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While a new facility setup program aimed at encouraging onshoring received a positive reception at a recent meeting, industry representatives said the current rules on existing production plants are the main regulatory issues facing manufacturing teams.
FEATURED STORIES
While the 10-fold increase in dose over injectable Wegovy has raised questions about the launch, Novo Nordisk has assured investors it has the manufacturing capacity to roll out oral semaglutide without restrictions on supply.
The HHS secretary recently canceled $500 million worth of BARDA contracts around mRNA vaccine research. But the U.S. government has already spent billions on this work, which has saved millions of lives.
President Donald Trump loves a deal, but Most Favored Nation drug pricing isn’t a good one for anyone.
Job Trends
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that its Board of Directors authorized a quarterly cash dividend of $0.39 per common share, payable on July 15, 2024, to shareholders of record as of June 14, 2024.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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The House Committee on Energy and Commerce has cleared proposed legislation that could bring back the FDA’s rare pediatric priority review voucher program, which allows for expedited drug reviews.
Nektar Therapeutics still needs to establish what differentiates rezpeg from other atopic dermatitis therapies, according to analysts at William Blair.
VectorY Therapeutics will evaluate the use of SHP-DB1, a capsid developed by Shape Therapeutics, to deliver therapies to the brain, including VectorY’s developmental Huntington’s and Alzheimer’s disease treatments.
This year, Novo Nordisk and Merck announced significant layoffs, with Novo planning to axe about 9,000 employees and Merck projecting it could let go of roughly 6,000. Meanwhile, Bayer, Bristol Myers Squibb, Novartis and Pfizer have also made noteworthy cuts.
In this episode of Denatured, BioSpace’s head of insights Lori Ellis and Colin Zick, partner at Foley Hoag LLP, spend time discussing some of the points brought up in the Bioprocessing Summit last month. They explore the connections between hammers, AI, The Planet of the Apes and monoliths.
Both BMS and Novo Nordisk have, in recent months, announced steep layoffs as they strive to cut back on costs.
Brepocitinib remains “ahead of competition” in the dermatomyositis space, according to analysts at Leerink, who projected that the drug candidate could hit $2 billion in sales in 2032.
Supporting Lexicon Pharmaceuticals’ decision to advance the non-opioid analgesic pilavapadin into late-stage development—despite a topline miss in March—is an “improving” regulatory environment for non-addictive options for chronic pain, according to analysts at Jefferies.
The star of the acquisition, which includes a contingent value right of $6 per share, is pegozafermin, an FGF21 analog in late-stage development for metabolic dysfunction-associated steatohepatitis.
In this deep dive, BioSpace explores the next big thing in obesity.