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  • Sanofi books over €1 billion impairment after ending eczema drug and halting two immunology programs
    Sanofi disclosed that it will record more than €1.03 billion in impairment charges for the second quarter. The bulk of the charge stems from the decision to terminate development of an eczema trea…
    Endpoints · 5h agoNegative↗ source
  • Johnson & Johnson prepares $2.58 billion option to acquire Sail Biomedicines, expanding in-vivo CAR-T portfolio
    Johnson & Johnson announced a $2.58 billion option agreement to purchase Sail Biomedicines, a Flagship Pioneering‑backed biotech focused on in‑vivo CAR‑T therapies. The deal includes an upfront pa…
    Endpoints · 10h agoDealNeutral↗ source
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  • Ipsen says €2 billion cash reserves give it firepower for more M&A
    Ipsen's CFO Aymeric Le Chatelier said the company ended June with €2 billion in cash, which it describes as "firepower" for acquisitions. The cash position gives the French biotech firm flexibilit…
    Endpoints · 32m agoDealPositive↗ source
  • Gerresheimer sells Centor and Primary Packaging Plastics units to Apax Partners for €1.5 billion
    Gerresheimer announced it is divesting two of its businesses, the Centor unit and the Primary Packaging Plastics (PPP) unit, to private‑equity firm Apax Partners. The transaction is valued at rough…
    Endpoints · 1h agoDealNeutral↗ source
  • Alnylam cuts Amvuttra sales guidance as demand shifts, hurting stock
    Alnylam’s second-quarter earnings report Thursday did little to assuage investor concerns in what has already been a difficult year for the company. The drugmaker lowered its full-year sales sales…
    Endpoints · 1h ago↗ source
  • Relation promises 'transformationally different success rates' in expanded AI pact with GSK
    GSK is set to pay Relation Therapeutics up to $110 million to expand their existing partnership to use AI modeling for drug discovery. Under the Thursday deal, Relation will build a ...
    Endpoints · 3h ago↗ source
  • Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules
    Argon Medical is correcting affected convenience kits by removing included Spectra Medical Devices Lidocaine Ampules.
    fda medwatch · 10h ago↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 22h agoApprovalPositive↗ source
  • FDA reviewers doubt Replimune’s melanoma therapy as shares tumble 40%
    Replimune's shares fell nearly 40% after FDA reviewers released briefing documents expressing skepticism about its experimental melanoma drug RP1. RP1 has been rejected twice before; the company l…
    BioPharma Dive · 23h agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 17h agoRegulatoryNegative↗ source
  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 17h agoNegative readoutNegative↗ source
  • FTC sues Hims & Hers over alleged health data sharing and deceptive billing practices
    The Federal Trade Commission filed a lawsuit against Hims & Hers, a telehealth company based in San Francisco, accusing it of improper handling of patient information. According to the complaint,…
    Endpoints · 19h agoRegulatoryNegative↗ source
  • US releases $600M pledged to global vaccine alliance Gavi after year‑long delay
    The United States has released the $600 million it pledged to Gavi, the global vaccine alliance. The funds had been held in limbo for about a year before the Treasury completed the transfer. Sena…
    Endpoints · 19h agoDealPositive↗ source
  • FDA and Capricor clash over Duchenne cell therapy efficacy at advisory committee
    At an FDA advisory committee meeting, the agency and Capricor Therapeutics presented conflicting views on the efficacy data for the company's experimental cell therapy aimed at Duchenne muscular dy…
    Endpoints · 20h agoRegulatoryNegative↗ source
  • Vertex and AbCellera team up to develop next-generation T-cell engagers for autoimmune diseases
    Vertex Pharmaceuticals has entered a partnership with AbCellera to create next-generation T-cell engagers aimed at autoimmune diseases. AbCellera will receive an upfront payment of $28 million, wit…
    BioPharma Dive · 23h agoDealPositive↗ source
  • Atea's hepatitis C combo therapy shows non-inferior results to Gilead's Epclusa
    Atea Pharmaceuticals announced that its oral combination of bemnifosbuvir and ruzasvir met the predefined non-inferiority criteria when compared with Gilead's Epclusa for treating hepatitis C. The…
    Endpoints · 23h agoPositive readoutPositive↗ source
  • Leqembi posts $184M Q2 sales, best quarter since launch, Biogen lifts guidance
    Leqembi, the anti-amyloid Alzheimer’s drug co-developed by Eisai and Biogen, generated $184 million in global sales in the second quarter, according to Biogen. The Q2 figure represents the stronge…
    Endpoints · 1d agoEarningsPositive↗ source
  • Teva says it has time to prepare for upcoming US tariffs on imported generic drugs
    Teva CEO Richard Francis said the company believes it has sufficient time to prepare for the tariffs the Trump administration is considering on generic drugs imported from outside the United States…
    Endpoints · 21h agoRegulatoryNeutral↗ source
  • Caldera Therapeutics merges with Synlogic, secures $278M to advance inflammation drug
    Caldera Therapeutics, a startup founded seven months ago with $112.5 million of venture funding, announced a merger with Synlogic, a company that previously went public via a reverse merger. The a…
    BioPharma Dive · 22h agoDealNeutral↗ source
  • Two biotech firms announce reverse mergers to list experimental bispecific antibody and BTK inhibitor on Nasdaq
    Two biotech companies have each entered reverse merger agreements to become publicly traded on Nasdaq. One firm, based in China, is developing a bispecific antibody and will use the merger to brin…
    Endpoints · 1d agoDealNeutral↗ source
  • Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.
    BioPharma Dive · 23h agoEarningsNeutral↗ source
  • AI startup Doctronic acquires text-message pediatric care provider Summer Health
    Doctronic, a startup that markets itself as an AI doctor, announced it has purchased Summer Health, a company that offers pediatric care via text messaging. The acquisition expands Doctronic’s ser…
    Endpoints · 1d agoDealNeutral↗ source
  • Former Recursion CEO Chris Gibson joins Dimension Capital as operating partner
    Chris Gibson, who led Recursion Pharmaceuticals for a decade, has taken a new role at venture firm Dimension Capital. At Dimension, he will serve as an operating partner, bringing his experience a…
    Endpoints · 1d agoPositive↗ source
  • NYU's Neil Vasan steps down as acting chair of FDA's oncology drug advisory committee
    Neil Vasan, a professor at NYU, has announced he is stepping down from his role as acting chair of the FDA’s Oncologic Drugs Advisory Committee (ODAC). Vasan has participated in 22 ODAC meetings a…
    Endpoints · 21h agoRegulatoryNeutral↗ source
  • GSK prepares for patent cliff with $2.5B cost-cutting plan
    The pharma hasn’t yet revealed what kind of job cuts might be involved in the plan, which will help it absorb the coming loss of patents important to its HIV drug franchise.
    BioPharma Dive · 1d agoLayoffsNegative↗ source