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Daily news and top headlines for drug research professionals

New Lilly Drug Promising Against Metastatic Breast Cancer

April 7, 2014 1:48 pm | News | Comments

The new oral drug LY2835219, an inhibitor of cyclin-dependent kinases 4 and 6, showed early promise as monotherapy for patients with metastatic breast cancer, particularly for those with hormone receptor-positive disease. Read more...     

Novartis Men B Vaccine Gets Breakthrough Designation from FDA

April 7, 2014 1:38 pm | News | Comments

Novartis announced that Bexsero (Meningococcal Group B Vaccine) has received a Breakthrough Therapy designation-the fourth such designation for Novartis-from the FDA. Read more...       

CRT, Teva Collaboration IDs New Cancer Drug Candidate

April 7, 2014 10:41 am | News | Comments

Cancer Research Technology announced a successful outcome to their existing collaboration with Teva through the identification of a novel atypical Protein Kinase C (aPKC) inhibitor pre-clinical candidate, licensed by Teva. Read more...     


Roche Buys Orphan Drug Molecule from Oryzon

April 7, 2014 10:35 am | News | Comments

Roche and Oryzon Genomics SA announced they have entered into a worldwide collaboration to research, develop and commercialize inhibitors of Lysine Specific Demethylase-1, an epigenetic modulator that regulates gene expression. Read more...   

Pfizer's New Breast Cancer Drug Shows Promise

April 7, 2014 8:30 am | by Christopher S. Rugaber, AP Economics Writer | News | Comments

An experimental drug has shown encouraging results in treating advanced breast cancer in an early clinical trial, pharmaceutical giant Pfizer reported Sunday. The drug prevented breast cancer from worsening for 20.2 months in trial. Read more...

Sanaria Malaria Vaccine Wins Excellence Award

April 4, 2014 1:40 pm | News | Comments

Sanaria received the 2014 Vaccine Industry Excellence Award for the "Best Prophylactic Vaccine" at a ceremony held last month in Washington, D.C. during the 14th World Vaccine Congress. Read more...                 

Merck, Ferring, WHO to Advance Temperature-Stable Bleeding Drug

April 4, 2014 10:53 am | News | Comments

Merck, Ferring Pharmaceuticals and the WHO are collaborating to advance a new, proprietary formulation of carbetocin, used to prevent excessive bleeding in women after childbirth, that is designed to be stable at room temperature, even in hot and tropical climates. Read more...

Halozyme Halts Pancreatic Cancer Trial

April 4, 2014 10:36 am | News | Comments

Halozyme Therapeutics announced that as a result of a recommendation from an independent Data Monitoring Committee, the company is temporarily halting patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial in patients with pancreatic cancer. Read more...


FDA Approves Easy-to-Use Heroin Overdose Antidote

April 4, 2014 10:24 am | by Lauran Neergaard and Mary Clare Jalonick | News | Comments

The FDA approved an easy-to-use device that automatically injects the right dose of an overdose antidote named naloxone before an ambulance arrives, enabling friends and family to take the first step to save a loved one from an overdose before an ambulance arrives. Read more...

New Drug Prevents Tumor Growth by Inhibiting Key Enzyme

April 4, 2014 10:19 am | Videos | Comments

A ground-breaking has shown that fast-growing cancer cells are sensitive towards imbalances in the metabolism of nucleotides, the building blocks of DNA. This vulnerability can be exploited for a radically novel antitumor therapeutic approach. Read more...

Astellas, Medivation Submit Amended MAA for New Xtandi Use

April 3, 2014 1:22 pm | News | Comments

Astellas Pharma and Medivation announced the submission of a variation to amend the European Marketing Authorization Application for Xtandi (enzalutamide) capsules for a new indication in the treatment of adult men with metastatic castration-resistant prostate cancer. Read more...

Gilead Hep C Combo Hits Primary Endpoint in Japan

April 3, 2014 11:10 am | News | Comments

Gilead Sciences announced top-line results from a Phase 3 clinical trial in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection. Read more...

EU Committee Backs Orphan Status for Alnylam RNAi Drug

April 3, 2014 11:02 am | News | Comments

Alnylam Pharmaceuticals announced that the European Medicines Agency Committee for Orphan Medicinal Products has adopted a positive opinion recommending ALN-TTRsc for designation as an orphan medicinal product for the treatment of transthyretin-mediated amyloidosis (ATTR). Read more...


Takeda Gets JPMA Suspension Over Candesartan Marketing

April 3, 2014 3:20 am | News | Comments

Takeda Pharmaceutical Co. Ltd. received notice of sanctions imposed by the Japan Pharmaceutical Manufacturers Association (JPMA) for promotional activities regarding Candesartan Antihypertensive Survival Evaluation in Japan (CASE-J). Read more...

FDA Gives Go-Ahead for Phase 2a Trial of CardioCell CHF Stem Cell Therapy

April 2, 2014 3:02 pm | News | Comments

CardioCell LLC has just received the FDA’s investigational new drug (IND) approval for a United States-based, Phase 2a clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than one million hospitalizations annually. Read more...

Bayer Launches Phase 3 Prostate Cancer Trial

April 2, 2014 10:35 am | News | Comments

Bayer HealthCare announced that the company has begun to enroll patients in a new Phase 3 trial with radium-223 dichloride (Xofigo) to evaluate radium-223 in combination with abiraterone acetate and prednisone/prednisolone. Read more...    

EMA App Withdrawn for GSK Ovarian Cancer Drug

April 2, 2014 10:28 am | News | Comments

GlaxoSmithKline announced that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorization for Votrient (pazopanib). Read more...                 

Janssen Hep C Combo Therapy Moves to Phase 3

April 2, 2014 10:21 am | News | Comments

Janssen R&D Ireland announced that two Phase 3 trials are recruiting patients to examine the efficacy and safety of simeprevir in combination with sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection. Read more...

GSK Ends Lung Cancer Immunotherapy Trial

April 2, 2014 9:58 am | News | Comments

GlaxoSmithKline announced the company will stop its current trial of MAGE-A3 in non-small cell lung cancer patients, after establishing that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment. Read more...

Sanofi-Regeneron Cholesterol Drug Excels in Japanese Trial

April 1, 2014 10:24 am | News | Comments

Sanofi and Regeneron announced that the first Phase 2 study with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), in Japanese patients met its primary endpoint. Read more...     

Halozyme’s Diabetes Drug Meets Primary Endpoint

March 31, 2014 3:54 pm | News | Comments

Halozyme Therapeutics Inc. announced that the primary endpoint of non-inferiority of A1C levels at six months was met for the CONSISTENT 1 trial. Read more...                            

Isis Antisense Drug Effectively Lowers Triglycerides in Phase 2

March 31, 2014 3:49 pm | News | Comments

Isis Pharmaceuticals Inc. announced the final results from its Phase 2 study of ISIS-APOCIIIRx in patients with high to severely high triglycerides on stable doses of fibrates. Read more...                  

FDA Grants Orphan Designation to Kite Cancer Immunotherapy

March 31, 2014 3:45 pm | News | Comments

Kite Pharma Inc. announced that the FDA granted orphan drug designation for the company's autologous engineered T cell product that targets CD19 expression on B cell malignancies, for the treatment of diffuse large B cell lymphoma (DLBCL). Read more...

Janssen Expands Global Cardiovascular Research with Three New Xarelto Studies

March 31, 2014 3:42 pm | News | Comments

Janssen Research & Development LLC (Janssen) announced it is adding three new clinical trials to its EXPLORER global cardiovascular research program for Xarelto, the most studied and broadly indicated oral Factor Xa inhibitor in the world. Read more...

Supreme Court Takes Up Teva Dispute

March 31, 2014 3:38 pm | News | Comments

The Supreme Court is wading into a patent dispute between rival pharmaceutical companies over the multiple sclerosis treatment Copaxone. Read more...                            

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