Chinook Therapeutics, a US-based biopharma company, has secured orphan drug designation for atrasentan from the European Commission (EC) for the treatment of primary IgA nephropathy (IgAN). The decision from the EC comes after the adoption of a positive opinion by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA). Atrasentan has […]
V114 pneumococcal conjugate vaccine candidate : Merck has submitted applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for V114, its 15-valent pneumococcal conjugate vaccine candidate. The Merck vaccine candidate is intended for use in adults 18 years of age and older. The pharma giant said that it […]
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) seeking the expanded approval for DARZALEX (daratumumab) in subcutaneous (SC) formulation to include the treatment of patients having light chain (AL) amyloidosis. Considered as a rare and potentially fatal disease, AL amyloidosis is due […]
Veklury EU approval : Gilead Sciences said that Veklury (remdesivir) has been given conditional marketing authorization from the European Commission as a treatment for SARS-CoV-2 infection, the virus behind COVID-19. According to the US pharma company, the conditional marketing authorization for Veklury was given in the interest of public health because of the coronavirus pandemic […]
Swedish biotech company Medivir has secured orphan medicinal product designation from the European Commission for MIV-818 for the treatment of hepatocellular carcinoma (HCC). The orphan medicinal product designation to the pro-drug in the European Union (EU) was granted in accordance with the opinion from the European Medicines Agency (EMA). Although hepatocellular carcinoma is considered to […]
Libtayo EMA approval : The European Commission has given conditional approval for Libtayo (cemiplimab) for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC), which is one of the most commonly diagnosed skin cancers. Libtayo, which is a fully-human monoclonal antibody targeting the immune checkpoint receptor programmed cell death […]
Alexion Pharmaceuticals has secured a significant milestone with the FDA granting priority review for its C5 complement inhibitor, SOLIRIS (eculizumab), as a treatment for neuromyelitis optica spectrum disorder (NMOSD) in patients who test positive for anti-aquaporin-4 (AQP4) autoantibodies. This critical approval comes as part of a supplemental Biologics License Application (sBLA), which has been accepted […]
Connecticut-based Biohaven Pharmaceutical has received a significant regulatory boost, with the US FDA granting orphan drug designation for its investigational drug verdiperstat for treating multiple system atrophy (MSA). This rare and debilitating neurodegenerative disease has long been a target for pharmaceutical companies seeking breakthroughs in treatment, and verdiperstat’s designation underscores its potential as a game-changer […]
In a significant step towards expanding biosimilar access, Pfizer and AbbVie have resolved all global intellectual property disputes concerning Pfizer’s proposed biosimilar to AbbVie’s blockbuster rheumatoid arthritis drug, Humira (adalimumab). This agreement marks a major milestone in Pfizer’s mission to broaden its portfolio of biosimilar medications, as it acquires a non-exclusive patent license to market […]
Mundipharma, a German pharmaceutical company, has achieved a significant milestone with the European Commission (EC)’s approval of Pelmeg, its pegylated biosimilar to Amgen’s Neulasta (pegfilgrastim). Designed to reduce the duration of neutropenia and associated infections in adults undergoing chemotherapy, Pelmeg provides a cost-effective alternative to traditional treatment options. EU Approval of Pelmeg for Neutropenia The […]