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In the first-ever instance of a state and drugmaker reaching a deal over price-fixing litigation, Teva Pharmaceuticals has agreed to fork over $925,000 to the state of Mississippi to settle allegations of conspiring to set prices of generic drugs. Read More
The FDA released two memos from officials and a long review document late Tuesday, shining new light on internal agency discussions over the past two years regarding Biogen’s Aduhelm, the very expensive new Alzheimer’s disease (AD) drug that’s caused a firestorm of controversy since the FDA approved it June 7 against the advice of its 11-member advisory panel, three of whom resigned in protest after the approval. Read More
HHS has withdrawn an advisory opinion issued in late December stating that drugmakers must offer 340B drug discounts through contracting pharmacies. Read More
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