Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility
Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance
FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time
FDA; complete response letters; real-time disclosure; drug applications; radical transparency; pending applications; regulatory transparency; public health; openFDA
Merck Moves All R&D Operations Out of UK, Citing Unfavorable Environment
Merck; MSD; R&D relocation; UK life sciences; drug discovery; Brexit impact; London Bioscience Innovation Centre; Francis Crick Institute; government investment; layoffs
Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA
Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission
PMV Pharma’s p53 Drug Shows Effect in Ovarian Cancer, but Financial Challenges Loom
PMV Pharmaceuticals; rezatapopt; p53; ovarian cancer; clinical trial; response rate; FDA filing; funding; cash runway
Odyssey Therapeutics Secures $213M Series D to Accelerate Autoimmune Clinical Portfolio
Odyssey Therapeutics; Series D financing; $213 million; autoimmune diseases; clinical pipeline; preclinical programs; precision immunomodulation; RIPK2 inhibitor; PROTAC technology; investors
J&J’s Inlexzo Bladder Cancer Therapy Wins ‘Practice-Changing’ FDA Approval
Inlexzo; FDA approval; bladder cancer; Johnson & Johnson; gemcitabine intravesical system; BCG-unresponsive; non-muscle invasive bladder cancer; SunRISe-1 trial; novel drug delivery; carcinoma in situ
Novo Nordisk to Cut 9,000 Jobs Globally as New CEO Targets $1.3B Savings by 2026
Novo Nordisk; layoffs; 9000 jobs; cost savings; CEO Doustdar; restructuring; weight-loss drugs; Wegovy; Ozempic; competition; Eli Lilly; profit guidance
Trump Administration Weighs Severe Restrictions on US Pharmas Licensing Chinese Medicines
Trump administration; Chinese medicines; executive order; pharmaceutical industry; licensing restrictions; national security; lobbying; Pfizer; AstraZeneca; biotech; drug manufacturing; FDA review
Lundbeck Offloads Assets to Three Partners as It Exits 27 Markets, Leaving 602 Jobless
Lundbeck; market exit; asset offloading; partnerships; job cuts; Swixx Group; Zuellig Pharma; NewBridge Pharmaceuticals; restructuring; neuro-rare diseases; neuro-specialty diseases