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Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
The FDA issued three final guidances on Wednesday, one on the use of real-world data (RWD) in noninterventional (observational) studies and two on the Drug Supply Chain Security Act (DSCSA). Read More
Pharmaceutical companies directly impacted by HHS’ Tuesday announcement of the initial 10 drugs slated for Medicare price negotiations via the Inflation Reduction Act (IRA) have swiftly reacted, with many of them already fighting the law’s provisions in court. Read More
The FTC and the Department of Justice (DOJ) will co-host a Sept. 5 workshop on draft merger guidelines the agencies propose to use when assessing whether a merger may violate antitrust law and stifle competition. Read More
HHS this morning released its list of the top 10 drugs for negotiation through the Inflation Reduction Act, a group that represents $50.5 billion in Medicare Part D prescription drug costs — 20 percent of total gross spent between June 1, 2022, and May 31. Read More
As word comes out that the Biden Administration may do a two-days-early reveal on the 10 drugs to be discounted through the Inflation Reduction Act (IRA), another pharma company — AstraZeneca — has filed a lawsuit challenging the IRA. Read More
The FDA “does not intend” to enforce the Drug Supply Chain Security Act (DSCSA) requirement that manufacturers electronically capture and share data that will track a drug at the individual package level from manufacture to sale until Nov. 27, 2024 the agency announced in a guidance published on Friday. Read More
HHS announced a slate of new funding initiatives this week, including $1.4 billion for Project NextGen to support development of novel COVID-19 technologies and $24 million for Curing the Uncurable via RNA-Encoded Immunogene Tuning (CUREIT), part of the Biden administration’s Cancer Moonshot program. Read More
Apellis Pharmaceuticals’ safety probe into reports of retinal vasculitis linked to its eye drug-device combo Syfovre (pegcetacoplan) has discovered that the culprit is likely the company’s injection kits, not the therapy itself. Read More