Drug Delivery
A push to reshore some drug production and progress in advanced manufacturing technologies have been prominent trends this year, industry leaders say.
FEATURED STORIES
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.
Subscribe to Manufacturing Brief!
Weekly insight into the biggest trends in biopharma manufacturing
THE LATEST
Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.
This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.
Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.
Expanded exemptions for orphan drugs could mean prolonged protections for top-selling drugs like Merck’s Keytruda, which was initially approved under this designation in 2014.
In this episode presented by PII, BioSpace’s head of insights discusses with guests Oliver Eden and Travis Webb how autoinjectors offer opportunities to improve delivery systems, patient compliance and clinical trial processes.
President Donald Trump last week announced that 100% pharma tariffs would come Oct. 1, but a White House official has clarified that that’s when the government will “begin preparing” the levies.
At the heart of the agreement is Pfizer’s $70 billion commitment to U.S.-based manufacturing and an exemption from tariffs for three years. While the reaction was mostly positive from Wall Street, other observers noted that the benefits for patients are unclear at best.
Pfizer CEO Albert Bourla directly credited the threat of tariffs with leading to the deal, in which the company will offer drugs on a soon-to-be-launched website called TrumpRx.
Companies are moving from using AI for distinct operations to applying the technology for control and optimization of the whole production process.
Reshoring generic pharmaceutical production is essential in today’s era of geopolitical instability and heightened awareness surrounding national health security. And it is possible—if done right.