Manufacturing
The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant.
Teams at facilities being developed by Eli Lilly, Regeneron and other companies will receive early technical guidance and additional perks from the FDA.
Unicycive Therapeutics and Sobi received complete response letters for kidney disease and gout filings, respectively, after the FDA found fault with their manufacturing partners.
The company is “especially excited” about an immune cell therapy manufacturing technology included in the deal, a Merck KGaA executive said.
Jubilant HollisterStier received a warning letter over problems that the FDA said necessitate an immediate and comprehensive assessment of the contract manufacturing organization’s global operations.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
Having stuck with local production in the years when offshoring to lower-cost locations was in fashion, Aquestive’s CEO is well placed to explain what the recent reshoring drive means for manufacturers.
Anticipated to be one of fastest-growing jobs in manufacturing, pharmaceutical jobs offer a salary 32% higher than the average U.S. manufacturing role.
If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
The U.S. government has argued that it pays too much of biopharma R&D costs, demanding that other high-income countries contribute fairly to global innovation efforts.
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