Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Adverum, Avenue, Basilea, Biosyngen, Gamida, Huidagene, Hutchmed, Hyloris, Madrigal.
Sanofi SA’s antitrust challenge of Mylan Inc.’s “exclusionary conduct” in the epinephrine auto-injector market met the end of the road April 17 when the U.S. Supreme Court denied cert.
Pharma groups are calling on Japan’s Ministry of Health, Labour and Welfare (MHLW) to reconsider its current drug pricing policies that include annual price cuts on innovative drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 2seventy, Abbvie, Affamed, Bristol Myers Squibb, Candel, Hanchorbio, Intelgenx, Lundbeck, Novo Nordisk, Otsuka.
Providing a much-needed lift to struggling Gamida Cell Ltd., the U.S. FDA has approved the firm’s advanced cell therapy Omisirge (omidubicel-onlv) to reduce the risk of infection in patients with hematologic malignancies aged 12 years and older who are scheduled to have umbilical cord blood transplantation.
After issuing three prior complete response letters, the U.S. FDA finally granted approval via the 505(b)(2) NDA pathway to Intelgenx Corp.’s Rizafilm Versafilm to treat acute migraine.
Despite concerns about a limited dataset to study, the urgent need to treat one of the toughest and most deadly infections propelled a U.S. FDA advisory committee to unanimously support the NDA for Entasis Therapeutics Inc.’s sulbactam-durlobactam (Sul-Dur). Sul-Dur, an injectable combination of beta-lactam antibiotic and beta-lactamase inhibitor for treating adults with hospital‐acquired bacterial pneumonia and ventilator‐associated bacterial pneumonia caused by susceptible strains of carbapenem-resistant Acinetobacter baumannii infections, has a May 29 PDUFA date.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Eli Lilly, Horizon, Ips, Minghui, Nicox, NS, Ocumension, Pfizer, Soligenix.
As expected, the serotonin-dopamine modulator Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. and H. Lundbeck A/S for agitation in Alzheimer’s disease (AD) dementia, found favor April 14 at the joint meeting of the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee (adcom) and the Peripheral and Central Nervous System Drugs Advisory Committee.
Manufacturing deficiencies stand in the way of two BLAs as complete response letters (CRLs) were issued to Eli Lilly and Co. and to Alvotech Holdings SA. The U.S. FDA issued the CRL to Lilly regarding the BLA for mirikizumab, a humanized IgG4 monoclonal antibody to treat ulcerative colitis, specifically citing manufacturing concerns. There’s a similar problem with Alvotech’s biosimilar candidate for Abbvie Inc.’s Humira (adalimumab). The FDA issued a CRL for AVT-02’s BLA, citing problems needing resolution at its Reykjavik, Iceland, manufacturing facility before it could approve the application.
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