News

Several sources are speculating that the potential buyer could be Eli Lilly, despite the breakdown of the pharma’s partnership with Nektar over atopic dermatitis therapy rezpeg.
FDA
FEATURED STORIES
Smarter design through targeted delivery and human-relevant testing can save the industry from costly safety failures.
While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination to keep the disease at bay.
Following up on previous, dimly received issuances, a new set of ideas published by the FDA to streamline regulatory pathways for cell and gene therapies ‘for small populations’ is receiving a warmer welcome—but experts warn it will take more to turn the tide for the fraught therapeutic space.
Job Trends
Although the job market did not pick up in April, layoffs were down year over year and month over month, according to BioSpace tallies. Meanwhile, Amgen, Novartis, Regeneron and Roche announced U.S. manufacturing investments that are sparking job creation.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
ALS
Misses from amyotrophic lateral sclerosis hopefuls Denali Therapeutics and partners AbbVie and Calico Life Sciences mark the latest setbacks for the controversial platform trial, the results from which have largely mirrored the dismal success rate in ALS overall.
THE LATEST
The startup, launched out of CEO Kevin Parker’s grad school idyll during the COVID lockdowns, is primed to find new targets where Big Pharmas won’t dare.
Reporting third quarter earnings on Tuesday, Johnson & Johnson CEO Joaquin Duato said the healthcare giant has not yet secured a drug pricing deal with the White House, but discussions are ongoing.
Kailera’s lead asset, KAI-9531, elicited an average weight loss of more than 17% in a Phase III study in China. The biotech expects to launch a global late-stage program for the drug this year.
In this bonus episode, BioSpace’s Vice President of Marketing ⁠Chantal Dresner⁠ and Careers Editor ⁠Angela Gabriel⁠ take a look at Q3 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.
Elecsys’ approval could help boost the uptake of currently approved Alzheimer’s disease therapies, including Biogen’s Eisai-partnered Leqembi, with CEO Chris Viehbacher recently noting that such biomarker-based tests could “remove some of the bottlenecks” in uptake.
J&J reports today, just two weeks after Pfizer secured certainty on tariffs and drug pricing. Analysts expect to hear about plans from the rest of the industry during third period earnings calls.
Slapped with the most severe post-inspection classification, the state of Novo Nordisk’s Indiana manufacturing site could pose a problem for clients, including Regeneron and Scholar Rock.
Nabla and Takeda first joined hands in 2022, to push “the boundaries of next-generation biologics discovery,” according to the startup’s CEO Surge Biswas.
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.
Regeneron is aiming to file a regulatory application for DB-OTO by the end of the year.