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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
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to sponsors for setting endotoxin limits for early and late-stage development of investigational oncology products in a draft guidance released yesterday.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
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
The House coronavirus subcommittee has asked the Government Accountability Office (GAO) to begin a review of the Trump administration’s Operation Warp Speed initiative. Read More
The company will also pay $10 million to settle accusations by the Federal Trade Commission that it engaged in anticompetitive activities to block generic competition for Suboxone. Read More
The EMA’s Committee for Medicinal Products for Human Use (CHMP) announced at its July meeting that it is reviewing trial data on dexamethasone for the treatment of COVID-19. Read More
Taro Pharmaceuticals has agreed to pay $205 million to settle charges by the Department of Justice that it conspired with other drugmakers to rig prices on various generic drugs. Read More
The Patent Trial and Appeals Board (PTAB) has dismissed claims by Moderna that a Canadian rival’s patent on lipid nanoparticle (LNP) technology is invalid, in a ruling that could have implications for Moderna’s COVID-19 vaccine candidate mRNA-1273. Read More
Taro has also reached a tentative agreement with the DOJ to pay $213.3 million to resolve separate claims related to federal healthcare programs. Read More