Drug Delivery
While the regulator conducts another review into the supply of Eli Lilly’s tirzepatide, compounders will be able to continue selling their own remixed versions of the blockbuster drug.
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Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
After a series of unfortunate regulatory rejections and manufacturing issues surfaced, Regeneron’s shares dipped to $483 this summer—the lowest they’d been since early 2021. But they now sit higher than they did at the start of the year.
The status could support staged transitions to new manufacturing processes, potentially mitigating some risks of high-stakes switches.
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The global contract development and manufacturing organization is investing $1.2 billion to boost production capabilities at its Holly Springs, North Carolina, site including mammalian cell culture bioreactors.
The American Society of Health-System Pharmacists has released statistics showing the number of active and ongoing U.S. drug shortages has reached 323, the highest number since it began tracking the data.
Moderna Thursday said it paused plans to build an mRNA manufacturing facility in Kenya to buy time to assess vaccine demand after being hit with $1 billion in losses and write-downs due to canceled orders.
The U.S. Department of Justice has filed a complaint against Regeneron alleging that the pharma knowingly omitted credit card price concessions for Eylea to inflate Medicare reimbursement rates.
Many promising small molecules have lost significant investment appeal as a result of lopsided incentives favoring biologics in 2022’s Inflation Reduction Act.
The FTC and the U.S. Department of Justice’s antitrust division will have another 30 days to examine Novo Nordisk Foundation’s acquisition of contract manufacturer Catalent, according to an SEC filing.
Congress and the Biden administration have set their sights on lowering prescription drug costs.
The four highest doses of Eli Lilly’s blockbuster diabetes treatment Mounjaro will be in short supply through the rest of the month due to strong demand, according to the regulator.
Plus, another big buy points to strength of CDMO market and a new treatment for pulmonary arterial hypertension
While some companies look to AI models to stop revenue leakage in business operations, experts say more fundamental issues must first be addressed.