RegulationApprovals March 20, 2019 Sage Therapeutics gets FDA nod for Zulresso to treat postpartum depression By PBR Staff Writer Zulresso is claimed to be the first and only medicine secured approval to treat PPD, which is the most common medical complication of childbirth. The medicine is an
RegulationMarketing Authorisation March 11, 2019 Roche gets EC nod for Tecentriq and Avastin combo for first-line lung cancer By PBR Staff Writer The EC has approved Tecentriq in combination with Avastin, paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC). Tecentriq, in
RegulationApprovals February 20, 2019 Merck gets FDA nod for Keytruda as adjuvant treatment for melanoma By PBR Staff Writer The recommended dose of Keytruda for the adjuvant treatment of adult patients with melanoma is 200 mg administered as an intravenous infusion over 30 minutes every three weeks
RegulationLawsuits February 13, 2019 US court rejects Indivior’s appeal on Suboxone generic version By PBR Staff Writer The US Court of Appeals for the Federal Circuit (CAFC) has rejected Indivior’s motion to stay issuance of the mandate following its ruling vacating the preliminary injunction (PI)
RegulationMarketing Authorisation February 5, 2019 CHMP recommends Keytruda-chemo combo in squamous NSCLC By PBR Staff Writer The CHMP’s positive opinion for Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel is for the first-line treatment of metastatic NSCLC in adults. Keytruda is an
Clinical TrialsHuman Trials January 30, 2019 Takeda’s TAK-003 dengue vaccine candidate succeeds in phase 3 efficacy trial By PBR Staff Writer The first analysis of the tetravalent immunization against dengue efficacy study (TIDES) trial demonstrated that TAK-003 effectively prevented dengue fever caused by any of the four serotypes of
RegulationApprovals January 22, 2019 EC approves Vertex’s CF treatment Orkambi for children aged two to five years By PBR Staff Writer The label extension has been granted to treat the most common form of CF based on data from a phase 3 open-label safety study in 60 patients. According
RegulationApprovals January 3, 2019 BMS’ Sprycel secures FDA approval to treat pediatric Ph+ ALL By PBR Staff Writer The expanded indication for Sprycel is in combination with chemotherapy. It was granted by the regulator following priority review based on the findings of the phase 2 study,
RegulationApprovals December 27, 2018 FDA accepts Kala Pharmaceuticals’ NDA for KPI-121 0.25% By PBR Staff Writer The FDA will review the NDA for KPI-121 0.25%, which is designed to provide temporary relief to the signs and symptoms of dry eye disease, including dry eye
Production & Sales December 24, 2018 Lupin awards MALT1’s licensing rights to AbbVie By PBR Staff Writer Indian pharmaceutical company Lupin has awarded the licensing rights of its Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1 (MALT1) programme to AbbVie. The deal gives AbbVie exclusive global