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Daily news and top headlines for drug research professionals

Hepatocellular Carcinoma Drug Gets Orphan Designation

July 7, 2014 2:13 pm | News | Comments

CASI Pharmaceuticals Inc. announced that its orally-active, Aurora A/angiogenic kinase inhibitor, ENMD-2076, has received Orphan Drug designation from the FDA for the treatment of hepatocellular carcinoma. Read more...         

Animal Vaccines Should Guide Malaria Research

July 7, 2014 2:07 pm | News | Comments

Research into vaccines for malaria in humans should be guided by the success shown in producing effective vaccines for malaria-like diseases in animals, according to a new study. Read more...                  

99% of Alzheimer's Drug Trials Fail, Study Says

July 7, 2014 1:53 pm | News | Comments

Researchers have conducted the first-ever analysis of clinical trials for Alzheimer’s disease (AD), revealing an urgent need to increase the number of agents entering the AD drug development pipeline and progressing successfully towards new therapy treatments. Read more...

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Chronic Pain Drug Pushes Through Phase 3

July 7, 2014 12:47 pm | News | Comments

Endo Pharmaceuticals Inc. and BioDelivery Sciences International Inc. announced positive top-line results from its pivotal Phase 3 efficacy study of BEMA buprenorphine in opioid-experienced patients. Read more...            

Diabetes Drug Receives MMA in Japan

July 7, 2014 11:23 am | News | Comments

Mitsubishi Tanabe Pharma Corp. and Daiichi Sankyo Co. Ltd., announced that Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2 inhibitor, Canaglu tablets (canagliflozin hydrate) 100 mg in Japan, for the treatment of patients with type 2 diabetes mellitus. Read more...

BioDelivery’s Pain Drug Better than Placebo, Stocks Soar

July 7, 2014 11:17 am | News | Comments

Shares of BioDelivery Sciences International - a Raleigh, North Carolina, company - surged Monday before markets opened and after the drug developer said its potential severe pain treatment fared better than a placebo, or fake drug, in another late-stage study. Read more...

Japan First to Approve Alectinib for ALK+ NSCLC

July 7, 2014 11:11 am | News | Comments

Roche announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved alectinib for the treatment of people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+). Read more...

BI Gets Priority Review for IPF Drug

July 3, 2014 12:00 pm | News | Comments

Boehringer Ingelheim announced that the New Drug Application for its investigational compound nintedanib has been accepted for filing by the FDA and granted Priority Review designation. Read more...                

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FDA Grants Orphan Designation to Galderma’s Skin Disease Drug

July 3, 2014 12:00 pm | News | Comments

Galderma announced that the U.S. Food and Drug Administration granted Orphan Drug Designation status for the company’s trifarotene molecule for the treatment of congenital ichthyosis. Read more...               

Insys Cannabidiol Snags Orphan Designation for Rare Epilepsy

July 3, 2014 12:00 pm | News | Comments

Insys Therapeutics Inc. announced that the FDA has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) for the treatment of Dravet syndrome, a rare pediatric-onset epilepsy. Read more...             

Jazz to Acquire Rights to Defibrotide from Sigma-Tau

July 2, 2014 3:50 pm | News | Comments

Jazz Pharmaceuticals plc announced that the company has signed a definitive agreement with Sigma-Tau Pharmaceuticals Inc. under which a subsidiary of Jazz Pharmaceuticals plc will acquire from Sigma-Tau rights to defibrotide in the United States and all other countries in the Americas. Read more...

Coming Soon: A Harder-to-Abuse Zohydro

July 2, 2014 3:43 pm | News | Comments

The drugmaker Zogenix said a harder-to-abuse version of its powerful painkiller Zohydro could be reviewed by regulators this fall and, if approved, might hit the market early next year, and they are also working to develop a tablet version that maintains the medicine's extended-release properties even when it is crushed or chewed. Read more...

BI Submits MAAs in Europe for COPD Combo Drug

July 2, 2014 3:34 pm | News | Comments

Boehringer Ingelheim announced the submission of Marketing Authorization Applications in 31 European countries for the once-daily fixed-dose combination of tiotropium + olodaterol Respimat as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease. Read more...

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Actavis Acquires Furiex Pharmaceuticals

July 2, 2014 3:28 pm | News | Comments

Actavis announced that its subsidiary Forest Laboratories has successfully completed its acquisition of Furiex Pharmaceuticals in an all-cash transaction valued at approximately $1.1 billion, and up to approximately $360 million in a Contingent Value Right that may be payable based on the status of eluxadoline, Furiex's lead product, as a controlled drug following approval. Read more...

Pfizer Receives Kosher Certification for Gaucher Disease Drug

July 2, 2014 10:55 am | News | Comments

Pfizer Inc. announced that the Orthodox Union has granted kosher certification to Elelyso (taliglucerase alfa) for injection, an enzyme replacement therapy for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. Read more...

Quark Completes Trial of siRNA Compound in Kidney Transplant Patients

July 2, 2014 8:30 am | News | Comments

Quark Pharmaceuticals reported completion of a randomized, placebo-controlled multicenter Phase 2 trial of QPI-1002 for the prophylaxis of delayed graft function in ESRD dialysis-dependent patients undergoing deceased donor kidney transplantation. Read more...

OncoGenex Opens Enrollment for Lung Cancer Trial

July 2, 2014 8:30 am | News | Comments

OncoGenex announced initiation of the Cedar clinical trial, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. Read more...      

Agenus Glioblastoma Vaccine Extends Survival in Phase 2

July 2, 2014 8:30 am | News | Comments

Agenus announced Phase 2 study results showing that patients with newly diagnosed glioblastoma multiforme who received Prophage autologous cancer vaccine, added to the standard of care treatment, lived nearly twice as long as expected. Read more...

PTC Therapeutics Begins Phase 3 Trial of Drug for Severe Cystic Fibrosis

July 1, 2014 1:36 pm | News | Comments

PTC Therapeutics announced the initiation of a global confirmatory Phase 3 clinical trial of Translarna (ataluren), an investigational new drug, in patients with nonsense mutation cystic fibrosis (nmCF). Read more...         

Childhood Vaccines Again Deemed Generally Safe

July 1, 2014 1:29 pm | by Mike Stobbe, AP Medical Writer | News | Comments

The latest analysis of childhood vaccines confirms they're generally safe. The report should be reassuring to parents, the researchers say. For example, there still is no evidence the measles-mumps-rubella vaccine causes autism. Nor is there any proof vaccines cause childhood leukemia. Read more...

CTI BioPharma Wraps Up Recruitment in Pivotal Trial of Myelofibrosis Drug

July 1, 2014 11:30 am | News | Comments

CTI BioPharma Corp. announced that it has completed recruitment in the PERSIST-1 pivotal Phase 3 clinical trial of pacritinib, a novel oral JAK2/FLT3 inhibitor that is being evaluated for the treatment of primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis, without exclusion for low platelet counts. Read more...

Ipsen Applies for US, EU GEP-NET Drug Marketing Authorizations

July 1, 2014 11:22 am | News | Comments

Ipsen announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline Depot 120 mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Read more...

GlycoVaxyn Kicks Off Trial of UTI Vaccine

July 1, 2014 11:17 am | News | Comments

GlycoVaxyn AG, a leader in the development of innovative conjugate vaccines, announced the initiation of a Phase 1 clinical trial of a candidate vaccine to prevent infections caused by Extra-intestinal Pathogenic Escherichia coli (ExPEC), such as urinary tract infections (UTIs). Read more...

Amgen’s Leukemia Drug Gets FDA Breakthrough Designation

July 1, 2014 11:10 am | News | Comments

Amgen announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to investigational bispecific T cell engager antibody blinatumomab, for adults with Philadelphia-negative relapsed/refractory B-precursor acute lymphoblastic leukemia, a rapidly progressing cancer of the blood and bone marrow. Read more...

Takeda, Sanofi Launch Diabetes Collaboration in Japan

June 30, 2014 10:27 pm | News | Comments

Sanofi K.K. and Takeda Pharmaceutical Co. Ltd. announced that the two companies have entered into an agreement to build a collaborative system within Japan in the field of diabetes awareness and education. Read more...          

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