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Daily news and top headlines for drug research professionals

Shire Says AbbVie Should Proceed with $55B Buyout

October 15, 2014 1:05 pm | by Tom Murphy | News | Comments

The drugmaker Shire wants AbbVie to stick with its roughly $55 billion acquisition bid, and it is reminding its U.S. counterpart of the hefty breakup fee it could receive if things don't work out. Read more...

Ex-Financial Analyst at Merck Faces Insider Trading Charge

October 15, 2014 12:43 pm | News | Comments

A former senior finance analyst at Merck & Co. is facing an insider trading charge after authorities said that he passed secrets to a friend he met at college that earned $722,000 in illegal profits. Read more...

Eisai's Thyroid Cancer Drug Gets FDA Priority Review

October 15, 2014 10:45 am | News | Comments

Eisai Inc. announced that the FDA has accepted for review the NDA for its in-house developed agent lenvatinib mesylate as a treatment for progressive RAI-refractory DTC and granted the NDA Priority Review status. Read more...

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Clinical Conductor Takes Aim at Optimizing Oncology Clinical Trials

October 15, 2014 10:38 am | News | Comments

 The team behind Clinical Conductor is proud to announce brand new enhancements to the industry-leading CTMS. This first oncology focused release of several in the coming quarters adds a multitude of advanced features and functionalities designed to optimize the management and execution of oncology studies at organizations of all sizes and makeups.Read more...

Selecta, JDRF, Sanofi Collaborate on SVP Immunotherapy for Type 1

October 15, 2014 10:31 am | News | Comments

Selecta Biosciences and JDRF, announced that they have extended their joint research collaboration and attracted Sanofi as a partner in support of their program to develop an SVP immunotherapy with the long-term goal to treat and potentially prevent the underlying cause of type 1 diabetes. Read more...

Reversing Idiopathic Pulmonary Fibrosis

October 15, 2014 10:14 am | by Cynthia Fox, Science Editor | News | Comments

Lethal fibrosis in lungs of idiopathic pulmonary fibrosis (IPF) mouse models can be reversed, say Yale University researchers. Read more...                                      

Medtronic Begins Study of First Predictive Low Glucose Management Technology

October 14, 2014 1:39 pm | News | Comments

Medtronic Inc. announced that the first patients have been enrolled in an investigational device exemption (IDE) study of its breakthrough Predictive Low Glucose Management (PLGM) technology, marking a critical step toward development of an artificial pancreas in the U.S. market. Read more...

Astellas Collaborates with Harvard for Retinal Degeneration Treatment

October 14, 2014 12:13 pm | News | Comments

Astellas Pharma Inc. announced a research collaboration with an investigator at Harvard focused on discovering the pathologic mechanism for retinitis pigmentosa and identification of new therapeutic targets. Read more...

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C3BS Enrolls Patients in Switzerland in its Phase 3 Clinical Trial Chart-1

October 14, 2014 10:39 am | News | Comments

C3BS, a leader in the discovery and development of regenerative, protective and reconstructive therapies, announced it has received authorization from Swissmedic, the Swiss agency for the authorisation and supervision of therapeutic products, to begin its Congestive Heart failure Cardiopoietic Regenerative Therapy (CHART-1) European Phase 3 trial for C-Cure in Switzerland. Read more...

Nuvilex Applies for Orphan Drug Designation for Pancreatic Cancer Treatment

October 13, 2014 2:43 pm | News | Comments

Nuvilex Inc. (NVLX), a clinical-stage biotechnology company developing cell therapy solutions for the treatment of diseases, announced that it has submitted an application to the FDA for Orphan Drug Designation for its Cell-in-a-Box(R) treatment for pancreatic cancer. Read more...

Pfizer Gets FDA Acceptance of Palbociclib

October 13, 2014 2:35 pm | News | Comments

Pfizer Inc. announced the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). Read more...                                

BMS, Pharmacyclics and Janssen Collaborate on Non-Hodgkin Lymphoma Drug

October 13, 2014 2:25 pm | News | Comments

Bristol-Myers Squibb Company, Pharmacyclics Inc., and Janssen Research & Development LLC announced they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in combination with Imbruvica. Read more...

Concert Pharmaceuticals' Spasticity Drug Gets Positive Reviews

October 13, 2014 10:54 am | News | Comments

Concert Pharmaceuticals Inc. announced Phase 1 data of CTP-354, a novel, potentially first-in-class, non-sedating, once-daily oral treatment for spasticity. Read more...                        

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Phase 2 Study to Evaluate Hepatitis C Drug Combination

October 13, 2014 10:41 am | News | Comments

Medivir AB announced that its partner Janssen recently initiated patient enrolment in a phase 2 study called IMPACT. This study evaluates the efficacy, safety and pharmacokinetics of the NS3/4A protease inhibitor simeprevir administered once daily in combination with Gilead’s nucleotide inhibitor sofosbuvir and Bristol-Myers Squibb’s (BMS) NS5A replication complex inhibitor daclatasvir. Read more...

FDA Approves Drug for Chemo-Associated Nausea, Vomiting

October 13, 2014 10:10 am | News | Comments

Helsinn Group and Eisai Inc. announced that the FDA approved Akynzeo for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy Read more...                

FDA Approves First Drug-Coated Angioplasty Balloon Catheter for PAD

October 10, 2014 3:23 pm | News | Comments

The U.S. Food and Drug Administration approved the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). Read more...                              

Gilead Sciences' Once-Daily Hepatitis C Drug Approved by FDA

October 10, 2014 3:02 pm | News | Comments

Gilead Sciences, Inc. announced that the U.S. FDA has approved Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Read more...

BIT225 Trial Results Show Effective Cure of Hepatitis C

October 10, 2014 10:41 am | News | Comments

Australian drug development company Biotron Ltd. announced that all Hepatitis C virus (HCV) genotype 3 (G3) patients completing a key Phase 2 trial of its lead antiviral drug, BIT225, have undetectable levels of HCV 12 weeks after ceasing all treatment. Read more...

Janssen Seeks Approval of Psoriasis Drug

October 10, 2014 10:34 am | News | Comments

Janssen-Cilag International NV (Janssen) announced that a Type 2 Variation has been filed with the European Medicines Agency seeking approval of Stelara (ustekinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients ages 12 to 17 years old who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Read more...

Amgen's ALL Drug Receives FDA Priority Review

October 10, 2014 10:23 am | News | Comments

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. Read more...

The Dwindling Stock of Antibiotics, and What to Do About It

October 10, 2014 10:13 am | by Diana Lutz | News | Comments

The Centers for Disease Control and Prevention has said that at least 2 million Americans are sickened by antibiotic resistant infections each year and survive. Read more...                        

Shaping the Future of Immunotherapy: Four Trends to Watch

October 10, 2014 8:30 am | by Merrilyn Datta, Ph.D., Chief Commercial Officer, Definiens | Articles | Comments

Just four years after the drug sipuleucel-T was approved for clinical adoption, the field of immunotherapy is on the cusp of a number of exciting advancements. Read more...                           

Endo Intl to Buy Auxilium in Deal Worth $2.6B

October 9, 2014 3:09 pm | News | Comments

Ireland's Endo International is planning to buy Auxilium Pharmaceuticals in a sweetened cash-and-stock deal valued at $2.6 billion a few weeks after Auxilium rejected a lower bid. The Auxilium board embraced the latest offer but its shareholders get to vote on it. Read more...

Purdue Pharma Launches Smaller Dosage of Chronic Pain Patch

October 9, 2014 3:03 pm | News | Comments

Purdue Pharma L.P. announced the U.S. commercial launch of the new 7.5 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans are now available: 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour and 20 mcg/hour. Read more...

DelMar Pharmaceuticals' Cancer Drug Shows Promise

October 9, 2014 10:49 am | News | Comments

DelMar Pharmaceuticals Inc., a clinical-stage oncology company, announced the presentation of promising new data supporting the activity of its lead drug compound, VAL-083, in the treatment of non-small cell lung cancer (NSCLC). Read more...

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