil the financials for its fiscal y…
    Endpoints · 4mo agoNegative↗ source
  • Pfizer strategy chief Andrew Baum departs, stays on as senior advisor; Helus Pharma appoints new CEO after two months
    Andrew Baum, formerly chief strategy and innovation officer at Pfizer, has left that role. He will continue to work with the company as a senior strategic advisor to CEO Albert Bourla. Meanwhile,…
    Endpoints · 4mo agoNeutral↗ source
  • Regeneron secures first FDA approval for gene therapy treating rare inherited hearing loss
    Regeneron announced that the U.S. Food and Drug Administration has approved its gene-based treatment Otarmeni, marking the first approval of a therapy for inherited hearing loss. The therapy is de…
    Endpoints · 4mo agoApprovalPositive↗ source
  • FDA approves Regeneron’s Otarmeni gene therapy for rare inherited hearing loss
    The FDA has approved Otarmeni, a gene therapy from Regeneron, marking the first therapy cleared under the agency’s national priority voucher program and will be provided to eligible patients at no…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • AbbVie to invest $1.4 billion in new 185-acre manufacturing campus in Durham, North Carolina
    AbbVie announced a $1.4 billion investment to build a large manufacturing campus in Durham, North Carolina. The 185-acre site will focus on producing small-volume parenteral medicines such as vial…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Novartis' Lutathera radioligand therapy may soon face first generic challenger
    Novartis has built a sizable business delivering radioligand therapies, with Lutathera being a leading product. A rival company is preparing to launch the first generic version, which could introd…
    Endpoints · 4mo agoNegative↗ source
  • Substance-use disorder biotech Tempero Bio shuts down after serious safety incident
    Tempero Bio, a biotech focused on treatments for substance use disorders, announced it will cease operations. The decision follows a serious adverse event that occurred during the company's develo…
    Endpoints · 4mo agoNegative↗ source
  • Trump nominates former deputy surgeon general Erica Schwartz as CDC director, testing MAHA influence
    President Trump has announced Erica Schwartz, a former deputy surgeon general, as the new CDC director. Schwartz is known for supporting vaccination and is seen as a traditional public‑health choic…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Roche, facing biosimilar threats, puts faith in new cancer and obesity drugs
    On a conference call, executives claimed that a closely watched breast cancer pill and portfolio of weight loss medicines could bank more than $9 billion annually.
    BioPharma Dive · 4mo ago↗ source
  • David Reese to retire from Amgen
    Longtime Amgen leader David Reese is retiring at the end of June, Amgen announced Wednesday evening. Reese, 63, currently serves as chief technology officer, a role he created at Amgen in 2023 ...
    Endpoints · 4mo ago↗ source
  • Sanofi posts upbeat sales as R&D pressure builds
    A string of research setbacks have left the pharmaceutical giant at a crossroads just as a new CEO is set to take over. But positive first-quarter earnings provided the company with a needed boost.
    BioPharma Dive · 4mo ago↗ source
  • The Godmother of Silicon Valley is helping launch an AI healthcare residency program
    Esther Wojcicki wants to help healthcare startup co-founders get along. That might seem simple, but co-founder disagreements are a big contributor to startups falling apart, she said. She’s got the…
    Endpoints · 4mo ago↗ source
  • Novo's pill for kids; Altimmune’s $225M offering; Merck teams with Google Cloud
    Novo Nordisk’s GLP-1 pill works in kids with diabetes: Type 2 diabetes patients aged 10 to 17 who took Rybelsus for about six months had a statistically significant 0.83% cut in their blood sugar l…
    Endpoints · 4mo ago↗ source
  • Amneal to buy a biosimilar company; Samsung Bio workers protest
    Plus, news about Avonik, a supply chain transparency bill and Nucleus RadioPharma: 💰 Amneal Pharmaceuticals to acquire biosimilar maker for $375M upfront: The generics and specialty drugmaker is s…
    Endpoints · 4mo ago↗ source
  • Endpoints wins Neal Awards for Trump and gene editing coverage, JPM event
    Endpoints News was recognized with three 2026 Neal Awards for its coverage of the drug industry's relationship with the Trump administration, a three-part series on the future of CRISPR gene editin…
    Endpoints · 4mo ago↗ source
  • Gravity Rail raises $2.75M from Redesign Health for AI patient communication
    A startup that helps healthcare providers handle calls, texts and follow-ups with patients using AI has raised seed funding, Endpoints News learned exclusively. Gravity Rail handles the process of…
    Endpoints · 4mo ago↗ source
  • Roche says its investigational breast cancer pill could outsell Herceptin
    Roche still has high sales hopes for its breast cancer pill giredestrant despite the drug’s failure in a first-line trial earlier this year. CEO Thomas Schinecker said Thursday that the drug could ...
    Endpoints · 4mo ago↗ source
  • Sanofi defends Garijo appointment, says it is 'fully committed' to immunology
    Sanofi’s first-quarter earnings call with the media on Thursday was an exercise in redirecting the narrative before its new CEO steps in next week. CFO François-Xavier Roger defended the company’s…
    Endpoints · 4mo ago↗ source
  • OpenAI's head of health lays out the AI giant’s healthcare ambitions
    OpenAI is launching ChatGPT for Clinicians, a free tool for doctors, nurse practitioners, physician assistants and pharmacists. It’s the latest product the AI giant has launched within healthcare,…
    Endpoints · 4mo ago↗ source