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DDD Update

Daily news and top headlines for drug research professionals

Amgen Laying Off at Least 2,400

July 30, 2014 10:20 am | by Linda A. Johnson, AP Business Writer | News | Comments

Biologic drugmaker Amgen said Tuesday that it will lay off 12 to 15% of its worldwide workforce and close four sites, even as it reported stellar second-quarter results trouncing Wall Street expectations and raised forecasts for its 2014 profit and revenue, driving up shares. Read more...

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Impax Labs Slumps After Problems with FDA Inspection

July 30, 2014 8:28 am | News | Comments

Shares of Impax Labs sank Tuesday after an FDA inspection uncovered potential problems at a facility where the company will make its experimental Parkinson's disease drug Rytary. Read more...                  

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Cancer Challenge Attracts Anonymous $100M Gift

July 29, 2014 2:54 pm | News | Comments

Oregon Health & Science University’s Knight Cancer Institute has received a $100 million gift to fuel its ambitious vision to stop cancer in its tracks. Read more...                       

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Neurotrope Initiates Phase 2a Alzheimer's Treatment Study

July 29, 2014 2:48 pm | News | Comments

Neurotrope Inc. announced that it has initiated a Phase 2a clinical trial to evaluate bryostatin for the treatment of patients with Alzheimer's disease (AD). Read more...                       

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FDA Approves Expanded Use of Imbruvica

July 29, 2014 2:43 pm | News | Comments

The FDA has approved the supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Read more...        

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Forced Mutations Doom HIV

July 29, 2014 2:32 pm | News | Comments

Fifteen years ago, researchers thought if they could induce the HIV virus to mutate uncontrollably, they could force it to weaken and eventually die out. But in a 2011 clinical trial, a drug based on this method did not eliminate the virus from patients. Now, researchers are aiming to develop better versions of that drug. Read more...

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$1,000 Sovaldi Now Choice Hep C Treatment

July 29, 2014 12:28 pm | by Ricardo Alonso-Zaldivar | News | Comments

The price may be high but so is demand. A new $1,000-per-pill drug has become the treatment of choice for Americans with hepatitis C, a liver-wasting disease that affects more than 3 million. Read more...             

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Glaucoma Drug Gets EU Approval

July 29, 2014 11:18 am | News | Comments

Alcon, the global leader in eye care and a division of Novartis, announced that Simbrinza eye drops suspension has been approved by the European Commission to decrease elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, for which monotherapy provides insufficient IOP reduction. Read more...

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Artes, Burnet Institute Partner on Malaria Vaccine

July 29, 2014 11:13 am | by Catherine Somerville | News | Comments

Artes Biotechnology and Burnet Institute have joined forces to develop a new type of malaria vaccine in a project funded by the PATH Malaria Vaccine Initiative (MVI), which will produce purified vaccine antigens as virus-like particles, a type of nano-particle, for testing in laboratory studies. Read more...

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European Commission Approves Leukemia Drug

July 29, 2014 11:04 am | News | Comments

Roche announced that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy). Read more...

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Merck Serono Kicks Off Study of Merkel Cell Carcinoma Drug

July 29, 2014 10:59 am | News | Comments

Merck Serono, the biopharmaceutical division of Merck, announced the initiation of an international Phase 2 study designed to assess the efficacy and safety of MSB0010718C, an investigational fully human IgG1 monoclonal antibody that binds to programmed death-ligand 1 (PD-L1). Read more...

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China to Put GSK Investigators on “Public Trial”

July 29, 2014 10:54 am | News | Comments

A Shanghai court said American and British investigators who worked for drug maker GlaxoSmithKline will stand trial - which now will be public - Aug. 8 on charges of illegally obtaining information on Chinese citizens. Read more...    

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Biologists Think Stem Cells May “Talk” to Each Other

July 29, 2014 10:47 am | News | Comments

Biologists at the University of Sheffield’s Centre for Stem Cell Biology led by Prof. Peter Andrews and engineers in the Complex Systems and Signal Processing Group led by Prof. Daniel Coca have completed a landmark study of human pluripotent stem cells. Read more...

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Merck Profit More Than Doubles in Q2

July 29, 2014 8:28 am | by Linda A. Johnson | News | Comments

A big one-time gain and a tax benefit helped drugmaker Merck & Co. more than double its second-quarter profit, raise the lower end of its profit forecast and easily top analysts' expectations. Read more...           

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FDA Rejects Zalviso Pain Treatment System

July 28, 2014 12:45 pm | News | Comments

AcelRx Pharmaceuticals Inc. announced that the FDA has issued a Complete Response Letter (CRL) for the company's NDA for Zalviso. The CRL contains requests for additional information on the system to ensure proper use of the device. Read more... 

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