Clinical TrialsHuman Trials December 18, 2018 Vedanta begins phase 2 trial of LBP candidate VE303 for rCDI By PBR Staff Writer VE303 is claimed to be the first drug featuring a rationally-defined bacterial consortium to advance to phase 2 study. The earlier announced phase 1a/1b study showed rapid, durable,
Drug DiscoveryResearch & Development December 14, 2018 AMAG Pharmaceuticals to buy biopharmaceutical firm Perosphere By PBR Staff Writer The deal will allow AMAG to acquire global rights of ciraparantag, a next generation anticoagulant reversal agent, from Perosphere. As per terms of the deal, Perosphere equityholders will
Production & SalesMarketing & Sales December 12, 2018 Circassia to acquire full US rights of AstraZeneca’s COPD treatment Tudorza By PBR Staff Writer Circassia has issued a notice of option exercise to AstraZeneca related to US commercial rights of Tudorza. The company intends to complete the option exercise by the end
RegulationDrug Filing December 4, 2018 FDA fast tracks Novartis’ Zolgensma SMA gene replacement therapy By PBR Staff Writer Zolgensma was previously granted breakthrough therapy designation by the US regulator. Novartis expects a regulatory action to be taken on the gene replacement therapy in May 2019. According
RegulationApprovals November 30, 2018 Novartis’ Gilenya gets approval in Europe to treat children and adolescents with MS By PBR Staff Writer Gilenya is claimed to be the first and only oral disease-modifying treatment approved for children and adolescents in the Europe. The approval allows the company to market Gilenya
RegulationDrug Filing November 26, 2018 AstraZeneca’s Fasenra secures FDA orphan drug designation for EGPA By PBR Staff Writer Developed by AstraZeneca with MedImmune, its research and development arm, Fasenra was in-licensed from BioWa, a subsidiary of Japanese pharma company Kyowa Hakko Kirin. Considered to be a
RegulationMarketing Authorisation November 23, 2018 Spark secures EC approval for Luxturna for inherited retinal disease By PBR Staff Writer The European approval for Luxturna is for the treatment of inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations in both adult and pediatric patients who have sufficient
Production & SalesManufacturing November 22, 2018 Cambrex to acquire contract drug developer Avista Pharma for $252m By vbandhakavi Through the acquisition of Avista, Cambrex will be adding early stage small molecule development and testing services to its capabilities. Avista, which is a portfolio company of Ampersand
RegulationApprovals November 21, 2018 Sobi, Novimmune secure FDA approval for Gamifant to treat HLH By PBR Staff Writer The approval for Gamifant is for paediatric, both new born and older, and adult HLH patients whose condition is refractory, recurrent or progressive or are intolerant to conventional
Clinical TrialsHuman Trials November 20, 2018 Pfizer and Merck’s avelumab fails to improve OS or PFS in Javelin ovarian cancer trial By PBR Staff Writer The companies reported that the trial assessing avelumab alone or in combination with PLD has not achieved the pre-specified primary endpoints of OS or PFS compared with PLD