Veralox Therapeutics Inc., a Maryland-based startup developing a small molecule for halting aberrant platelet activation and thrombosis, said the FDA has granted the candidate, VLX-1005, orphan drug status for the treatment of heparin-induced thrombocytopenia (HIT).
Following the FDA giving the green light to seven new medicines in December, it brought the approval total of new molecular entities (NMEs) in 2020 to 53, an amount that equals the number of new medicines that were approved in 1996 and ranking it second equal all-time just behind the 59 NMEs that were approved in 2018.
The latest global regulatory news, changes and updates affecting biopharma, including: Endo, Impax under antitrust scrutiny again; More on EMA cyberattack.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Biontech, Cardiff, Cidara, Edesa, Faron, Fosun, Immunicum, Meiragtx, Merck, Mundipharma, Nanoscope, OS Therapies, Recordati, Veralox, Vertex.
Theranica Bioelectronics Ltd. has snagged an expanded clearance from the U.S. FDA for use of its smartphone-controlled Nerivio device to treat migraines in adolescents. The new indication, for acute treatment of episodic or chronic migraine in people 12 years and older, is supported by a study published last month in the journal Headache.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Telehealth bill resurfaces in 117th Congress; OIG includes telehealth in FY 2021 workplan.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aerobiotix, Choicespine, Orthospin, Pedra Technology, Theranica.
Aurinia Pharmaceuticals Inc. got its first drug approval with the FDA’s nod to Lupkynis (voclosporin) for treating active lupus nephritis in adults. It’s the first FDA-approved oral therapy for the indication and the second approval in little more than a month for those patients, following the agency’s Dec. 17 approval of Glaxosmithkline plc’s Benlysta (belimumab), for treating active LN.
A consequence of one of President Joe Biden’s first executive orders (EOs) is that some low-income patients may have to wait at least two more months to get the out-of-pocket relief they were promised for insulin and injectable epinephrine.
RSS
