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Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Biopharma companies are expanding beyond the traditional confines of Massachusetts and California with hubs forming – most notably – in the South and Southeast.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
Shares of Rocket Pharmaceuticals jumped Friday morning after the company announced positive clinical updates from a Phase I study of patients diagnosed with Danon disease.
In its ongoing battle against counterfeit drug rings, Gilead Sciences announced it has identified two “kingpins” behind the scheme to sell illegitimate HIV medications.
The HHS Office of Inspector General found that of 278 accelerated approvals between 1992 and 2021, 104 had incomplete confirmatory trials, according to a report issued Thursday.
As it gears up to launch several new products, Moderna has created a new leadership role and onboarded an industry veteran.
Solid Biosciences and AavantiBio – announced Friday they are merging to develop a portfolio of neuromuscular and cardiac programs, initially focusing on Duchenne muscular dystrophy.
Two years after receiving a Complete Response Letter for its hemophilia gene therapy, BioMarin is heading back to the FDA with stronger and more robust data for potential approval.
Biogen and Eisai’s lecanemab win this week provides an opportunity to stop and consider whether science is closer to a cure or symptom management for Alzheimer’s disease.
The biopharma world - and markets - spent Thursday evening reacting after the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s Relyvrio.