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 Federal Trade Commission and Department of Health and Human Services on Wednesday said they are investigating group purchasing organizations and drug wholesalers’ possible involvement.
This week, Greg, Heather and Tyler discuss reaction to Novo Nordisk’s purchase of Catalent and speculate on what that means for existing manufacturing contracts, customers and consequences with regulators.
Analysts say Novo Holdings made the right decision last week in scooping up the CDMO to increase manufacturing capacity for Novo Nordisk’s diabetes and weight-loss drugs.
On Monday, the Biden administration got an early victory in pharma’s legal challenge to the Inflation Reduction Act, with a Texas judge dismissing a complaint from the Pharmaceutical Research and Manufacturers of America.
The CEOs of BMS, J&J and Merck testified Thursday before the Senate health committee that pharmacy benefit managers bear much of the blame for high pricing, while declining to commit to price cuts.
The European Medicines Agency is looking into how Novo Holdings’ recently announced $16.5 billion acquisition of contract manufacturer Catalent might affect the availability of drugs.
This week Lori, Greg and Tyler discuss drug pricing reforms. CMS sent offers to manufacturers of the 10 drugs that have been selected for Medicare price negotiations. What’s the best way forward that benefits patients while still supporting the innovation that makes these drugs possible? How will the election impact negotia
While analysts are bullish on Novo Holdings’ $16.5 billion acquisition of Catalent, they say it raises questions for companies that have contracted the CDMO for manufacturing.
Eli Lilly on Tuesday said it is already making manufacturing investments for orforglipron, its next-generation oral weight-loss candidate that recently moved into Phase III development.
With manufacturing issues persisting, last year’s shortages of medicines, including chemotherapies, weight-loss drugs and antibiotics, will continue into 2024.