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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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GSK is planning a Phase III trial evaluating bepirovirsen as a potential functional cure for chronic hepatitis B infection, despite the most recently released data appearing less robust than the interim analyses.
Sanofi entered into a partnership with Insilico Medicine to develop drugs for up to six targets. The deal is worth a potential $1.2 billion.
Juvena Therapeutics pulled in $41 million in Series A financing to advance research into the therapeutic potential of secreted proteins to target chronic and age-related diseases.
Researchers from the University of Washington have developed an investigational vaccine that can safely elicit an immune response against the HER2 protein, a key marker in breast cancer.
A request for additional data may cause a 3-month delay for potential approval of BioMarin Pharmaceutical’s hemophilia A gene therapy.
Sanofi inked a research collaboration and license agreement with Stockholm, Sweden-based Salipro Biotech to develop therapeutic antibodies or small molecules that target membrane proteins.
The FDA presented briefing documents Monday outlining what it called “uncertainties” in the data presented by Veru regarding its COVID-19 antiviral. An advisory committee will meet Wednesday.
AbbVie’s investigational neurotoxin, designed to prevent postoperative atrial fibrillation, missed the primary endpoint in a Phase II trial, the company announced Monday.
Sensorium Therapeutics, which closed a $30 million Series A Tuesday, is embracing the complexity of neuropsychiatric diseases with nature-inspired psychoactive medicines.
Verve Therapeutics’ base editing program has been forced into a detour after the FDA placed a hold on its investigational new drug application. Beam has also posted its own regulatory update.