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  • UniQure prepares for FDA advisory committee on Huntington’s gene therapy amid rare-disease regulatory jitters
    UniQure said it is ready to present its Huntington's disease gene therapy, AMT-130, to an FDA advisory committee, as discussed in its Q2 earnings call. The company expects the FDA may schedule the…
    BioSpace · 3mo agoRegulatoryNeutral↗ source
  • Lidl US expands recall of Eridanous shortbread cookies over undeclared wheat, soy, milk, egg and coconut allergens
    Lidl US announced it is widening a recall that began on July 24, 2026 to cover all units of its Eridanous Shortbread Cookies that feature foreign-language packaging. The affected items include the…
    fda recalls · 3mo agoRegulatoryNeutral↗ source
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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 · 3mo 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 · 3mo agoDealNeutral↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoPositive readoutPositive↗ 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 · 3mo 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 · 3mo agoDealPositive↗ source
  • Ukrop’s Homestyle Foods voluntarily recalls six baked goods over possible aluminum fragments
    Ukrop’s Homestyle Foods, a Richmond, Virginia based company, announced a voluntary recall of six baked products after a routine inspection found a small piece of aluminum in the baking pan. The re…
    fda recalls · 3mo agoCRLNegative↗ 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 · 3mo 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 · 3mo agoDealPositive↗ 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 · 3mo agoApprovalPositive↗ source
  • Biogen's $5.6B Apellis Purchase Boosts Q2 Revenue Above Forecasts
    Biogen began reporting revenue from its $5.6 billion acquisition of Apellis in the second quarter, pushing earnings above analysts' consensus estimates. CEO Chris Viehbacher said the company will…
    BioSpace · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoNegative readoutNeutral↗ source
  • Biopharma job postings in New York rise 34% over past year, seven companies now hiring
    Biopharma employment opportunities in New York appear to be expanding, with job listings on BioSpace increasing 34% between July 2025 and July 2026. Although the number of postings dipped slightly…
    BioSpace · 3mo agoNeutral↗ source
  • 529 Commerce recalls Rooted in Rare Aquafaba Powder over possible undeclared egg allergen
    529 Commerce, LLC of Parkland, Florida announced a recall of its Rooted in Rare brand Aquafaba Powder. The recall includes 3,860 units packaged in 4‑oz and 12‑oz flexible foil pouches that were so…
    fda recalls · 3mo agoRegulatoryNegative↗ source