Drug DiscoveryResearch & Development August 29, 2018 Genentech, Affimed sign $5bn cancer deal By PBR Staff Writer As part of the deal, Affimed will authorize its redirected optimized cell killing (ROCK) platform to discover and optimize innate immune cell engager-based immunotherapeutics of interest to Genentech.
RegulationApprovals August 28, 2018 FDA approves Tetraphase’s Xerava for complicated intra-abdominal infections By PBR Staff Writer Xerava has been developed for the treatment of cIAI in patients 18 years of age and older. In clinical trials, Xerava has showed statistical non-inferiority to two widely
Clinical TrialsHuman Trials August 22, 2018 Rexahn partners with Merck on combo study in TNBC By PBR Staff Writer The partnership will assess Rexahn’s RX-5902 and Merck’s anti-PD-1 therapy in a phase 2 study in patients with metastatic triple negative breast cancer (TNBC). The trial has been
RegulationApprovals August 21, 2018 Roche’s lung cancer drug Alecensa secures approval in China By PBR Staff Writer The approval follows the priority review of Alecensa in China, just eight and nine months after European Medicines Agency (EMA) and US Food and Drug Administration (FDA) approvals,
Drug DiscoveryResearch & Development August 20, 2018 AbbVie, Tolero to collaborate on acute myeloid leukemia trial By PBR Staff Writer The partnership will carry out clinical trial to explore the potential of combination therapy with AbbVie’s venetoclax and Tolero’s investigational agent alvocidib to treat relapsed/refractory AML. Alvocidib is
RegulationApprovals August 14, 2018 Roche’s Xolair gets FDA breakthrough status for food allergies By PBR Staff Writer Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases, and to help ensure people have access to
Drug DiscoveryResearch & Development August 14, 2018 Orchard Therapeutics raises $150m to advance gene therapies for rare diseases By vbandhakavi The Series C round was led by Deerfield Management while RA Capital Management, Venrock, Foresite Capital, Perceptive Advisors and others made significant new investments in the gene therapy
Clinical TrialsHuman Trials August 8, 2018 Spark Therapeutics reports mixed results from hemophilia gene therapy trial By PBR Staff Writer Spark Therapeutics reported that although most of the patients could have their bleeding reduced by its gene therapy, one participant though did not quickly respond to oral steroids. The
RegulationLawsuits August 8, 2018 AstraZeneca to pay $110m to settle Texas whistleblower drug lawsuits By rdharma@digitalinsightresearch.in The company will pay the amount to clear two whistleblower lawsuits brought by the state of Texas under the Texas Medicaid Fraud Prevention Act (TMFPA). Under the first
Drug DiscoveryPre-clinical Studies August 7, 2018 Oxford BioMedica forms three-way partnership for cystic fibrosis treatment By PBR Staff Writer Cystic fibrosis (CF) is characterized by abnormal ion transport in the apical membrane of epithelial cells. The partnership will use a novel and replication deficient lentiviral vector in