September 2025 – Page 5

FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

4 weeks ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing

Eli Lilly Picks Houston for $6.5 Billion API Manufacturing Facility

4 weeks ago talkbio0Tagged alpha 1-antitrypsin, cardiometabolic, Eli, Eli Lilly, Generation Park, Houston, Immunology, Investments, Manufacturing, Neoplasms, Neuroscience discipline, pharmaceutical manufacturing, small molecule medicines

Eli Lilly; Houston; API manufacturing; $6.5 billion investment; Generation Park; small molecule medicines; pharmaceutical manufacturing; cardiometabolic; oncology; immunology; neuroscience

BMS Breaks Clinical Losing Streak with Positive Phase 3 Myeloma Readout for Iberdomide

4 weeks ago talkbio0Tagged CELMoD, Clinical Trials, EXCALIBER-RRMM, iberdomide, Minimal Residual Disease Negativity, Multiple Myeloma, Myers, Phase 3, Progression-Free Survival, Protein Degradation, Metabolic, Relapsing course, squibb, Unresponsive to Treatment

Bristol Myers Squibb; iberdomide; multiple myeloma; clinical trial; EXCALIBER-RRMM; minimal residual disease negativity; CELMoD; protein degradation; progression-free survival; phase 3; relapsed or refractory

Seres Therapeutics Cuts 25% of Workforce Following FDA Feedback on Microbiome Therapy Trial

4 weeks ago talkbio0Tagged Biopharma, cash runway, Clinical Research, Feedback - system communication, layoffs, Microbiome, Microbiome SER-155, Seres, United States Food and Drug Administration

Seres Therapeutics; layoffs; microbiome; FDA feedback; SER-155; phase 2 trial; workforce reduction; biopharma; clinical studies; cash runway

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

4 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

4 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

4 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

4 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

4 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

4 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