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Daily news and top headlines for drug research professionals

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...

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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...

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...

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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...             

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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...

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...

Shire to Pay $56.5M Over False Drug Claims

September 25, 2014 8:30 am | News | Comments

The U.S. Department of Justice said Wednesday that Irish drugmaker Shire will pay $56.5 million to settle allegations it broke the law in promoting five different drugs, including its attention deficit disorder drugs Adderall XR and Vyvanse. Read more...

FDA Approves New Indication for Celgene's Otezla

September 24, 2014 3:29 pm | News | Comments

Celgene Corp. announced that the FDA has approved Otezla for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Read more...                

Gilead's Investigational HIV Drug Meets Trial Goals

September 24, 2014 3:17 pm | News | Comments

Gilead Sciences Inc. announced that two Phase 3 clinical trials evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. Read more...

New FDA Label Bolsters Safety Case for Chantix

September 24, 2014 2:18 pm | by Matthew Perrone, AP Health Writer | News | Comments

New government-approved labeling on Pfizer's drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the Food and Drug Administration's strongest warning more than five years ago. Read more...

Abraxane Approved in Switzerland for Pancreatic, Breast Cancers

September 24, 2014 11:00 am | News | Comments

Celgene International Sàrl announced that Swissmedic, the regulatory authority for Switzerland, has granted approval for Abraxane as a treatment for metastatic pancreatic cancer (in combination with gemcitabine), and as a treatment for metastatic breast cancer. Read more...

Monkey Antibodies Help Fight Chikungunya Virus

September 24, 2014 10:48 am | News | Comments

New research provides details of how the immune system responds to the chikungunya virus, findings that could support the development of vaccines and therapies. Read more...                      

WHO: Ebola Vaccine Could be Ready by Year-End

September 24, 2014 10:15 am | News | Comments

The World Health Organization (WHO) says a vaccine might be available in large enough quantities by the end of the year to help control West Africa's Ebola outbreak. Read more...                        

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