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Daily news and top headlines for drug research professionals

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...   

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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...                  

Novartis Starting New Head-to-Head Psoriasis Trial

March 21, 2014 2:10 pm | News | Comments

Novartis announced that a new Phase 3b head-to-head study of IL-17A inhibitor secukinumab (AIN457) versus Stelara (ustekinumab) in moderate-to-severe plaque psoriasis has started patient enrollment. Read more..           

Simeprevir for Hep C Closer to EU Approval

March 21, 2014 11:19 am | News | Comments

Medivir AB announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending Marketing Authorization in the European Union for the use of simeprevir. in combination with other drugs, for the treatment of chronic hepatitis C. Read more...

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Takeda's UC, Crohn's Drug Gets OK from EU Committee

March 21, 2014 11:08 am | News | Comments

Takeda announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has issued a positive opinion for Entyvio (vedolizumab) for the treatment of adults with ulcerative colitis (UC) and Crohn's disease (CD). Read more...

Oral Chemotherapy Trial Launched in New Zealand

March 21, 2014 11:00 am | News | Comments

Kinex Pharmaceuticals announced that the company has received regulatory and ethics approvals to initiate the first clinical study of an oral form of paclitaxel (Oraxol) in Dunedin Hospital in Otago, New Zealand. Read more...        

CHMP Recommends EU Approval of Empagliflozin for Diabetes

March 21, 2014 10:41 am | News | Comments

Boehringer Ingelheim and Eli Lilly and Co. announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, recommending approval of empagliflozin in adults with type 2 diabetes. Read more...

UK Panel Backs Bexsero for National Immunization Program

March 21, 2014 10:24 am | News | Comments

Novartis announced that the Joint Committee on Vaccination and Immunization in the UK has recommended the inclusion of Bexsero (Meningococcal Group B Vaccine) in the National Immunization Program. Read more...           

Canada Gives First Approval of Biogen Hemophilia Drug

March 21, 2014 10:04 am | News | Comments

Biogen Idec announced that Health Canada has approved Alprolix for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B. Read more...           

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Janssen Halts Schizophrenia Drug Trial on Positive Efficacy

March 20, 2014 3:10 pm | News | Comments

Janssen Research & Development announced that following an Independent Data Monitoring Committee (IDMC) recommendation based on positive efficacy, it has halted early a Phase 3 clinical study of an investigational schizophrenia treatment. Read more...

FDA Names Pfizer MenB Vaccine as Breakthrough Therapy

March 20, 2014 3:02 pm | News | Comments

Pfizer announced that the FDA has granted Breakthrough Therapy designation to Pfizer’s vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B. Read more...

Hawaii Sues BMS, Sanofi Over Plavix

March 20, 2014 2:43 pm | by Jennifer Sinco Kelleher | News | Comments

Hawaii's attorney general is suing the makers of a widely prescribed blood thinner that he says a significant portion of the state's population has difficulty metabolizing. The suit names Bristol-Myers Squibb and Sanofi-Aventis as defendants. Read more...

Agenus-GSK Lung Cancer Drug Disappoints in Trial

March 20, 2014 2:18 pm | News | Comments

Shares of Agenus tumbled more than 13% Thursday before markets opened and after the biopharmaceutical released more ineffective study results from its collaboration with GlaxoSmithKline. Read more...               

Court Tosses $1.2B Risperdal Judgment Against J&J

March 20, 2014 10:25 am | by Chuck Bartels | News | Comments

The Arkansas Supreme Court on Thursday overturned a $1.2 billion judgment against Johnson & Johnson in a lawsuit challenging the drugmaker's marketing of the antipsychotic drug Risperdal. Read more...             

Qiagen TB Test to Aid Disease Control in China

March 20, 2014 10:22 am | News | Comments

Qiagen NV announced the commercial launch in China of its QuantiFERON-TB Gold In-Tube, a blood test that accurately identifies people infected with Mycobacterium tuberculosis, the bacterium that causes tuberculosis (TB). Read more...       

Eisai Launches Academic Partnership to Discover Filariasis Drugs

March 20, 2014 9:56 am | News | Comments

Eisai announced that it has entered a collaboration with the Liverpool School of Tropical Medicine and the University of Liverpool to identify new drugs that are effective against two major types of the parasitic tropical disease filariasis. Read more...

Actavis Settles Daytrana Patent Challenge

March 20, 2014 9:48 am | News | Comments

Actavis announced that it has entered into an agreement with Noven Pharmaceuticals Inc. to settle all outstanding patent litigation related to Actavis' generic version of Daytrana. Read more...                 

Mallinckrodt Completes $1.21B Cadence Pharma Deal

March 20, 2014 9:21 am | News | Comments

Health care products maker Mallinckrodt said Wednesday it completed its $1.21 billion purchase of Cadence Pharmaceuticals. Read more...                                 

Alder BioPharma Files for $115M IPO

March 19, 2014 6:19 pm | News | Comments

Drug developer Alder BioPharmaceuticals filed for an initial public offering worth as much as $115 million. The company is studying an experimental migraine prevention drug designated ALD403 and is working with BMS on a drug called clazakizumab. Read more...

Team Proposes New Model for Clinical Trials

March 19, 2014 3:01 pm | News | Comments

Experts across academia, industry and government propose a new method for health care providers to get the right treatments to the right patients at the right time. Read more...                     

FDA Approves First Mixed Protocol IVF Treatment

March 19, 2014 2:52 pm | News | Comments

Ferring Pharmaceuticals Inc. announced FDA approval of new labeling for their fertility products, MENOPUR and BRAVELLE. Read more...                                  

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