September 23, 2025

FDA Rejects Scholar Rock’s SMA Drug Due to Catalent Indiana Manufacturing Issues

2 weeks ago talkbio0Tagged apitegromab, Catalent Indiana, Complete, Drug Approval, manufacturing issues, Response Letter, Scholar Rock, SMA, Spinal Muscular Atrophy, United States Food and Drug Administration

FDA; Scholar Rock; Apitegromab; SMA; Spinal Muscular Atrophy; Catalent Indiana; Complete Response Letter; Manufacturing issues; Drug approval

FDA Rejects Lundbeck and Otsuka’s Rexulti for PTSD on Insufficient Efficacy Evidence

2 weeks ago talkbio0Tagged brexpiprazole, Clinical Trials, Complete, Drug Approval, Lundbeck, Otsuka, Post-Traumatic Stress Disorder, Response Letter, Rexulti, sertraline, sNDA, United States Food and Drug Administration

FDA; Rexulti; Lundbeck; Otsuka; PTSD; brexpiprazole; sertraline; Complete Response Letter; sNDA; clinical trials; drug approval

Roche’s Top Three Ambition in Obesity Not Dependent on a Single Megablockbuster

2 weeks ago talkbio0Tagged cardiometabolic care, Diagnostics, digital health, Ecosystem, Obesity, Portfolio diversification, Roche (company), Weight-Loss Agents

Roche; obesity strategy; ecosystem approach; pharmaceuticals; diagnostics; digital health; cardiometabolic care; portfolio diversification; weight-loss drugs

Celltrion Acquires Eli Lilly’s New Jersey Manufacturing Site for $330 Million

2 weeks ago talkbio0Tagged Acquisition, Biopharmaceutical manufacturing, Biosimilars, Celltrion, Contract agreement, eli lilly, Investments, Jersey site, supply chain, US tariffs

Celltrion; Eli Lilly; New Jersey site; acquisition; biopharmaceutical manufacturing; US tariffs; contract manufacturing; supply chain; biosimilars; investment

Fierce Biotech Fundraising Tracker ’25: Avenzo adds $60M Series B; Ollin debuts with $100M

2 weeks ago talkbio0Tagged Antibodies, Bispecific, Avenzo, Clinical Trials, Neoplasms, Ollin Biosciences, Ophthalmology specialty, pipeline development, Series B financing, venture capital

Avenzo Therapeutics; Series B financing; Ollin Biosciences; biotech fundraising; oncology; ophthalmology; venture capital; pipeline development; bispecific antibody; clinical trials

Pfizer Acquires Metsera to Compete with Zepbound in Obesity Market

3 weeks ago talkbio0Tagged Acquisition, Amylin, Clinical Trials, dosing, Glucagon-Like Peptide 1, MET-097i, MET-233i, Metsera, mimetics, monthly, Obesity, Pfizer, Zepbound

Pfizer; Metsera; obesity treatment; Zepbound; GLP-1 therapies; MET-233i; monthly dosing; amylin mimetic; MET-097i; acquisition; clinical trials

Neurocrine Biosciences Reports Positive Phase 2 Results for Osavampator in Major Depressive Disorder

3 weeks ago talkbio0Tagged adjunctive treatment, AMPA-PAM, Biosciences, Clinical Research, Clinical Trials, Mental Depression, Neurocrine, osavampator, safety profile, SAVITRI

Neurocrine Biosciences; osavampator; Phase 2 results; major depressive disorder; AMPA-PAM; SAVITRI study; clinical trial; adjunctive treatment; depression; safety profile

Bristol Myers Squibb to Launch Schizophrenia Drug Cobenfy in UK at US Price

3 weeks ago talkbio0Tagged Antipsychotic Agents, Cholinergic Receptors, Cobenfy, drug price, launch, Myers, Nance-Horan syndrome, Prices, Schizophrenia, squibb, U.S., UK

Bristol Myers Squibb; Cobenfy; schizophrenia; UK launch; drug pricing; US list price; NHS; cholinergic receptors; antipsychotic; 2026

FDA Delays Decision on Sanofi’s Oral Multiple Sclerosis Drug to December 2025

3 weeks ago talkbio0Tagged BTK inhibitor, Clinical action, December 2025, drug review, Multiple Sclerosis, nrSPMS, PDUFA, sanofi, Tolebrutinib, United States Food and Drug Administration

FDA action date; Sanofi; tolebrutinib; multiple sclerosis; BTK inhibitor; nrSPMS; drug review delay; December 2025; PDUFA

Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease

3 weeks ago talkbio0Tagged access program, Alexander Disease, Antisense Oligonucleotides, Fast Track, Identifier, Improvement, Infrequent, Ionis Pharmaceuticals, nervous system disorder, orphan drug designation, Phase I – III study, Speed, United States Food and Drug Administration, Zilganersen

Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation