Shanghai Junshi Biosciences Co. Ltd. has submitted a new drug application (NDA) for its anti-PD-1 monoclonal antibody toripalimab to the European Medicines Agency, which marks the first NDA filing of toripalimab in Europe.
GSK plc said it will restrict the second-line maintenance indication for ovarian cancer drug Zejula (niraparib) to only patients with deleterious or suspected germline BRCA mutations, at the request of the FDA, in a sign that U.S. regulators aren’t going to relax scrutiny on PARP inhibitors any time soon.
Luye Pharma Group has received marketing approval from China’s NMPA for the triple monoamine reuptake inhibitor Ruoxinlin (toludesvenlafaxine hydrochloride) to treat patients with major depressive disorder, a condition that “has become one of the most prevalent mental disorders in China, causing a heavy burden on patients, their families and the entire society,” said Luye President Yang Rongbing.
Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China.
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space.
Expanding its mandate to accelerate access to essential medicines to people in low- and middle-income countries, the Medicines Patent Pool signed its first voluntary licensing agreement for a cancer treatment, Novartis AG’s Tasigna (nilotinib).
A vaccine for dengue fever, an advanced therapy for a complication after transplants, and a potential first-in-class drug for a form of psoriasis were among medicines recommended for approval by European regulators on Oct. 14.
South Korea’s drug regulator should consider revising orphan drug definitions or allow more new innovative drugs to be excluded from pharmacoeconomic assessments, which are required for new drugs to be reimbursed under Korea’s single-payer system, the European Chamber of Commerce in Korea said.
A review of Australia’s National Medicines Policy was begun in August 2021 but was paused until after the federal election in May to allow stakeholders more time to provide feedback.
Hua Medicine Ltd. has received marketing approval from China's NMPA for its glucokinase activator (GKA), Huatangning (dorzagliatin tablets), for two indications: as a monotherapy to improve blood glucose control for drug-naïve type 2 diabetes patients and in combination with metformin in metformin-tolerated type 2 diabetes patients to control blood glucose level. It marks the first GKA drug to gain approval in any market, according to Hua.
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