Manufacturing – Talk Bio

FDA Announces Flexible Manufacturing Approach for Cell and Gene Therapies on January 11, 2026

2 weeks ago talkbio0Tagged calcium glucarate, Candidiasis, Chronic Mucocutaneous, Cells, gene therapy, Manufacturing, Pliability, requirements, United States Food and Drug Administration

FDA; cell and gene therapies; CGT; manufacturing flexibility; CMC requirements; Marty Makary

J&J-backed Cellular Origins raises $40M for cell therapy manufacturing

2 months ago talkbio0Tagged cell therapy manufacturing, Cellular Origins, Constellation platform, cyclic adenosine-5'-trimetaphosphate, Groups, Johnson & Johnson, Manufacturing, Purpura, Thrombotic Thrombocytopenic, robotic automation

Cellular Origins; Johnson & Johnson; Series A; $40 million; cell therapy manufacturing; Constellation platform; robotic automation; ATMP; TTP Group; scalable manufacturing

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

2 months 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

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

2 months 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

WuXi AppTec Divests China Clinical Services to Hillhouse Capital, Refocuses on Manufacturing Business

3 months ago talkbio0Tagged China, Clinical, clinical research services, CRDMO, Divestment, Hillhouse Capital, Manufacturing, WuXi, WuXi AppTec

WuXi AppTec; Hillhouse Capital; divestment; clinical research services; CRDMO; manufacturing; China; WuXi Clinical; MedKey

Lilly Commits $1.2 Billion to Expand GLP-1 Pill Manufacturing Facility in Puerto Rico

3 months ago talkbio0Tagged Carolina, eli lilly, expansion, Investments, Manufacturing, Oral Medicine, orforglipron, pharmaceutical production, Product containing glucagon-like peptide 1 receptor agonist (product), Puerto Rico, supply chain, United States

Eli Lilly; Puerto Rico; GLP-1 receptor agonist; orforglipron; manufacturing expansion; oral medicines; investment; Carolina; pharmaceutical production; U.S. supply chain

Drugmakers Push US Expansion After Trump’s 100% Pharma Tariff Threat

3 months ago talkbio0Tagged branded drugs, drugmakers, genentech, Manufacturing, Roche (company), Section 232, supply chain, Trump tariff, U.S.

Trump tariff; pharmaceuticals; US manufacturing; branded drugs; drugmakers; Genentech; Roche; Novo Nordisk; Section 232; supply chain

Roche in Talks With US on Drug Pricing; Sets Out Pipeline and Dealmaking Ambitions

3 months ago talkbio0Tagged Benefit, dealmaking, direct-to-consumer sales, drug price, gene therapy, Government, Hemlibra, Investments, manager, Manufacturing, Ocrevus, Pharmaceutical Services, pipeline, R&D, Roche (company), U.S., Vabysmo

Roche; drug pricing; US government; pharmacy benefit managers; direct-to-consumer sales; pipeline; dealmaking; US investment; manufacturing; gene therapy; R&D; Ocrevus; Hemlibra; Vabysmo

Companies Struggle to Accelerate Production of Bespoke mRNA Therapies

3 months ago talkbio0Tagged bespoke, Cancer Vaccines, cold chain logistics, Efficiency, innovation, Manufacturing, manufacturing challenges, mRNA production, mRNA therapies, Optimization, Precision Medicine, regulatory complexity, scalability

bespoke mRNA therapies; personalized medicine; manufacturing challenges; cancer vaccines; scalability; manufacturing efficiency; cold chain logistics; regulatory complexity; mRNA production innovation; AI optimization

Ypsomed Invests $248 Million to Establish First U.S. Manufacturing Site in North Carolina

3 months ago talkbio0Tagged CHF, expansion, Facility (object), global growth strategy, Holly Springs, Manufacturing, medical technology, North Carolina, self-injection systems, Surgical construction, United States, Ypsomed

Ypsomed; manufacturing expansion; U.S. facility; Holly Springs; North Carolina; CHF 200 million; self-injection systems; job creation; global growth strategy; medical technology