Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Biontech, Catalyst, Elusys, Kempharm, LG Chem, Mesoblast, Oyster Point, Pfizer, Protagonist, Regent, Telix, Vanda, Wanbang.
Investors in Minerva Neurosciences Inc. on Dec. 1 gave a chilly reception to reported FDA feedback on the company's experimental treatment for the negative symptoms in schizophrenia, roluperidone. Though the drug failed to deliver statistically significant differences vs. placebo in a phase III study this year, CEO Remy Luthringer outlined a potential path to NDA filing for the candidate using a modified intent-to-treat analysis of the trial and evidence from other ongoing evaluations.
The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine.
Rhythm Pharmaceuticals Inc., a company developing medicines for rare genetic disorders of obesity, has won FDA approval for its first product, Imcivree (setmelanotide), following a priority review. The drug is designed to restore a biological pathway that, when disrupted, can lead to constant hunger. The approval covers the treatment of three types of ultrarare early onset obesity tied to pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) and leptin receptor (LEPR) deficiencies, when confirmed by genetic testing.
Moderna Inc., late on Nov. 30, said it has asked the FDA to bless emergency use of its COVID-19 vaccine mRNA-1273 after phase III data confirmed it to be 94.1% effective in preventing symptomatic cases of the disease and 100% effective in preventing severe cases. The Cambridge, Mass.-based company said efficacy was "consistent across age, race and ethnicity and gender demographics."
The latest global regulatory news, changes and updates affecting biopharma, including: Pandemic not the time for trade restrictions; Longer-term vaccine follow-up crucial; Labeling update advised for chloroquines; FDA stands up new DDT path; FDA drafts DDI guidance; MHRA continues Brexit updates; FDA debars three.
Just ahead of the U.S. celebration of Thanksgiving, the FDA granted an accelerated approval for Danyelza (naxitamab), a new therapy for certain adults and children with relapsed or refractory high-risk neuroblastoma. The antibody, which Y-mabs Therapeutics Inc. initially sublicensed via a deal with Mabvax Therapeutics Inc. in 2018, is approved for use in combination with granulocyte macrophage colony-stimulating factor. The regulator had assigned the BLA a Nov. 30 PDUFA date.<
The latest global regulatory news, changes and updates affecting biopharma, including: The other shoe drops for former Insys CEO; NICE gives nod to new myeloma regimen; MHRA prepares for January; FDA guidances finalized.
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