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.
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.
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