Drug Delivery
With Novo Holdings’ $16.5 billion buyout of Catalent being reviewed by regulators, what work the contract drug manufacturer may or may not be performing for Eli Lilly remains a point of contention.
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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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While GLP-1 drugs remain wildly popular and are a highly lucrative sector, data analytics firm GlobalData contends manufacturing and cost will remain overhangs on the obesity market.
The BIOSECURE Act, which seeks to protect U.S. national security from Chinese biotech companies, will not be part of the House of Representatives vote on the 2025 fiscal year National Defense Authorization Act.
Sen. Bernie Sanders (I-Vt.), chair of the Senate health committee, has proposed issuing a subpoena to Novo Nordisk President Doug Langa forcing him to testify regarding the company’s pricing for Wegovy and Ozempic.
The House Select Committee asks the FBI for a briefing on GenScript’s links to China, fueling the challenge facing public relations and investor relations teams at US biopharma firms and Chinese CDMOs.
Given their seven-figure price tags, it’s not clear how accessible the would-be cures will be to U.S. patients on public or private insurance.
Securing top talent in research and development and manufacturing will remain challenging for life sciences companies in 2024, according to a new report by CBRE.
Amid shortages of its Mounjaro and Zepbound blockbuster drugs, Eli Lilly on Friday said it is investing an additional $5.3 billion in its production site in Lebanon, Indiana, to boost output of their active ingredient.
An appellate court ruled on Tuesday that pharmaceutical companies can lawfully impose restrictions on covered drugs under the 340B Drug Pricing Program.
The PR departments of Chinese CDMOs affected by the BIOSECURE Act and their U.S. partners must step up to ensure proposed legislation doesn’t squash innovation.
To support its growing antibody-drug conjugate portfolio, AstraZeneca on Monday said it is investing $1.5 billion in a Singapore production site that will include all steps of the ADC manufacturing process.