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Drugs.com - Clinical Trials



Clinical trial news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.



 



Syndax Pharmaceuticals Announces Clinical Collaboration to Evaluate Entinostat in Combination with anti-PD-L1 Cancer Immunotherapy in Breast Cancer

Wed, 10 Jan 2018 00:01:55 GMT

WALTHAM, Mass., Jan. 10, 2018 /PRNewswire/ -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today...



AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis

Mon, 08 Jan 2018 05:01:51 GMT

NORTH CHICAGO, Ill., Jan. 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the...



Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients

Thu, 04 Jan 2018 05:01:25 GMT

Cambridge, Mass. – January 4, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for...



Cantex Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation Has Been Granted to CX-01 for Treatment of Acute Myeloid Leukemia

Wed, 03 Jan 2018 22:01:02 GMT

WESTON, Fla., January 3, 2018 -- Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals that improve the treatment of cancers and other life-threatening disorders, today announced that the...



FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response

Fri, 22 Dec 2017 05:12:46 GMT

December 22, 2017 -- The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by...



Rhizen Pharmaceuticals S.A. Receives FDA Orphan-Drug Designation for Tenalisib (RP6530) for Treatment of Peripheral T-Cell Lymphoma (PTCL)

Fri, 22 Dec 2017 05:12:42 GMT

La Chaux-de-Fonds, Switzerland, Dec. 22, 2017 (GLOBE NEWSWIRE) -- Rhizen Pharmaceuticals S.A., today announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for the active moiety of Tenalisib (RP6530), the...



AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints

Wed, 20 Dec 2017 05:01:09 GMT

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing...



Blueprint Medicines Announces New Data from Ongoing Phase 1 Clinical Trial of Avapritinib (BLU-285) in Patients with Advanced Systemic Mastocytosis Showing Evidence of Strong Clinical Activity

Wed, 20 Dec 2017 01:12:25 GMT

CAMBRIDGE, Mass., Dec. 10, 2017 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, today announced new data from its...



Asklepion Pharmaceuticals Announces Special Protocol Assessment (SPA) Agreement with FDA for Phase 3 Program of Intravenous Citrulline

Tue, 19 Dec 2017 05:01:09 GMT

BALTIMORE, Dec. 19, 2017 (GLOBE NEWSWIRE) — Asklepion Pharmaceuticals, LLC (“Asklepion” or “the Company”) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment...



Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide for the Treatment of Leber’s Hereditary Optic Neuropathy

Mon, 18 Dec 2017 04:01:33 GMT

BOSTON – December 18, 2017 – Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has granted...



Chi-Med Initiates Fruquintinib U.S. Clinical Trials

Fri, 15 Dec 2017 04:01:44 GMT

London: Friday, December 15, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of...



FDA Grants Fast Track Designation to Renova Therapeutics’ RT-100 AC6 Gene Transfer for the Treatment of Heart Failure

Thu, 14 Dec 2017 23:12:53 GMT

San Diego, CA - December 14, 2017 – Renova™ Therapeutics, a biotechnology company developing gene and peptide-based treatments for cardiovascular and metabolic diseases, announced today that the U.S. Food and Drug Administration (FDA) has...



Talazoparib Significantly Extends Progression-Free Survival in Phase 3 EMBRACA Trial of Patients with Metastatic Breast Cancer

Wed, 13 Dec 2017 21:12:49 GMT

December 8, 2017 -- Pfizer Inc. (NYSE:PFE) today announced that the Phase 3 EMBRACA trial in patients with germline (inherited) BRCA1/2-positive (gBRCA+) locally advanced and/or metastatic breast cancer (MBC) demonstrated superior progression-free...



Sanofi and Regeneron Announce Positive Topline Pivotal Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma

Wed, 13 Dec 2017 03:01:24 GMT

Paris, France & Tarrytown, N.Y. – December 13, 2017 – Sanofi and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a pivotal Phase 2 clinical study of cemiplimab in 82 patients with advanced...



Loxo Oncology Announces Updated Larotrectinib Pediatric Clinical Trial Data Demonstrating Continued Durability of Response in TRK Fusion Cancers

Tue, 12 Dec 2017 05:12:12 GMT

STAMFORD, Conn., Dec. 04, 2017 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced updated...



TapImmune Announces Enrollment of First Patient in Phase 2 Clinical Trial for Treating Triple-Negative Breast Cancer Funded by U.S. Department of Defense

Tue, 12 Dec 2017 05:01:15 GMT

JACKSONVILLE, Florida, December 12, 2017 / TapImmune Inc. (NASDAQ: TPIV), a leading clinical-stage immuno-oncology company with ongoing clinical trials in ovarian and breast cancer, today announced that the first patient has been enrolled in a Phase...



Clementia Initiates Pivotal Phase 3 MOVE Trial for Palovarotene in Patients with Fibrodysplasia Ossificans Progressiva

Tue, 12 Dec 2017 05:01:11 GMT

MONTREAL, Dec. 12, 2017 (GLOBE NEWSWIRE) -- Clementia Pharmaceuticals Inc. (NASDAQ:CMTA), a clinical-stage biopharmaceutical company innovating new treatments for people with ultra-rare bone disorders and other diseases, today announced the start of...



Kite Announces Data From ZUMA-3 Study of KTE-C19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Mon, 11 Dec 2017 21:12:35 GMT

ATLANTA--(BUSINESS WIRE)--Dec. 11, 2017-- Kite, a Gilead Company (Nasdaq: GILD), announced updated results from the ongoing Phase 1/2 ZUMA-3 study of KTE-C19, a CD19 chimeric antigen receptor T (CAR T) cell therapy, which is investigational for the...



Novartis Drug Crizanlizumab Shown to Prolong Time to Patients' First Sickle Cell Pain Crisis in Subgroup Analysis of SUSTAIN Study

Mon, 11 Dec 2017 03:12:08 GMT

Basel, December 11, 2017 - Results from a post hoc subgroup analysis of the Phase II SUSTAIN study show that crizanlizumab, an investigational humanized anti-P-selectin monoclonal antibody, delayed the time to first sickle cell pain crisis (SCPC) in...



Phase II Data Showed Genentech’s Investigational Polatuzumab Vedotin Plus Bendamustine and Rituxan (BR) Increased Complete Response Rates Compared to BR Alone in Previously Treated Aggressive Lymphoma

Sun, 10 Dec 2017 23:01:00 GMT

South San Francisco, CA -- December 10, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the randomized Phase II GO29365 study that compared polatuzumab vedotin in combination with...



Kite Announces Long-Term Data From Pivotal ZUMA-1 Study of Yescarta (Axicabtagene Ciloleucel) in Patients With Refractory Large B-cell Lymphoma

Sun, 10 Dec 2017 21:12:46 GMT

ATLANTA--(BUSINESS WIRE)--Dec. 10, 2017-- Kite, a Gilead Company (Nasdaq: GILD), announced long-term follow-up data from the pivotal ZUMA-1 study of Yescarta (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum...



Primary Analysis Results from Novartis Pivotal JULIET Trial Show Kymriah (tisagenlecleucel) Sustained Complete Responses at Six Months in Adults with r/r DLBCL, a Difficult-to-Treat Cancer

Sun, 10 Dec 2017 02:12:56 GMT

Basel, December 10, 2017 - Novartis today announced updated results from the JULIET clinical trial demonstrating sustained responses with Kymriah (tisagenlecleucel) suspension for intravenous infusion, formerly CTL019, in adult patients with...



MediciNova Announces Positive Top-Line Results from the Clinical Trial of MN-166 (ibudilast) in ALS

Thu, 07 Dec 2017 05:01:11 GMT

LA JOLLA, Calif., Dec. 07, 2017 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive...



Spark Therapeutics and Pfizer Announce Publication in The New England Journal of Medicine of Interim Data from Phase 1/2 Clinical Trial of Investigational Gene Therapy for Hemophilia B

Wed, 06 Dec 2017 21:01:19 GMT

December 6, 2017 Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, and Pfizer Inc. (NYSE:PFE), today announced that The New England Journal of Medicine has...



Kadmon Presents Encouraging Data on Tesevatinib in EGFR-Mutated Non-Small Cell Lung Cancer with Brain Metastases and/or Leptomeningeal Metastases

Wed, 06 Dec 2017 02:12:52 GMT

NEW YORK--(BUSINESS WIRE) December 6, 2017 -- Kadmon Holdings, Inc. (NYSE: KDMN) (“Kadmon” or the “Company”) today announced encouraging data from its ongoing Phase 2 clinical study of tesevatinib, the Company’s blood-brain barrier...



Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study

Mon, 04 Dec 2017 05:01:15 GMT

NORTH CHICAGO, Ill., Dec. 4, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from IMMhance, the fourth pivotal Phase 3 clinical trial evaluating...



Aimovig (erenumab) Phase 3 STRIVE Data Published In The New England Journal Of Medicine Demonstrate Significant, Sustained Efficacy In Migraine Prevention

Wed, 29 Nov 2017 03:11:35 GMT

THOUSAND OAKS, Calif., Nov. 29, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase 3 STRIVE study evaluating Aimovig™ (erenumab) versus...



Novartis Announces Phase III STRIVE Data Published in NEJM Demonstrating Significant and Sustained Efficacy of Erenumab (AMG334) in Migraine Prevention

Wed, 29 Nov 2017 02:12:55 GMT

Basel, November 29, 2017 - Novartis today announced that the New England Journal of Medicine (NEJM) published positive results from the six-month Phase III STRIVE study evaluating erenumab in the prevention of episodic migraine (defined in STRIVE as...



Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate

Tue, 28 Nov 2017 02:11:26 GMT

Osaka, Japan, November 28, 2017 – Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1...



Biohaven Completes Enrollment in Second Pivotal Phase 3 Clinical Trial of Oral CGRP-Receptor Antagonist Rimegepant

Mon, 27 Nov 2017 23:11:36 GMT

NEW HAVEN, Connecticut, November 27, 2017 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) (“Biohaven” or the “Company”) announced today completion of enrollment in Study BHV3000-302, the Company’s second pivotal...



Menlo Therapeutics Begins Phase 2 Clinical Trial for Serlopitant for Pruritus Associated with Psoriasis

Tue, 21 Nov 2017 05:11:25 GMT

REDWOOD CITY, Calif., November 21, 2017 /PRNewswire/ — Menlo Therapeutics Inc., a late- stage biopharmaceutical company developing a neurokinin 1 (NK‐1) receptor antagonist (serlopitant) for the treatment of pruritus (itch) and refractory...



FDA Grants Orphan Drug Designation for TRM-201 (rofecoxib) for the Treatment of Hemophilic Arthropathy

Tue, 21 Nov 2017 03:11:49 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE) November 21, 2017 --Tremeau Pharmaceuticals, Inc., a new pharmaceutical company focused on providing non-opioid pain treatments for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has...



Acorda Discontinues Tozadenant Development Program

Mon, 20 Nov 2017 21:11:08 GMT

ARDSLEY, N.Y.--(BUSINESS WIRE)--November 20, 2017 -- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including...



Intra-Cellular Therapies Receives FDA Fast Track Designation for Lumateperone for the Treatment of Schizophrenia

Mon, 20 Nov 2017 02:11:49 GMT

NEW YORK, Nov. 20, 2017 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug...



Three-year Follow-up Phase 3 Data Provide Additional Information on Efficacy, Durability and Safety of Investigational Luxturna (voretigene neparvovec) in Patients with Biallelic RPE65-mediated Inherited Retinal Disease

Fri, 10 Nov 2017 23:11:01 GMT

PHILADELPHIA, Nov. 10, 2017 (GLOBE NEWSWIRE) -- Spark Therapeutics (NASDAQ:ONCE), a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, today announced new three-year follow-up data from the...



Alnylam Announces Successful Outcome Following FDA Type A Meeting to Discuss Fitusiran Program in Hemophilia

Thu, 09 Nov 2017 04:11:49 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE) November 9, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today a successful Type A meeting with the U.S. Food and Drug Administration (FDA) where alignment...



Sage Therapeutics Announces Brexanolone Achieves Primary Endpoints in Both Phase 3 Clinical Trials in Postpartum Depression

Thu, 09 Nov 2017 02:11:12 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 9, 2017-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced positive...



Bristol-Myers Squibb and Five Prime Present Phase 1a/1b Data Evaluating Cabiralizumab (anti-CSF-1 receptor antibody) with Opdivo (nivolumab) in Patients with Advanced Solid Tumors

Thu, 09 Nov 2017 01:11:49 GMT

PRINCETON, N.J. & SOUTH SAN FRANCISCO, Calif.-- November 9, 2017 (BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and Five Prime Therapeutics, Inc. (NASDAQ:FPRX) today announced preliminary results from a dose escalation and expansion...



Seattle Genetics and Astellas Initiate Phase 1b Trial of Enfortumab Vedotin in Combination with Immune Checkpoint Inhibitor Therapies in Locally Advanced or Metastatic Urothelial Cancer

Wed, 08 Nov 2017 04:11:43 GMT

BOTHELL, Wash. & TOKYO--(BUSINESS WIRE)--Nov. 8, 2017-- Seattle Genetics, Inc. (NASDAQ: SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”), today announced dosing of the first patient in EV-103, a...



Alnylam Initiates ENVISION Phase 3 Clinical Study with Givosiran, an Investigational RNAi Therapeutic for the Treatment of Acute Hepatic Porphyrias (AHPs)

Tue, 07 Nov 2017 04:11:08 GMT

CAMBRIDGE, Mass.--(BUSINESS WIRE) November 7, 2017 -- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today the initiation of the ENVISION Phase 3 clinical study with givosiran, a subcutaneously...