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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Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact.
President Biden called for expanding the Inflation Reduction Act to lower prescription drug prices. What would Trump do if he wins the 2024 election?
Judge Zahid Quraishi on Thursday appeared unconvinced by the pharmaceutical companies’ arguments that the Inflation Reduction Act’s Drug Price Negotiation Program violated the U.S. Constitution.
The Anglo-Swedish drugmaker is making the investment to bolster its vaccine manufacturing and research and development capabilities in the U.K.
President Joe Biden has proposed expansions to the Inflation Reduction Act, including an increase in the annual number of prescription drugs that would be subject to price negotiations to 50, up from 20.
Despite its overall survival and disease progression benefits, the U.K.’s drug cost watchdog has declined to recommend AstraZeneca and Daiichi Sankyo’s Enhertu due to a lack of cost-effectiveness.
Examining 50 existing drugs, researchers find that the IRA could cause drug developers to shy away from pursuing subsequent indications for their marketed drugs, thereby reducing the number of new approvals.
Exosomes show potential to treat myriad conditions, including cancer and inflammation, but experts are divided on whether the therapies are ready for the limelight.
Pfizer’s oncology strategy to build up its biologics portfolio and dramatically reduce small molecules was influenced by the Inflation Reduction Act’s drug price negotiation provisions.
A federal court in Delaware ruled Friday that the pharma company had no “entitlement” to any price above what the buyer is willing to pay.