Biological Factors

Gilead Unveils New Manufacturing Site in California as Part of $32B U.S. Investment Plan

2 weeks ago talkbio0Tagged Billion, Biological Factors, California, economic impact, expansion, Foster City, Gilead Sciences, Investments, Manufacturing, Manufacturing Facilities, R&D, Surgical construction, United States

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

2 weeks ago talkbio0Tagged Accelerated, Approved, Biological Factors, conditional approval pathway, drug review, Endpoints, Infrequent, real-world data, streamlined process, Surrogate, United States Food and Drug Administration

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

2 months ago talkbio0Tagged Arenaria, Biological Factors, Biological Science Disciplines, biopharma financing, Conditional, HilleVax, Investments, LAVA, M&A, mezigitamab, OrbiMed, royalty acquisition, XOMA Royalty

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

2 months ago talkbio0Tagged Biological Factors, CBER, CDER, Cells, Drug Industry, gene therapy, George Tidmarsh, Makary, Marty, Prasad, regulatory harmonization, United States Food and Drug Administration

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

3 months ago talkbio0Tagged Biological Factors, biotech industry, California, co-location, expansion, Facility (object), Foster City, Gilead Sciences, layoffs, Oceanside

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

3 months ago talkbio0Tagged Biological Factors, biomanufacturing, economic impact, expansion, Investments, Manufacturing, U.S., UCB

UCB; biologics manufacturing; US expansion; biomanufacturing; biopharmaceutical; investment; jobs; economic impact

About 5% of CBER and CDER Left After FDA Staff Cuts, Analysis Finds

4 months ago talkbio0Tagged Biological Factors, CBER, CDER, Drug Approval Process, drug review, layoffs, Staff, Trump administration, United States Food and Drug Administration

FDA layoffs; CBER; CDER; drug review; biologics; staff cuts; Trump administration; drug approval process

Teva plots thousands of job cuts as restructuring drive enters ‘acceleration’ phase

4 months ago talkbio0Tagged 8, Biological Factors, Financial cost, Financial savings, generics, Investments, Operational streamlining, Pivot Device, R&D, Strategic Overhaul, Workforce reduction

Workforce reduction (8%), $700 million cost savings, Strategic overhaul, Generics to biopharmaceuticals pivot, Operational streamlining, R&D investment