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  • 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 · 3mo 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 · 3mo agoNegative↗ source
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Nephrology760
  • 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoDealPositive↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda medwatch · 3mo agoCRLNegative↗ 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoRegulatoryNeutral↗ source
  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 3mo agoNegative readoutNegative↗ source
  • Eli Lilly's $3.8 B acquisition of AtaiBeckley signals growing confidence in psychedelics for depression
    Psychedelics are being touted as a potential solution for patients who still struggle to find lasting relief from existing FDA‑approved psychiatric medicines. The article notes that many individual…
    BioSpace · 3mo agoDealPositive↗ source
  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Jazz Pharma to acquire Actio Biosciences for up to $1.3 billion, adding experimental KCNT1 epilepsy drug
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, paying $820 million in cash with up to $500 million in milestone payments. The deal is expected to close by the end of the year.…
    BioSpace · 3mo agoDealPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 3mo agoDealPositive↗ source
  • Biogen’s ALS drug shows symptom improvement in some patients three years after approval
    Biogen’s antisense therapy tofersen, marketed as Qalsody, received FDA approval three years ago as the first treatment to target a genetic form of ALS linked to the SOD1 gene. Since then, a number…
    BioSpace · 3mo agoPositive readoutPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Trump orders MMR vaccine to be administered as three separate shots, citing autism concerns
    President Donald Trump announced via an executive order that the combined measles, mumps and rubella (MMR) vaccine should be split into three individual injections for children. He claimed the cha…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • FDA rejects ITM's radiopharma drug for neuroendocrine tumors over manufacturing issues
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical candidate from ITM Isotope Technologies Munich intended for treating neuroendocrine tumors. The agency cited manu…
    Endpoints · 3mo agoRegulatoryNegative↗ source