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  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 3h agoApprovalPositive↗ source
  • Sentynl inks up to $475M licensing deal to commercialize Mereo’s alvelestat for rare lung disease
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, signed an agreement to obtain exclusive U.S. rights to market alvelestat, Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin…
    BioSpace · 1h agoDealPositive↗ source
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  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 2h agoPositive readoutPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 2h agoDealPositive↗ source
  • AI-focused biotech firms drive biopharma toward a 'fail-fast' drug development model
    AI is quickly becoming a central force in drug development as tech capital pours into biopharma, reshaping how new medicines are discovered. Tyrone Lam, chief business officer at GATC Health, says…
    BioSpace · 7h agoPositive↗ source
  • Missed promotion often reflects organizational timing, not personal failure
    A missed promotion can feel like a verdict on one’s potential, yet the source notes that employees and organizations often develop at different speeds. Executive coach Angela Justice recounts a ca…
    BioSpace · 6h agoNeutral↗ source
  • BridgeBio continues ATTR ascent as Alnylam’s Amvuttra falls short of expectations
    BridgeBio Pharma’s transthyretin amyloidosis medicine Attruby is off to a strong launch, while Alnylam lowered full-year sales guidance for competitor Amvuttra.
    BioSpace · 1h ago↗ source
  • Eli Lilly fronts $2 billion for vaccine biotech deals as Infinimmune secures $75 million funding
    Eli Lilly announced it has paid $2 billion up front as part of its ongoing strategy to acquire vaccine‑focused biotechnology companies, a portion of a larger deal that could total up to $3.8 billio…
    Endpoints · 22h agoDealPositive↗ source
  • Insilico Medicine CEO touts billions in pipeline deals at BIO International Convention
    At the BIO International Convention in June, Insilico Medicine chief Alex Zhavoronkov made a high‑energy appearance that attracted considerable attention. Zhavoronkov handed out a postcard‑sized l…
    BioSpace · 1d agoDealPositive↗ source
  • Epicrispr and Infinimmune secure $165 million in venture funding for epigenetic and antibody programs
    Epicrispr Biotechnologies announced a $90 million Series C round to push its epigenetic therapy program for facioscapulohumeral muscular dystrophy (FSHD). The lead candidate, EPI-321, is in a firs…
    BioSpace · 1d agoDealPositive↗ source
  • AbCellera’s antibody ABCL635 cuts hot flash frequency in early trial, outperforms oral competitors
    AbCellera Biologics reported that its investigational antibody ABCL635 markedly reduced the number of moderate and severe hot flashes in post‑menopausal women during a Phase 1/2 study. At week four…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Vaderis raises $152M Series B to launch Phase 3 trial of engasertib for hereditary hemorrhagic telangiectasia
    Vaderis Therapeutics, a Swiss biotech, announced it has closed an oversubscribed $152 million Series B financing round. The new capital will fund the initiation of a Phase 3 study, named HEROIC, e…
    BioSpace · 1d agoDealPositive↗ source
  • Researchers suspect Exelixis used a minor tweak to cabozantinib to sidestep patent cliff
    Exelixis' 2025 financial results highlighted the importance of its drug cabozantinib, which has been a major revenue source for the company. A group of analysts argue that the company introduced a…
    Endpoints · 18h agoNegative↗ source
  • FDA issues complete response letter rejecting ITM Isotope's radiopharma therapy over manufacturing concerns
    FDA sent a complete response letter rejecting the NDA for ITM Isotope's investigational radiopharmaceutical, citing manufacturing and third-party facility issues. The agency said there were no con…
    BioSpace · 23h agoCRLNeutral↗ source
  • Hims & Hers says it can quickly launch six wellness peptides if FDA lifts ban
    Hims & Hers used its second‑quarter earnings call to explain that it is preparing to offer six consumer wellness peptides that are currently prohibited for compounding pharmacies. The company says…
    Endpoints · 1d agoRegulatoryPositive↗ source
  • Scholar Rock pulls Indiana fill-finish plant from SMA therapy filing after FDA flags violations
    Scholar Rock has removed Novo Nordisk's former Catalent fill‑finish facility in Bloomington, Indiana, from its regulatory filing for a spinal muscular atrophy therapy after the FDA classified the p…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • Epicrispr raises $90 million Series C after promising early data on epigenetic FSHD therapy
    Epicrispr Biotechnologies announced a $90 million Series C financing round to advance its research program. The company shared early data suggesting that an epigenetic approach could address facio…
    Endpoints · 1d agoDealPositive↗ source
  • Former Legend Biotech chief Ying Huang named CEO of K2, targets $250 million Series A to license Asian assets
    Ying Huang spent the past seven years building one of the leading cancer cell‑therapy companies before stepping down as CEO of Legend Biotech. Weeks after announcing his departure, Huang has taken…
    Endpoints · 1d agoDealPositive↗ source
  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 1d agoDealPositive↗ source
  • Austria launches up to €100 million anchor investment for growth fund, aiming to channel half‑billion euros into biotech
    Austria's government announced a new national Startup & Scaleup Fund as part of the 2027/2028 budget, with an anchor investment of up to €100 million. The public money is designed to attract priva…
    BioSpace · 1d agoPositive↗ source
  • Health insurers' AI spending meets reality check as UnitedHealth pledges $1.5 billion and CVS outlines its own budget
    Two of the largest publicly traded health insurers are emphasizing their artificial‑intelligence initiatives, but industry observers say the hype may outpace actual results. UnitedHealth Group dis…
    Endpoints · 21h agoNeutral↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 1d agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 1d agoRegulatoryNeutral↗ source
  • AbbVie, Novartis and Bristol Myers Squibb sue Illinois over 340B drug discount law
    AbbVie, Novartis and Bristol Myers Squibb each filed separate lawsuits in Illinois this week. The suits challenge a state law that seeks to regulate how manufacturers participate in the 340B drug…
    Endpoints · 19h agoRegulatoryNeutral↗ source