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The incidence of brain blood clots in one healthcare system increased by almost four times after introduction of the Johnson & Johnson (J&J) COVID-19 vaccine, according to data published in the Nov. 1 issue of the Journal of the American Medical Association. Read More
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Read More
A federal judge has ruled that HHS acted incorrectly in warning drugmakers that ending discounts via the 340B Drug Price Program would constitute a violation of the law. Read More
The House of Representatives passed a bill in a bipartisan 368-56 vote on Oct. 19 that aims to promote innovation in continuous manufacturing, which is used to produce drugs more efficiently than the conventional batch production process. Read More
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Read More
Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA has issued a 21-page draft guidance to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Read More
A primary aim of the consortium is to improve understanding of the basic biology of the adeno-associated virus, a common gene-delivery vector. Read More
Since President Biden abandoned any provisions seeking to reduce prescription drug prices in the approximately $1.75 trillion Build Back Better bill framework unveiled last week, Democratic lawmakers have been trying to resolve internal divisions and put drug pricing reform provisions back into the bill. Read More
The FDA is slated to receive a one-time infusion of $300 million to upgrade its physical and technological infrastructure, according to the updated text of the proposed $1.75 trillion Build Back Better Act released last week. Read More