Category: Clinical trials

Allergan and Paratek Announce Positive Results From Two Phase 3 Trials of Sarecycline for the Treatment of Moderate to Severe Acne

DUBLIN and BOSTON, March 27, 2017 /PRNewswire/ -- Allergan plc, (NYSE: AGN), a leading global pharmaceutical company and Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a biopharmaceutical company focused on the development and commercialization of...

Immunomedics Announces Publication of Results in Journal of Clinical Oncology, Demonstrating Treatment With Sacituzumab Govitecan (IMMU-132) Produces Early and Durable Responses in Patients With Metastatic Triple-Negative Breast Cancer

MORRIS PLAINS, N.J., March 15, 2017 /PRNewswire/ -- Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or "the Company") today announced that sacituzumab govitecan (IMMU-132), the Company's lead antibody-drug conjugate (ADC), was highly active in...

FDA Grants Orphan Drug Designation to Boehringer Ingelheim’s Investigational Anti-CD33 Monoclonal Antibody BI 836858 for Treatment of Myelodysplastic Syndromes

Ridgefield, Conn., March 9, 2017 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic...

FDA Grants Orphan Drug Designation to Boehringer Ingelheim’s Investigational Anti-CD33 Monoclonal Antibody BI 836858 for Treatment of Myelodysplastic Syndromes

Ridgefield, Conn., March 9, 2017 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic...

Servier and Pfizer Announce FDA Clearance of IND Application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia

March 9, 2017 - Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq: CLLS), announced today that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational...

Servier and Pfizer Announce FDA Clearance of IND Application for UCART19 in Adult Relapsed/Refractory Acute Lymphoblastic Leukemia

March 9, 2017 - Servier, together with Pfizer Inc. (NYSE:PFE) and Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS; Nasdaq: CLLS), announced today that the U.S. Food and Drug Administration (FDA) has granted Servier with an Investigational...

Ocera to Announce Additional Encouraging Results from its Phase 2b STOP-HE Study of IV OCR-002 in Patients with Hepatic Encephalopathy

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 08, 2017 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced it will...

Ocera to Announce Additional Encouraging Results from its Phase 2b STOP-HE Study of IV OCR-002 in Patients with Hepatic Encephalopathy

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., March 08, 2017 (GLOBE NEWSWIRE) -- Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced it will...

Menlo Therapeutics Announces Successful Pruritus Reduction Results from Phase 2 Serlopitant Trial (TCP-102) in 127 Subjects With Prurigo Nodularis

Menlo Park, CA - March 8, 2017 -- Menlo Therapeutics Inc. announced today that the phase 2 trial (TCP-102) evaluating serlopitant for the treatment of pruritus (itch) associated with prurigo nodularis successfully met its primary efficacy endpoint...