Pharmaceutical industry
The U.S. Food and Drug Administration (FDA) has approved NINLARO, a once-weekly oral proteasome inhibitor, for the treatment of patients with multiple myeloma who have received at least one prior therapy. This approval marks a significant milestone in the treatment of multiple myeloma, a devastating and incurable rare cancer.
Pharmaceutical industry
The Takeda Pharmaceutical Company Limited has announced positive results from the TOURMALINE-MM1 trial, a Phase 3 clinical trial evaluating the efficacy of NINLARO (ixazomib) capsules in combination with lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma. The trial demonstrated that treatment with NINLARO is effective in
Pharmaceutical industry
The US Food and Drug Administration's (FDA) Arthritis Advisory Committee (AAC) has voted 10-4 in favor of recommending the approval of lesinurad 200 mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). The decision was based on safety and
Pharmaceutical industry
Collegium Pharmaceutical, a Massachusetts-based specialty pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (FDA) for its new drug application (NDA) for Xtampza ER, a medication designed to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment. The FDA has recognized Xtampza ER&
Pharmaceutical industry
Oncolytics Biotech Inc. ("Oncolytics") has announced the initiation of the first clinical trial examining the effects of REOLYSIN in combination with a checkpoint inhibitor in human patients. The Phase Ib study will investigate the safety and efficacy of REOLYSIN, a proprietary formulation of the human reovirus, in combination
Pharmaceutical industry
Agilent's Dako subsidiary, a worldwide provider of cancer diagnostics, has announced that the U.S. Food and Drug Administration (FDA) has approved a new test for identifying PD-L1 expression levels on the surface of non-small cell lung cancer tumor cells. The test, known as PD-L1 IHC 28-8 pharmDx,
Pharmaceutical industry
The Massachusetts Attorney General's office announced that PharMerica Corp. has agreed to pay $9.25 million to settle allegations of illegal off-label marketing of its drugs, resulting in the promotion of Depakote for uses not approved by the FDA. The multistate and federal settlement is expected to return
Pharmaceutical industry
The US Food & Drug Administration (FDA) has approved Merck & Co.'s Keytruda (pembrolizumab), an immune therapy drug, for the treatment of advanced non-small cell lung cancer (NSCLC) in patients whose tumors have progressed after other treatments. This approval marks a significant breakthrough in the fight against lung
Pharmaceutical industry
Quest Diagnostics, the world's leading provider of diagnostic information services, has announced that it will provide clinical laboratory testing using the PD-L1 IHC 22C3 PharmDx companion diagnostic, helping to identify patients who may benefit from new oncology immunotherapy. This move comes on the heels of the U.S.
Pharmaceutical industry
The US Food and Drug Administration (FDA) has given the green light to Novo Nordisk's diabetes drug Tresiba, a long-acting insulin that can reduce the frequency of shots for people with type 1 and 2 diabetes. The approval comes after two years of rejections, with the agency initially
Pharmaceutical industry
Regeneron Pharmaceuticals, in partnership with the Biomedical Advanced Research and Development Authority (BARDA), has announced an agreement to develop, test, and manufacture a monoclonal antibody therapy for the treatment of Ebola virus infection. The U.S. Department of Health and Human Services (HHS) will provide initial funding of approximately $17
Pharmaceutical industry
The recent FDA approval of Amgen's Repatha has brought attention to the prices of cholesterol-lowering medicines, with Amgen's new treatment and Regeneron Pharmaceuticals and Sanofi's Praluent costing patients over $14,000 per year. The high prices of these medications pose a significant challenge for
