Archive for August 2023

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. Source: Drug Industry Daily

CVS Health has launched a subsidiary, Cordavis, to work directly with manufacturers to commercialize and/or co-produce FDA-approved biosimilar products at more affordable prices. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Over the past week, the FDA issued a draft guidance on product-specific guidances, extended the comment period on a draft guidance for human cellular and gene therapy products, published a list of bulk drugs for which there is a clinical need under section 503B of the FD&C Act and notices of advisory committee meetings for…

The FDA has announced a new testing tool, and approved several systems for cryoablation, donor lung preservation and cervical disc replacement. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Draeger Medical has voluntarily recalled its Carina Sub-Acute Care ventilators — which the FDA has deemed a class I recall — to address the potential presence of contaminants in the device’s airpath. Source: Drug Industry Daily

This month, FDAnews tackles studies for two promising obesity drugs, a first-of-its-kind pneumococcal vaccine for adults and a partial clinical hold for a blood cancer drug. Source: Drug Industry Daily

Although unanimously endorsing the safety of Medtronic’s Symplicity Spyral Multi-electrode Renal Denervation system, members of the FDA’s Circulatory System Devices Panel were split on both the efficacy and risk/benefit balance of the ultrasound-powered device, intended to treat hypertension by ablating sympathetic nerves in the renal arteries. Source: Drug Industry Daily

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. Source: Drug Industry Daily