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Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for .
Cara Therapeutics, Inc.March 8, 2021 GMT
FDA has set Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021
If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients
STAMFORD, Conn, and ST. GALLEN, Switzerland, March 08, 2021 (GLOBE NEWSWIRE) Cara Therapeutics (Nasdaq:CARA) and Vifor Pharma today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the
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BEVERLY HILLS, Calif., March 4, 2021 /PRNewswire/ GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage biopharmaceutical company focused on the development and commercialization of its disruptive, target-directed Natural Killer (NK) cell engager immunotherapy protein biologic platform technology: TriKE™ for cancer and infectious diseases, today announced the addition of a new clinical trial site for its ongoing GTB-3550 TriKE™ multicenter Phase I/II trial (ClinicalTrials.gov NCT03214666). The University of Wisconsin – Madison Carbone Cancer Center will serve as the second site for this program, with Kalyan Vara Ganesh Nadiminti M.D., UW Assistant Professor in Hematology, Oncology and Palliative Care, serving as lead investigator. Dr. Nadiminti will be working closely with Jeffery S. Miller, M.D., GT Biopharma s Consulting Chief Medical Officer and developer of TriKE™ and the trial design, and Erica Warlick, M.D., Principal Investigato
4D pharma plc: 4D Pharma to Present at Upcoming Investor Conferences in March
4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs) a novel class of drug derived from the microbiome, today announced that 4D management will present at three upcoming investor conferences:
Chardan s Virtual 3rd Annual Microbiome Medicines Summit: Monday March 8, 2021 at 11:45 am ET (16:45 GMT).
H.C. Wainwright Global Life Sciences Conference: Available on-demand starting Tuesday, March 9, 2021 at 7:00 am ET (12:00 GMT).
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About 4D pharma
Founded in February 2014, 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx, that rationally identifies Live Biotherap
Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical fact contained in this announcement, including without limitation statements regarding timing of the clinical trial are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended (the Securities Act ), and Section 21E of the United States Securities Exchange Act of 1934, as amended (the Exchange Act ). Forward-looking statements are often identified by the words believe, expect, anticipate, plan, intend, foresee, should, would, could, may, estimate, outlook and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company s current expectations, beliefs and assumptions concerning future developments and busin