In Vitro DiagnosticsApprovals August 16, 2023 FDA accepts Venatorx’s NDA for cefepime-taniborbactam antibiotic By PBR Staff Writer The regulatory agency has granted priority review for this NDA with Prescription Drug User Fee Act (PDUFA) target action date of 22 February next year. It earlier granted
Other Diseases August 15, 2023 Eli Lilly and Company completes acquisition of Versanis Bio By PBR Staff Writer Lilly signed the definitive agreement to acquire Versanis Bio in July this year. At the time of the deal announcement, its terms specified that shareholders of Versanis were
Infectious Disease August 14, 2023 Novartis acquires Chinook Therapeutics for $3.5bn upfront By PBR Staff Writer Stockholders of Chinook will receive $40.00 in cash per share, a total of $3.2bn, from Novartis. Upon achieving certain regulatory milestones, they will further receive $4.00 in cash
Oncology August 11, 2023 Genprex receives FDA orphan drug designation for lung cancer therapy By PBR Staff Writer In June this year, the therapy, in combination with Genentech’s Tecentriq received FDA fast track designation (FTD) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) patients.
Cell Therapy August 10, 2023 AGC concludes cell and gene therapy site expansion in Milan, Italy By PBR Staff Writer The expansion involved addition of one 50L, two 200L, and two 1,000L suspension single-use bioreactors. It also offers the flexibility to accommodate up to four iCellis500 adherent single-use
Cardiovascular August 9, 2023 Amarin signs agreement with Neopharm to market VAZKEPA in Israel By PBR Staff Writer The agreement for VAZKEPA capsules comes after approval from Israel’s Ministry of Health (MOH) Pharmaceuticals Division. The approval of these capsules has been granted for reducing cardiovascular events
Research & Development August 8, 2023 Daiichi Sankyo to close Japanese research and development subsidiary By PBR Staff Writer The subsidiary, Daiichi Sankyo RD Novare (RD Novare), with nearly 400 employees was initially named as Daiichi Sankyo RD Associe in 2006 and was changed to the current
Neurology August 7, 2023 Sage and Biogen receive FDA approval for PPD therapy By PBR Staff Writer Said to be the first and only oral, once-a-day, 14-day treatment, ZURZUVAE can provide quick improvements in depressive symptoms for women with PPD. Shortly after scheduling as a
Hematological Disorders August 4, 2023 Agios and Alnylam sign agreement for siRNA candidate By PBR Staff Writer As per the terms of the exclusive worldwide agreement, Agios will acquire the rights to develop and market Alnylam’s preclinical candidate that targets TMPRSS6, a key driver of
Ulcerative Colitis August 3, 2023 InDex receives new formulation patent in Europe for ulcerative colitis drug By PBR Staff Writer The company received the patent from the European Patent Office. The drug is being assessed in the ongoing Phase III programme CONCLUDE for treating patients with moderate to