Dan Samorodnitsky

Dan Samorodnitsky

News Editor

Dan Samorodnitsky is the news editor at BioSpace. He has a decade of experience covering biotech, genetics and medicine. Before coming to BioSpace he was an editor at Drug Discovery News and Massive Science, and his writing has appeared in outlets such as Quanta, STAT, GROW and many others. He is based in Minneapolis. You can reach him at dan.samorodnitsky@biospace.com.

Insmed’s freshly approved lung condition drug soared past sales expectations for 2025, netting $144.6 million in its first full quarter of sales.
The DC-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for Hetlioz and promised to keep pushing for an approval.
The company announced a $350 million public offering on Monday shortly after revealing positive Phase II results for its investigational congenital adrenal hyperplasia drug, with hopes to one day compete with Neurocrine’s Crenessity.
Novo Nordisk follows Christmas oral Wegovy approval with quick launch; Eli Lilly is headed for $94.3 billion in annual revenue by 2027, analysts predict; nine more pharmas strike Most Favored Nation deals but half remain unsigned; experts call for stability and rare disease action at FDA, and all eyes are on M&A ahead of the J.P. Morgan Healthcare conference next week.
The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
After getting the crucial first-mover advantage with an FDA approval for a weight loss pill, Novo Nordisk looks to win the market before rival Lilly can arrive with its own oral option for obesity.
Pfizer and Metsera, Sarepta and uniQure made the list with dramatic tales. The other two spots went to the regulatory challenges facing biopharma under the new administration, especially in the vaccines sector.
FDA
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
A report from analysts at Jefferies suggested that new screenings for metachromatic leukodystrophy and Duchenne muscular dystrophy could bump sales of the gene therapy Libmeldy by more than $100 million.
BioMarin Pharmaceutical has faced a rocky road, promising and then backing off revenue targets and cutting assets that have underperformed. But Amicus’ rare disease portfolio is already bringing in $600 million annually.
After 27 years in business, Cytokinetics hopes to pit its own cardiac myosin inhibitor against one it initially developed—now owned by Bristol Myers Squibb—in a market worth billions. Aficamten has a PDUFA date of Dec. 26.
The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market.
The money replaces a small portion of a contract Moderna lost when the Department of Health and Human Services canceled $760 million in backing to develop the vaccine, called mRNA-1018.
The CDC accepted the recommendation of its advisory committee that the shot be delayed for many patients until they are at least two months of age due to safety concerns. The CDC itself has said the vaccine is safe and effective.
Eli Lilly’s retatrutide exceeds expectations in Phase III, capping off a sparkling 2025 for the obesity titan; an internal FDA safety review finds no confirmed pediatric deaths caused by COVID-19 vaccines, and Commissioner Marty Makary says no black box warning will be attached to the shots; and BioSpace looks at six biotechs that could be pharma’s next buy.