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Daily news and top headlines for drug research professionals

GSK Pulls EMA App for Cancer Treatment Combo

March 27, 2014 11:11 am | News | Comments

GlaxoSmithKline announced that it has withdrawn its Marketing Authorization Application to the European Medicines Agency for the use of Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. Read more...

Tampering Forces Massive Alli Recall

March 27, 2014 11:04 am | News | Comments

GlaxoSmithKline Consumer Healthcare is voluntarily recalling all Alli weight loss products from U.S. and Puerto Rico retailers as the company believes that some packages of the product were tampered with and may contain product that is not authentic Alli. Read more...

Germany's Merck Launches Phase 3 Fertility Study

March 27, 2014 10:35 am | News | Comments

Merck announced the enrollment of the first patient into a new Phase 3 study in the area of fertility, marking another step in its efforts to explore innovative solutions in areas of unmet medical need.  Read more...          

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New Cancer Drug Targets CEA Protein

March 27, 2014 10:17 am | News | Comments

A new cancer drug, based on further development of a discovery originally made by Cancer Research UK, has entered a clinical trial to target a wide range of cancers. Read more...                      

Takeda, Otsuka to Co-Promote Gastrointestinal Drug in Japan

March 27, 2014 5:26 am | by Takeda | News | Comments

Otsuka Pharmaceutical Co. Ltd. and Takeda Pharmaceutical Co. Ltd. announced that the two firms have entered into a co-promotion agreement in Japan for TAK-438, a drug discovered by Takeda for the treatment of acid-related diseases. Read more...

Pfizer's Genotropin Hits Phase 3b Endpoints

March 26, 2014 2:09 pm | News | Comments

Pfizer Inc. announced the top-line results from a Phase 3b study evaluating the 24-month efficacy of Genotropin (somatropin) on the height in small-for-gestational-age (SGA) children 24 to 30 months old. Read more...           

Under Fire, Zohydro Maker Touts Safety Board

March 26, 2014 1:54 pm | by Matthew Perrone, AP Health Writer | News | Comments

After months of criticism over its recently launched painkiller Zohydro, the maker of the powerful narcotic is highlighting an unusual oversight board that it's assembled to try and prevent abuse of the drug. Read more...             

SwRI Wins $8.3M HHS Grant for Cyanide Antidote Development

March 26, 2014 1:38 pm | News | Comments

The U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority has awarded Southwest Research Institute an $8.3 million contract extension to continue development of a nasal-delivery, first-line treatment system to combat cyanide poisoning. Read more...

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Drugs for Terminally Ill Clear New Hurdle

March 26, 2014 1:05 pm | News | Comments

A proposal to allow terminally ill people access to drugs that are still completing clinical trials cleared its first test in the Colorado Legislature on Tuesday. Read more...                      

Pharmacists Urged to Withhold Compounded Execution Drugs

March 26, 2014 12:56 pm | by Andrew Welsh-Huggins, AP Legal Affairs Writer | News | Comments

Several human rights and anti-death penalty groups have asked the American Pharmacists Association to prohibit members from participating in executions, a request that comes as states increasingly turn to pharmacists for lethal injection drugs. Read more...

AM-Pharma Announces Phase 1 AKI Drug Data

March 26, 2014 12:15 pm | News | Comments

AM-Pharma B.V. announced the results of its Phase 1 trial with of recAP (recombinant human Alkaline Phosphatase), showing that both single and multiple ascending doses are safe and well tolerated. Read more...          

FDA Approves Actavis-Valeant Bacterial Gel

March 26, 2014 12:03 pm | News | Comments

Actavis and Valeant Pharmaceuticals announced that the FDA has approved the New Drug Application (NDA) for Metronidazole 1.3% Vaginal Gel, an antibiotic for the treatment of bacterial vaginosis (BV). Read more...             

Inovio Snags Best Therapeutic Award at World Vaccine Congress

March 26, 2014 10:05 am | News | Comments

Inovio Pharmaceuticals Inc. announced that it was recognized with three industry awards at the World Vaccine Congress, being held this week in Washington, D.C. Read more...                       

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Astellas Wins Prostate Cancer Approval for Xtandi in Japan

March 25, 2014 2:15 pm | News | Comments

Astellas Pharma announced that Astellas has obtained marketing approval of their oral androgen receptor signaling inhibitor, Xtandi capsules 40mg (enzalutamide) for the treatment of patients with castration-resistant prostate cancer in Japan. Read more...

Spark, Genable Technologies Collaboration on Rare Gene Therapy

March 25, 2014 2:04 pm | News | Comments

Spark Therapeutics and Genable Technologies announced that they have entered into a collaboration agreement for Genable's lead therapeutic to treat rhodopsin-linked autosomal dominant retinitis pigmentosa (RHO adRP), GT038. Read more...    

Study Questions First-Line Treatment for Advanced Sarcoma

March 25, 2014 1:50 pm | News | Comments

A new study does not support administration of intensified doxorubicin and ifosfamide for palliation of advanced soft tissue sarcoma, unless the objective is to shrink the tumor. Read more...                 

Marijuana Pill, Spray May Ease Some MS Symptoms

March 25, 2014 1:37 pm | News | Comments

A new guideline from the American Academy of Neurology states that oral cannabis, or medical marijuana pills, and oral medical marijuana spray may ease the symptoms of multiple sclerosis (MS). Read more...          

Pfizer's Xalkori Extends Lung Cancer Survival

March 25, 2014 1:28 pm | News | Comments

Pfizer announced that PROFILE 1014, a Phase 3 study of anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) when compared to standard platinum-based chemotherapy regimens. Read more...

Ferrer, Medimetriks in Licensing Agreement for Impetigo Drug

March 25, 2014 11:20 am | News | Comments

Medimetriks Pharmaceuticals Inc. announced a licensing agreement with Ferrer for the commercialization rights to Ozenoxacin 1% Cream in the United States. Ozenoxacin is a novel, bactericidal non-fluorinated quinolone in development as a topical treatment for impetigo. Read more...

Takeda Hypertension Drug Gets OK in Japan

March 25, 2014 11:05 am | News | Comments

Takeda announced that the Japanese Ministry of Health, Labor and Welfare has approved the New Drug Application of Zacras tablets for treatment of hypertension. Read more...                       

Daiichi's Antiplatelet Agent Approved in Japan

March 25, 2014 10:52 am | News | Comments

Daiichi Sankyo Co. Ltd. announced that it has received approval from the Ministry of Health, Labor and Welfare in Japan for the antiplatelet agent Efient for the treatment of patients with ischemic heart disease undergoing percutaneous coronary intervention (PCI). Read more...

EU Approves New Thyroid Cancer Indication for Cometriq

March 25, 2014 10:31 am | News | Comments

Exelixis Inc. announced that the European Commission has approved Cometriq (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). Read more...     

Agios Enrolls First Patient in Phase 1 Cancer Trial

March 24, 2014 3:23 pm | News | Comments

Agios Pharmaceuticals Inc. announced dose administration for the first patient in a Phase 1 study of AG-120 in patients with advanced solid tumors with an isocitrate dehydrogenase-1 (IDH1) mutation. Read more...           

Statins May Provide Cough Relief to Lung Disease Patients

March 24, 2014 3:18 pm | News | Comments

Common cholesterol-lowering drugs could provide relief to patients suffering from a chronic lung disease, a study has shown. The drugs- known as statins- were found to help alleviate the chronic coughing associated with the disease for some patients. Read more...

Pfizer Releases First Phase 3 Tofacitinib Psoriasis Results

March 24, 2014 3:01 pm | News | Comments

Pfizer Inc. announced detailed results from OPT Compare, a Phase 3 study of tofacitinib, the safety and efficacy of which are being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis. Read more...     

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