Press Releases

Fate Therapeutics, Inc., a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today announced that ONO Pharmaceutical Co., Ltd. (ONO) has exercised its option to FT825/ONO-8250, a multiplexed-engineered, iPSC-derived, chimeric antigen receptor (CAR) T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2)-expressing solid tumors. The preclinical product candidate incorporates multiple

US Biologic, a leading global entity in the development, commercialization, and distribution of orally delivered vaccines, announced today that Dr. Jolieke G. van Oosterwijk, US Biologic Chief Scientific Officer, will present key findings on a chewable flu vaccine that US Biologic is developing in partnership with the Biomedical Advanced Research and Development Authority (BARDA) Division of Research, Innovation, and Ventures (DRIVe) as part of its Beyond the Needle program. The pre

Centessa Pharmaceuticals plc  today announced that new data from an additional 18-months of continued treatment with SerpinPC from the open-label extension (OLE) of AP-0101, a Phase 2a study of SerpinPC for the treatment of hemophilia, has been accepted for oral presentation at the 64th American Society of Hematology (ASH) Annual Meeting, to be held in New Orleans, LA, from December 10 - 13, 2022. The ASH presentation will include efficacy, safety, and tolerability data from 18-months of

Teva, today announced that it recently completed the re-submission to a New Drug Application to the U.S. FDA for mdc-IRM, a risperidone subcutaneous Long-Acting Injectable (LAI) for the maintenance treatment of schizophrenia using MedinCell’s proprietary technology. Following a complete response letter from the FDA in mid-April, Teva worked quickly to align on a path forward and to conduct a complete quality check of all clinical data. Teva now expects review and app

Cocrystal Pharma, Inc. announces it has been granted European patent EP3866778 titled "Combinations Of Inhibitors of Influenza Virus Replication,” which covers the Company’s broad-spectrum oral PB2 inhibitor CC-42344 in combination with approved influenza antiviral drugs including Tamiflu®, Xofluza® or Favipiravir. Cocrystal recently announced the completion of enrollment in a Phase 1 study with CC-42344 for the treatment of pandemic and seasonal influenza A, wit

Simulations Plus, Inc. a leading provider of modeling and simulation software and services for pharmaceutical safety and efficacy, today announced that, through a joint proposal with the University of Florida’s College of Pharmacy, it has been awarded a new funded contract from the U.S. Food and Drug Administration (FDA) to advance in vitro and (patho)physiology-based pharmacokinetics (PBPK) models to understand and predict pulmonary absorption and tissue retention of inhaled drugs.

NEWTON, Mass. and FLORENCE, Italy, Oct. 31, 2022 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the European Commission (EC) has granted orphan medicinal product designation for selinexor for the treatment of myelofibrosis (MF). Selinexor was granted orphan drug designation

Reviva Pharmaceuticals Holdings, Inc. a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases, today announced over 30% enrollment in the United States, and initiation and ongoing enrollment across sites in Europe for the pivotal Phase 3 RECOVER study evaluating brilaroxazine for the treatment of schizophrenia. The Company has received regulatory app

WILMINGTON, Del. Noramco, LLC, a leading North American producer of controlled substance and specialty bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has reactivated its previously filed Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient methylnaltrexone bromide. The DMF number is 026528 and the FDA has acknowledged the DMF is again active. Methylnaltrexone bromide is

TFF Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced program updates for Voriconazole Inhaled Powder (TFF VORI) and Tacrolimus Inhaled Powder (TFF TAC) clinical programs. We expect to deliver preliminary patient data from the Phase 2 study of TFF VORI in the first quarter of 2023 and TFF TAC in the second quarter of 20