DUBLIN – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company has completed the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a Monday/Wednesday/Friday (M/W/F) intramuscular (IM) dosing schedule for Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn), for use as...
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DUBLIN, Ireland — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for the HER2-targeted bispecific antibody zanidatamab as a treatment for previously-treated, unresectable, locally advanced, or...
DUBLIN, Ireland — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the conditional marketing authorization of zanidatamab, an investigational dual human epidermal growth factor receptor 2 (HER2)-targeted bispecific antibody, as monotherapy...
NEWPORT BEACH, Calif. – jCyte, Inc., a private biotechnology company dedicated to improving the lives of patients with retinal degenerative diseases, announced the continued expansion of the company’s executive management team with the appointment of Adrian Morris as Chief Development Officer. Mr. Morris brings to jCyte over three decades of...
NEWPORT BEACH, Calif. – jCyte, Inc., a biotech company dedicated to improving the lives of patients with retinal degenerative diseases, today announced the further expansion of the company’s executive management team with the appointment of John Sholar as General Counsel. Mr. Sholar brings to jCyte more than 20 years of...
NEWPORT BEACH, Calif. — jCyte, Inc., a pioneering biotechnology company dedicated to preserving and restoring vision in patients with retinitis pigmentosa (RP) and other degenerative retinal disorders, is pleased to announce the successful outcome of its pre-phase 3 Type B meeting with the US Food and Drug Administration (FDA) held...
TORONTO, Canada – JDRF and Sanofi Canada are announcing a partnership aimed at amplifying awareness around type 1 diabetes (T1D), a chronic autoimmune condition, and the role screening could play in the early detection of this disease. Nationally, the number of individuals diagnosed with T1D is growing at an estimated...
PHILADELPHIA – A protein related to aggressive cancers can actually improve the efficacy of gemcitabine at treating pancreatic cancer, according to a Priority Report in Cancer Research, published by researchers at Thomas Jefferson University. The protein, called Hu antigen R (HuR), is a stress response protein found in the cytoplasm...
SHANGHAI, China — Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration...
SHANGHAI, China — In another milestone since the implementation of CAR-T therapy at Jiahui, the first myeloma patient treated with CAR-T at Jiahui International Hospital was recently discharged two weeks after infusion. The foreign patient was first diagnosed with multiple myeloma in 2008. Despite multiple treatments including chemotherapy, immunotherapy, target...