Manufacturing – Page 2

Eli Lilly to Invest Over $1 Billion to Expand Manufacturing Footprint in India

2 months ago talkbio0Tagged Alzheimer 's, Autoimmune, contract manufacturing, Diabetes, eli lilly, expansion, Hyderabad, India, Malignant Neoplasms, Manufacturing, Obesity

Eli Lilly; India; manufacturing expansion; contract manufacturing; Hyderabad; pharmaceuticals; obesity; diabetes; Alzheimer’s; cancer; autoimmune

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

2 months 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

Ansa Biotechnologies Raises $54.4M in Series B to Scale US DNA Synthesis Manufacturing

2 months ago talkbio0Tagged Ansa Biotechnologies, Biotechnology, Cerberus Ventures, DNA Replication, Manufacturing, Series B financing, synthetic construct, U.S.

Ansa Biotechnologies; Series B financing; DNA synthesis; Cerberus Ventures; US manufacturing; biotechnology; synthetic DNA; fundraising

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

2 months ago talkbio0Tagged biotech, Complete, CUTX-101, deficiencies, Drug Approval, Fortress, Infrequent, Manufacturing, Menkes disease, Pediatric Disorder, Sentynl Therapeutics, United States Food and Drug Administration

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback

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

3 months 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

Trump Administration Launches Tariff Probe into Medtech and Pharmaceutical Industries

3 months ago talkbio0Tagged Evaluation, Manufacturing, Medical Devices, medtech industry, National Security, pharmaceutical imports, Sectioning technique, semiconductor tariffs, supply chain, tariffs, Transplant Registry Unified Management Program

Trump administration; tariffs; medtech industry; pharmaceutical imports; Section 232 investigation; semiconductor tariffs; national security; supply chain; manufacturing; medical devices

Biogen Plans Resubmission After FDA Declines High-Dose Spinraza for SMA, Requests More Production Information

3 months ago talkbio0Tagged Biogen, Candidiasis, Chronic Mucocutaneous, Complete, controls, High dose, Manufacturing, New Drug Application, nusinersen, regulatory, Response Letter, resubmission, Science of Chemistry, Spinal Muscular Atrophy, Spinraza, United States Food and Drug Administration

Biogen; Spinraza; nusinersen; high dose; FDA; Complete Response Letter; spinal muscular atrophy; SMA; supplemental New Drug Application; Chemistry Manufacturing and Controls; CMC; regulatory; resubmission

Eli Lilly Picks Houston for $6.5 Billion API Manufacturing Facility

3 months 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

bluebird bio Rebrands as Genetix Biotherapeutics Following Private Equity Buyout

3 months ago talkbio0Tagged Anemia, Sickle Cell, Bluebird Bio, Capital Partners, Carlyle, Cerebral Adrenoleukodystrophy, commercial, David Meek, DKK1 gene, execution, FDA-approved therapies, gene therapy, Genetix Biotherapeutics, Investments, Manufacturing, Private Equity, rebranding, Thalassemia

bluebird bio; Genetix Biotherapeutics; private equity buyout; Carlyle; SK Capital Partners; gene therapy; rebranding; FDA-approved therapies; David Meek; sickle cell disease; β-thalassemia; cerebral adrenoleukodystrophy; commercial execution; manufacturing investment

GSK Commits $30 Billion to Bolster U.S. R&D and Manufacturing

3 months ago talkbio0Tagged Biopharma, Digital Technology, expansion, Investments, Manufacturing, R&D, SmithKline Beecham, supply chain, United States

GSK; $30 billion investment; U.S. expansion; R&D; manufacturing; biopharma; supply chain; advanced digital technologies