Now that the U.S. judge overseeing Purdue Pharma LP’s bankruptcy proceedings has conditionally signed off on a $10 billion settlement intended to resolve 3,000 opioid lawsuits filed by states, tribes and local governments, the privately owned drugmaker can take the first steps to transform itself into a public service company owned mostly by the National Opioid Abatement Trust and governed by a new independent board.
U.S. Attorney General (AG) Merrick Garland has rescinded two important policy documents, including the Brand memo, which limited the ability of federal prosecutors to use non-compliance with federal agency guidance as proof of violations of the law. The rescission of these memos increases the risk that drug and device companies will be prosecuted more vigorously due to deviation from FDA guidance documents, which at times conflict with other guidances and thus may create a series of nearly unavoidable compliance failures.
Although COVID-19 is still dictating how things are done in the U.S. and throughout the world, the FDA looked beyond the pandemic in an update to its guidance on conducting clinical trials of medical products during the public health emergency.
The CDC’s Advisory Committee on Immunization Practices (ACIP) heard a safety update on COVID-19 vaccines, took up the matter of booster shots, and voted on whether to recommend the vaccine from Pfizer Inc. and Biontech SE for people 16 and older, now that it’s fully licensed. Under an emergency use authorization, the vaccine can be given to people 12-15 years old.
Sure H.R. 3 could save the U.S. government hundreds of billions of dollars on drug spending, but that savings comes at a long-term cost in innovation that’s higher than the Congressional Budget Office (CBO) initially forecast.
Kite Pharma Inc. is no longer on the hook for $1.2 billion in damages and royalties a jury awarded to Juno Therapeutics Inc. and the Sloan Kettering Institute for Cancer Research in a patent infringement suit involving Kite’s CAR T therapy Yescarta (axicabtagene ciloleucel).
In a passionately worded 141-page decision, the U.S. Court of Appeals for the First Circuit said the lower court was wrong in overturning part of a jury verdict convicting former Insys Therapeutics Inc. executives of a scheme to bribe doctors to prescribe Subsys (fentanyl), which was approved only to treat breakthrough cancer pain.
The U.S. Federal Trade Commission (FTC) is hardly alone in its antipathy toward Illumina Inc.'s acquisition of Grail Inc., and FTC attorney Susan Musser said Aug. 24 that Illumina’s dominance of the market for next-generation sequencing (NGS) is perhaps the key aspect of the FTC’s case. Musser invoked the wide number of companies that jumped into the fray to develop a vaccine for the COVID-19 pandemic as an illustration of the need to maintain competition in the multicancer testing space.
Advancing efforts from PDUFA VI, the seventh iteration of the user fee agreement negotiated between the U.S. FDA and drugmakers is intended to take patient involvement in drug development to the next level, support a new wave of biologics, and provide more tools for developing therapies and cures for rare and ultra-rare diseases.
After years of transitioning in the requirement for drug and biologics sponsors to submit applications to the U.S. FDA in the electrical common technical document format (eCTD), the agency is getting serious about the proper use of eCTD.
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