News

Eli Lilly notches another win over Novo Nordisk, as Zepbound bests CagriSema in a head-to-head trial sponsored by Novo; The FDA kicked off Rare Disease Week, providing draft guidance on its new plausible mechanism pathway, while a bipartisan senate hearing on Thursday will focus on the authorization process for rare conditions; Another leadership change shakes up CDC; and Gilead acquires CAR T partner Arcellx for nearly $8 billion.
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Corsera Health’s Chief Operating Officer Rena Denoncourt and CFO Meredith Kaya speak with BioSpace about the biotech’s mission and vision for the next generation of cardiovascular care.
Billions of dollars’ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
Sales of Merck’s longtime oncology blockbuster Keytruda will erode more starkly in about 2033 rather than 2029, predicts Bloomberg Intelligence, translating to some $22 billion more in revenue.
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Read our takes on the biggest stories happening in the industry.
FDA
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Roche has already signed several high-ticket deals this year, including the $3.5 billion acquisition of 89bio and Genentech’s $2.1 billion molecular glue pact with Orionis Biosciences.
In this episode presented by Element Materials Technology, guests Dr. Jihye Jang-Lee and Dr. Khanh Courtney discuss how small biotechs face mounting pressure amid manufacturing uncertainties.
Despite showing no meaningful benefit on lung function, Arcturus’ mRNA therapy ARCT-032 reduced mucus volume in patients with cystic fibrosis—an outcome William Blair found “potentially promising.”
With Avadel under its fold, Alkermes expects to accelerate its expansion into the sleep market, laying the foundation for its late-stage narcolepsy asset alixorexton.
A key question for investors going forward will be whether Moderna’s other latent virus vaccines for Epstein-Barr and shingles can succeed after the failure of the CMV program.
Looking for a job in regulatory? Check out the BioSpace list of eight companies hiring life sciences professionals like you.
Biopharma professionals have become increasingly likely to be dishonest when interviewing for jobs, based on BioSpace interviews with three talent acquisition experts. The experts discuss the reasons why as well as the types of fraud happening, including people posing as applicants.
The deal focuses on ICT01, a monoclonal antibody being tested in acute myeloid leukemia. ImCheck is also developing assets in infectious disease and other oncology indications.
While the threat of tariffs dies down for the pharma industry, President Donald Trump is reportedly weighing a new investigation that could result in import taxes against U.S. trading partners that don’t pay enough for drugs.
Seven in 10 U.S. hiring managers say their company usually considers employing overqualified applicants, according to a survey from Express Employment Professionals and The Harris Poll. However, 75% of employers believe such hires struggle to stay motivated in lower-level roles.