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
RegulationDrug Filing June 25, 2019 Tesaro’s niraparib secures FDA priority review for late stage ovarian cancer By PBR Staff Writer Under the supplemental new drug application (sNDA) submitted to the regulator, Tesaro is seeking approval of niraparib for the treatment of advanced ovarian, fallopian tube, or primary peritoneal
RegulationApprovals June 24, 2019 Allergan’s Botox secures FDA paediatric approval for upper limb spasticity By vbandhakavi The latest FDA approval for Botox is for patients aged between two and 17 years whose movement at the joints of the upper limb is restricted due to
RegulationDrug Filing June 21, 2019 Alexion gets FDA priority review for Ultomiris to treat atypical hemolytic uremic syndrome By PBR Staff Writer Ultomiris is said to be the first and only long-acting C5 inhibitor administered every eight weeks and it works by inhibiting the C5 protein in the terminal complement
RegulationApprovals June 18, 2019 Novo Nordisk’s Victoza secures FDA paediatric approval for type 2 diabetes By PBR Staff Writer Victoza was approved by the regulator for the treatment of type 2 diabetes in adult patients in 2010. It is now the first non-insulin drug to be approved
Clinical TrialsHuman Trials June 17, 2019 AstraZeneca’s Lokelma shows significant effect in ESRD trial By PBR Staff Writer The Dialize trial has evaluated the efficacy and safety of Lokelma to treat hyperkalaemia, which is a serious condition indicated by elevated potassium levels in the blood. According
Drug DiscoveryResearch & Development June 13, 2019 Dassault Systèmes to buy Medidata Solutions for £4.5bn By PBR Staff Writer The acquisition of Medidata will help Dassault to create its first end-to-end scientific and business platform for life sciences industry. As per terms of the deal, Dassault will