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bimekizumab (UCB4940) / UCBUCB Achieves Important Regulatory Milestone for Bimekizumab (UCB Press Release) - Sep 22, 2020 - "UCB...today announced that the FDA and EMA have accepted the Biologics License Application (BLA) and Marketing Authorization Application (MAA), respectively, for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis; This accepted submission is supported by a robust data package including three Phase 3 studies which demonstrate superiority of bimekizumab to placebo, Stelara[®] (ustekinumab) and Humira[®] (adalimumab) in achieving skin clearance at week 16."CTX001 / Vertex, CRISPR Therap, Molecular TemplatesCRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001 for the Treatment of Sickle Cell Disease (GlobeNewswire) - Sep 22, 2020 - "CRISPR Therapeutics and Vertex Pharmaceuticals Announce Priority Medicines (PRIME) Designation Granted by the European Medicines Agency (EMA) to CTX001™ for the Treatment of Sickle Cell Disease (SCD)....PRIME designation was granted based on clinical data from CRISPR and Vertex’s ongoing Phase 1/2 trial of CTX001 in patients with severe SCD." ifenprodil (NP-120) / Algernon PharmaAlgernon Announces 50% Enrollment in Multinational 2b/3 Human Study of Ifenprodil for Treatment of COVID-19 (GlobeNewswire) - Sep 22, 2020 - "Algernon Pharmaceuticals Inc....is pleased to announce that it has now enrolled 75 patients, which is 50% of its enrollment target, for its multinational Phase 2b/3 human study of NP-120 (Ifenprodil) for the treatment of COVID-19. The Company is now projecting that the study will be completed in November 2020 with a planned data readout before the end of Q4, 2020." Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research InstituteIndia trials for Russia's 'Sputnik-V' vaccine could start in next few weeks: exec (Reuters) - Sep 22, 2020 - "Dr Reddy’s Laboratories Ltd could begin late-stage Indian clinical trials of Russia’s potential coronavirus vaccine in the next few weeks....Indian trials of the Sputnik-V vaccine candidate...will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country....Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India....The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India." idecabtagene vicleucel (bb2121) / bluebird bio, BMSU.S. Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121) (Businesswire) - Sep 22, 2020 - “Bristol Myers Squibb…and bluebird bio, Inc…announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review their Biologics License Application (BLA) for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2021…The BLA is based on results from the pivotal Phase 2 KarMMa study…”
