The agency’s green light is a shot in the arm for ImmunityBio, which had reiterated doubts in a regulatory filing last month about its ability to remain in business.
Boehringer Ingelheim is paying $35 million in upfront and near-term fees to work with Ochre Bio to identify and validate regenerative targets for metabolic dysfunction-associated steatohepatitis and other chronic liver diseases.
In 2023, cell and gene therapy saw an unprecedented surge with seven FDA approvals, and this year, an even greater number of these treatments could reach the market. So far in 2024, the regulator has given the green light to three new CGTs, and at least seven additional cell and gene therapy products are expected to receive approval by year’s end, according to a March report from the Alliance for Regenerative Medicine.
The U.S. Supreme Court on Monday declined to hear a bid by Vanda Pharmaceuticals to revive patents for its sleep-disorder drug Hetlioz that were previously declared invalid in a dispute with generic drugmakers Teva and Apotex.
Initially, MRSA infections were typically acquired in a healthcare environment, however in more recent years community-acquired MRSA infections have predominated. According to GlobalData epidemiologists, there were 552,000 community-acquired hospitalized incident cases of MRSA in 2023, and 162,000 healthcare-acquired cases in the 7MM.
“Today’s announcement was a worst-case scenario for Cardinal Health’s Optum renewal,” EvercoreISI analyst Elizabeth Anderson wrote in a note.
Drugmakers, including the genetic testing company 23andMe, are using novel approaches to stimulate NK cells’ intrinsic ability to recognize and kill tumor cells.
CVS Health has lost a bid to escape a proposed class action lawsuit accusing the company of discriminating against people with HIV by requiring them to receive their medications by mail.
Though a Sanofi spokesperson declined to provide details about the operations overhaul, including its timeline, scope and the number of employees that will be terminated, they said that the changes are part of Sanofi’s push to implement “a streamlined strategic sales structure.”
Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
