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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Though details remain scant, the pending order is expected to be the latest effort in President Donald Trump’s campaign to bring drug prices down to the same level as economically similar countries.
The issues the regulator found include the failure to comprehensively review complaints and product defects.
Lilly expects to open 615 high-wage roles in Texas in connection with its new facility, plus around 4,000 construction roles.
Small and large drugmakers alike have made big, proactive moves to secure the production capacity that will be vital to serving the weight loss market.
In an interview with German-language outlet Neue Zuercher Zeitung, Novartis CEO Vas Narasimhan said the company is exploring ways to remove or minimize the drug price gap between the U.S. and its other markets in similarly developed countries.
Bluebird bio has re-emerged after a private equity buyout as Genetix Biotherapeutics, marking a return to its roots and a new path forward for manufacturing.
The multi-billion, multi-year investment comes as many of GSK’s pharma peers pull away from the U.K., either suspending or completely canceling previous commitments.
This manufacturing site in Richmond, Virginia, is the first of four projects that Eli Lilly plans to reveal this year as part of a $27 billion U.S. investment announced earlier this year.
While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.