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Daily news and top headlines for drug research professionals

Pfizer, Kyowa Hakko Kirin Partner on Immuno-Oncology Combo Study

September 30, 2014 10:49 am | News | Comments

Pfizer Inc. and Kyowa Hakko Kirin announced that they've entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s PF-05082566 with Kyowa Hakko Kirin’s anti-CCR4 antibody mogamulizumab. Read more...         

NIH Awards Seven New Vaccine Adjuvant Discovery Contracts

September 30, 2014 10:37 am | News | Comments

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded seven research contracts to discover and characterize new adjuvants, or substances formulated as part of vaccines to enhance their protective ability. Read more...

Takeda, Seattle Genetics Receive Positive Data from Lymphoma Trial

September 30, 2014 10:02 am | News | Comments

Seattle Genetics and Takeda Pharmaceutical Co. Ltd. announced that patients with Hodgkin lymphoma (HL) who received Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplantation (ASCT) lived significantly longer without disease progression compared to patients who received placebo. Read more...

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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 Phase 2b BESTFIT study of TNX-102 SL as a chronic bedtime treatment for fibromyalgia. The study did not achieve statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12. Read more...

Insys Therapeutics' Cannabidiol Receives FDA Orphan Drug Designation

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

Insys Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its pharmaceutical cannabidiol (CBD) for the treatment of glioma. Read more...             

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...

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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...

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...

WHO: 1000s of Ebola Vaccine Doses in Coming Months

September 26, 2014 4:05 pm | News | Comments

Thousands of doses of experimental Ebola vaccines should be available in the coming months and could eventually be given to health care workers and other people at high risk of the deadly disease, according to the World Health Organization. Read more...

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...

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NIH, FDA Win IP Award for Meningitis Vaccine

September 26, 2014 2:48 pm | News | Comments

The National Institutes of Health and the U.S. Food and Drug Administration will receive a top national award for the year’s most outstanding intellectual property licensing deal for technology transfer of a pioneering, low-cost meningitis vaccine launched in sub-Saharan Africa. Read more...

Pharm Startup Creates Prefabricated Drug Dosages

September 26, 2014 2:15 pm | News | Comments

Officials of a pharmaceutical startup based on a Purdue University innovation say their company is creating prefabricated drug dosages that could be used by compounding pharmacists to support patient-centered medicine. 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...    

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...             

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...               

Chemists Recruit Anthrax to Deliver Cancer Drugs

September 25, 2014 1:58 pm | News | Comments

Bacillus anthracis bacteria have very efficient machinery for injecting toxic proteins into cells, leading to the potentially deadly infection known as anthrax. A team of MIT researchers has now hijacked that delivery system for a different purpose: administering cancer drugs. 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...

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...

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