Governmental or Regulatory Activity – Page 3

Moderna Wins UK Appeals Court in Covid-19 Patent Case Against Pfizer/BioNTech

1 month ago talkbio0Tagged appeal, BioNTech, court, COVID19 (disease), EP'949, infringement, Legal patent, legal victory, Moderna, Pfizer, UK, Vaccines

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

1 month ago talkbio0Tagged CEO, competition, Drops - Drug Form, drug market, Leadership, Maziar Mike Doustdar, Nordisk, Obesity, Prices, Regulatory Affairs, Shakeup, SmithKline Beecham, United States Food and Drug Administration

Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA

Vinay Prasad Departs FDA Amid Conservative Criticism and Sarepta Gene Therapy Controversy

1 month ago talkbio0Tagged CBER, conservative criticism, departure - ActRelationshipType, Drug Approval, gene therapy, Muscular Dystrophy, Duchenne, Prasad, Transplant Registry Unified Management Program, United States Food and Drug Administration, Vinay

Vinay Prasad; FDA; departure; Sarepta Therapeutics; gene therapy; Duchenne muscular dystrophy; conservative criticism; CBER; drug approval controversy; Trump administration

RFK Jr. Reportedly Weighs Preventive Services Panel Revamp, Raising Risks for HIV PrEP Drugmakers

2 months ago talkbio0Tagged Advisory Committees, drugmakers, health disparity, HIV Prevention, Insurance, PREP gene, preventive services panel, public health policy, revamp, RFK Jr., USPSTF

RFK Jr.; preventive services panel; USPSTF; PrEP; HIV prevention; insurance coverage; public health policy; drugmakers; health disparities; revamp; task force

GSK Strengthens COPD Offering via $12 Billion Multi-Program Deal with China’s Hengrui Pharma

2 months ago talkbio0Tagged biobucks, COPD, Hengrui Pharma, HRS-9821, Immunology, Licensing, Neoplasms, Nucala, PDE3/4 inhibitor, SmithKline Beecham

GSK; Hengrui Pharma; COPD; biobucks; PDE3/4 inhibitor; HRS-9821; Nucala; immunology; oncology; licensing deal

Lack of Transparency Tarnishes Sarepta’s Sheen as Patient Deaths Trigger FDA Battle

2 months ago talkbio0Tagged ELEVIDYS, gene therapy, lack of transparency, Market, Muscular Dystrophies, Limb-Girdle, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, United States Food and Drug Administration, Withdraw (activity)

Sarepta Therapeutics; Elevidys; patient deaths; FDA; lack of transparency; gene therapy; market withdrawal; regulatory action; limb-girdle muscular dystrophy (LGMD); Duchenne muscular dystrophy

FDA Threatens Action After Sarepta Refuses to Halt Elevidys Shipments

2 months ago talkbio0Tagged ELEVIDYS, gene therapy, Liver Failure, Market, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Authority, United States Food and Drug Administration, Withdraw (activity)

FDA; Sarepta Therapeutics; Elevidys; gene therapy; market withdrawal; patient deaths; Duchenne muscular dystrophy; liver failure; regulatory authority

FDA Advisory Committee Rejects Lundbeck and Otsuka’s PTSD Bid for Rexulti

2 months ago talkbio0Tagged Advisory Committees, brexpiprazole, Clinical Trials, drug efficacy, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Rexulti, sertraline, United States Food and Drug Administration

Lundbeck; Otsuka; Rexulti; FDA advisory committee; PTSD; brexpiprazole; sertraline; clinical trials; drug efficacy; setback

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

2 months ago talkbio0Tagged AAVrh74, CHARGE Syndrome, drug safety, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Ships, Suspensions, United States Food and Drug Administration

Sarepta; Elevidys; FDA; HHS; gene therapy; Duchenne muscular dystrophy; drug safety; shipping suspension; patient deaths; AAVrh74; regulatory action

FDA Advisory Panel Rejects GSK’s Blenrep in New Combinations Over Safety, Efficacy Concerns

2 months ago talkbio0Tagged Advisory Panel, Blenrep, concerns, DREAMM, Drug Approval, Multiple Myeloma, Ocular Toxicity, Refractory Plasma Cell Myeloma, Relapsing course, Safety, SmithKline Beecham, trials, United States Food and Drug Administration

Blenrep; GSK; FDA Advisory Panel; multiple myeloma; ocular toxicity; safety concerns; DREAMM trials; drug approval; relapsed or refractory multiple myeloma