With 10 cases of serious shock and anaphylaxis, including one death, in the month since Seikagaku Corp.’s osteoarthritis drug, Joyclu (diclofenac etalhyaluronate sodium), launched in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) issued a blue letter to health care professionals and is adding a warning section to the drug’s Japanese label.
Alkermes plc worked its way through a complete response letter (CRL) issued in late 2020 as the FDA has approved Lybalvi (olanzapine and samidorphan) for treating adults with schizophrenia and bipolar I disorder. The once-daily, oral antipsychotic treatment, the company’s first, is for maintenance monotherapy or acute treatment of manic or mixed episodes and as a monotherapy or adjunct to lithium or valproate. The therapy had a June 1 PDUFA date.
Little more than two months after inking a $2 billion-plus commercialization deal with Swiss oncology specialist Helsinn Group around the fibroblast growth factor receptor (FGFR) inhibitor infigratinib, Bridgebio Pharma Inc.'s subsidiary, QED Therapeutics Inc., has won accelerated FDA approval for the therapy, to be marketed as Truseltiq. Approval for the oral medicine covers the treatment of patients with previously treated locally advanced chemotherapy-resistant bile duct cancer (cholangiocarcinoma) harboring an FGFR2 fusion or rearrangement as detected by an FDA-approved test.
Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
The second oral CGRP antagonist to win FDA approval for acute migraine care is now the first to add preventive treatment to its label, marking a valuable win for Biohaven Pharmaceutical Holding Co. Ltd. and its oral dissolving tablet, Nurtec (rimegepant). The U.S. approval, for preventive treatment of episodic migraine, officially blesses a use for the medicine already adopted by many doctors, Piper Sandler analyst Christopher Raymond wrote, while opening up a potentially rich new stream of revenue for Biohaven.
Bristol Myers Squibb Co. said the FDA has approved Zeposia (ozanimod) as the first and only oral sphingosine 1-phosphate (S1P) receptor modulator for the treatment of ulcerative colitis (UC). The medicine, first FDA-approved in March 2020 for certain adults with multiple sclerosis, can now be used to treat patients with moderately to severely active UC.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affamed, Amgen, Astrazeneca, Biohaven, BMS, Calliditas, Diurnal, Eton, Fennec, Humanigen, Iterum, Lantheus, Novo, PCI, Provention, Ryvu, Verrica.
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