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The Lead

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...

Insys Therapeutics' Cannabidiol Receives FDA Orphan Drug Designation

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

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

Bristol-Myers Squibb Gets Positive Results for Nivoluma

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

Bristol-Myers Squibb Co. announced positive...

Perrigo Acquires Women's Healthcare Products from Lumara

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

Perrigo Company plc announced that it has signed...

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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...              

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...

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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...

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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...    

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...

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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...

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...

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...                      

NIH Funds Next Phase of Tissue Chip for Drug Screening Program

September 24, 2014 10:40 am | News | Comments

The National Institutes of Health will award funds to support the next phase of its Tissue Chip for Drug Screening program to improve ways of predicting drug safety and effectiveness. 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...                        

Muscle-on-a-chip Mimics Asthma, May Help Test Drugs

September 23, 2014 3:38 pm | News | Comments

Hope for healthier airways may be on the horizon thanks to a human airway muscle-on-a-chip that could be used to test new drugs because it accurately mimics the way smooth muscle contracts in the human airway, under normal circumstances and when exposed to asthma triggers. Read more...

NIH Awards $35M for Centers for Collaborative Research in Fragile X

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

NIH is awarding $35 million over the next five years to support the Centers for Collaborative Research in Fragile X program. Investigators at these centers will seek to better understand Fragile X-associated disorders and work toward developing effective treatments. Read more...

Investigational Drug Could be Treatment for AML, Multiple Myeloma

September 23, 2014 1:57 pm | News | Comments

The investigational drug CX-5461 prolonged survival in mouse models of highly aggressive AML and multiple myeloma, according to data presented at the AACR special conference Hematologic Malignancies: Translating Discoveries to Novel Therapies. Read more...

TKIs May Improve Treatment for Ph-Like ALL

September 23, 2014 11:28 am | News | Comments

Tyrosine kinase inhibitors (TKIs) may improve treatment outcome for children and young adults with Ph-like acute lymphoblastic leukemia (Ph-like ALL), a disease with dismal prognosis, according to new data. Read more...         

Battling Superbugs

September 22, 2014 3:57 pm | News | Comments

Engineers have turned a powerful new weapon on superbugs. Using a gene-editing system that can disable any target gene, they have shown that they can selectively kill bacteria carrying harmful genes that confer antibiotic resistance or cause disease. Read more...

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