MedTech Business - July 5, 2023
Devyser has inaugurated its CLIA-certified laboratory
The new laboratory in Atlanta, Georgia, will offer clinical test services for hereditary diseases, oncology, and post-transplant monitoring. The laboratory has already processed its first commercial test, examining a patient sample for fetal Rhesus D blood group status, states the company in a press release. “The opening of our new CLIA-certified laboratory in Atlanta is […]
Financing - June 28, 2023
Moberg Pharma is recommended EU approval and proposes a rights issue
The company has announced that the Decentralized Procedure has ended with a positive outcome and that MOB-015 is recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults. The Decentralized Procedure includes the following EU countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, […]
New Market - June 27, 2023
AstraZeneca’s Xigduo XR approved in China
Xigduo XR, a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycaemic control. “People living with type-2 diabetes often have comorbidities such as heart failure and chronic kidney disease, leading to cardiorenal […]
New Market - June 26, 2023
AstraZeneca’s Soliris recommended for approval in the EU
Soliris has been recommended for marketing authorisation in the European Union (EU) for expanded use to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). If authorised, Soliris would be the first and only targeted therapy approved for the […]
Agreement - June 2, 2023
InDex Pharmaceuticals enters license agreement with Viatris Japan
InDex Pharmaceuticals has announced that a license agreement has been signed with Viatris Pharmaceutical Japan to register and commercialize cobitolimod in Japan for the treatment of ulcerative colitis. “We are excited to start our collaboration with Viatris Japan with the common goal to register and commercialize cobitolimod for the Japanese market. Viatris Japan shares our […]
New Market - May 15, 2023
AstraZeneca’s Ultomiris approved in the EU
Ultomiris has been approved in the European Union as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). “Just four years since delivering the first approved NMOSD treatment to the EU, we are pleased to once again advance the treatment […]
