Gastric Cancer June 5, 2023 NMPA grants BTD to Innovent’s olverembatinib to treat SDH-deficient GIST By PBR Staff Writer The designation was granted based on the results from an ongoing Phase Ib/II study of olverembatinib carried out in China. The study demonstrated a clinical benefit rate of
Osteoarthritis June 2, 2023 Levolta partners with Tabuk for OA therapy commercialisation in MEA region By PBR Staff Writer Tabuk is a fully owned subsidiary of Astra Industrial Group. Under the agreement, Tabuk will hold the marketing authorisation and will be responsible for registering, importing, and commercialising
Approvals June 1, 2023 EMA grants PRIME designation to Rocket’s AAV-based gene therapy By PBR Staff Writer The designation for the investigational gene therapy was granted based on positive safety and efficacy data from the Phase I study in patients with Danon Disease. A favourable
Cell Therapy May 31, 2023 eXmoor pharma raises $35m to boost cell and gene therapy production By PBR Staff Writer The fundraise saw the participation of new and existing investors Kineticos Ventures and MVM Partners, respectively. Kineticos Ventures president and CEO Frank Lis is joining eXmoor board as
DermatologyOsteoarthritis May 30, 2023 Abiogen Pharma acquires 97.09% stake in EffRx Pharmaceuticals By PBR Staff Writer Abiogen Pharma’s business spans across many integrated aspects: research and development, manufacturing of pharmaceuticals under its own brand or third-party contracts, and marketing of its own and licensed
Neurology May 29, 2023 Marinus Pharmaceuticals gets positive opinion for ZTALMY from CHMP By PBR Staff Writer This recommendation is for ZTALMY to serve as the adjunctive treatment of epileptic seizures related with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17
Clinical Trials May 26, 2023 VarmX raises funds to seek IND approval for VMX-C001 By PBR Staff Writer VMX-C001 is a modified recombinant human blood clotting factor X that enables patients taking direct oral anticoagulant blood thinners to undergo emergency surgery without the risk of bleeding.
Marketing & Sales May 25, 2023 Alvotech partners with Advanz for biosimilars commercialisation in Europe By PBR Staff Writer Under the partnership, the biosimilars will be developed and supplied by Alvotech while Advanz Pharma will be responsible for registration and marketing in Europe. Alvotech and Advanz’s agreement
Infectious Disease May 24, 2023 Innoviva receives FDA approval for HABP/VABP therapy By PBR Staff Writer Co-packaged with sulbactam and durlobactam injections, XACDURO is said to be the first pathogen-targeted therapy addressing Acinetobacter, including resistant strains. It is intended for use in patients aged
Metabolic Disorders May 23, 2023 Rhythm and Genpharm to commercialise IMCIVREE in GCC countries By PBR Staff Writer As per the terms of the exclusive agreement, Genpharm will distribute IMCIVREE to patients in GCC countries, including United Arab Emirates, Saudi Arabia, Kuwait, Oman, Qatar and Bahrain.