Production & SalesManufacturing December 3, 2019 STADA to acquire Biopharma’s prescription and consumer health business By PBR Staff Writer As part of the deal, STADA will also acquire Biopharma’s two GMP-certified production facilities in the city of Bila Tserkva, Kiev. The shareholders of Biopharma will retain the
RegulationDrug Filing November 29, 2019 AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC By PBR Staff Writer Imfinzi holds approvals for the curative-intent setting of unresectable, stage III non-small cell lung cancer (NSCLC) following chemoradiation therapy across 54 countries, including the US, the European Union,
Production & SalesMarketing & Sales November 27, 2019 Asahi Kasei to acquire Veloxis Pharmaceuticals for $1.3bn By PBR Staff Writer The Japanese conglomerate plans to acquire Veloxis Pharmaceuticals through its Danish subsidiary Asahi Kasei Pharma Denmark in a move to accelerate its transformation into a global healthcare company.
Clinical TrialsHuman Trials November 25, 2019 Roche’s Tecentriq, Avastin combo improves OS in unresectable HCC By PBR Staff Writer The late-stage trial called IMbrave150 evaluated the Tecentriq, Avastin combination in comparison with sorafenib in 501 patients with unresectable HCC, who did not receive prior systemic therapy. Data
Drug DiscoveryResearch & Development November 21, 2019 Bristol-Myers Squibb completes $74bn acquisition of biotechnology firm Celgene By PBR Staff Writer With the closing of the acquisition, Celgene became a wholly-owned subsidiary of BMS. Under the deal, Celgene shareholders secured for each share, 1.00 share of BMS common stock
RegulationDrug Filing November 20, 2019 Newron’s sarizotan secures FDA rare paediatric status in Rett syndrome By PBR Staff Writer Sarizotan was granted the orphan drug designation from the FDA for the treatment of the rare neurodevelopmental disorder. Rett syndrome is known to affect mainly females and currently
Clinical TrialsHuman Trials November 14, 2019 GSK’s mepolizumab succeeds in phase 3 trial in hypereosinophilic syndrome By PBR Staff Writer The late-stage study evaluated subcutaneously administered mepolizumab 300mg (3x100mg) every four weeks against placebo in 108 adolescent and adult patients with severe HES. The HES trial met its
Production & SalesManufacturing November 13, 2019 Lupin to sell its stake in Kyowa to Unison for $526m By PBR Staff Writer Founded in 1998, Unison is an independent private equity firm investing in the healthcare sector across Japan, Korea and Singapore, with an emphasis on the pharmaceutical sector. Unison
RegulationDrug Filing November 8, 2019 Johnson & Johnson seeks EMA approval for Ebola vaccine regimen By PBR Staff Writer The company has submitted marketing authorisation applications (MAAs) to the EMA to prevent Ebola Virus Disease (EVD) caused by Zaire ebolavirus species. Janssen has submitted two MAAs in
RegulationApprovals November 6, 2019 Sandoz secures FDA approval for pegfilgrastim biosimilar Ziextenzo By PBR Staff Writer Ziextenzo, like its reference drug pegfilgrastim, has been indicated to reduce the chances of infection caused by low white blood cell count with a fever – a condition