Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: American Gene Technologies, Arvelle, Atyr, Clearside, Equillium, Fennec, Kyorin, Mersana, Mesoblast, Neurogene, Protalix.
Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist.
Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS.
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Aquestive, Chi-Med, Diurnal, Gilead, Mallinckrodt, Ocugen, Pluristem, Reata, Seelos, Trevena, Vaxart.
More than two weeks ahead of its expected PDUFA date, PTC Therapeutics Inc.’s spinal muscular atrophy (SM) drug, risdiplam, gained FDA approval, making it the first at-home, oral treatment intended for use in adults and children 2 months and older.
Bayer AG’s Lampit (nifurtimox) to treat Chagas disease in pediatric patients, approved by the FDA on Friday, is an oral, antiprotozoal medication for newborns to patients under 18, who weigh at least 2.5 kg and are diagnosed with Chagas disease caused by Trypanosoma cruzi.
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz, especially as the companies noted in their press release that the FDA “if possible, plans to act early” on the anti-amyloid beta (a-beta) monoclonal antibody. Regulators’ decision came about 30 days after they took receipt of the submission; they could have waited 60.
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