Shots: The P-I clinical study evaluates the safety, PK, and PD of single & multiple ascending doses of DNL343 in 95 healthy volunteers with ALS & other P-I studies assess SAR443820 for the same indication The results showed that DNL343 was generally well tolerated for ~14 days of dosing, dose-related increases in CNS distribution & PK profile […]Read More
Shots: The IDMC has recommended the discontinuation of the P-III CHAMPION-ALS trial for Ultomiris (IV, q8w) in adults with ALS. Additionally, enrolled patients will discontinue the study medication and complete any required follow-up assessment The discontinuation is due to lack of efficacy based on the pre-specified interim analysis. No new safety was identified while the […]Read More
Shots: EMA’s COMP has granted ODD to SLS-005 for the treatment of amyotrophic lateral sclerosis Under ODD, Seelos will get benefit from several incentives such as protocol assistance, reduced regulatory fees and market exclusivity Trehalose is a low molecular weight disaccharide (0.342 kDa) that crosses the BBB, stabilizes proteins and activates autophagy and has received […]Read More
Shots: Aquestive will receive upfront, milestones, royalties on net sales for Exservan (oral film formulation) in the US and will earn revenue pursuant to the exclusive supply agreement MTPA to commercialize Exservan in the US while Aquestive will serve as the exclusive sole manufacturer and supplier for the product Exservan is an oral film formulation […]Read More
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
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