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The FDA has issued a revised draft guidance on complying with labeling requirements for the pregnancy and lactation subsections of prescription drug and biological product labeling. Read More
Maryland-based Emergent BioSolutions was the government’s highest-paid drug or vaccine vendor as of mid-June at $643 million, out of nearly $9 billion issued by HHS for COVID-19, according to a new report released yesterday by the Government Accountability Office (GAO). Read More
Sanofi and GlaxoSmithKline have reached a deal with the British government that will secure up to 60 million doses of the drugmakers’ experimental COVID-19 vaccine for the UK. Read More
Roche’s rheumatoid arthritis blockbuster Actemra (tocilizumab) showed no benefit for hospitalized COVID-19 patients in a phase 3 trial, but the company still has high hopes for the drug as a potential treatment for COVID-19 infections. Read More
Calls for clarification of FDA guidance on interpreting the sameness of gene therapies under orphan drug regulations featured in comments submitted to the agency. Read More
The FDA offers recommendations to sponsors for setting endotoxin limits for early and late-stage development of investigational oncology products in a draft guidance released yesterday. Read More
Stason Pharmaceuticals did not ensure that capsules of the brain cancer drug temozolomide that it manufactured met dissolution attributes throughout their shelf life, and did not ensure proper computer security for its quality control data, the FDA said in a warning letter. Read More
Following the cancellation of a meeting yesterday at the White House to discuss drug pricing, PhRMA and BIO have come out strongly against a Trump administration executive order that would require Medicare to purchase certain drugs at the lower prices paid by other countries, arguing that the move will hurt innovation and the industry’s efforts during the COVID-19 pandemic. Read More
The U.S. Court of Appeals for the Ninth Circuit has nixed the Association for Affordable Medicines’ challenge against a California law banning pay-for-delay arrangements, finding that the generics group and its constituents did not suffer economic setbacks as a result of the legislation. Read More