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Daily news and top headlines for drug research professionals

Newly Approved Kidney Drug Gets Unexpected Safety Warning

September 5, 2014 2:34 pm | News | Comments

Keryx Biopharmaceuticals received approval Friday for a pill to treat complications of kidney disease in dialysis patients, but the company's stock fell as investors reacted to an unexpected safety warning in the drug's prescribing label. Read more...

NeuroDerm Starts Phase 2a Study of Parkinson’s Drug

September 5, 2014 11:11 am | News | Comments

NeuroDerm Ltd. announced that the first patients with severe Parkinson’s disease have been enrolled and dosed in a Phase 2a trial of ND0612H, a high-dose form of NeuroDerm’s proprietary liquid levodopa/carbidopa (LD/CD) drug formulation. Read more...

Antisense Acromegaly Drug Shows Efficacy in Phase 2

September 5, 2014 11:04 am | News | Comments

Antisense Therapeutics Ltd. reported the primary efficacy results from its Phase 2 clinical trial of ATL1103 in patients with the potentially life threatening growth disorder, acromegaly. Read more...               

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Flu Vaccine Protects Mothers, Babies

September 5, 2014 10:53 am | News | Comments

A new study shows that the influenza vaccination of pregnant HIV-uninfected and HIV-infected women is safe and protects the women against confirmed influenza illness. Read more...                     

U.S. to Give $75M to Expand Ebola Care Centers

September 5, 2014 10:19 am | by Jonathan Paye-Layleh and Sarah DiLorenzo | News | Comments

The American aid agency announced Thursday it would donate $75 million to fund 1,000 more beds in Ebola treatment centers in Liberia and buy 130,000 more protective suits for health care workers. Read more...            

Mallinckrodt's Pain Drug Shows Efficacy in Phase 3

September 4, 2014 2:52 pm | News | Comments

Mallinckrodt reported that a Phase 3 efficacy trial of investigational MNK-155 met the study’s primary endpoint of improved pain scores vs. placebo over the first 48 hours following bunionectomy. Read more...            

HIV Antibody Binds to Novel Target on Virus

September 4, 2014 2:46 pm | News | Comments

A team of scientists has discovered a new vulnerability in the armor of HIV that a vaccine, other preventive regimen or treatment, could exploit. Read more...                           

J&J to Accelerate Ebola Vaccine Development

September 4, 2014 2:40 pm | News | Comments

J&J announced it will fast-track the development of a promising new combination vaccine regimen against Ebola and broadly collaborate with its partners in global health to deliver immediate relief aid to address the current Ebola outbreak. Read more...

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Google's Health Startup Forges Venture with AbbVie

September 4, 2014 2:34 pm | News | Comments

Google's ambitious health startup is teaming up with biotechnology drugmaker AbbVie in a $500 million joint venture that will try to develop new ways to treat cancer and other diseases such as Alzheimer's. Read more...          

Lilly's Insulin Fares Well in Late-Stage Tests

September 4, 2014 11:31 am | News | Comments

Eli Lilly and Co. plans to seek approval early next year for a new insulin it developed after the diabetes treatment fared better than the competition in two late-stage clinical studies. Read more...               

How Outsourcing Can Accelerate the Drug Development Process

September 4, 2014 10:36 am | by Matthew Weinberg, CEO, The Weinberg Group | Articles | Comments

Outsourcing is an old concept in the healthcare industry that has recently been applied to a new area: regulatory affairs. Traditionally conducted in-house, regulatory affairs is extremely critical to a product’s success. For certain companies, this entire function can and should be outsourced in its entirety, not just for discrete projects. Read more...

Blood from Ebola Survivors May Help Treat Patients

September 4, 2014 10:32 am | by Maria Cheng, AP Health Writer | News | Comments

As West Africa struggles to contain the biggest ever outbreak of Ebola, some experts say an unusual but simple treatment might help: the blood of survivors. Read more...                       

Takeda Ordered to Pay $6B in Diabetes Drug Case

September 4, 2014 10:26 am | News | Comments

Takeda Pharmaceutical Co. said Thursday it has been ordered by a U.S. district court to pay $6 billion in punitive damages over a lawsuit filed by a man who claimed his bladder cancer was caused by Takeda's diabetes medicine Actos. Read more...  

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Chimerix's Brincidofovir Shows Activity Against Ebola

September 3, 2014 3:18 pm | News | Comments

Chimerix Inc. announced in vitro activity of its investigational antiviral brincidofovir (BCV) against the Ebola virus, following testing at the CDC the NIH. Read more...                       

Exelixis to Cut 70% of Staff After Disappointing Trial Results

September 3, 2014 3:02 pm | News | Comments

Exelixis Inc. announced that COMET-1, the Phase 3 pivotal trial of cabozantinib in men with metastatic castration-resistant prostate cancer, did not meet its primary endpoint. As a result, Exelixis will initiate a significant workforce reduction. Read more...

FDA: Little Evidence to Support Testosterone Drugs

September 3, 2014 2:56 pm | by Matthew Perrone | News | Comments

The FDA says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks. Read more...       

AbbVie, Infinity Team Up to Develop Cancer Drug

September 3, 2014 2:53 pm | News | Comments

Shares of Infinity Pharmaceuticals Inc. soared Wednesday after it said it could receive more than $800 million from a collaboration with fellow drug developer AbbVie on a potential cancer treatment. Read more...            

Alkermes Wraps Enrollment for Phase 2 Antipsychotic Drug Trial

September 3, 2014 11:19 am | News | Comments

Alkermes plc announced completion of patient enrollment in a Phase 2 study of ALKS 3831, an investigational, novel, oral, broad-spectrum atypical antipsychotic medicine in development for the treatment of schizophrenia. Read more...      

AstraZeneca, Redx Pharma Collaborate on Cancer Drugs

September 3, 2014 10:57 am | News | Comments

AstraZeneca announced that it has entered into a research collaboration with Redx Pharma Limited to discover and develop new molecules targeting a genetic driver of tumor growth and survival. Read more...              

ZMapp: Best Anti-Ebola Drug Yet

September 3, 2014 10:15 am | by Cynthia Fox, Science Editor | Articles | Comments

ZMapp, the experimental drug that may have already have saved a few patients in Africa, is the most effective anti-Ebola therapy yet, according to a recent Nature paper on rhesus macaques monkeys. Read more...           

AstraZeneca Releases Phase 4 Brilinta Data

September 2, 2014 3:35 pm | News | Comments

AstraZeneca announced the results of the Phase 4 ATLANTIC study, which indicates that the profile of Brilinta/Brilique (ticagrelor) is comparable whether administered in a pre-hospital or in-hospital setting to ST segment elevation myocardial infarction (STEMI) patients. Read more...

Scientists Make Diseased Cells Synthesize Their Own Drug

September 2, 2014 3:08 pm | News | Comments

In a new study that could ultimately lead to many new medicines, scientists have adapted a chemical approach to turn diseased cells into unique manufacturing sites for molecules that can treat a form of muscular dystrophy. Read more...     

Amgen Submits MAA for Melanoma Treatment

September 2, 2014 2:59 pm | News | Comments

Amgen announced the submission of a Marketing Authorization Application to the European Medicines Agency via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. Read more...

World is ‘Losing Battle Against Ebola,’ Group Says

September 2, 2014 2:53 pm | by Alexandra Olson and Sarah DiLorenzo | News | Comments

The international group Doctor Without Borders warned Tuesday that the world is losing the battle against Ebola and lamented that treatment centers in West Africa have been "reduced to places where people go to die alone" as authorities race to contain the disease. Read more...

Single Animal-to-Human Transmission Event Sparked 2014 Ebola Outbreak

September 2, 2014 10:32 am | News | Comments

Scientists used advanced genomic sequencing technology to identify a single point of infection from an animal reservoir to a human in the current Ebola outbreak in West Africa. Read more...                  

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