Press Releases
14 July 2023
Osceola Capital announced today the seventeenth and eighteenth additions to the Revelation Pharma platform, adding significant scale and capabilities to the business. Revelation acquired Eagle Pharmacy, located in Hoover, Alabama, and Lee Silsby Compounding Pharmacy, located in Beachwood, Ohio. Eagle is a 503B outsourcing compounding pharmacy that serves healthcare facilities, medical offices, patients, and prescribers in over 29 U.S. states & territories, and its capabilities will allow
Read more...Race Oncology Limited is pleased to announce that it has signed an agreement with Ardena Holding NV one of the world's leading contract development and manufacturing companies to provide additional good manufacturing practice (cGMP) manufacturing capability for the intravenous (IV) formulation of bisantrene, RC220, Race's lead product. Ardena is a fully integrated CDMO that supports biopharmaceutical companies by providing services spanning the drug development cycle. The co
Read more...13 July 2023
Rentschler Biopharma SE, a leading global contract development and manufacturing organization for biopharmaceuticals, today announced the appointment of Dr. Dominik Kugelstadt as Head of Clinical and Commercial Manufacturing, Laupheim, effective July 1, 2023. In this position, Dr. Kugelstadt is responsible for all areas of production and reports to Laupheim’s Site Head as a member of the Laupheim Site Leadership Team. With his extensive experience in the manufacture of complex biologics
Read more...Sciwind Biosciences Co., Ltd., a clinical-stage biopharmaceutical company focusing on discovering and developing innovative therapies to treat metabolic disease, today announced the publication of discovery, preclinical characterization, and Phase 1 clinical trial results of its GLP-1 analog ecnoglutide (XW003) in Molecular Metabolism. Ecnoglutide is a novel, fatty acid-conjugated long-acting GLP-1 analog consisting of only natural amino acids, which simplifies the manufacturing pro
Read more...12 July 2023
PTC Therapeutics, Inc., announced today that the company will provide a virtual presentation on PKU including discussion of the current therapeutic and commercial landscape with an expert key opinion leader. In addition, the company will discuss the sepiapterin clinical program followed by a Q&A session. The event will occur on Wednesday, July 19, from 12 to 1:30 p.m. ET. Presenters will include Ania C. Muntau, MD, Professor of Pediatrics, Chair, University Children's Hospital, Univer
Read more...11 July 2023
Sumitomo Pharma America, Inc. as previously announced on April 3, 2023, is pleased to share it has successfully launched its operations in the U.S. and related markets. The newly combined company is focused on addressing unmet patient needs in critical disease areas across psychiatry & neurology, oncology, urology, women's health, rare disease, and cell & gene therapies. SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-s
Read more...11 July 2023
Acasti Pharma Inc. a late-stage, biopharma company advancing GTX-104, today announced WuXi Clinical Development, Inc. a wholly owned subsidiary of WuXi AppTec, a global Contract Research Organization (CRO), will conduct Acasti's STRIVE-ON Phase 3 safety trial for GTX-104. GTX-104 is Acasti's novel, injectable nimodipine formulation for intravenous infusion (IV) that addresses high, unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH). STRIVE-ON (Safety, To
Read more...10 July 2023
Sensorion a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announced that it has submitted a first Clinical Trial Application (CTA) for OTOF-GT to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The phase 1/2 clinical trial (Audiogene), aims to evaluate the safety, tolerability and efficacy of intra-cochlear injection of
Read more...Horizon Therapeutics plc today announced the publication of the long-term data from the MIRROR randomized controlled clinical trial of KRYSTEXXA® injection with methotrexate, a commonly used immunomodulator, in ACR Open Rheumatology [https://doi.org/10.1002/acr2.11578]. “Publication of these 12-month data reinforces key findings shown at Month 6, including the durability of urate-lowering response, reduced infusion reactions and reduced immunogenicity of pegloticase when c
Read more...Today, the U.S. Food and Drug Administration converted Leqembi indicated to treat adult patients with Alzheimer's Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer's disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological f
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