Sanofi’s MS Drug Tolebrutinib Faces FDA Delay Amid Extended Review
Sanofi; tolebrutinib; FDA delay; multiple sclerosis; nrSPMS; Bruton’s tyrosine kinase inhibitor; breakthrough therapy; HERCULES trial; GEMINI trial; PERSEUS trial; NDA; regulatory review
Merck Wins FDA Approval for Subcutaneous Keytruda as Exclusivity Challenges Approach
Merck; Keytruda; subcutaneous injection; FDA approval; Keytruda Qlex; patent expiration; biosimilars; checkpoint inhibitors; solid tumors; cancer immunotherapy
Recent News: Gain Peace of Mind with the Lentiviral Experts
lentiviral vectors; CAR-T therapy; gene therapy; biologics; immuno-oncology; market growth; advanced manufacturing; regulatory approval
ACIP Vote Restricts Combined MMRV Vaccine for Children Under 4, Raising Access Concerns
ACIP; MMRV vaccine; measles; mumps; rubella; varicella; childhood immunization; Vaccines for Children (VFC) program; CDC vaccine recommendation; vaccine access
Ono Pharmaceutical and Jorna Therapeutics Announce AI-Driven Research Pact to Develop Novel RNA Editing Medications
Ono Pharmaceutical; Jorna Therapeutics; RNA editing; AI drug discovery; SkyEngine; biotech partnership; Japan
Langers Team Launch $77.5M Fund to Invest at Intersection of Technology and Biology
T.Rx Capital; Robert Langer; Michael Langer; intersection of technology and biology; biotech investments; venture capital; Fund I
Pfizer and Arvinas Abandon Commercialization of PROTAC Inhibitor, Triggering Layoffs and Pipeline Refocus
Pfizer; Arvinas; PROTAC; vepdegestrant; layoffs; out-licensing; FDA; breast cancer; oncology; CDK inhibitors
Genentech Names Zoë Harris Lazarre as New Chief Marketing Officer as Erica Taylor Moves to Roche Role
Genentech; Chief Marketing Officer; Erica Taylor; Zoë Harris Lazarre; Roche; leadership change; pharmaceutical marketing; biotech industry
Lilly’s Mounjaro Shows Strong Results in Youth Type 2 Diabetes, Paving Way for Expansion
Mounjaro; tirzepatide; type 2 diabetes; children; adolescents; SURPASS-PEDS; A1C reduction; BMI reduction; clinical trial; Eli Lilly
VectorY Strikes $1.2B Option and License Pact with Shape Therapeutics for Brain-Penetrant Gene Therapy Delivery
VectorY Therapeutics; Shape Therapeutics; SHP-DB1; adeno-associated virus (AAV) capsid; brain-penetrant delivery; gene therapy; neurodegenerative diseases; Huntington’s disease; Alzheimer’s disease; biobucks; pipeline; milestone payments; vectorized antibodies