Shots: The US FDA has granted ODD to Prosetin for the treatment of ALS. ODD provides incentives for the development of drugs, biologics, and devices for diseases affecting 200,000 or fewer Americans By obtaining ODD, Prosetin is now eligible for benefits including up to 7yrs. of marketing exclusivity if it receives regulatory approval, exemption from […]Read More
Shots: The P-III CHAMPION-ALS study will assess Ultomiris vs PBO (every q8w following an initial loading dose) in ~350 patients in a ratio (2:1) with sporadic or familial ALS for 50wks. Following 50wks. study, Ultomiris will be evaluated in a 2yr. open-label extension study at 90 sites across NA, EU and Asia-Pacific The 1EPs will […]Read More
Shots: Aquestive to receive up front, development & commercial milestones and royalties on sales of Riluzole oral film (ROF) in EU. Zambon to get a license for the development and commercialization of ROF to treat ALS in EU Zambon will be responsible for the regulatory approval and marketing of ROF in the EU while Aquestive […]Read More
Shots: Exservan (riluzole) Oral Film received the US FDA approval and has also received FDA’s ODD in Jan 2019 and has been evaluated to assess PK bioequivalence to the Rilutek The ODD is granted to novel drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases affecting […]Read More
Shots: Post MHLW approval in Japan in 2015, the company has received NMPA approval for Edaravone and is approved in six countries of China. Additionally, the product is approved in South Korea in Dec 2015, the US in May 2017, Canada in Oct 2018, and Switzerland Mitsubishi Tanabe Pharma Development (Beijing) is an R&D firm […]Read More
Shots: The BCI application focuses on human auditory cortex for the reconstruction of unspoken thoughts into speech for patients have who lost their ability to speak due to stroke, injury, and disease such as ALS The technology includes vocoder, a computer algorithm used for interpreting brain activity will that connects a direct pathway with brain […]Read More
Shots: Voyager’s program for Huntington’s Disease and Amyotrophic Lateral Sclerosis assessing VY-HTT01 at five wks. post-dosing in adult non-human primates & VY-SOD102 one-time intraparenchymal infusion after laminectomy The program demonstrated reduction in HTT mRNA by 68% in the caudate, 67% in the putamen, 73% in the thalamus, and 32% in cortical neurons & reduction in […]Read More
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