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Daily news and top headlines for drug research professionals

Merck, Endocyte Withdraw Ovarian Cancer CMAs

May 20, 2014 10:31 am | News | Comments

Merck and Endocyte Inc. announced the withdrawal of conditional marketing authorization applications from the European Medicines Agency for vintafolide and companion imaging components for the treatment of adult patients with ovarian cancer. Read more...

InterMune to Resubmit IPF Drug NDA Based on Positive Phase 3 Findings

May 19, 2014 2:13 pm | News | Comments

InterMune Inc. reported that results from the Phase 3 ASCEND study evaluating pirfenidone in patients with idiopathic pulmonary fibrosis were presented at the International Conference of the American Thoracic Society (ATS) in San Diego, and published on-line in the New England Journal of Medicine. Read more...

Sanofi Pasteur Posts Positive C. Diff Vaccine Findings

May 19, 2014 2:02 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, presented Phase 2 trial results for an investigational vaccine for the prevention of Clostridium difficile infection (CDI) at the 114th General Meeting of the American Society for Microbiology. Read more...

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Boehringer Ingelheim's Nintedanib Slows IPF Progression

May 19, 2014 10:34 am | News | Comments

Newly published results from Boehringer Ingelheim's Phase 3 INPULSIS trials show nintedanib significantly slowed disease progression in patients with idiopathic pulmonary fibrosis (IPF). Read more...               

FDA Passes on Novartis Heart Failure Drug

May 16, 2014 2:45 pm | News | Comments

Novartis announced today that the U.S. FDA has issued a Complete Response Letter regarding the Biologics License Application for RLX030 (serelaxin) for the treatment of acute heart failure, stating that further evidence on the efficacy of RLX030 is required for a U.S. license to be granted. Read more...

Pfizer Seeks Early Approval for Breast Cancer Drug

May 16, 2014 1:32 pm | News | Comments

Pfizer Inc. says the Food and Drug Administration will let the drugmaker apply for approval of its heavily touted experimental breast cancer medicine - palbociclib, a breakthrough therapy - based on midstage patient testing results. Read more...

Reckitt Benckiser Adds to Growing Addiction Treatment Pipeline

May 16, 2014 1:19 pm | News | Comments

Reckitt Benckiser Pharmaceuticals Inc. and XenoPort Inc. announced that they have entered into a license agreement pursuant to which Reckitt Benckiser Pharmaceuticals will be granted exclusive worldwide rights for the development and commercialization of XenoPort's arbaclofen placarbil. Read more...

PTC Therapeutics Posts Positive Results for CF Drug

May 16, 2014 12:48 pm | News | Comments

PTC Therapeutics Inc. announced that the results of a Phase 3 study of ataluren in patients with nonsense mutation cystic fibrosis, demonstrating positive trends in both the primary endpoint and in the secondary outcome measure, were published in Lancet Respiratory Medicine. Read more...

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NovoNordisk Weight Management Drug Excels in Phase 3a

May 16, 2014 10:51 am | News | Comments

Results from the SCALE Obesity and Pre-diabetes Phase 3a trial showed that after 56 weeks of treatment, liraglutide 3 mg, in combination with diet and exercise, provided significantly greater weight loss of 8% from baseline compared to 2.6% with placebo. Read more...

BMS Reports 2- and 3-Year Survival Data for Melanoma Drug

May 15, 2014 2:23 pm | News | Comments

Bristol-Myers Squibb Co. announced updated survival data from the advanced melanoma cohort (n=107) of the expanded Phase 1b dose-ranging study of nivolumab, an investigational PD-1 immune checkpoint inhibitor, administered as a single agent (Study -003). Read more...

Transition Therapeutics Kicks Off Phase 2 Diabetes Trial

May 15, 2014 2:17 pm | News | Comments

Transition Therapeutics Inc. announced the dosing of the first patient in a randomized, double-blind, placebo-controlled, Phase 2 clinical study of TT-401 (LY2944876), a drug candidate for the treatment of type 2 diabetes. Read more... 

Lilly's NSCLC Drug Extends Overall Survival

May 15, 2014 1:49 pm | News | Comments

Lung cancer patients with metastatic squamous cell carcinoma have seen few treatment advancements over the last two decades, leaving these patients with a poor prognosis, in contrast to the progress seen in nonsquamous non-small cell lung cancer (NSCLC). Read more...

Measles Vaccine Promising Against Multiple Myeloma

May 15, 2014 10:27 am | Videos | Comments

Researchers have demonstrated that virotherapy— destroying cancer with a virus that infects and kills cancer cells but spares normal tissues— can be effective against the deadly cancer multiple myeloma. Read more...          

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Boehringer Ingelheim’s Lung Cancer Drug Ups OS in Patients with EGFR Mutations

May 15, 2014 10:00 am | News | Comments

Boehringer Ingelheim announced new overall survival results from a post-hoc analysis combining the data of two Phase 3 trials. The analysis showed patients with NSCLC with common epidermal growth factor receptor mutations lived longer if treated with first-line afatinib compared to chemotherapy. Read more...

Amakem Kicks Off Glaucoma Dose-Ranging Study

May 14, 2014 2:37 pm | News | Comments

Amakem Therapeutics, a clinical stage ophthalmology company, announced that first patients have commenced treatment in a Phase 2 dose-ranging study of its lead drug candidate, AMA0076 - a highly potent locally-acting Rho Kinase (ROCK) inhibitor - for the treatment of glaucoma. Read more...

Isis Posts Positive Phase 2 Results on Diabetes Drug

May 14, 2014 2:09 pm | News | Comments

Isis Pharmaceutical Inc. announced positive data from a Phase 2, double-blinded, randomized, placebo-controlled study of Isis-GCGRRx in 75 patients with type 2 diabetes who had uncontrolled blood sugar despite treatment with stable metformin therapy. Read more...

Amgen’s Monoclonal Antibody Slashes LDL-C

May 14, 2014 1:59 pm | News | Comments

Amgen announced the publication of data from the Phase 3 LAPLACE-2 (LDL-C Assessment with PCSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy-2) study in the Journal of the American Medical Association (JAMA). Read more...

AbbVie Eyes Hepatitis C Cure with New Regimen

May 14, 2014 1:47 pm | by Christina Jakubowski, News Editor | Articles | Comments

AbbVie is tossing its metaphorical hat into the quickly growing and highly competitive hepatitis C treatment ring with an experimental, all-oral, interferon-free regimen – one that is boasting sustained viral response rates 12 weeks post treatment (SVR12 rates) that range from 90 to 100%. Read more...

AstraZeneca Diabetes Treatment Looks Promising

May 14, 2014 10:58 am | News | Comments

AstraZeneca announced results from a Phase 3 study evaluating the investigational combination of saxagliptin/dapagliflozin as a dual add-on therapy in adult patients with type 2 diabetes who were inadequately controlled on metformin. Read more...

MedImmune, Incyte to Trial Cancer Treatment Combo

May 14, 2014 10:49 am | News | Comments

MedImmune has entered into a clinical study collaboration with Incyte Corp. to launce a Phase 1/2 oncology study evaluating the efficacy and safety of MedImmune’s anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte’s indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360. Read more...

FDA Transfers Pain Med Orphan Drug Designation to Sorrento

May 13, 2014 1:19 pm | News | Comments

Sorrento Therapeutics Inc. announced that the U.S. Office of Orphan Products Development has approved the transfer of sponsorship of the Orphan Drug Designation for intrathecal resiniferatoxin in the treatment of intractable pain in end-stage disease from the NIH to Sorrento. Read more...

Bayer HealthCare to Share Clinical Trial Data

May 13, 2014 12:51 pm | News | Comments

Bayer HealthCare announced that it will start sharing data from its clinical studies through the internet portal enabling qualified researchers to request anonymized patient-level data from Bayer HealthCare sponsored clinical studies listed on the website. Read more...

Janssen Files Invega Sustenna Schizoaffective Disorder sNDAs

May 13, 2014 12:41 pm | News | Comments

Janssen Pharmaceuticals Inc., announced the submission of supplemental (sNDAs) for once-monthly atypical long-acting antipsychotic Invega Sustenna to the U.S. FDA for approval to treat schizoaffective disorder as either monotherapy or adjunctive therapy. Read more...

Taiho's Colon Cancer Drug Ups OS in Phase 3

May 13, 2014 10:56 am | News | Comments

Taiho Pharmaceutical Co. Ltd. announced results from its global Phase 3 RECOURSE trial on its oral combination anticancer drug TAS-102 in refractory metastatic colorectal cancer (mCRC). Read more...               

New Positive Trial Results Added to MedImmune's RIA Portfolio

May 13, 2014 10:32 am | News | Comments

AstraZeneca announced that two key molecules in MedImmune’s Respiratory, Inflammation and Autoimmune (RIA) portfolio– mavrilimumab and sifalimumab– met their primary endpoints in respective Phase 2 studies. Read more...         

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