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A substantial proportion of Medicare Part D spending purchases drugs with absent or low-quality cost-effectiveness analyses, and this lack of analyses may cause problems for developing policies that address value in drug spending. Read More
The court said 80 million doses must be delivered by Sept. 27, and that the company will face a fine for each dose not delivered by that deadline. Read More
All post-approval changes to a Biologics License Application (BLA) should be submitted based on three categories organized by risks to safety and efficacy, the FDA said in a final guidance released yesterday. Read More
A 2017 California law banning the use of co-payment coupons for brand-name drugs with direct generic competitors was associated with no significant increase in generic substitution in its first year. Read More
The third batch joins two others cleared last week, allowing the drug substance to be used in vaccine production in either the U.S. or abroad. Read More
The FDA approved Blueprint Medicines’ Ayvakit (avapritinib) for treating adults with advanced systemic mastocytosis (SM), a group of rare diseases in which white blood cells accumulate in various organs. Read More
A federal judge in Delaware has turned down a request by HHS to throw out a lawsuit by AstraZeneca (AZ) over the department’s mandate that the company offer 340B drug discounts to contract pharmacies. Read More
Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab) could account for more than 1 percent of all U.S. prescription drug spending by 2025, a health research group predicted this week. Read More
The Biden administration yesterday launched a $3 billion program to develop antiviral medicines for treating COVID-19 and confronting future pandemics. Read More
The new forum will offer a confidential platform for discussion of policies in development, including draft guidances for industry, the agency said. Read More