UK-based Virax Biolabs Group Limited has started distribution of Monkeypox Virus Antigen Rapid Test Kits, which were launched in markets accepting CE mark like the European Union. The test kits are for use in point of care settings and to assist healthcare professionals to identify a monkeypox infection in persons suspected of carrying the monkeypox […]
PDS Limited, an Indian consumer-driven manufacturing and sourcing company, said that its UK-based subsidiary Poetic Brands has signed a license agreement with the Authentic Brands Group (ABG) for the Forever 21 fashion clothing brand. Under the agreement, Poetic Brands will hold the rights for manufacturing, marketing, and distributing Forever 21 products in the UK and […]
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) said that Kapruvia (difelikefalin) has secured approval from the European Commission (EC) for the treatment of moderate-to-severe pruritus linked to chronic kidney disease (CKD) in adult hemodialysis patients. The marketing authorization enables Kapruvia to be used in all member states of the European Union along […]
Windlas Biotech has cleared a GMP inspection of the European Union (EU) done by the National Institute of Pharmacy and Nutrition, Hungary for its plant-IV in Dehradun. The Indian domestic pharma formulations contract development and manufacturing organization (CDMO) said that there were zero critical observations reported by the licensing and administrative authority. Windlas Biotech had […]
SeQuent Scientific Limited said that its tablets dosage manufacturing line in Turkey has secured the European Union good manufacturing practices approval (EU GMP approval). The Mumbai-based pure-play animal health company said that the approval was complemented further by the renewal of EU GMP license for eight other manufacturing lines for multiple dosage forms. The dosage […]
Sedana Medical has submitted an application seeking approval for its drug candidate Sedaconda (isoflurane), previously called IsoConDa, for inhaled sedation in intensive care. The application has been filed with the German Medicines Agency BfArM and various other European Medicines Agencies via the DCP procedure. The market approval application is based on the results of the […]
Opdivo EC approval : Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for its immunotherapy Opdivo (nivolumab) as a second-line treatment for unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in adults. The approval of the programmed death-1 (PD-1) immune checkpoint inhibitor is for patients who were previously subjected […]
Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC). The approval is for the Opdivo/Yervoy combination to be used with two cycles of platinum-based chemotherapy in adult patients, whose tumors have no sensitizing epidermal growth […]
Jyseleca EC approval : Gilead Sciences and Galapagos have secured marketing authorization for Jyseleca (filgotinib 200 mg and 100 mg tablets) from the European Commission (EC) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults. The approval of the once-daily, oral, JAK1 inhibitor is rheumatoid arthritis patients who showed inadequate response […]
PCI Pharma Services, a drug development solutions provider, is set to expand its global clinical trial services with a new clinical center of excellence (COE) at its Berlin location in Germany. The pharma and biopharma outsourcing solutions provider said that the new center will enable it to grow its clinical supply-chain network into continental Europe […]