New Market - September 4, 2023
AstraZeneca’s Calquence approved in China
Calquence, a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in China for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy. “Today’s approval is another step towards our goal of making Calquence available to as many patients […]
MedTech Business - August 23, 2023
Episurf’s first commercial case in the US scheduled
Episurf Medical has announced that the company’s first commercial case in the US has been scheduled for surgery. This is also the first case ever with the newly introduced product Episealer Patellofemoral System, states the company. The product is a fully individualized implant system for patients with isolated osteoarthritis of the patellofemoral joint in the […]
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 […]
