Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Molecular, Akeso, Antengene, Biomarin, Enzychem, Genentech, Hoth, Micurx, NS, Passage, Scholar Rock, TG.
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.”
Amid all the political positioning, finger-pointing, blame games and mountains of misinformation that have been as much a part of the COVID-19 pandemic as the coronavirus itself, there’s one point of agreement: The pandemic has been a painful experience that everyone needs to learn from so it’s not repeated in the future.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Arca, Ascendis, Eli Lilly, Epirium, Eyegate, Indian, Innovent, Kahr, Kineta, Pliant, Redhill, Regeneron, Seattle Genetics, Theranexus.
The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter (CRL) highlighting safety concerns.
Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors.
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
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.
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