Biological Factors
Rezon Bio Launches Two State-of-the-Art CDMO Facilities for Biologics in Europe
Rezon Bio; biologics; CDMO; contract manufacturing; Gdańsk; Warsaw-Duchnice; Europe; digital innovation; GMP manufacturing; biosimilars; EMA; FDA
Big Pharma-Backed MapLight Plots IPO to Advance Neuro Pipeline
MapLight Therapeutics; IPO; neuro pipeline; Alzheimer’s disease psychosis; schizophrenia; M1/M4 muscarinic agonist; Series D financing; Morgan Stanley; biopharmaceutical; clinical trials
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
Gilead Unveils New Manufacturing Site in California as Part of $32B U.S. Investment Plan
Gilead Sciences; Foster City; California; manufacturing facility; biopharmaceuticals; $32 billion investment; economic impact; expansion; R&D; job creation; U.S. manufacturing
FDA Announces New Rare Disease Approval Programme
FDA; rare disease; conditional approval pathway; accelerated approval; biologics; drug review; surrogate endpoints; real-world data; streamlined process
Royalty Market Accelerates with XOMA Biotech Acquisitions and OrbiMed’s Major Fundraise
royalty acquisition; XOMA Royalty; biotech M&A; OrbiMed; biopharma financing; mezigitamab; Turnstone Biologics; HilleVax; LAVA Therapeutics; contingent value rights; life sciences investment
FDA Seeks Greater Alignment Between CBER and CDER: Makary Informs Industry Leaders
FDA; CBER; CDER; regulatory harmonization; Marty Makary; George Tidmarsh; Vinay Prasad; cell and gene therapy; biologics; pharmaceutical industry
Gilead Lays Off 36 Employees After Cancelling Oceanside, California Expansion
Gilead Sciences; layoffs; Oceanside; California; biologics; facility expansion; job cuts; biotech industry; co-location; Foster City
UCB Announces Major Investment to Expand US Biologics Manufacturing Capacity
UCB; biologics manufacturing; US expansion; biomanufacturing; biopharmaceutical; investment; jobs; economic impact
About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds
FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process