Drug Delivery
Eli Lilly this week announced plans to sell single-dose vials of its weight loss drug Zepbound directly to consumers. Novo Nordisk could adopt a similar strategy for Wegovy as its CEO is set to testify Sept. 24 before the Senate health committee.
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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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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.
Politics aside, both the government and the pharmaceutical industry want to bring affordable effective therapies to patients. Implementation is the obstacle. Working together is the only way to modify the IRA to do what it intends to do: benefit patients.
The investment arm of the Novo Nordisk Foundation is acquiring contract development and manufacturing organization Catalent to help meet high demand for Ozempic and Wegovy.