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Array's Melanoma Drug Promising in Phase 2

September 29, 2014 3:46 pm | News | Comments

Final results from a Phase 2 trial of binimetinib in patients with advanced NRAS mutant melanoma were presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain. Invented by Array BioPharma Inc. and licensed to Novartis in 2010, binimetinib is a small molecule selective inhibitor of the kinases MEK1 and MEK2. Read more...

Tonix Fibromyalgia Pain Drug Misses Endpoint in Phase 2b

September 29, 2014 3:28 pm | News | Comments

Tonix Pharmaceuticals announced results of the...

Insys Therapeutics' Cannabidiol Receives FDA Orphan Drug Designation

September 29, 2014 3:23 pm | News | Comments

Insys Therapeutics, Inc. announced that the U.S....

Amag Pharma to Acquire Lumara Health for $675M

September 29, 2014 3:09 pm | News | Comments

Shares of anemia treatment maker Amag...

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Combo Treatment Ups PFS in Advanced Melanoma Patients

September 29, 2014 3:07 pm | News | Comments

Shares of Exelixis jumped Monday before markets opened and after the drugmaker said its treatment for a deadly form of skin cancer fared better than another drug in a late-stage clinical study. Read more...

Bristol-Myers Squibb Gets Positive Results for Nivoluma

September 29, 2014 2:58 pm | News | Comments

Bristol-Myers Squibb Co. announced positive results from CheckMate-037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma. Read more...

Perrigo Acquires Women's Healthcare Products from Lumara

September 29, 2014 11:02 am | News | Comments

Perrigo Company plc announced that it has signed a definitive agreement to acquire a portfolio of women's healthcare products from Lumara Health, Inc., a privately-held, Chesterfield, Missouri-based specialty pharmaceutical company, for $82 million in cash. Read more...

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Janssen's Rezolsta Receives Positive Opinion from CHMP

September 29, 2014 10:49 am | News | Comments

Janssen announced that the CHMP of the European Medicines Agency has granted a Positive Opinion recommending Rezolsta (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in adults aged 18 years or older. Read more...

EMA Validates Marketing Authorization Application for Nivoluma

September 29, 2014 10:31 am | News | Comments

Bristol-Myers Squibb announced that the European Medicines Agency has validated for review the Marketing Authorization Application for nivolumab in non-small cell lung cancer– the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type. Read more...

Cancer Research UK Increases Drug Development Investment

September 29, 2014 10:21 am | News | Comments

Cancer Research UK is to increase investment by nearly 50% over the next five years in its Drug Development Office, which is also changing its name to the Center for Drug Development (CDD). Read more...              

Daiichi Sankyo to Acquire Ambit Bioscience

September 29, 2014 10:09 am | News | Comments

Daiichi Sankyo Co. Ltd. and Ambit Biosciences jointly announced that they have entered into a definitive merger agreement under which Daiichi Sankyo will acquire all of the outstanding common stock of Ambit Biosciences for approximately $315 million on a fully diluted basis. Read more...

Genentech’s Perjeta Regimen Extended Lives

September 29, 2014 9:59 am | News | Comments

Genentech announced final survival results from the Phase 3 Cleopatra study, which showed that adding Perjeta to Herceptin and docetaxel chemotherapy extended the lives of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy. Read more...

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MicroBiome Therapeutics' Drug May Limit Metformin Side Effects

September 26, 2014 3:47 pm | News | Comments

MicroBiome Therapeutics reported positive topline results from a proof-of-concept study testing whether its investigational drug, NM 505, can improve the tolerability of metformin, the first-line therapy for Type 2 diabetes worldwide. Read more...

Ebola Shot Turned Down by WHO is Best Hope as Virus Rages

September 26, 2014 11:16 am | by Makiko Kitamura and Shannon Pettypiece | News | Comments

The calls started coming in August to the office of GlaxoSmithKline Plc from the head of the World Health Organization, Margaret Chan. The Ebola outbreak was raging out of control and Chan needed the drugmaker’s vaccine as quickly as possible. The sudden sense of urgency was an about face from a few months earlier when Glaxo contacted the WHO, asking whether its vaccine could help with the outbreak. Read more...

Bausch + Lomb Receives Successful Results from Phase 3 Study

September 26, 2014 10:59 am | News | Comments

Bausch + Lomb announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase 3 study. Read more...

Gilead Gets Positive Opinion for HCV Tablet

September 26, 2014 10:48 am | News | Comments

Gilead Sciences Inc. announced that the CHMP, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application (MAA) for Harvoni, an investigational once-daily tablet combining the NS5A inhibitor (LDV) 90 mg and the nucleotide analog polymerase inhibitor (SOF) 400 mg for the treatment of HCV infection in adults. Read more...

AstraZeneca's Lung Cancer Drug Gets EU Label Update

September 26, 2014 10:32 am | News | Comments

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update to the European label for Iressa (gefitinib). The label update will help doctors identify lung cancer patients who could benefit from treatment but are unable to provide a suitable tumor sample. Read more...    

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Roche Launches Global Program for HIV Viral Load Testing

September 26, 2014 10:08 am | News | Comments

Roche announced the launch of a new Global Access Program for HIV viral load testing. To support the Global Access Program, Roche has committed to expanding access to its COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0 through a special pricing scheme for qualifying organizations in eligible countries. Read more...

Novo Nordisk Establishes New Obesity Research Unit

September 26, 2014 9:52 am | News | Comments

Novo Nordisk announced that the company will establish a new obesity research unit in Seattle, Washington, in the US. The new unit is a result of Novo Nordisk's increasing focus on treatment of obesity. Read more...                       

NIH Announces Network to Accelerate Medicines for RA, Lupus

September 25, 2014 3:23 pm | News | Comments

The National Institutes of Health (NIH) has awarded grants to 11 research groups across the United States to establish the Accelerating Medicines Partnership in Rheumatoid Arthritis and Lupus (AMP RA/Lupus) Network. Read more...             

Pfizer Completes Acquisition of InnoPharma

September 25, 2014 3:03 pm | News | Comments

Pfizer Inc.announced that it has completed its acquisition of the pharmaceutical development company, InnoPharma Inc., following receipt of United States (U.S.) regulatory approval from all government authorities required by the agreement and other closing conditions. Read more...

MabVax Neuroblastoma Vaccine Gets Orphan Drug Designation

September 25, 2014 2:51 pm | News | Comments

MabVax Therapeutics Holdings Inc. announced that the FDA has granted orphan drug designation to the company's vaccine intended for the treatment of the childhood cancer neuroblastoma. Read more...               

Pacira Shares Drop as FDA Warns on Misleading Ads

September 25, 2014 2:13 pm | News | Comments

Pacira Pharmaceuticals Inc. said Thursday that it received a warning letter from regulators about marketing for an injectable drug that numbs post-surgical pain that the letter says is misleading. Read more...           

Boehringer Ingelheim Announces FDA Approval of COPD Drug

September 25, 2014 1:31 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Read more...

Genzyme to Collaborate on Gene Therapy for Blindness-Causing Disease

September 25, 2014 10:54 am | News | Comments

Genzyme, a Sanofi company announced the establishment of a research collaboration with the University of Florida and the University of Pennsylvania to develop a gene therapy for the treatment of a rare genetic disease that causes childhood blindness. Read more...

Drug for Rigid Muscles Moves Ahead in Clinical Trials

September 25, 2014 10:40 am | News | Comments

A new formulation for a University of Minnesota-developed drug targeted at rare disorders is under development, with the potential to help a small number of Americans each year. Read more...

MedImmune, CRUK Partner to Develop New Cancer Biologics

September 25, 2014 10:22 am | News | Comments

AstraZeneca announced that MedImmune, its global biologics research and development arm, and Cancer Research UK, with its commercial arm, Cancer Research Technology (CRT), have entered into an innovative collaboration to establish a joint laboratory in Cambridge, UK. Read more...

Novartis Psoriatic Arthritis Drug Hits Endpoints in Two Phase 3 Trials

September 25, 2014 10:06 am | News | Comments

Novartis announced that two pivotal Phase 3 studies (FUTURE 1 and FUTURE 2) of AIN457 (secukinumab) in psoriatic arthritis (PsA) met primary and key secondary endpoints. Read more...

Valeant Pitches Potential Eye Drug, Research Focus

September 25, 2014 9:46 am | by Tom Murphy, AP Business Writer | News | Comments

Valeant Pharmaceuticals is drawing attention to a potential glaucoma treatment and its focus on product development, as the Canadian drugmaker continues to build its case to investors for a takeover of Botox-maker Allergan. Read more...

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