Drug Delivery
A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.
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Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
Experts suggest the FDA’s Advanced Manufacturing Technologies designation could be a lifeline for improving production processes for approved cell and gene therapies.
Novo Nordisk goes “on the offensive” following Trump deal that also included rival Eli Lilly, putting an exclamation point on rapidly declining GLP-1 drug prices. Experts say the unusual situation makes it hard to predict what’s next.
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The PR departments of Chinese CDMOs affected by the BIOSECURE Act and their U.S. partners must step up to ensure proposed legislation doesn’t squash innovation.
To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.
Belgian biotech Galapagos is teaming with Blood Centers of America to help deploy its decentralized CAR-T therapy manufacturing platform closer to treatment centers across the U.S.
While the FTC continues to review its $16.5 billion buy of Catalent, Novo Holdings announced Wednesday it has acquired a majority stake in Single Use Support, an Austrian life sciences tools company.
Crackdowns on drug pricing have forced one major insulin out of the market. Are more to come?
The major biopharma players have promised to increase their investments in France to help boost their respective global manufacturing and R&D capabilities, with Sanofi committing more than $1 billion.
An updated draft of the BIOSECURE Act introduced on Friday would give U.S. drug manufacturers additional leeway for existing contracts with certain Chinese “companies of concern” until 2032.
Tuesday afternoon’s session was standing room only as representatives from various biopharma companies presented on their work to improve the efficiency and quality of AAV production.
With appeals and additional cases still pending, it remains to be seen if any of the arguments being brought by biopharma companies against the U.S. government will hold up in court.
The Federal Trade Commission has asked for an additional 30 days for its review of Novo Nordisk’s $16.5 billion acquisition of Catalent, with the companies expecting to complete the merger by the end of 2024.