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  • 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 · 1d agoDealNeutral↗ source
  • Trump administration delays start of first pharma tariff wave originally set for July 31
    President Donald Trump's administration had scheduled the first set of pharmaceutical tariffs to begin on July 31, but the rollout has been postponed. A White House official said the implementation…
    Endpoints · 1d agoRegulatoryNeutral↗ source
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  • UCB shares dip as investors worry forecast may be too optimistic despite Bimzelx sales beat
    UCB reported that sales of its lead drug Bimzelx exceeded analysts' expectations for the quarter. However, the company also gave a full-year revenue outlook that some investors view as overly opti…
    Endpoints · 1d agoEarningsNegative↗ source
  • Sanofi CEO Garijo outlines R&D overhaul, M&A push and China focus to counter patent cliff
    Garijo, three months into her tenure as Sanofi chief executive, shared her strategy for the company’s next phase of growth. She said the firm will conduct a thorough cleanup of its research and de…
    Endpoints · 1d agoPositive↗ source
  • Included Health to acquire Firefly Health, signaling push into alternative health plans
    Included Health announced it will acquire Firefly Health, a move aimed at expanding its presence in the emerging alternative health plan market. The acquisition reflects the company's belief that…
    Endpoints · 1d agoDealPositive↗ source
  • 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 · 1d agoDealPositive↗ source
  • Alnylam lowers Amvuttra sales outlook amid waning demand, shares slide
    Alnylam released its second‑quarter earnings, highlighting a challenging year for the biotech firm. The report showed continued pressure on its product portfolio. The company cut its full‑year sal…
    Endpoints · 1d agoEarningsNegative↗ source
  • Rising oil prices could lift manufacturing costs of an HIV drug, Unitaid report says
    Rising oil prices, driven in part by geopolitical tensions, have raised concerns about the stability of medicine supply chains. Analysts note that higher energy costs can translate into increased p…
    STAT · 1d agoNeutral↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 1d agoRegulatoryNegative↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 1d agoNeutral↗ source
  • GSK to invest up to $110 million in expanded AI drug-discovery partnership with Relation Therapeutics
    GSK announced it will pay Relation Therapeutics up to $110 million to broaden their existing collaboration that uses artificial‑intelligence models to identify new drug candidates. The expanded ag…
    Endpoints · 1d agoDealPositive↗ source
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 1d agoCRLNegative↗ source
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee rates
    The FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…
    raps · 1d agoRegulatoryNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 1d agoNegative↗ source
  • FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAs
    The U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The r…
    raps · 1d agoRegulatoryNeutral↗ source
  • Regeneron and Sanofi explore expanded partnership for Dupixent follow-on candidates
    Regeneron and Sanofi said they are in early discussions about expanding their collaboration beyond the existing Dupixent partnership. The companies indicated the potential scope could include deve…
    Endpoints · 22h agoDealPositive↗ source
  • Replimune argues its oncolytic virus plus checkpoint inhibitor benefits advanced melanoma patients at FDA advisory meeting
    Replimune presented data from its pivotal advanced melanoma trial to an FDA advisory committee. The company defended the trial design and results, emphasizing the added benefit of its oncolytic vi…
    Endpoints · 22h agoRegulatoryNeutral↗ source
  • Senate health panel confirms Trump picks for CDC director and pandemic preparedness chief
    The Senate health committee approved two Trump administration nominees for key health positions on Thursday. Erica Schwartz was confirmed as CDC director with bipartisan support from all Republica…
    STAT · 1d agoRegulatoryNeutral↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 1d agoRegulatoryNeutral↗ source
  • EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
    raps · 1d agoRegulatoryNeutral↗ source
  • Podcast debates FDA’s handling of Duchenne drugs and upcoming executive changes
    Allison DeAngelis, Adam Feuerstein and Elaine Chen host this week’s Readout Loud podcast, a STAT series that examines biotech trends and business moves. The trio questions whether the FDA is apply…
    STAT · 22h agoNeutral↗ source
  • Takeda, Regeneron, Sanofi and Bristol Myers Squibb announce pipeline cuts in quarterly updates
    Takeda, Regeneron, Sanofi and Bristol Myers Squibb disclosed that they are trimming several drug development programs as part of their recent earnings releases. The cuts affect a mix of early‑stage…
    Endpoints · 1d agoNeutral↗ source
  • Experts warn U.S. pharma reliance on China poses national security threat
    The authors of a recent Council on Foreign Relations report argue that the United States’ dependence on China for biopharmaceutical manufacturing creates a clear national security risk. They point…
    STAT · 1d agoNegative↗ 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 · 1d agoDealNeutral↗ source