BioIntelliSense, a continuous health monitoring and clinical intelligence company, announces FDA clearance of the rechargeable BioButton® Multi-Patient wearable and BioDashboard™ system to cost-effectively grow and scale hospital virtual care programs.
Emulate, Inc., the leading provider of next-generation in vitro Organ-Chip models, announced the release of its new Chip-R1™ Rigid Chip, designed to minimize drug absorption and enhance biological modeling. Constructed using low-drug-absorbing plastics, Chip-R1 builds upon the core microfluidic design of Organ-Chips, offering researchers greater precision in predicting human drug responses.
Spineology Inc., the pioneer of Conform and Expand™ Technology, unveiled a new brand and visual identity, logo, and product positioning as part of an extensive rebranding initiative. This new brand defines Spineology’s flagship interbody fusion portfolio, OptiMesh®, and establishes it within a category of its own.
Wheeler Bio, Inc., an agile contract development and manufacturing organization (CDMO), announced an expansion in capabilities through the licensing of ATUM's innovative miFuc™ platform designed for expression of recombinant proteins containing afucosylated glycans.
Axion BioSystems and STEMCELL Technologies are pleased to announce a strategic partnership that will enable STEMCELL to sell Axion’s state-of-the-art Maestro Pro™ and Maestro Edge™ multielectrode array (MEA) systems within North America and Europe. The industry-leading Maestro MEA systems will also continue to be available for purchase worldwide directly from Axion BioSystems.
Novavax, Inc. a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced that doses of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) to prevent COVID-19 in individuals aged 12 and older are in stock at major pharmacy retailers across the U.S.
Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and commercial-scale cell therapy manufacturing, announced the commissioning of the first cGMP Cell Shuttle™ at the IDMO Smart Factory in Bridgewater, New Jersey. This marks an important milestone on the way to a fully fitted facility, which will be capable of producing up to 40,000 standard CAR-T cell therapy doses per year, or up to 100,000 doses of novel, two-day process CAR-T cell therapies.
Pyros Pharmaceuticals, Inc. a leader in the development of enhanced specialty pharmaceuticals for rare diseases, is pleased to announce that VIGAFYDE™ (vigabatrin) oral solution is now available. VIGAFYDE™ is the first and only ready-to-use vigabatrin oral solution, indicated as a monotherapy for the treatment of pediatric patients 1 month to 2 years of age with infantile spasms (IS), where the potential benefits outweigh the potential risk of vision loss. Please see full Prescribing Information below to view Important Safety Information, including BOXED WARNINGS.
Linpharma, a global leader in high quality supplement distribution, has announced the launch of a unique and highly effective cold sore treatment, Lyranda, in the United States. Lyranda is a convenient and pleasant-tasting lozenge, eliminating the need for messy creams to apply topically, no need to touch the cold sore, and cutting the healing time compared to other popular remedies.
Octapharma USA announced the results from the Phase III (LEX-209) study on the efficacy and safety of Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) have been published by the JAMA Network Open, an American Medical Association peer-reviewed journal.