Activity – Talk Bio

Pfizer Veteran Suneet Varma Named CEO of Phase 3-Ready Biotech Startup Intent Biologics

1 day ago talkbio0Tagged Appointments, biotech startup, CEO, Clinical Trials, Immunology, Inflammation, Intent Biologics, Pfizer vet, Phase 3, Regenerative Medicine, Suneet Varma

Suneet Varma; Pfizer vet; Intent Biologics; CEO appointment; regenerative medicine; Phase 3 clinical trials; biotech startup; inflammation and immunology

Takeda and Alkermes Detail Strong Clinical Results for Orexin Drugs in Narcolepsy – Head-to-Head Race Accelerates

2 days ago talkbio0Tagged agonists, alixorexton, Alkermes, Cataplexy, Clinical Trials, Daytime Somnolence, Excessive (qualifier value), Maintenance, MWT, Narcolepsy, orexins, oveporexton, Phase 3, Takeda, Wakefulness Test

Takeda; Alkermes; orexin agonists; narcolepsy; oveporexton; alixorexton; clinical trials; Phase 3; excessive daytime sleepiness; cataplexy; maintenance of wakefulness test (MWT)

Eisai Secures FDA Approval for Leqembi Autoinjector for Maintenance Dosing in Alzheimer’s Patients

1 week ago talkbio0Tagged Alzheimer 's disease, Approved, at-home, AutoInjector, Biogen, dosing, Eisai, Lecanemab, Leqembi, Maintenance, Subcutaneous Injections, United States Food and Drug Administration

Eisai; Leqembi; lecanemab; FDA approval; autoinjector; subcutaneous injection; maintenance dosing; Alzheimer’s disease; at-home treatment; Biogen

Nucleus RadioPharma Appoints Former FDA Commissioner Dr. Stephen Hahn as CEO

3 weeks ago talkbio0Tagged Appointments, biotech leadership, Cancer Therapeutic Procedure, CEO, Commissioner, Hahn, Nucleus RadioPharma, Radiopharmaceuticals, supply chain, United States Food and Drug Administration

Nucleus RadioPharma; Stephen Hahn; FDA Commissioner; CEO appointment; radiopharmaceuticals; cancer therapy; supply chain; biotech leadership

FDA may not renew Pfizer’s pediatric COVID-19 shot authorization, creating uncertainty for fall child vaccinations

4 weeks ago talkbio0Tagged Advice, authorization, Centers for Disease Control and Prevention (U.S.), Child, Comparison, COVID19 (disease), EUA, Eua (gastropod), Moderna, Pediatric brand name, Pfizer-BioNTech, Regulatory Framework, renewal, United States Food and Drug Administration, Vaccination, Vaccines

FDA; Pfizer-BioNTech; pediatric COVID-19 vaccine; EUA renewal; authorization not renewed; child vaccinations; fall 2025; regulatory framework; Moderna comparison; CDC guidance

Endpoints 11: Biopharma’s most promising startups revealed live in Boston this September

1 month ago talkbio0Tagged Aves, Biopharma, biotech startups, biotechs, Boston event, Endpoints, GALA peptide, Industry, Rating (action), real-time, State Room

Endpoints 11; biotech startups; biopharma; Boston event; State Room; awards gala; early bird rate; industry insiders; 2025 most promising biotechs; real-time reveal

Assembly Bio Reports Phase 1b Success in Herpes; Gilead Increases Stake with 2.3M Shares

1 month ago talkbio0Tagged ABI-5366, Assembly (construction), Bio, Collaboration, genital lesion reduction, Gilead Sciences, herpesvirus 2, human, safety profile, Simplexvirus, stock purchase, viral shedding

Assembly Bio; Phase 1b trial; ABI-5366; herpes simplex virus (HSV-2); viral shedding reduction; genital lesion reduction; safety profile; Gilead Sciences; collaboration; stock purchase

Novo Nordisk Names Insider Maziar Mike Doustdar as New CEO Amid Growth Challenges

1 month ago talkbio0Tagged Appointments, CEO, Drug Industry, drug market, growth outlook, international operations, Leadership Change, Maziar Mike Doustdar, Nordisk, Obesity

Novo Nordisk; Maziar Mike Doustdar; CEO appointment; leadership change; pharmaceutical industry; growth outlook; obesity drug market; international operations

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

Sarepta Stands Behind Elevidys After FDA Requests Withdrawal Amid Safety Concerns

2 months ago talkbio0Tagged Cessation of life, Clinical Trials, concerns, ELEVIDYS, gene therapy, Market, Muscular Dystrophy, Duchenne, Safety, United States Food and Drug Administration, Withdraw (activity)

Sarepta; Elevidys; FDA; gene therapy; market withdrawal; safety concerns; Duchenne muscular dystrophy; deaths; clinical trial hold