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310 stories matching this filter · ← front page

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  • BMS beats Q2 forecasts and lifts 2026 outlook despite delays in Cobenfy and milvexian data
    BMS reported second‑quarter revenue of $12.97 billion, topping analysts' estimate of $11.73 billion, and earnings per share of $2.04, well above the $1.60 consensus. The strong results prompted the…
    BioSpace · 17h agoEarningsNeutral↗ 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 · 20h agoDealNeutral↗ source
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  • 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 · 19h agoNegative↗ 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 · 10h agoRegulatoryPositive↗ 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 · 17h agoEarningsNeutral↗ 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 · 20h agoNeutral↗ 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 · 1d 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 · 1d agoPositive readoutPositive↗ 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
  • 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 · 21h 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 · 1d agoDealPositive↗ 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
  • FDA advisory panel votes 9-3 against Capricor's Duchenne therapy deramiocel
    During an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting, reviewers focused on the Phase 3 HOPE-3 trial's secondary cardiac endpoint and described the data as very fragile. The…
    BioSpace · 1d agoApprovalNegative↗ source
  • Caldera and Vidya secure $478M via reverse mergers to go public
    Caldera Therapeutics, a U.S. bispecific antibody biotech, announced a reverse merger with Nasdaq-listed Synlogic to become a public company. The deal includes a $278 million private placement from…
    BioSpace · 1d agoDealPositive↗ source
  • Novo Nordisk faces shareholder fraud lawsuit over undisclosed dosing changes in CagriSema Phase 3 trial
    New Jersey federal judge Robert Kirsch ruled that shareholders can pursue claims that Novo Nordisk misled investors about its Phase 3 study of the weight‑loss drug CagriSema. The plaintiffs allege…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • FDA briefing hints tough road for Capricor and Replimune ahead of advisory committee meetings
    The FDA released briefing documents for upcoming advisory committee meetings concerning Capricor Therapeutics' Duchenne muscular dystrophy cell therapy and Replimune's advanced melanoma candidate.…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • FDA advisory panel votes 9-3 against approval of Capricor’s Duchenne muscular dystrophy therapy deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee focused heavily on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, describing the data as very fragile. Committee…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • Kyverna partners with ElevateBio to supply its autologous CAR-T therapy for autoimmune launches
    Kyverna Therapeutics has signed a five‑year manufacturing agreement with contract development and manufacturing organization ElevateBio. The deal makes ElevateBio the primary supplier of Kyverna's…
    BioSpace · 1d agoDealPositive↗ source
  • Incyte drops early-stage JAK2 inhibitor to prioritize next-generation pipeline
    Incyte announced it is terminating development of its early-stage oral JAK2 inhibitor, INCB160058, after a Phase 1 study in myeloproliferative neoplasms. The company said the decision reflects the…
    BioSpace · 1d agoNegative↗ source
  • Biotech earnings season kicks off as Agios reports Phase 2 setback for sickle-cell drug
    The second‑quarter earnings window has begun, and analysts are zeroing in on a handful of biotech companies with high‑profile catalysts. Smaller biotechs are increasingly opting to launch their pr…
    BioSpace · 2d agoNegative readoutNeutral↗ source
  • Biogen shifts M&A strategy as Apellis acquisition pushes revenue above analyst expectations
    Biogen officially began reporting revenue from the $5.6 billion acquisition of Apellis in the second quarter, shaking up analysts’ consensus estimates and leading to a beat.
    BioSpace · 1d agoDealNeutral↗ source