In December 2020, Servier Pharmaceuticals LLC bought Agios Pharmaceuticals Inc.’s approved acute myeloid leukemia drug, Tibsovo (ivosidenib), and the rest of its oncology business in a deal valued at up to $2 billion. Now, the U.S. FDA has approved one of those assets, with the brand name Voranigo (vorasidenib), for treating gliomas.
With time running out on the 118th U.S. Congress, a group of lawmakers is urging the leadership of the House Energy and Commerce Committee to consider a bipartisan path forward on strengthening the 340B drug discount program.
The U.S. FDA’s discussion paper for health equity for medical devices reiterates standing policy on clinical trial enrollment, such as that the device’s pivotal study should be reflective of the intended use population.
The U.S. FDA’s program to foster at-home health care is in its early stages and seeks to promote the development of technologies that will enable home health care services.
Medtronic plc looks to establish a moat around its diabetes pump position with an exclusive global partnership with Abbott Laboratories to develop a Freestyle Libre-based CGM that works with Medtronic’s smart dosing devices and insulin pump.
The European Medicines Agency seems focused on pharmaceuticals to the near exclusion of medical technology, but the agency recently reported the launch of a pilot program for orphan medical devices.
U.S. federal enforcement authorities rang up some significant settlements under the False Claims Act in the first half of 2024, amounting to a record $1 billion in total settlements, according to a report by the law firm of Gibson, Dunn & Crutcher LLP.
Haemonetics Corp. received CE mark certification for the Savvywire pre-shaped pressure guidewire, a sensor-guided three-in-one guidewire for transcatheter aortic valve implantation. The solution, which is expected to enhance TAVI procedures and improve patient outcomes, is already being used in procedures in European countries.
China will deepen its health care reforms and will focus on enhancing its public health care capacity at the primary care level and at public hospitals, according to resolutions passed at the third plenary session of the 20th Central Committee of the Communist Party of China in July.
Meta Pharmaceuticals Inc. announced that the FDA has granted rare pediatric disease designation to its investigational new drug META-001-PH for the treatment of primary hyperoxaluria (PH), an autosomal recessive metabolic disorder in which oxalate is overproduced and deposited in the body.
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