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Neurovance reports positive results from EB-1020 SR phase 2a pilot study in adult ADHD patients

Neurovance, Inc. today announced complete results from its phase 2a pilot study of EB-1020 SR, a non-stimulant, in adult male patients with all subtypes of ADHD (attention deficit hyperactivity disorder).

8 May 2014

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

Janssen Research & Development, LLC (Janssen) today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as OLYSIO™ in the United States, in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed by Gilead Sciences, Inc.

8 May 2014

WHI: Combined hormone therapy clinical trial yields massive economic return

Economic findings were released today on the Women's Health Initiative (WHI), estrogen plus progestin (E+P) trial.

8 May 2014

Controlling low-density lipoprotein-cholesterol levels: an interview with Jay Edelberg, M.D., Sanofi and Bill Sasiela, Ph.D., Regeneron

Lipids, primarily cholesterol and triglycerides, come from two sources: what is naturally manufactured in the liver and what comes from the intestines through the diet.

From Sanofi 7 May 2014

New data presented at EADO on investigational MEK inhibitor in combination with BRAF inhibitor for metastatic melanoma

New data have been presented for the first time at the European Association of Dermato Oncology (EADO) Congress today on the investigational MEK inhibitor cobimetinib (GDC-0973) in combination with BRAFV600 inhibitor Zelboraf® (vemurafenib) for metastatic melanoma, the most aggressive form of skin cancer. The findings illustrate that cobimetinib and vemurafenib can be safely co-administered and that the combination shows promising anti-tumour activity, with a median progression-free survival (mPFS) of 13.7 months for BRAF inhibitor-naive patients.1

7 May 2014

Exelixis presents final Phase 1b data on investigational MEK-BRAF inhibitor combination therapy for metastatic melanoma

Exelixis, Inc. today announced final results from BRIM7, an ongoing phase 1b clinical trial conducted by Roche and Genentech, Exelixis' collaborator and a member of the Roche Group, of the BRAF inhibitor (BRAFi) vemurafenib in combination with the MEK inhibitor cobimetinib in patients with locally advanced/unresectable or metastatic melanoma carrying a BRAFV600 mutation.

7 May 2014

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

Drug Trial News

Neurovance reports positive results from EB-1020 SR phase 2a pilot study in adult ADHD patients

Janssen submits sNDA to FDA for simeprevir in combination with sofosbuvir for treatment of HCV genotype 1 infection

WHI: Combined hormone therapy clinical trial yields massive economic return

Controlling low-density lipoprotein-cholesterol levels: an interview with Jay Edelberg, M.D., Sanofi and Bill Sasiela, Ph.D., Regeneron

New data presented at EADO on investigational MEK inhibitor in combination with BRAF inhibitor for metastatic melanoma

Exelixis presents final Phase 1b data on investigational MEK-BRAF inhibitor combination therapy for metastatic melanoma

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

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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