RegulationApprovals April 6, 2022 Novartis receives approval for PIK3CA-related overgrowth spectrum treatment By PBR Staff Writer A kinase inhibitor, vijoice is intended for the treatment of rare overgrowth conditions which are caused by the effects of PIK3CA mutations in adults and children aged two
Drug Delivery March 29, 2022 Axsome Therapeutics signs agreement for Sunosi acquisition By PBR Staff Writer Under the terms of the deal, Axsome will gain global development, manufacturing commercial, and intellectual property rights to Sunosi, a dual-acting dopamine and norepinephrine reuptake inhibitor, except for
RegulationApprovals March 9, 2022 Janssen submits application to EMA for mantle cell lymphoma therapy approval By PBR Staff Writer The company sought approval for the combination therapy to treat previously untreated mantle cell lymphoma (MCL) adult patients not suitable for autologous stem cell transplantation (ASCT). Jointly developed
Research & Development March 3, 2022 Epsilogen to develop antibodies for cancer treatment with new funding By PBR Staff Writer The funding round included new investors Schroders Capital, 3B Future Health Fund, Caribou Property, and British Patient Capital. Existing investors Epidarex Capital and ALSA Ventures have also participated
RegulationApprovals March 2, 2022 EMA accepts GlaxoSmithKline’s MAA for chronic kidney disease therapy By PBR Staff Writer Daprodustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that is indicated to treat anaemia of CKD in adult patients not on dialysis and on dialysis.
Oncology February 14, 2022 US FDA accepts Spectrum Pharmaceuticals’ poziotinib NDA for review By vbandhakavi The acceptance by the FDA is based on the positive data from a Phase II study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Drug Discovery February 8, 2022 NHS to roll out new drug to treat advanced womb cancer By PBR Staff Writer The drug attaches to a specific protein on the cancer cells’ surface and helps the immune system to detect and attack them. Approximately 100 women with advanced and
Drug DiscoveryResearch & Development January 10, 2022 Absci and Merck collaborate to develop new enzymes By PBR Staff Writer As part of the collaboration, the company will use its Deep Learning-Enabled Drug Creation and Bionic Protein non-standard amino acid technologies to create enzymes to meet Merck’s biomanufacturing
Drug Manufacturing January 6, 2022 Pfizer and Biohaven close collaboration agreements By PBR Staff Writer The latest move follows a collaboration and license agreement signed by the companies in November last year. Sold in the US under the brand name Nurtec ODT, rimegepant
Research & DevelopmentDrug Manufacturing January 3, 2022 Ascletis expands ritonavir oral tablets production amid Covid-19 surge By PBR Staff Writer The production capacity of ritonavir oral tablets has been expanded to 100 million tablets per year and can also be increased further in future based on the market