The day in pharma, read in minutes.
NewsEmpatica Gains FDA Clearance for Continuous Parkinson's Disease Monitoring Platform
Empatica's FDA-cleared Parkinson's monitoring platform raises the bar for objective endpoint design in CNS clinical trials.
FDA Finalizes Therapeutic Equivalence Guidance Changing Orange Book TE Codes
FDA Issues 55 New Guidances to Speed Up Generic Drugs Development
Zydus Gains FDA Approval for Ascorbic Acid Injection, Lifting ANDA Portfolio to 448
Merck and Moderna Achieve Phase 3 Primary Endpoint with mRNA Cancer Vaccine in Melanoma
Latest news
11 storiesCadila Pharma Appoints Surender Narain Singh as VP of Business Development
Cadila Pharma appoints Surender Narain Singh as VP of Business Development, signalling a push into regulated export markets.
Johnson & Johnson Wins EU Approval for Teclistamab Combo in Myeloma
EC approves J&J's teclistamab plus daratumumab for second-line RRMM, backed by Phase 3 OS data, raising supply and GMP implications for combination biologics.
Ipsen Acquires Kartos Therapeutics, Adding Navtemadlin to Oncology Pipeline
Ipsen closes Kartos Therapeutics acquisition, adding Phase III MDM2 inhibitor navtemadlin for myelofibrosis to its oncology pipeline.
AuroPeptides Clears FDA Inspection With Just One Observation
AuroPeptides cleared a USFDA inspection with one minor observation, initiating corrective action during the inspection itself.
Abbott Settles 2,000 NEC Claims for $670M, Shifts Legal Strategy
Abbott settles ~2,000 NEC claims for $670M; learned intermediary doctrine rulings reshape labeling defense strategy for specialty products.
Tilray Expands Annual Cannabis Production Capacity to 275 Tonnes Across Quebec and Portugal
Tilray scales medical cannabis output to 275 tonnes annually, with EU-GMP certification for its Quebec site targeted within 12 months.
FibroBiologics Secures Australian Patent Acceptance for Cannabidiol-Fibroblast Combination in Disc Degeneration
IP Australia accepts FibroBiologics' patent on cannabidiol-fibroblast combination therapy for degenerative disc disease, extending its IP estate into Asia-Pacific.
Genentech Invests $750M in Hillsboro Fill-Finish Facility to Expand U.S. Device Manufacturing
Genentech commits $750M to a flexible fill-finish device facility in Hillsboro, Oregon, targeting commercial operations by 2031.
PacBio Launches SPRQ-Nx Chemistry on Vega Benchtop System with 21 CFR Part 11 Audit Logging
PacBio ships SPRQ-Nx for Vega, adding 21 CFR Part 11 audit logging and 90 Gb HiFi yield to benchtop long-read sequencing.
Optimal Balance Pharmacy Recalls Compounded Glutathione Vials After Elevated Endotoxin Levels Detected
Optimal Balance Pharmacy recalls one lot of compounded glutathione 200 mg/mL multi-dose vials after internal testing found elevated bacterial endotoxin levels.
Ultragenyx Gains FDA Accelerated Approval for Genglycos in GSD1a, First-Ever Gene Therapy for the Disease
FDA grants accelerated approval to Ultragenyx's Genglycos, the first gene therapy for GSD1a, based on a 48-week surrogate endpoint trial.
Worth your time this week
Tilray Expands Annual Cannabis Cultivation Capacity Across EU-GMP-Certified Sites
Kyverna Therapeutics Gains RMAT Designation for Miv-Cel in Progressive Multiple Sclerosis
Strides Pharma Gains FDA Report for Bengaluru Manufacturing Facility
