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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 · 12d agoNegative↗ source
  • J&J strikes up to $925M deal with Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson announced a collaboration with Flagship Pioneering’s Sail Biomedicines to develop in vivo CAR‑T therapies for immune‑mediated diseases. The agreement provides up to $925 million i…
    BioSpace · 12d agoDealNeutral↗ source
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  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 12d agoPositive readoutPositive↗ source
  • Analysts say Daiichi Sankyo’s ADC pipeline lags rivals as cash flow peaks, cutting expectations
    Jefferies analysts warned that Daiichi Sankyo's early‑stage antibody‑drug conjugate (ADC) pipeline is falling behind competitors, even as the company approaches a peak in cash flow from its existin…
    BioSpace · 12d 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 · 12d agoDealNeutral↗ source
  • FDA advisory panel backs Replimune’s melanoma immunotherapy combined with Opdivo
    The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10-3 to recommend Replimune’s RP1 immunotherapy, used together with Bristol Myers Squibb’s Opdivo, for patients with advanced…
    BioSpace · 11d agoRegulatoryPositive↗ 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 · 12d agoRegulatoryNeutral↗ source
  • Regeneron defends M&A stance as cash hoard reaches $18 billion amid trial setbacks
    Analysts on Regeneron's second‑quarter earnings call questioned the company's lack of merger and acquisition activity, pointing to an $18 billion cash reserve and recent clinical trial setbacks. C…
    BioSpace · 12d agoEarningsNeutral↗ source
  • 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d agoEarningsNegative↗ source
  • Sanofi CEO pledges deeper review of late-stage pipeline before Phase 3 moves
    Sanofi's new chief executive, Belén Garijo, announced that the company will examine its late-stage pipeline more closely. The goal is to ensure that data from Phase 2 (or Phase 1b, depending on th…
    BioSpace · 12d 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 · 12d agoDealPositive↗ source
  • Biopharma layoffs in 2026 often marred by impersonal and poorly timed communications
    Over 50 biopharma companies have announced workforce cuts or plan to do so in 2026. According to a BioSpace survey, the manner in which these layoffs are communicated can leave a lasting negative i…
    BioSpace · 12d agoLayoffsNegative↗ source
  • Biogen’s early Phase 2 data supports tau-targeting Alzheimer’s approach
    Biogen has released early Phase 2 results for its experimental Alzheimer’s therapy diranersen, indicating that reducing tau protein levels may lead to cognitive benefits. The findings add to a lon…
    BioSpace · 12d agoPositive readoutPositive↗ 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d 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 · 12d agoRegulatoryNeutral↗ source
  • Arvinas CEO outlines strategy to rebuild pipeline after lead asset departure
    In a recent episode of the Denatured podcast, Arvinas President and CEO Randy Teel discussed how the company is shifting focus to an early‑stage pipeline after its lead asset was out‑licensed or di…
    BioSpace · 12d agoPositive↗ source
  • Four biotech firms secure Series B funding and open new hiring opportunities
    Biotech companies that closed Series B financing rounds this year are actively recruiting as they expand their operations. Atavistik Bio, based in Cambridge, Massachusetts, announced a $40 million…
    BioSpace · 12d agoDealPositive↗ source