The day in pharma, read in minutes.
NewsTMIV Imaging Launches AI-Driven CLARION CT in India
TMIV Imaging launches the CLARION CT System in India, combining AI reconstruction with the Aegis Detector System for low-dose imaging workflows.
Evonik Invests C$150M to Triple Vancouver Pharma Capacity
FDA Approves First Targeted Therapy for Metastatic Pancreatic Cancer
Lilly Wins FDA Nod for Mounjaro Cardiovascular Benefit
Cipla's Pune Unit Loses Drug Licence Over Reactin Plus Issue
Latest news
11 storiesFDA Approves Janssen's Stelara for Pediatric Colitis Use
FDA approves Stelara for paediatric UC in patients aged 2+, using an adult-data extrapolation plus paediatric PK pathway that sets a precedent for biologic sponsors.
Takeda's Mimrylo Gains FDA Approval for Polycythemia Vera
FDA approves Takeda's Mimrylo (rusfertide), the first hepcidin mimetic for polycythemia vera, following priority review and Phase 3 VERIFY trial data.
FDA, ISoP Workshop Targets Oncology Dosage Optimization
FDA and ISoP's November 2023 workshop advances model-informed dosage optimization as a core regulatory expectation for oncology development.
FDA, PDA Host 33rd Joint Conference on CGMP Quality
FDA and PDA's 33rd Joint Regulatory Conference addresses CGMP quality systems, data integrity, aging facilities, and supplier oversight across three days in September 2024.
FDA Workshop Advances PBPK Modeling for Bioequivalence
FDA's PBPK workshop signals growing regulatory acceptance of absorption modeling to support BE submissions, biowaivers, and pediatric BA assessments.
AbbVie Files EMA Bid for Subcutaneous SKYRIZI in Crohn’s
AbbVie files with EMA for subcutaneous SKYRIZI induction in Crohn's, raising comparability and fill-finish questions for biologics manufacturers.
FDA Updates Withdrawn Product-Specific Guidance List
FDA updated its CDER withdrawn product-specific guidances list on August 28, requiring ANDA sponsors to audit pipelines for strategy gaps.
CDT Equity Validates AI-Driven Crystal Structures for Drugs
CDT Equity confirms AI-identified crystal structures show improved stability, solubility, and manufacturability, with patents filed to extend IP life.
B. Braun Recalls Sodium Chloride Lots Over Zinc Oxide
B. Braun recalls three lots of 0.9% Sodium Chloride Injection USP over zinc oxide particulate, distributed nationwide Feb–Aug 2026.
Teva Bids $125M for BioXcel’s IGALMI in Bankruptcy Sale
Teva bids $57.5M upfront for BioXcel's dexmedetomidine sublingual film via Section 363 bankruptcy auction, with up to $125M total consideration.
Celularity Signs U.S. Deal with MuseCell for Dezawa Cells
Celularity's Florham Park cGMP site will manufacture Dezawa MuseCells and derived products for MCI, with $300M in projected purchases over five years.
Worth your time this week
FDA Warns Compounders on Glutathione After 30 Adverse Events
FDA Extends Use Dates on Hospira, Baxter Vials Amid Shortages
