September 2025 – Page 2

GSK Appoints Luke Miels as New CEO, Succeeding Emma Walmsley on Jan. 1, 2026

3 weeks ago talkbio0Tagged Appointments, CEO, Emma Walmsley, Leadership Transition, Luke Miels, R&D pipeline, SmithKline Beecham, specialty medicines, Vaccines

GSK; Luke Miels; Emma Walmsley; CEO appointment; pharmaceuticals; leadership transition; specialty medicines; vaccines; R&D pipeline

Genmab CEO on the $8B Acquisition of Merus: Strategy Behind the ‘Very Fair’ Deal and Plans to Polish a Rough Diamond

3 weeks ago talkbio0Tagged Acquisition, Antibodies, Bispecific, Breakthrough Therapy, Cancer of Neck, CEO, expansion, Genmab, Head, Merus, Neoplasms, Perspective, Petosemtamab, pipeline, United States Food and Drug Administration

Genmab; Merus; petosemtamab; acquisition; oncology; head and neck cancer; bispecific antibody; FDA Breakthrough Therapy; pipeline expansion; biotech; $8B deal; CEO perspective

White House ‘Most Favored Nation’ Deadline Drives Pharma Concessions Amid Threats of Enforcement

3 weeks ago talkbio0Tagged deadline, drug manufacturers, drug price, Medicaid, Medicare, Nation, Pharma Concessions, pharmaceutical companies, prescription drug costs, Trump administration, White House

most favored nation; drug pricing; White House; executive order; pharmaceutical companies; Medicaid; Medicare; drug manufacturers; Trump administration; prescription drug costs; deadline; pharma concessions

Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe

3 weeks ago talkbio0Tagged Biological Factors, Biosimilars, CDMO, Contract agreement, Digital innovation, Europe, Gdańsk, Guanosine Monophosphate, Manufacturing, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Rezon Bio, United States Food and Drug Administration, Warsaw-Duchnice

Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA

Continuous Bioprocessing for Bispecific Antibodies: Innovations Accelerating Therapeutic Antibody Production (2024–2025)

3 weeks ago talkbio0Tagged Antibodies, Bispecific, antibody engineering, Automation, bioprocess, bioprocessing, Continuous, high-throughput, innovation, oncology therapeutics, production, Protein Purification, scale-up, Therapeutic Antibody

continuous bioprocessing; bispecific antibodies; therapeutic antibody production; bioprocess innovation; high-throughput production; antibody engineering; scale-up; oncology therapeutics; protein purification; automation

Biogen Shuffles Staff and Exits AAV Gene Therapy Programs After Strategic Shift

3 weeks ago talkbio0Tagged AAVS1 gene, Biogen, Biotech Layoffs, Discontinuation (procedure), gene therapy, layoffs, Pharma, staff reorganization

Biogen; AAV gene therapy; layoffs; staff reorganization; biotech layoffs; pharma restructuring; gene therapy discontinuation

GSK CEO Emma Walmsley Steps Down After 9 Years; Luke Miels to Succeed

3 weeks ago talkbio0Tagged CEO, Drug Industry, Emma Walmsley, Haleon demerger, Leadership Change, Luke Miels, SmithKline Beecham, specialty medicines, Succession planning, Transition Mutation, Vaccines

Emma Walmsley; GSK; CEO transition; Luke Miels; leadership change; pharmaceutical industry; Haleon demerger; specialty medicines; vaccines; succession planning

New Confirmatory Study Suggests Progress in Applied Therapeutics–FDA Alignment for Rare Disease Drug

3 weeks ago talkbio0Tagged Apply, Clinical Trials, CMT-SORD, confirmatory study, Govorestat, Infrequent, regulatory alignment, United States Food and Drug Administration

Applied Therapeutics; govorestat; CMT-SORD; rare disease; FDA; confirmatory study; clinical trial; regulatory alignment

Sanofi Expands $35 Insulin Program to All U.S. Patients Nationwide

3 weeks ago talkbio0Tagged Affordability, Diabetes, Insulin, Insurance, Medicare, monthly, Programs - Publication Format, sanofi, United States

Sanofi; Insulin; $35 monthly program; Insulins Valyou Savings Program; diabetes; insurance coverage; Medicare; affordability; United States

Eli Lilly’s Oral SERD Inluriyo Approved by FDA for ESR1-Mutated Breast Cancer

3 weeks ago talkbio0Tagged Approved, Carcinoma breast stage IV, Eli, Eli Lilly, EMBER-3 trial, ESR1 gene, Estrogen receptor positive, HER2-negative, Imlunestrant, Inluriyo, Mutation, Oral SERD, United States Food and Drug Administration

Eli Lilly; Inluriyo; oral SERD; imlunestrant; FDA approval; ESR1 mutation; metastatic breast cancer; estrogen receptor positive; HER2-negative; EMBER-3 trial