Shots: GSK, Evotec, J&J, Otsuka, the Bill & Melinda Gates Medical Research Institute and its foundation have launched the ‘PAN-TB collaboration’ project to collaboratively accelerate the development of novel TB treatment regimens The global collaboration will focus on developing a new regimen with the drug candidates that demonstrated efficacy in its P-II studies with limited […]Read More
Shots: The approval is based on P-III ASCLEPIOS I and II studies involves assessing of ofatumumab (20mg, SC) vs Aubagio (14mg oral tablets) in 1882 adults with MS between the ages of 18 and 55 years The study resulted in reduction in ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25), Risk reduction […]Read More
Shots: The JV leverages the expertise of three companies that includes Wilson Wolf’s G-Rex technology, BioTechne’s proteins, reagents, media, and gene-editing technologies and Fresenius Kabi’s Lovo cell processing system washes, concentrates and harvests cells The JV focus on providing scalable manufacturing technologies and processes required to develop and commercialize new cell and gene therapies. All […]Read More
Shots: The approval is based on the Nix-TB trial assessing bedaquiline, pretomanid and linezolid collectively called BPaL regimen in 109 patients with XDR-TB treatment-intolerant or non-responsive MDR-TB across three sites in South Africa The study demonstrated successful outcomes in @6mos. 95/107 patients and for two of the patients the study was extended to nine months. […]Read More
Shots: The acceptance of NDA is based on P-III SUNBEAM and RADIANCE Part B study results assessing oral ozanimod (0.92/0.46 mg) in 1,346 & 1,320 patients with RMS across 152 & 150 sites in 20 & 21 countries respectively The US FDA and EMA accepted the NDA for ozanimod to treat relapsing forms of multiple […]Read More
Shots: The approval is based on the results of P-III PARADIGMS study assessing Gilenya (0.5mg/ 0.25mg, qd) vs Extavia (interferon beta-1a, qw) in 215 patients with MS aged 10 to <18 yrs, across 80 centers and 25 countries P-III PARADIGMS study Results: annualized relapse rates by 82%; relapse-free @ 24 months (85.7% vs 38.8%); reduction […]Read More
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