Patients with an aggressive form of lymphoma who have failed prior therapies now have a new option for treatment with the U.S. FDA’s accelerated approval of Columvi (glofitamab-gxbm), which was granted under priority review a few weeks ahead of the July 1 PDUFA date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Altamira, Anavex, Avenge, Biostar, Glycomimetics, Ipsen, Mabwell, Medexus, Mersana, NS, Seagen, Takeda, UCB.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Alentis, Eagle, Ipsen, Paxmedica, Pepgen.
In their continuing battle against high prescription drug prices, U.S. lawmakers are firing yet another volley at the middlemen – this time to delink their administrative fees from drug prices. Several members of the Senate Finance Committee, including the leadership, introduced the bipartisan Patients Before Middlemen Act June 14 with the intent of wrapping it into a larger drug pricing legislative package the committee plans to complete over the next few months.
A higher rate than expected of serious bleeding, including five deaths, in ovarian cancer patients receiving upifitamab rilsodotin (UpRi) led the U.S. FDA to place a partial clinical hold on two trials, possibly delaying Mersana Therapeutics Inc.’s BLA filing targeted for later this year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Can-Fite, Ferring, Highfield, Ironwood, Starton, Stealth.
As new and ongoing drug shortages in the U.S. limit patients’ access to essential medicines and life-saving cancer treatments, the blame largely has fallen on increased demand, quality problems, the supply chain and lack of transparency in that chain.
The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years.
Using his new platform as chair of the U.S. Senate Health, Education, Labor and Pensions Committee, Sen. Bernie Sanders (I-Vt.) is again pushing the Biden administration to reinstate, and strengthen, a “reasonable pricing clause” in all future research agreements involving government agencies, especially those funding drug R&D.
The need to reauthorize the U.S. Pandemic and All-Hazards Preparedness Act (PAHPA) prompted a June 13 hearing in the House of Representatives, but a major fissure appeared between the Republican and Democratic Parties regarding FDA’s authorities for managing drug shortages.
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