ORG
Scientists Protest FDA’s Rejection of Replimune’s Tumor Destroying Therapy
Replimune; RP1; FDA rejection; oncolytic immunotherapy; melanoma; clinical trial; IGYNTE study; scientist protest; drug approval; patient heterogeneity
Praxis Seizure Drug Vormatrigine Shows Strong Efficacy in Phase 2 Trial
Praxis Precision Medicines; vormatrigine; epilepsy; seizures; RADIANT study; focal onset seizures; Phase 2 trial; sodium channel blocker
Praxis touts ‘best-in-disease’ epilepsy data, but shares dip
Praxis Precision Medicines; epilepsy; vormatrigine; RADIANT study; focal onset seizures; Phase 2 trial; seizure reduction; clinical trial; anti-seizure medication; stock market
Replimune Awaits FDA Direction After Complete Response Letter for Advanced Melanoma Therapy
Replimune; FDA; Complete Response Letter; RP1; vusolimogene oderparepvec; nivolumab; advanced melanoma; cancer treatment; IGNYTE trial; accelerated approval
Royalty Market Accelerates with XOMA Biotech Acquisitions and OrbiMed’s Major Fundraise
royalty acquisition; XOMA Royalty; biotech M&A; OrbiMed; biopharma financing; mezigitamab; Turnstone Biologics; HilleVax; LAVA Therapeutics; contingent value rights; life sciences investment
Untangling Sarepta’s Gene Therapy Fallout and Trust Deficit
Sarepta Therapeutics; gene therapy; Elevidys; Duchenne muscular dystrophy; limb-girdle muscular dystrophy; patient deaths; FDA; AAVrh74 vector; regulatory action; clinical holds; transparency
Allogene Reports Patient Death Linked to ALLO-647 Conditioning Antibody in CAR-T Trial
Allogene; ALLO-647; CAR-T; patient death; monoclonal antibody; lymphodepletion; large B-cell lymphoma; ALPHA3 trial; liver failure; adenovirus infection
Moderna Wins UK Appeals Court in Covid-19 Patent Case Against Pfizer/BioNTech
Moderna; Pfizer; BioNTech; UK Court of Appeal; COVID-19 vaccine; patent infringement; EP’949 patent; Comirnaty; legal victory
Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK
Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA
FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia
FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision