Glaxo Files BLA for shingles vaccine in U.S-GlaxoSmithKline $GSK filed a Biologics License Application (BLA) with the FDA, seeking approval of its shingles vaccine, branded as Shingrix, for the prevention of herpes zoster in people aged 50 and above. In the clinical trials, a two-dose regimen of shingrix demonstrated 90% efficacy in participants at least 70 years old and was maintained in those aged 80 and over, considerably better than Merck’s $MRK ZOSTAVAX, which is merely 18% effective in people above 80 years. Regulatory submissions in Europe and Canada will be made before the end of the year, followed by Japan next year.
Marinus to progress with Phase 2 studies with ganaxolone for treating epilepsy-Results from a 36-participant Phase 1 dose-escalation clinical trial to evaluate the safety, pharmacokinetics and pharmacodynamics of Marinus Pharmaceuticals’ $MRNS lead product candidate ganaxolone as an ascending bolus dose or continuous infusion achieved dose levels targeted for efficacy in patients with status epilepticus, an emergency-situation for of epilepsy characterized by prolonged or recurrent grand mal seizures. The data were shown at the 141st Annual Meeting of the American Neurological Association in Baltimore, MD. The Phase 2 clinical trial will start in 2017.
Aduro’s new patient enrollment for LADD clinical trial put on hold-Aduro Biotech $ADRO fell sharply amid heavy trading volume in response to its announcement that the FDA has put a partial clinical hold on its LADD (Listeria-based immunotherapy construct) clinical trials. The action, which halts new subjects enrollment , comes after a blood culture sample from an indwelling port of a metastatic pancreatic cancer patient with gastrointestinal symptoms tested positive for Listeria, suspected to be product candidate CRS-207. The patient is doing well after treatment with intravenous antibiotics. Subsequent blood cultures have been Listeria-negative.
aTyr Pharma’s Resolaris Fast Tracked-The FDA designated aTyr Pharma’s $LIFE Resolaris for Fast Track review for the treatment of facioscapulohumeral muscular dystrophy (FSHD), an unusual and severe genetic disorder characterized by muscle weakness and wasting. It affects roughly 19,000 Americans every year. There no approved drugs for the ailment. Fast Track designation provides more frequent interactions with the FDA review team and a rolling review of the Biologics License Application (BLA). The company expects to submit results from three Phase 1b/2 studies in December.