GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia. Ojjaara is a once-a-day, oral JAK1/JAK2 and
Basel, September 18, 2023 — Sandoz, a global leader in generic and biosimilar medicines, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending marketing authorization for their biosimilar trastuzumab (150 mg, for intravenous use), developed by
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” This draft guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products. The recommendations for biosimilar and interchangeable
FLORHAM PARK, N.J., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to
BEERSE, Belgium, 8 September 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible
Apollo is a part of a research and development platform for the development of new medicines, with program selection being hesitant to indication and primarily driven by quality of science or the potential to transform the standard of care in major commercial markets, according to the press release. Apollo Therapeutics
Harleysville, Pennsylvania, USA, 5 th September 2023, Colorcon, a world leader in the development and supply of film coating systems, speciality excipients and functional packaging for the healthcare industries, announces the launch of a new Opadry® film coating system to address the moisture management needs for pharmaceutical tablets, without the
The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases. Otsuka Pharmaceutical and ShapeTX announced on Sept.7, 2023 a multi-target collaboration to develop
Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization. Nurix Therapeutics announced on Sept. 7, 2023, that it has entered a multi-year, multi-target strategic collaboration agreement with Seagen, to further advance a new
Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK. Rentschler Biopharma, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced on Sept.
Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide. Recipharm is partnering with Ahead Therapeutics, a Spanish start-up biotech company, to develop a ground-breaking treatment for a rare autoimmune disease,