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Daily news and top headlines for drug research professionals

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...             

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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...                       

AstraZeneca Buys Out Sumitomo’s Stake in Japan Subsidiary

March 26, 2014 9:55 am | News | Comments

AstraZeneca announced it has completed the purchase of Sumitomo Chemical’s remaining shares in AstraZeneca K.K. The purchase was valued at approximately 10 billion Japanese yen. Read more...               

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...    

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...

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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...           

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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...     

Ariad Launches Phase 2 Lung Cancer Trial

March 24, 2014 2:46 pm | News | Comments

Ariad Pharmaceuticals Inc. announced the initiation of a pivotal global Phase 2 trial of AP26113 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who were previously treated with crizotinib. Read more...    

AMRI to Acquire Cedarburg Pharmaceuticals for $38.2M

March 24, 2014 2:24 pm | News | Comments

Albany Molecular Research Inc. (AMRI) announced that it has signed a definitive agreement to acquire all the outstanding shares of Cedarburg Pharmaceuticals Inc. for $38.2 million in cash. Read more...              

Japan OKs World-First ADPKD Therapy

March 24, 2014 11:03 am | News | Comments

Otsuka Pharmaceutical Co. Ltd. announced it has become the first company in the world to obtain regulatory approval for a pharmacological treatment of autosomal dominant polycystic kidney disease (ADPKD). Read more...         

New Analyses Show Edoxaban Comparable to Warfarin

March 24, 2014 10:53 am | News | Comments

Daiichi Sankyo Co. Ltd. announced late-breaking data from two pre-specified subgroup analyses of East Asian patients with non-valvular atrial fibrillation (NVAF) or venous thromboembolism (VTE) enrolled in two Phase 3 edoxaban studies. Read more...

Roche Chronic Hive Drug Gets FDA Green Light

March 24, 2014 10:42 am | News | Comments

Roche announced that the FDA approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives, in people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy. Read more...

AstraZeneca Snags Forxiga Approval in Japan

March 24, 2014 10:03 am | News | Comments

AstraZeneca announced that the Japanese Ministry of Health, Labor and Welfare approved Forxiga (dapagliflozin) as a once-daily oral treatment for type 2 diabetes. Read more...                     

Simeprevir for Hepatitis C Approved in Russia

March 24, 2014 9:50 am | News | Comments

Medivir AB announced that that the Russian Ministry of Health has approved Sovriad (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection. Read more...                       

FDA Approves Celgene's Specialty Arthritis Drug

March 24, 2014 9:40 am | News | Comments

The Food and Drug Administration on Friday said it approved Celgene Corp.'s drug Otezla to treat adults with psoriatic arthritis, a form of arthritis that causes joint pain, stiffness and swelling in patients with psoriasis. Read more...   

Emmaus Sickle Cell Drug Hits Phase 3 Endpoints

March 21, 2014 3:04 pm | News | Comments

Emmaus Life Sciences Inc. announced that preliminary top-line results of its Phase 3 clinical trial evaluating the safety and efficacy of its treatment for sickle cell anemia and sickle beta-0 thalassemia met both the primary and secondary endpoints of the clinical trial. Read more...

Endocyte Drug Slows Lung Cancer Progression

March 21, 2014 2:55 pm | News | Comments

Endocyte Inc. announced results from a Phase 2b trial, which showed that the study met the primary endpoint for the combination of vintafolide and docetaxel in folate receptor-positive recurrent non-small cell lung cancer patients. Read more...  

Committee OKs Expanded Use of Novo Nordisk Drugs

March 21, 2014 2:44 pm | News | Comments

The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for expanded use of Tresiba (insulin degludec) and Victoza (liraglutide) in type 2 diabetes. Read more...                  

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