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FDA accepts Merck's MK-3475 BLA for review

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application (BLA) for MK-3475, Merck's investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab.

6 May 2014

Naurex's two lead antidepressant programs achieve major milestones

Naurex Inc., a privately held biopharmaceutical company leveraging its unique platform to develop novel drugs for diseases of the central nervous system (CNS), today announced that its two lead antidepressant programs achieved major milestones.

6 May 2014

Novartis presents Phase III results of Signifor LAR therapy in patients with acromegaly

Novartis today presented results from a pivotal Phase III trial of investigational therapy Signifor® LAR (pasireotide LAR; SOM230) in patients with acromegaly for whom current standard of care provides inadequate disease control.

6 May 2014

Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

Bristol-Myers Squibb Company today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3.

6 May 2014

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

UCB announced today results from the PRECiSE 3 7-year open label extension clinical trial of Cimzia (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease.

6 May 2014

Covagen begins COVA322 Phase Ib/IIa study to treat patients with rheumatoid and psoriatic arthritis

Covagen today announced it has initiated a Phase Ib/IIa study with COVA322, a bispecific TNF/IL-17A inhibitor.

6 May 2014

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

Alexion Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris® (eculizumab) for the treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).

6 May 2014

New phase III clinical trial shows non-invasive focused ultrasound treatment relieves cancer pain

When cancer progresses and spreads to the bone, patients often suffer debilitating pain. Now, a new phase III clinical trial shows that non-invasive magnetic resonance guided focused ultrasound treatment that heats the cancer within the bone, relieves pain and improves function for most patients when other treatment options are limited.

6 May 2014

BeiGene receives $5M from Merck to develop BGB-283 BRAF inhibitor

BeiGene (Beijing), Co., Ltd., an innovative oncology company focused on developing targeted and immune-oncology therapeutics, today announced the achievement of a clinical milestone in the company's collaboration with Merck Serono, the biopharmaceutical division of Merck, Darmstadt, Germany, for BGB-283, a second-generation BRAF inhibitor candidate currently in Phase 1 development.

6 May 2014

ERYTECH Pharma gets authorization to initiate Phase II study in pancreatic cancer

ERYTECH Pharma, a French biopharmaceutical company that develops innovative treatments for acute leukemia and other oncology indications with unmet medical needs, announces that the ANSM, French healthcare agency, has granted the authorization to start a Phase II study in second line treatment of patients affected by pancreatic cancer.

6 May 2014

MEI Pharma begins ME-344 Phase Ib clinical study in patients with solid tumors

MEI Pharma, Inc., an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patient has been dosed in a Phase Ib clinical study of its investigational mitochondrial inhibitor drug candidate ME-344 in combination with Hycamtin (topotecan) in patients with solid tumors, including small cell lung and ovarian cancers.

6 May 2014

New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

New two-year data from the Phase 3 ADVANCE clinical trial for peginterferon beta-1a in adults with relapsing forms of multiple sclerosis (RMS) has been presented at the 66th American Academy of Neurology (AAN) annual meeting.

5 May 2014

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Ruthigen, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics designed to prevent and treat infection in invasive applications, today announced that the Company has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration for its lead drug candidate RUT58-60.

2 May 2014

Isis Pharmaceuticals reports final data from ISIS-APOCIIIRx Phase 2 study in patients with FCS

Isis Pharmaceuticals, Inc. announced the final data from its Phase 2 study of ISIS-APOCIIIRx as a monotherapy in patients with familial chylomicronemia syndrome, or FCS.

2 May 2014

FDA approves Parion’s investigational new drug application for treatment of dry eye disease

Parion Sciences, a company dedicated to the development of novel treatments for ocular and pulmonary diseases, announced today that it has received acceptance from the U.S. Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for P-321 Ophthalmic Solution for the treatment of dry eye disease.

2 May 2014

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Teva Pharmaceutical Industries Ltd. today announced positive results from a pivotal Phase III study of hydrocodone bitartrate extended-release tablets designed with Teva's proprietary technology providing potential abuse-deterrent properties (CEP-33237).

30 Apr 2014

Boehringer announces first results of Phase III INPULSIS trials at 2014 ATS International Conference

Boehringer Ingelheim announced today that the first results of the two confirmatory Phase III INPULSISTM trials, investigating nintedanib* in the treatment of idiopathic pulmonary fibrosis (IPF), will be presented at the 2014 American Thoracic Society (ATS) International Conference taking place 16 - 21 May in San Diego

30 Apr 2014

Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Braeburn Pharmaceuticals announced today the initiation of a new clinical trial for Probuphine® based on clear guidance from the U.S. Food and Drug Administration (FDA). The study, which was submitted for FDA review in mid-March, is expected to begin enrollment by mid-year and to be completed by the middle of 2015.

30 Apr 2014

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

Synergy Pharmaceuticals Inc. today announced positive top-line results from a phase 2b dose-ranging study assessing plecanatide's safety and efficacy in 424 patients with irritable bowel syndrome with constipation (IBS-C).

30 Apr 2014

Can-Fite BioPharma submits study protocol to FDA for CF102 Phase II trial for advanced liver cancer

Can-Fite BioPharma Ltd., a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today that it has submitted a study protocol to the U.S. Food and Drug Administration for its Phase II clinical trial of CF102 for the treatment of advanced liver cancer.

29 Apr 2014

Drug Trial News

FDA accepts Merck's MK-3475 BLA for review

Naurex's two lead antidepressant programs achieve major milestones

Novartis presents Phase III results of Signifor LAR therapy in patients with acromegaly

Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

Covagen begins COVA322 Phase Ib/IIa study to treat patients with rheumatoid and psoriatic arthritis

FDA approves Alexion’s Soliris drug for treatment of atypical hemolytic uremic syndrome

New phase III clinical trial shows non-invasive focused ultrasound treatment relieves cancer pain

BeiGene receives $5M from Merck to develop BGB-283 BRAF inhibitor

ERYTECH Pharma gets authorization to initiate Phase II study in pancreatic cancer

MEI Pharma begins ME-344 Phase Ib clinical study in patients with solid tumors

New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

Ruthigen files IND Application to FDA for lead drug candidate RUT58-60

Isis Pharmaceuticals reports final data from ISIS-APOCIIIRx Phase 2 study in patients with FCS

FDA approves Parion’s investigational new drug application for treatment of dry eye disease

Teva announces positive results from pivotal Phase III study of hydrocodone bitartrate extended-release tablets

Boehringer announces first results of Phase III INPULSIS trials at 2014 ATS International Conference

Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Synergy reports positive top-line results from plecanatide phase 2b study in patients with IBS-C

Can-Fite BioPharma submits study protocol to FDA for CF102 Phase II trial for advanced liver cancer

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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