Novartis’ Ligelizumab (QGE031) Receives the US FDA’s Breakthrough Designation for Patients with Chronic Spontaneous Urticaria Published: Jan 15, 2020 | Tags: Novartis, ligelizumab, (QGE031), Receives, US, FDA, Breakthrough designation, chronic spontaneous urticaria (CSU) Philips Collaborates with Merck KGaA to Advance Personalized Fertility Treatment Published: Jan 15, 2020 | Tags: Philips, Merck KGaA, Personalized Fertility Treatment, […]Read More
Shots: Chi-Med to receive ~$95M and ~$135M as development & commercial milestones along with royalties on commercialization of each drug candidates. Inmagene to get an exclusive option for four drug candidates solely for immunological diseases If Inmagene exercises the option, it will get the right to further develop, manufacture and commercialize the specific drug candidate […]Read More
Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, […]Read More
Shots: Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA submission in the H1’21 The NDA is based on two P-III studies that demonstrated a reduction in risk of progression or death by 67% & 51%, extending PFS of non-pancreatic […]Read More
Shots: The P-III FRESCO-2 study involves assessing of fruquintinib vs PBO in patients with m-CRC in ~130 sites across 10 countries The company has initiated the study in the US, EU, and Japan, while the first has been dosed in the US on Sept 03, 2020. The clinical data from P-III FRESCO study in Chinese […]Read More
Shots: Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains all rights to fruquintinib outside of China The agreement allows […]Read More
Shots: The two companies collaborated to evaluate the safety, tolerability and efficacy of Chi-Med’s surufatinib and fruquintinib, with BeiGene’s tislelizumab against multiple solid tumor cancer indications in the US, EU, China and Australia. Both the companies will mutually supply drug and other support Tislelizumab is an anti PD-1 mAb, specifically designed to minimize binding to […]Read More
1. Sinovac Initiates the P-I Clinical Study for Vaccine Candidate Against COVID-19 Published: Apr 17, 2020 | Tags: Sinovac, Initiates, P-I, Clinical Study, Vaccine Candidate, Against, COVID-19 2. 1Health.io Launches Self-Collection Kits to Detect COVID-19 Published: Apr 16, 2020 | Tags: 1Health.io, Launches, Self-Collection Kits, Detect, COVID-19 3. Chi-Med’s Surufatinib Receives the US FDA’s Fast Track Designations […]Read More
Shots: The US FDA has granted FT designation to Chi-Med’s surufatinib for the treatment of both advanced and progressive pancreatic NET and non-pancreatic NET in patients who are not amenable for surgery Based on two P-III studies and ongoing P-Ib study, the company is planning for regulatory interactions in the US, EU and Japan. In […]Read More
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