Manufacturing
Neither Chongqing Qiancan Technology nor Tianjin Healthcare Medical Technology provided the records requested by the FDA, leading the agency to issue import alerts and warning letters.
Less than two weeks away from a highly anticipated FDA ruling on its cell therapy for Duchenne muscular dystrophy, Capricor Therapeutics has reported increased investment in its San Diego plant to support commercial production.
The seven proposals in the Bio Advance plan include easing clinical trial starts, boosting manufacturing and establishing a new White House office to coordinate the government’s biotech policy.
Twelve marketed drugs, including Eli Lilly’s and Novo’s weight loss mega-blockbusters, will require a label change under the new FDA update.
SK pharmteco’s Tatiana Nanda, chief technical officer of SK pharmteco Viral Vector North America discusses what gene therapy sponsors must account for sooner rather than later when preparing for GMP manufacturing.
The BioSpace 40 Under 40 honoree helped steer Forge’s sale to Ajinomoto. Now, Samantha Piteri-Molina sees opportunities in AI-driven analytics and Ohio’s gene therapy ecosystem—with a responsibility to patients worldwide.
Personalized cancer vaccines are getting closer to market. Merck and Moderna just showed successful manufacturing in a large Phase 3 trial, proving they can deliver the goods.
The Swiss contract development and manufacturing organization will more than double its U.S. footprint by acquiring the Merck KGaA plants.
By allowing compounding pharmacies to produce certain unapproved peptides, the Department of Health and Human Services could, in the short term, put patients in harm’s way. Longer term, the policy shift threatens the industry that brings new medicines to market.
The cessation of manufacturing activities follows a Sun Pharma recall and reports that regulators found fault with the company’s quality system.
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