RegulationDrug FilingSkin Inflammation June 27, 2022 FDA accepts Emergent BioSolutions’ anthrax vaccine candidate for review By PBR Staff Writer The vaccine candidate seeks to prevent anthrax in people after suspected or confirmed exposure to Bacillus anthracis. AV7909 is being assessed in adult persons between 18 and 65
RegulationApprovals June 24, 2022 FDA approves Novartis’ Tafinlar + Mekinist combination therapy By PBR Staff Writer The combination therapy is indicated to treat unresectable or metastatic solid tumours with the BRAF V600E mutation in adult and paediatric patients aged six years and above whose
RegulationApprovals June 23, 2022 FDA approves Ellipses’ application for advanced RET-altered cancer treatment By PBR Staff Writer EP0031 is a potent next generation selective RET inhibitor (SRI) with broad activity against common RET fusions and mutations, like solvent front resistance mutations. It is jointly developed
RegulationApprovals June 23, 2022 EC approves variation of Rhythm’s Imcivree to treat renal impairment patients By PBR Staff Writer Imcivree is a melanocortin-4 receptor (MC4R) agonist which is indicated for chronic weight management in adult and paediatric patients aged six years and above with monogenic or syndromic
RegulationApprovals June 22, 2022 VBI Vaccines gets orphan drug designation for glioblastoma therapy By PBR Staff Writer VBI-1901 is a new cancer vaccine immunotherapeutic candidate that uses cytomegalovirus (CMV) as a foreign viral antigen approach to treat cancer by expressing two highly immunogenic CMV antigens,
RegulationApprovals June 22, 2022 AbbVie submits sNDA to FDA for atogepant label expansion By PBR Staff Writer Atogepant is an oral calcitonin gene-related peptide [CGRP] receptor antagonist (gepant) which has been specifically developed as the preventive migraine treatment. In September last year, the drug received
BiotechnologyRespiratory June 21, 2022 Chinese biotech firm Therorna closes $42m Series A financing round By PBR Staff Writer The funding round was co-led by an industrial investment firm and MSA Capital. Sherpa Healthcare Partners, 3H Health Investment, and the company’s existing investors Quan Capital and Cenova
RegulationApprovalsCrohn's Disease (Regional Enteritis) June 20, 2022 FDA approves AbbVie’s Skyrizi to treat Crohn’s Disease in adults By PBR Staff Writer The medicine is said to be the first and only specific interleukin-23 (IL-23) inhibitor approved for treating moderately to severely active CD in adults. The approval follows the
Metabolic Disorders June 17, 2022 Rhythm Pharmaceuticals secures FDA approval for sNDA for IMCIVREE to treat BBS By PBR Staff Writer With this FDA approval, IMCIVREE is indicated for chronic weight management in adult and pediatric patients aged six years and older with monogenic or syndromic obesity due to
DermatologyImmunology June 16, 2022 Quoin Pharmaceuticals signs license, distribution agreement with WinHealth Pharma By PBR Staff Writer This agreement will allow Quoin to offer healthcare professionals and patients in greater China, including Hong Kong, Macau and Taiwan, with access to its products following receipt regulatory