RegulationApprovals May 31, 2022 FDA grants fast track designation for Priothera’s AML therapy By PBR Staff Writer The new investigational drug, also known as KRP203, is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. It has been evaluated in Phase I and Phase II trials for
RegulationApprovals May 30, 2022 US FDA approves Amneal’s application for biosimilar By PBR Staff Writer To be marketed under the proprietary name fylnetra, pegfilgrastim-pbbk was developed in collaboration with Kashiv Biosciences. Fylnetra is used for the treatment of neutropenia, a condition that occurs
Oncology May 25, 2022 EMA grants orphan drug designation to Cornerstone Pharmaceuticals’ CPI-613 (devimistat) By PBR Staff Writer Biliary tract cancer, which is also called as cholangiocarcinoma, is an extremely rare and hard to treat cancer. It impacts more than 2,000 people in the UK annually
Neurology May 19, 2022 SwanBio raises $56m to advance new gene therapies for neurological conditions By PBR Staff Writer This round was led by founding investors Syncona and Mass General Brigham Ventures. With this new funding round, SwanBio has so far raised $133m. SwanBio chair and chief
Gastrointestinal May 16, 2022 Statera Biopharma, Lay Sciences announce intent to enter strategic partnership By PBR Staff Writer Statera Biopharma president and CEO Michael K Handley said: “The strategic partnership with Lay Sciences has the potential to produce near term revenue. “The agreement allows Statera the
Haematology April 28, 2022 EC grants marketing authorisation for Kapruvia to treat pruritus in hemodialysis patients By PBR Staff Writer This marketing authorisation is applicable for use of Kapruvia in all member states of the European Union besides Iceland, Liechtenstein and Norway. The approval comes after the US
Oncology April 26, 2022 FDA accepts AstraZeneca’s BLA review for tremelimumab to treat HCC By vbandhakavi The move supports the indication of a single priming anti-CTLA4 antibody dose added to the human monoclonal antibody Imfinzi (durvalumab) to treat HCC patients. AstraZeneca also submitted a
Oncology April 22, 2022 Tvardi Therapeutics receives ODD for lead product TTI-101 to treat HCC By PBR Staff Writer Although HCC is the most common type of liver cancer, options to treat the disease are restricted. The total prognosis for survival is poor, with a five-year survival
Research & DevelopmentDrug Manufacturing April 19, 2022 Asahi Kasei Medical agrees to buy Bionova Scientific By PBR Staff Writer Bionova Scientific is a portfolio company of private investment firm Great Point Partners. It offers contract process development services as well as GMP-compliant contract manufacturing services to biopharmaceutical
Drug DiscoveryResearch & Development April 12, 2022 Ardelyx amends license deal with Kyowa Kirin for tenapanor By PBR Staff Writer Initially executed in 2017, the agreement grants exclusive rights to Kyowa Kirin for the development and commercialisation of Ardelyx’s tenapanor to treat cardiorenal diseases including hyperphosphatemia in Japan.