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 Biden administration on Thursday announced that the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will save the U.S. government around $6 billion in its first year of implementation.
The new Medicare prices for the first 10 drugs negotiated under the Inflation Reduction Act are expected soon. Analysts and researchers are divided on the long-term effects of the law.
As the U.S. moves away from reliance on Chinese CDMOs, Southern cities provide a model for how we can bolster domestic production capacity.
At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals.
With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D.
In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue.
Patients in the U.K. with transfusion-dependent beta-thalassemia will have access to Vertex Pharmaceuticals’ gene editing therapy Casgevy, thanks to an agreement with the National Health Service on the price.
A day after Eli Lilly’s obesity and weight-loss therapies were removed from the regulator’s database, Novo Nordisk also made strides in boosting the supply of all but one of semaglutide’s shortages.
All doses of Eli Lilly’s type 2 diabetes medication Mounjaro and weight-loss drug Zepbound are now available, according to an update on Friday to the FDA’s drug shortage database.
Ultracompact CRISPR systems, which are in some cases one-third the size of Cas9, are being designed to be more specific and enable in vivo gene editing in difficult to reach tissues.