GPE – Page 2 – Talk Bio

Boehringer Ingelheim; Jascayd; nerandomilast; FDA approval; idiopathic pulmonary fibrosis; IPF; lung scarring; first new treatment; chronic lung disease

FDA Launches Pilot Program to Prioritize U.S. Generic Drug Manufacturing and Testing

3 weeks ago talkbio0Tagged ANDA, bioequivalence testing, domestic manufacturing, Drug Approval, Pharmaceutical Supply Chain, pilot program, Prioritization, resilience, supply chain, United States, United States Food and Drug Administration

FDA; pilot program; generic drugs; ANDA prioritization; domestic manufacturing; bioequivalence testing; U.S. pharmaceutical supply chain; drug approval; supply chain resilience

Meeting on the Mesa 2025 Arrives Amid Mixed Signals for Cell and Gene Therapy Sector

3 weeks ago talkbio0Tagged Advanced therapies, Alternative, Cells, Clinical Trials, commercialization, Gene Modification, gene therapy, Industry, meeting, MESA, partnerships, payment, Phoenix Arizona, regulatory challenges, RNA, Messenger, Study models

Cell and gene therapy; Meeting on the Mesa; Commercialization; Clinical trials; Advanced therapies; Industry partnerships; Regulatory challenges; Phoenix Arizona; mRNA; Gene editing; Alternative payment models

Vaxcyte Strikes up to $1B Fill-Finish Manufacturing Deal with Thermo Fisher at North Carolina Facility

4 weeks ago talkbio0Tagged biomanufacturing, commercial supply chain, Manufacturing, North Carolina, PCVs, pneumococcal conjugate vaccines, production, Thermo Fisher Scientific, United States, Vaccines, VAX-24, VAX-31, Vaxcyte

Vaxcyte; Thermo Fisher Scientific; fill-finish manufacturing; North Carolina; pneumococcal conjugate vaccines; PCVs; VAX-31; VAX-24; commercial supply chain; biomanufacturing; U.S. vaccine production; $1 billion deal

Barinthus Biotherapeutics Announces Reverse Merger with Clywedog Therapeutics to Form New Metabolic Disease-Focused Company

4 weeks ago talkbio0Tagged Autoimmune Diseases, Barinthus, biotherapeutics, Board Composition, Clywedog Therapeutics, Delaware merger, lock-up, Menstruation, Metabolic Diseases, reverse merger, Scheme of Arrangement, Shareholder Ownership Structure, Topco, UK

Barinthus Biotherapeutics; Reverse Merger; Clywedog Therapeutics; Metabolic Diseases; Autoimmune Diseases; Topco; Shareholder Ownership Structure; UK Scheme of Arrangement; Delaware Merger; Self-Tender Offer; Lock-Up Period; Board Composition

Novartis and Boehringer Ingelheim Launch Direct-to-Consumer Drug Sales, Bypassing Middlemen

4 weeks ago talkbio0Tagged Boehringer Ingelheim, Cosentyx, Direct-to-Consumer, drug price, DTC, middlemen, Novartis, Patient access, Pharmaceutical Sales, PhRMA, Spiriva Respimat

Boehringer Ingelheim; Novartis; Direct-to-consumer (DTC); Pharmaceutical sales; Middlemen; Drug pricing; Patient access; Cosentyx; Spiriva Respimat; PhRMA

AstraZeneca Plans Direct US Stock Listing While Maintaining UK Headquarters

4 weeks ago talkbio0Tagged American Depositary Receipts, AstraZeneca, Capital Markets, Drug Industry, headquarters, London, Nasdaq Stockholm, NYSE, shareholders, Stock exchange, U.S., UK

AstraZeneca; US stock listing; NYSE; London Stock Exchange; Nasdaq Stockholm; American Depositary Receipts; capital markets; pharmaceutical industry; shareholders; UK headquarters