October 2025 – Page 4

Recent Advances Shifting Perspectives in Cell Therapy (2025)

5 days ago talkbio0Tagged CAR T-cell, Cell Therapy, Clinical Trials, controllable, CRISPR therapies, immune cells, Labels (device), Mesenchymal Stem Cells, patient-specific therapy, Solid Neoplasm, United States Food and Drug Administration, Updates

cell therapy; CAR T-cell; solid tumors; FDA label updates; mesenchymal stem cells; CRISPR therapies; patient-specific therapy; ultrasound controllable immune cells; clinical trials

Rocket Pharmaceuticals Withdraws FDA Application for Rare Blood Disease Gene Therapy

5 days ago talkbio0Tagged Fanconi Anemia, gene therapy, Mozafancogene Autotemcel, pipeline pivot, Rocket Pharmaceuticals, United States Food and Drug Administration

Rocket Pharmaceuticals; FDA; RP-L102; Fanconi Anemia; Gene Therapy; Pipeline Pivot

Legal Pressure Escalates as FDA Intensifies Crackdown on Direct-to-Consumer Pharma Advertising

1 week ago talkbio0Tagged Advertising (activity), CHARGE Syndrome, Compound, Direct-to-Consumer Advertising, enforcement, Legal Challenges, pharmaceutical advertising crackdown, Pharmacy facility, prescription drug ads, Preventive monitoring, United States Food and Drug Administration, warning letters

FDA enforcement; direct-to-consumer advertising; pharmaceutical advertising crackdown; warning letters; legal challenges; AI monitoring; prescription drug ads; transparency in advertising; HHS; compounding pharmacies

Recent Law Expands Orphan Drug Protections, Shielding Blockbusters from Medicare Price Negotiations

1 week ago talkbio0Tagged Big Beautiful Bill, Congress (U.S. Legislature), Drug Industry, drug price, Inflation Reduction Act, Keytruda, Medicare, negotiation, OBBBA, Opdivo, orphan drug exclusion

orphan drug exclusion; Medicare negotiation; One Big Beautiful Bill; Keytruda; Opdivo; Inflation Reduction Act; OBBBA; drug pricing; Congress; pharmaceutical industry

Transforming Patient Data into Therapeutic Breakthroughs in 2025

1 week ago talkbio0Tagged Diagnostics, Digital therapeutics, Precision Medicine

AI diagnostics; Digital therapeutics; Personalized medicine

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

1 week 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

Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

1 week ago talkbio0Tagged amgen, Approved, Cardiovascular Diseases, Cardiovascular event, Cerebrovascular accident, LDL-C, Myocardial Infarction, PCSK9 inhibitor, Primary Prevention, Repatha, United States Food and Drug Administration, VESALIUS-CV trial

Amgen; Repatha; VESALIUS-CV trial; primary prevention; cardiovascular disease; PCSK9 inhibitor; LDL-C; FDA approval; major adverse cardiovascular events; heart attack; stroke

Cartography Biosciences Closes $67 Million Series B Round Led by Pfizer to Advance CRC T-cell Engager

1 week ago talkbio0Tagged Antibodies, Biosciences, Cartography, CBI-1214, Cervical Atlas, Colorectal Carcinoma, Neoplasms, Pfizer Ventures, Platform, Series B funding, summit, T-Cell engager

Cartography Biosciences; Series B Funding; Pfizer Ventures; CBI-1214; T-cell engager; colorectal cancer (CRC); ATLAS platform; SUMMIT platform; antibody therapeutics; oncology