Government
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.
The FDA’s Vinay Prasad recently claimed in an internal memo that at least 10 children have died from coronavirus vaccines, but an internal safety review showed that the count was much lower.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The Commissioner’s National Priority Voucher program was launched in June to shorten review times for companies that align with various national priorities, such as improving domestic drug production and supply.
Pfizer deals again in obesity space as Wave and Structure drop splashy weight loss results; what CDER Director Richard Pazdur’s sudden retirement means for biopharma; neuro diseases take center stage at CTAD; and more.
Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies seeking approval for new drugs.
Høeg is the fifth person to lead the Center for Drug Evaluation and Research this year.
Experts unpack the implications of CBER Director Vinay Prasad’s claim that COVID vaccines have caused 10+ child deaths; the 2025 Clinical Trials on Alzheimer’s Disease conference continues following two disappointing readouts; and Novo Nordisk’s amycretin yields promising weight loss results.
U.K.-based pharmas will not face tariffs as long as Donald Trump is president, according to the agreement.
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