RegulationApprovals April 23, 2020 Novartis gets FDA RMAT designation for Kymriah in follicular lymphoma By PBR Staff Writer Follicular lymphoma, which is said to be the second most common form of non-Hodgkins lymphoma (NHL), is an indolent lymphoma and represents around 22% of NHL cases. Claimed
Drug DiscoveryResearch & Development April 22, 2020 Gilead, oNKo-innate to develop NK cells-focused cancer immunotherapies By PBR Staff Writer In this regard, Gilead Sciences and Kite have signed a three-year research collaboration agreement with oNKo-innate on cancer immunotherapies with an objective to support the discovery and development
Drug DiscoveryResearch & Development April 16, 2020 Novartis, TScan collaborate to develop TCR therapies for solid tumours By PBR Staff Writer The deal is said to leverage TScan’s advanced platform to discover novel cancer antigens, which are expected to be targeted by TCR-based therapies. TScan chief scientific officer Gavin
RegulationApprovals April 9, 2020 FDA approves Pfizer’s Braftovi plus cetuximab to treat BRAFV600E-mutant metastatic CRC By PBR Staff Writer Braftovi, an oral small molecule kinase inhibitor, has been developed to target BRAF V600E. The approval was based on data from the BEACON CRC trial, which is claimed
RegulationDrug Filing April 8, 2020 Alnylam seeks FDA approval for lumasiran in primary hyperoxaluria type 1 By PBR Staff Writer In this connection, the RNAi therapeutics company completed the rolling submission of a new drug application (NDA) for lumasiran with the regulator. Considered to be an ultra-rare, life-threatening
RegulationDrug Filing March 26, 2020 Infinity gets FDA fast track status for IPI-549, Opdivo combo in urothelial cancer By PBR Staff Writer IPI-549 is an oral immuno-oncology candidate which has been designed to preferentially inhibit PI3K-gamma. The FDA fast track designation will enable the development and accelerate the review of
Clinical TrialsHuman Trials March 24, 2020 FDA approves COVACTA trial for RA drug Actemra in COVID-19 patients By PBR Staff Writer The company, which is a subsidiary of Roche, will evaluate the safety and efficacy of Actemra given intravenously plus standard of care in hospitalised adults with severe COVID-19
RegulationApprovals March 23, 2020 ViiV Healthcare secures Canadian approval for HIV drug regimen CABENUVA By PBR Staff Writer CABENUVA is now the first once-monthly, complete long-acting regimen for the treatment of HIV-1 in adults, which has been indicated to replace the current antiretroviral (ARV) regimen in
Clinical TrialsHuman Trials March 19, 2020 Pfizer’s abrocitinib meets co-primary efficacy endpoints in phase 3 AD trial By PBR Staff Writer The late-stage study assessed the safety and efficacy of abrocitinib in adult patients with the skin condition, who were also on background topical therapy. According to Pfizer, the
Clinical TrialsHuman Trials March 17, 2020 Moderna doses first patient with mRNA-1273 in coronavirus vaccine trial By PBR Staff Writer Moderna has announced the dosing of the first participant in a phase1 study of mRNA-1273, the company’s mRNA vaccine candidate against the novel coronavirus (SARS-CoV-2). The early-stage study