We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The FDA has approved a third batch of Johnson & Johnson (J&J) COVID-19 vaccine drug substance for release from the embattled Emergent plant in Baltimore, Maryland — but still hasn’t authorized the Bayview facility to resume production. Read More
A proposed regulatory science pilot program and the FDA’s cost estimates under the next iteration of the Biosimilar User Fee Act (BsUFA) program were the focus of discussions in a recent negotiation meeting. Read More
The U.S. and EU reached an agreement to reduce export restrictions for COVID-19 vaccines and therapeutics at a Tuesday summit meeting in Brussels. Read More
As the first infusion of Biogen’s newly approved Alzheimer’s drug Aduhelm was given to a patient in Rhode Island, advocacy group Public Citizen called for the resignations of FDA officials, including Acting FDA Commissioner Janet Woodcock, claiming “the indefensible approval” of the drug showed “a stunning disregard for science.” Read More