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FDA Pushes for Onshoring and Improved Data Fidelity in Generic Drug User Fee (GDUFA IV) Negotiations

1 day ago talkbio0Tagged bioequivalence, Data Fidelity, GDUFA IV, Manufacturing, Metric (substance), onshoring, Performance, public health medicine (field), United States Food and Drug Administration, user fee

FDA; onshoring; data fidelity; generic drugs; user fee; GDUFA IV; manufacturing; bioequivalence; public health; performance metrics

Nxera Pharma to Cut 15% of Workforce in Japan and UK as Part of Restructuring Plan

1 day ago talkbio0Tagged GPCR pipeline, Japan, Nxera Pharma, Optimization, Organization administrative structures, profitability, restructuring, Surgical aspects, UK, Workforce reduction

Nxera Pharma; workforce reduction; restructuring; Japan; UK; R&D operations; profitability; GPCR pipeline; organizational optimization

Arrowhead Secures Maiden FDA Approval for Redemplo in Rare Genetic Metabolic Disorder (FCS)

1 day ago talkbio0Tagged Approved, Arrowhead Pharmaceuticals, commercial, Familial chylomicronemia syndrome, Hereditary Diseases, Infrequent, Interferes with, Plozasiran, Redemplo, RNA, Triglycerides, TRiM platform, United States Food and Drug Administration

Arrowhead Pharmaceuticals; FDA approval; Redemplo; plozasiran; familial chylomicronemia syndrome; rare genetic disorder; RNA interference; TRiM platform; triglyceride reduction; first commercial drug

Spotlight On: Big Pharma’s Big Bets on In Vivo Cell Therapy

1 day ago talkbio0Tagged AbbVie, Acquisition, AstraZeneca, Autoimmune Diseases, CAR-T, Cell Therapy, gene therapy, Gilead, in vivo, Manufacturing, Myers Squibb, scalability

in vivo cell therapy; CAR-T; acquisition; autoimmune disease; gene therapy; manufacturing; scalability; Bristol Myers Squibb; Gilead; AbbVie; AstraZeneca

Zymeworks Pivots to Royalty-Driven Model After Strong Ziihera Data in Gastric Cancer

1 day ago talkbio0Tagged Biological Factors, buyback, erbB-2 Receptor, Jazz, Malignant neoplasm of stomach, milestone payments, Regulatory Filing, Royalty-Driven Model, Strategy, Ziihera, Zymeworks

Zymeworks; royalty-driven model; Ziihera; gastric cancer; HER2; biologics; milestone payments; stock buyback; biotech strategy; Jazz Pharmaceuticals; regulatory filing

Scott Gottlieb, M.D., Joins UnitedHealth Group Board of Directors

2 days ago talkbio0Tagged board of directors, Health care facility, Health Policy, innovation, medical breakthroughs, Patient access, Scott Gottlieb, Technology, United States Food and Drug Administration, UnitedHealth Group

Scott Gottlieb; UnitedHealth Group; Board of Directors; FDA; health policy; innovation; patient access; medical breakthroughs; technology in healthcare

Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx PCR Platform to Support Submission to the U.S. FDA

2 days ago talkbio0Tagged Clinical Evaluations, Co-Diagnostics, Co-Dx PCR platform, COVID19 (disease), Flu A/B, multiplex test, point-of-care, regulatory submission, Respiratory syncytial virus, United States Food and Drug Administration

Co-Diagnostics; clinical evaluations; multiplex test; point-of-care; Co-Dx PCR Platform; FDA 510(k); Flu A/B; COVID-19; RSV; regulatory submission

Roche’s Oral SERD Giredestrant Delays Early Breast Cancer Recurrence in Late-Stage Trial

2 days ago talkbio0Tagged Adjuvant Therapy, Disease-Free Survival, ER-positive, giredestrant, HER2-negative, Malignant neoplasm of breast, Oral SERD, Phase 3 trial, recurrence prevention, Roche (company)

Roche; oral SERD; giredestrant; Phase 3 trial; early breast cancer; ER-positive; HER2-negative; disease-free survival; adjuvant therapy; recurrence prevention

Pressure On, Purpose Questioned as Second Round of FDA Priority Review Vouchers Revealed

2 days ago talkbio0Tagged Anemia, Sickle Cell, Biosimilars, Commissioner 's National Priority Voucher, Drug Approval, drug price, eli lilly, erbB-2 Receptor, Malignant neoplasm of lung, Obesity, Priority Review, public health medicine (field), Tuberculosis, Drug-Resistant, United States Food and Drug Administration, voucher program

FDA; Commissioner’s National Priority Voucher; priority review; drug approval; voucher program; Eli Lilly; Novo Nordisk; her2 lung cancer; obesity drugs; drug-resistant tuberculosis; sickle cell disease; biosimilars; public health; drug pricing; regulatory controversy

Merck Continues Cuts: 204 Employees Laid Off in New Jersey

2 days ago talkbio0Tagged Biopharma Industry, Cautionary Warning, cost-cutting, Dosage Forms, Gardasil, global workforce reduction, Keytruda, layoffs, Merck, New Jersey, Rahway, restructuring

Merck; layoffs; New Jersey; Rahway; pharmaceutical; cost-cutting; restructuring; WARN notice; global workforce reduction; Keytruda; Gardasil; biopharma industry