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 […]
Biotech Business - May 10, 2023
AstraZeneca’s Koselugo approved in China
Koselugo (selumetinib) has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above. “Koselugo offers hope for children whose quality of life and overall well-being is impacted by the growth of painful, debilitating tumours throughout the body. We are […]
Biotech Business - April 5, 2023
STADA and Xbrane launch ranibizumab in Europe
Ranibizumab biosimilar is being launched in major European markets. Ranibizumab is the first product brought to market through a strategic collaboration between STADA and Xbrane Biopharma, marking Xbrane’s first commercial launch and STADA’s first co-development asset, in its growing biosimilars portfolio. Developed and manufactured solely in Europe, ranibizumab is the sixth biosimilar marketed in Europe […]
New Market - March 27, 2023
AstraZeneca’s Calquence granted first regulatory approval in China
Calquence, a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This is the first approved indication for Calquence in China. “This approval for Calquence offers people living with mantle cell […]
MedTech Business - March 15, 2023
EpiGuard approved by TGA in Australia
The EpiShuttle is approved by the Therapeutic Goods Administration (TGA) and is now fully available for use in the Australian market. “Even though The EpiShuttle has been with RAAF for some time now, we are happy to see that the safe isolation and transport system now fully available to the civil Australian market,” says Michael […]
