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Clinical Trial News

This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.

IL-23 Inhibitor Risankizumab Induces Remission in Phase II Study in Patients with Moderate-to-Severe Crohn's Disease

Posted 7 days ago in Clinical Trials

INGELHEIM, Germany, and NORTH CHICAGO, Ill., May 24, 2016 /PRNewswire/ -- Results were presented today from a proof-of-concept, Phase II, randomized, placebo-controlled study (NCT02031276) in Crohn's disease with investigational biologic, risankizumab (formerly BI 655066), a compound from Boehringer Ingelheim research and recently licensed by AbbVie (NYSE: ABBV). Risankizumab was shown to be more effective than...

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Celator Pharmaceuticals Announces Vyxeos Granted Breakthrough Therapy Designation

Posted 12 days ago in Clinical Trials

EWING, N.J., May 19, 2016 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today announced that the United States Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Vyxeos (also known as CPX-351). Vyxeos is an investigational product in development as a treatment for AML and other blood cancers. The Breakthrough Therapy designation is primarily based upon the positive...

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AstraZeneca announces positive results from benralizumab phase III programme in severe asthma

Posted 13 days ago in Clinical Trials

May 17, 2016 -- AstraZeneca today announced that benralizumab, a potential new medicine and anti-eosinophil monoclonal antibody, was well tolerated and achieved the primary endpoint in two pivotal Phase III registrational trials (SIROCCO and CALIMA), demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo. Sean Bohen, Executive Vice President, Global Medicines Development...

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Selumetinib granted Orphan Drug Designation in the US for adjuvant treatment of differentiated thyroid cancer

Posted 13 days ago in Clinical Trials

May 12, 2016 -- AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational MEK 1/2 inhibitor, selumetinib (AZD6244, ARRY-142886) for adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC). DTC is diagnosed in approximately 60,000 people in the US each year,1 and radioactive iodine (RAI) is recommended for...

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Poliovirus Therapy Wins 'Breakthrough' Status

Posted 2 weeks ago in Clinical Trials

May 16, 2016 -- In a poignant, two-part segment May 15, CBS’s 60 Minutes returned to Duke to update viewers on the poliovirus therapy developed and tested by researchers at the Preston Robert Tisch Brain Tumor Center. Anchor Scott Pelley again led the reporting of the program, which spanned more than two years. It provides major updates to the news magazine’s initial two-part segment, “Killing Cancer,” which aired...

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Tetraphase Pharmaceuticals Provides Update on Eravacycline Regulatory and Development Status

Posted 2 weeks ago in Clinical Trials

WATERTOWN, Mass., May 12, 2016 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that it has received guidance from the U.S. Food and Drug Administration (FDA) regarding the regulatory path of the Company's lead candidate, eravacycline, an...

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Paratek Receives FDA Affirmation for Design of Proposed Omadacycline Oral-Only Skin Infection Phase 3 Study

Posted 3 weeks ago in Clinical Trials

BOSTON, May 10, 2016 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that it has received favorable feedback from the U.S. Food and Drug Administration regarding the design of a proposed oral-only Phase 3 study of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI). In their feedback, the FDA confirmed that the proposed comparator is...

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Epizyme Announces FDA Acceptance of Investigational New Drug Application for Tazemetostat in Mesothelioma

Posted 3 weeks ago in Clinical Trials

CAMBRIDGE, Mass., May 4, 2016 --(BUSINESS WIRE)-- Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, today announced that the U.S. Food and Drug Administration has accepted the company's Investigational New Drug (IND) application for tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function. In...

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Semaglutide significantly reduces the risk of major adverse cardiovascular events in the SUSTAIN 6 trial

Posted 4 weeks ago in Clinical Trials

Bagsværd, Denmark, 28 April 2016 - Novo Nordisk today announced the top-line results from the sixth and last global phase 3a trial, SUSTAIN6, for semaglutide; a new GLP-1 analogue, which is administered subcutaneously once weekly in the SUSTAIN trials. This double-blinded trial investigated the long-term cardiovascular and other safety outcomes of 0.5 mg and 1.0 mg semaglutide compared with placebo, both in addition ...

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Agenus Commences Phase 1 Clinical Trial of its CTLA-4 Checkpoint Antibody to Treat Solid Tumors

Posted 4 weeks ago in Clinical Trials

LEXINGTON, Mass., April 27, 2016 --(BUSINESS WIRE)--Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company developing checkpoint antibodies and cancer vaccines, today announced that the first patient has been dosed in the company’s Phase 1 clinical trial of AGEN1884, an anti-CTLA-4 checkpoint (CPM) antibody. The open-label, multicenter trial in patients with advanced or refractory cancer is designed to evaluate the s...

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SIGA Announces Enrollment of First Patients in the Final Cohort of Phase III Study of Tecovirimat

Posted 5 weeks ago in Clinical Trials

NEW YORK--(BUSINESS WIRE), April 25, 2016 -- SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, announced today that it has begun enrolling the second and final cohort of healthy subjects for the Phase III clinical study for its lead drug candidate, TPOXX (tecovirimat), for the treatment of orthopoxvirus. This Phase III...

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Ohr Pharmaceutical, Inc. Announces Enrollment of First Patient in Phase III Wet AMD Clinical Program

Posted 6 weeks ago in Clinical Trials

NEW YORK, April 18, 2016 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (NASDAQ:OHRP), a clinical-stage biotechnology company developing novel therapies for ophthalmic diseases, today announced that the first patient has been enrolled in the first Phase III clinical trial of its lead drug candidate squalamine lactate ophthalmic solution, 0.2% (“Squalamine”, also known as OHR-102), for the treatment of neovascular age...

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Acucela Announces End of Treatment Period in Phase 2b/3 Clinical Trial of Emixustat Hydrochloride

Posted 6 weeks ago in Clinical Trials

SEATTLE (April 18, 2016) — Acucela Inc. (Tokyo: 4589) (“Acucela”), a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, announced today the completion of the treatment period in the ongoing Phase 2b/3 clinical trial, the S.E.A.T.T.L.E. study, of the investigational visual cycle modulator emi...

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Ignyta Announces Updated Data from Entrectinib Phase 1 Clinical Trials at the 2016 AACR Annual Meeting

Posted 6 weeks ago in Clinical Trials

SAN DIEGO, April 17, 2016 --(BUSINESS WIRE)-- Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, today announced that updated results of its Phase 1 clinical trials of entrectinib, the company's proprietary oral tyrosine kinase inhibitor targeting solid tumors harboring activating alterations to NTRK1, NTRK2, NTRK3, ROS1 or ALK, were presented in an oral plenary session at the 2016 Annual...

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ARIAD Presents Updated Phase 1/2 Clinical Data on Brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer

Posted 6 weeks ago in Clinical Trials

GENEVA & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 15, 2016-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced updated clinical data on its investigational tyrosine kinase inhibitor, brigatinib, in patients with advanced malignancies, including anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC), from an ongoing Phase 1/2 trial. This report includes updated data on the brigatinib...

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Nabriva Initiates Second Phase 3 Clinical Trial of Lefamulin (“LEAP 2”) in Patients with Community-Acquired Bacterial Pneumonia (CABP)

Posted 7 weeks ago in Clinical Trials

VIENNA, Austria, and KING OF PRUSSIA, Pa., April 11, 2016 (GLOBE NEWSWIRE) -- Nabriva Therapeutics AG (NASDAQ:NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents, with a focus on the pleuromutilin class of antibiotics to treat serious infections, today announced the initiation of the second of two Phase 3 multinational pivotal trials evaluating the...

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FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer

Posted 7 weeks ago in Clinical Trials

South San Francisco, CA -- April 10, 2016 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose d...

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Eli Lilly And Company And AstraZeneca Announce Continuation Of Pivotal Clinical Trial For People With Early Alzheimer's Disease

Posted 7 weeks ago in Clinical Trials

INDIANAPOLIS, April 8, 2016 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and AstraZeneca today announced that AMARANTH, a Phase 2/3 study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer's disease, will continue to Phase 3 of the Phase 2/3 seamless trial. The AMARANTH independent data monitoring committee recommended...

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AstraZeneca and Eli Lilly and Company Announce Continuation of Pivotal Clinical Trial for People with Early Alzheimer’s Disease

Posted 7 weeks ago in Clinical Trials

8 April 2016 -- AstraZeneca and Eli Lilly and Company today announced that AMARANTH, a Phase II/III study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease, will continue into Phase III of the Phase II/III seamless trial. The AMARANTH independent data monitoring committee recommended the study continue without m...

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Results from Vericel's Positive Phase 2b ixCELL-DCM Clinical Trial of Ixmyelocel-T Published in The Lancet

Posted 8 weeks ago in Clinical Trials

CAMBRIDGE, Mass., April 04, 2016 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the presentation and publication of results from the company's Phase 2b ixCELL-DCM clinical study of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy...

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