RegulationApprovals September 13, 2019 FDA approves GSK’s Nucala for young children with severe eosinophilic asthma By PBR Staff Writer Nucala is claimed to be the only targeted biologic to secure approval for the condition in the six to 11-year age group in the US. The FDA approval
Drug DiscoveryResearch & Development September 11, 2019 Mallinckrodt to divest BioVectra for £202m By PBR Staff Writer The deal includes a fixed consideration of $175m (£141m), comprised of an upfront payment of $135 (£109m) and a long-term note for $40m (£32m), as well as contingent
Clinical TrialsHuman Trials September 10, 2019 Esketamine nasal spray reduces depressive symptoms in two phase 3 studies By PBR Staff Writer The ASPIRE I and II trials evaluated the efficacy and safety of esketamine nasal spray in 465 patients with the moderate-to-severe major depressive disorder who have active suicidal
RegulationApprovals September 9, 2019 Boehringer Ingelheim’s Ofev secures FDA approval for SSc-ILD By PBR Staff Writer Ofev has been indicated for slowing the rate of decline in pulmonary function in adult patients with SSc-ILD, which makes it the first FDA-approved treatment for the rare
Drug DiscoveryResearch & Development September 5, 2019 Boehringer Ingelheim signs £574m deal for Lupin’s MEK inhibitor compound By PBR Staff Writer The partnership between Boehringer Ingelheim and Lupin will develop LNP3794 as a potential targeted therapy for patients with difficult-to-treat cancers. The companies will develop the MEK inhibitor compound
Drug DiscoveryResearch & Development September 4, 2019 Insilico Medicine develops AI-based drug discovery platform By PBR Staff Writer The Maryland-based Insilico Medicine claimed that GENTRL can fast track the drug discovery process from years to days. The company is said to have validated the AI technology
Clinical TrialsHuman Trials September 2, 2019 Novartis’ ofatumumab meets primary endpoints in two phase 3 RMS trials By PBR Staff Writer The late-stage trials – ASCLEPIOS I and II probed the efficacy and safety of ofatumumab 20mg given as a once-monthly subcutaneous injection, in comparison to daily once oral
RegulationDrug Filing August 29, 2019 AstraZeneca’s Fasenra gets FDA ODD status for eosinophilic oesophagitis By PBR Staff Writer Fasenra, which was developed by AstraZeneca’s MedImmune, was in-licensed from BioWa, a subsidiary of Japan-based Kyowa Hakko Kirin. Prior to receiving the orphan drug designation for eosinophilic oesophagitis,
Drug DiscoveryResearch & Development August 26, 2019 Gilead, Galapagos finalise £4.1bn research and development deal By PBR Staff Writer The deal signed last month by the US-based Gilead Sciences and Galapagos has been cleared under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 by the US Federal Trade
Drug DiscoveryResearch & Development August 22, 2019 Oncorus raises £65.5m funding to advance oncolytic virus therapies By PBR Staff Writer Oncorus, which is headquartered in Cambridge, Massachusetts, is an oncolytic virus company. It is engaged in advancing a portfolio of locally and systemically administered (IV) OV therapies based