An FDA culture that discourages scientific disagreement with U.S. administration policies may be a perennial problem regardless of the party in power. That’s one of the between-the-lines takeaways from a Jan. 3 letter the Republican leadership of the House Energy and Commerce Committee sent to FDA Commissioner Robert Califf – along with a stern warning that the agency had better respond in a timely manner.
The U.S. FDA’s Center for Devices and Radiological Health is no stranger to controversy, but the final guidance for clinical decision support (CDS) systems seems to have broken new ground in this regard.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocomposites, Ingelheim, Immunexoress, Irhythm, Kuros, Mentice, Renovos, Simbiosys.
Renovos Biologics Ltd. was granted a U.S. FDA breakthrough device designation for its Renovite BMP-2 (bone morphogenetic protein-2) product, which is designed for interbody spinal fusion.
The U.S. FDA granted breakthrough device designation for CT-155, a prescription digital therapeutic co-developed by Boehringer Ingelheim GmbH and Click Therapeutics Inc. to treat the negative symptoms of schizophrenia. Designed as an adjunctive to pharmaceutical therapy for schizophrenia, among the most challenging mental health conditions to treat, the PDT is one of several products in the collaboration’s pipeline.
One of the latest state laws impacting prescription drug prices is a per se unconstitutional taking, a U.S. district judge said last week, but he refused to grant a preliminary injunction to shield manufacturers from the effects of Colorado’s new law while Teva Pharmaceuticals USA Inc.’s constitutional challenge moves through the courts.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anx Robotica, Sofwave.
Obi Pharma Inc. has received FDA clearance for its IND application to conduct a phase I/II study of OBI-992, a novel antibody-drug conjugate (ADC) cancer therapy targeting TROP2. The trial will open shortly and aims to enroll patients with advanced solid tumors, including non-small-cell lung cancer, small-cell lung cancer and gastric cancer, although several other cancers are also potential targets.
Shares of Corcept Therapeutics Inc. (NASDAQ:CORT) fell 26% Jan. 2 on news that a U.S. court determined that Teva Pharmaceuticals Ltd. does not infringe on patents related to use of cortisol receptor blocker Korlym (mifepristone) in Cushing’s syndrome, opening the possibility of Teva’s generic version to enter the market.
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