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 […]
Agreement - January 4, 2023
Orion and Amneal enter strategic partnership
Orion Corporation has signed a long-term license agreement with Amneal Pharmaceuticals to commercialize Amneal’s generic products in Orion territories. Under the terms of the agreement, Orion is granted exclusive licence to commercialize and sell Amneal’s generic products in most parts of Europe as well as in Australia and New Zealand. The initial portfolio will include […]
Biotech Business - October 4, 2022
Oncopeptides starts commercialization of Pepaxti in Europe
The company has submitted the AMNOG dossier to “The Federal Joint Committee” (G-BA) in Germany. This initiates the commercial launch of Pepaxti (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched, states the company in a press release. “The launch of Pepaxti in Germany is an important […]
