Pharmaceuticals, Biotechnology and Life Sciences
The U.S. Food and Drug Administration has approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has unanimously (10-0) recommended approval of CTL019 (tisagenlecleucel), an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of relapsed or refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL).
Biocartis Group said on Wednesday that on the day before, July 11, 2017 the US FDA published a final list of devices that it has exempted from 510(k) premarket notification requirements in accordance with the US 21st Century Cures Act (signed into US law 13 December 2016).
As the the number of orphan drug designation requests has steadily increased over the past five years, the FDA has a new plan to complete reviews of all orphan drug designation requests 90 days, that are older than 120 days (the backlog) while maintaining consistent, scientifically rigorous reviews; and after 90 days, 100% of all new orphan drug designation requests will receive a response by the agency within 90 days of receipt.
The U.S. Food and Drug Administration has approved the first generic version of Gilead’s Truvada for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk.
Rebinyn got US FDA’s approval and is hoped to become an important tool for physicians to help patients manage their bleeds.
The number of new drugs approved for sale in United States and Europe has bounced back this year, suggesting a marked slowdown in 2016 was an aberration rather than a sign of flagging research and development productivity.
Diplomat Pharmacy will sell Sanofi’s and Regeneron Pharmaceuticals’s Kevzara (sarilumab), recently approved by the FDA to treat adults with moderately to severely active rheumatoid arthritis (RA) who have an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs).
FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of Puma Biotechnology’s PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable.
The U.S. Food and Drug Administration (FDA) has approved Roche’s Actemra/RoActemra (tocilizumab) subcutaneous injection for the treatment of GCA, a chronic and severe autoimmune condition.