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.
RegulationApprovals May 22, 2023 FDA committee backs Pfizer’s RSV vaccine candidate for infants By PBR Staff Writer The committee voted in support of approval for the vaccine candidate to help prevent the virus in infants through maternal immunisation. According to the committee, the available findings
Drug Manufacturing May 19, 2023 NICE recommends Cara’s Kapruvia to treat CKD-associated pruritus By PBR Staff Writer Kapruvia has been recommenced to treat moderate-to-severe CKD-associated pruritus in adult patients who are undergoing haemodialysis. This will allow patients in Northern Ireland, England, and Wales to get