RegulationApprovals July 18, 2019 FDA approves Merck’s Recarbrio to treat complicated infections By PBR Staff Writer The FDA has approved Recarbrio to treat patients 18 years of age and older who have limited or no alternative treatment options for cUTI, including pyelonephritis, caused by
RegulationDrug Filing July 17, 2019 Novartis’ crizanlizumab secures FDA priority review for sickle cell disease By PBR Staff Writer In January 2018, the company announced that crizanlizumab was granted breakthrough therapy designation by the FDA. Novartis’ application for the investigational drug is backed by results from a
RegulationDrug Filing July 16, 2019 AstraZeneca’s Imfinzi gets FDA orphan drug status for small cell lung cancer By PBR Staff Writer Last month, a phase 3 trial called CASPIAN met its primary endpoint with Imfinzi by delivering a statistically-significant and clinically-meaningful improvement in overall survival for patients suffering from
RegulationDrug Filing July 11, 2019 FDA accepts to review Sanofi’s multiple myeloma candidate isatuximab By PBR Staff Writer An investigational monoclonal antibody, isatuximab, has been designed to target a specific epitope on the CD38 receptor of a plasma cell. The drug has been designed to activate
Clinical TrialsHuman Trials July 9, 2019 ViiV Healthcare begins study on implementation of once-monthly injectable HIV treatment By PBR Staff Writer ViiV Healthcare said that its team will work with clinical staff at different sites across the US to conduct one-year CUSTOMIZE trial (cabotegravir plus rilpivirine in the US
Clinical TrialsHuman Trials July 8, 2019 BiondVax enrols first patient in phase 3 second cohort of M-001 flu vaccine By PBR Staff Writer Close to 8,000 participants are being enrolled by BiondVax for the second cohort for the late-stage trial of M-001 in 85 sites across seven countries in eastern Europe.
RegulationMarketing Authorisation July 4, 2019 EC approves ViiV Healthcare’s Dovato to treat HIV-1 infection By PBR Staff Writer Dovato is a new once-daily, single-pill and two-drug regimen approved for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least
Production & SalesMarketing & Sales July 2, 2019 Novartis wraps up acquisition of Takeda’s dry eye drug Xiidra By PBR Staff Writer The sale of Xiidra has also provided an option to Takeda to receive up to an additional $1.9bn (£1.5bn) in potential milestone payments from Novartis. Takeda intends to
RegulationApprovals July 1, 2019 Pfizer gets FDA nod for Avastin’s biosimilar Zirabev By PBR Staff Writer Pfizer said that Zirabev has been approved to treat five types of cancer, including metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer
RegulationApprovals June 28, 2019 FDA approves Alexion’s Soliris to treat adults with neuromyelitis optica spectrum disorder By PBR Staff Writer The NMOSD is a rare and severe autoimmune disease, which attacks the central nervous system without warning. Also referred as relapses, the attacks may result in progressive and