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Daily news and top headlines for drug research professionals

Pfizer's New Cancer Drug May Get Early Approval

January 8, 2015 1:27 pm | by Linda A. Johnson - AP Business Writer | News | Comments

Analysts believe Pfizer's new cancer drug appears poised for approval within a few months and could be a new blockbuster. Read more...                    

Pharming and Salix: HAE Trial's First Patient Treated

January 8, 2015 10:26 am | by Ruconest | News | Comments

Pharming Group NV and Salix Pharmaceuticals, Ltd. announced that the first patient was treated in their Phase 2 clinical study of Ruconest, (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg, for prophylaxis in patients with hereditary angioedema (HAE).  Read more...

Eisai Responds: Decision to Remove Halaven Therapy from CDF

January 8, 2015 10:03 am | by Eisai | News | Comments

Eisai announced its extreme disappointment that the National Cancer Drugs Fund (NCDF) panel has apparently made the decision to remove Halaven(eribulin) from the Cancer Drugs Fund (CDF), following a process of arbitrary evaluation. Read more...

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ContraVir Pharmaceuticals: FDA Meeting About Antiviral Drug Trial

January 7, 2015 10:51 am | News | Comments

ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced that it has been granted a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss its proposal for the design of a Phase 3 trial of ContraVir's lead antiviral candidate, FV-100.  

Gilead Climbs After CVS Health Favors Its Hep C Drugs

January 5, 2015 2:56 pm | by Associated Press | News | Comments

Shares of Gilead Sciences climbed on a rough day for the overall market after CVS Health said Gilead's pricey hepatitis C treatments will become a preferred treatment on several of its pharmacy benefits management plans. Read more...

Aethlon Medical Announces Approval of Ebola Treatment Protocol

January 2, 2015 10:16 am | News | Comments

Aethlon Medical, Inc. (AEMD), the pioneer in developing targeted therapeutic devices to address infectious diseases and cancer, today announced that the United States Food and Drug Administration (FDA) has approved a clinical protocol to treat Ebola-infected individuals in the U.S. with the Aethlon Hemopurifier. 

FDA Approves sBLA for CLL Treatment

December 26, 2014 9:54 am | by Associated Press | News | Comments

Genentech, a member of the Roche Group announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for Gazyva in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL). read more...

Spectrum Pharmaceuticals: Submission of NDA for Multiple Myeloma

December 26, 2014 9:47 am | by Associated Press | News | Comments

Ligand Pharmaceuticals Incorporated announces that its partner Spectrum Pharmaceuticals has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Captisol-enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. Read more...

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Researchers Take 'First Baby Step' Toward Anti-Aging Drug

December 26, 2014 9:11 am | by Science Translation Medicine | News | Comments

Researchers could be closing in on a "fountain of youth" drug that can delay the effects of aging and improve the health of older adults, a new study suggests. Seniors received a significant boost to their immune systems when given a drug that targets a genetic signaling pathway linked to aging and immune function, researchers with the drug maker Novartis report. Read more...

FDA Approves Myriad's PARP Inhibitor for Ovarian Cancer

December 19, 2014 2:08 pm | News | Comments

Myriad Genetics, Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca’s drug Lynparza (olaparib). Read more...

Combo Drug Therapy Doubles Positive Effect for Women with Breast Cancer

December 19, 2014 1:20 pm | News | Comments

In a groundbreaking study that offers new hope for women with advanced breast cancer, UCLA researchers published final clinical trial results that showed the amount of time women with advanced breast cancer were on treatment without their cancer worsening was effectively doubled when they took the experimental drug palbociclib. Read more...

10 Up-and-Coming Healthcare Medical Innovations

December 18, 2014 12:10 pm | by Christina Jakubowski, Managing Editor, Bioscience Technology | Articles | Comments

The Cleveland Clinic recently unveiled their annual Top 10 Medical Innovations for 2015– a list that casts an optimistic light on up-and-coming healthcare advances that may reach consumers next year. Their number one? Read more...                         

Inovio Initiates DNA Immunotherapy Trial for Cancers

December 18, 2014 10:48 am | News | Comments

Inovio Pharmaceuticals, Inc. announced it has initiated a phase 1 trial of its hTERT DNA immunotherapy (INO-1400) alone or in combination with Inovio's 1L-12 immune activator (INO-9012) in adults with breast, lung, or pancreatic cancer at high risk of relapse after surgery and other cancer treatments. Read more...

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GSK Shingles Vaccine Hits Goal in Major Study

December 18, 2014 9:02 am | News | Comments

GSK announced that a pivotal phase 3 study to assess the efficacy of HZ/su, an investigational vaccine for the prevention of shingles, has met its primary endpoint. Read more...                                 

FDA Approves First Pathogen Reduction System to Treat Plasma

December 17, 2014 12:02 pm | News | Comments

The U.S. Food and Drug Administration today approved the Intercept Blood System for plasma, the first pathogen reduction system for use by blood establishments in the preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI). Read more...

'Darwinian' Test Uncovers an Antidepressant's Hidden Toxicity

December 16, 2014 10:14 am | by University of Utah | News | Comments

Because of undetected toxicity problems, about a third of prescription drugs approved in the U.S. are withdrawn from the market or require added warning labels limiting their use. An exceptionally sensitive toxicity test invented at the University of Utah could make it possible to uncover more of these dangerous side effects early in pharmaceutical development so that fewer patients are given unsafe drugs. Read more...

Pfizer: Breast Cancer Treatment Results

December 16, 2014 9:17 am | News | Comments

Pfizer Inc. announced the publication of the detailed results from PALOMA-1, a randomized Phase 2 study of palbociclib in combination with letrozole versus letrozole alone, in The Lancet Oncology.  Read more...             

Study Shows Potential for Faster Drug Development

December 15, 2014 1:47 pm | News | Comments

A new study demonstrates the ability to conduct robust cardiac safety characterizations several years earlier than current practice. Read more...                    

Ebola Vaccine Trial Suspended After Side Effects

December 11, 2014 9:17 am | by Associated Press | News | Comments

Swiss researchers have suspended the testing of one of the leading Ebola vaccine candidates after some volunteers reported unexpected side effects. Read more...                                

Actavis Launches Generic Version of Celebrex

December 11, 2014 9:09 am | News | Comments

Actavis plc announced that it has launched a generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules, as part of a settlement agreement with Pfizer, Inc.  Read more...                                   

New HPV Vaccine Strengthens Cancer Protection

December 10, 2014 4:42 pm | by Associated Press | News | Comments

The drugmaker Merck & Co. Inc. has received approval for an updated version of its Gardasil vaccine that protects against an additional five strains of the virus that causes most cases of cervical cancer. Read more..                  

Mylan Launches Generic Versions of Celebrex Capsules

December 10, 2014 12:51 pm | News | Comments

Mylan Inc. announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's Celebrex Capsules, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Read more...

Combo Treatment Benefits Women with Metastatic Breast Cancer

December 10, 2014 10:07 am | News | Comments

Results of a Phase 2, open-label, dose-confirmation study of eribulin in combination with capecitabine, suggests that this therapy is efficacious in women with metastatic breast cancer (overall response rate 42.9% and clinical benefit rate 57.1%), with a safety and tolerability profile consistent with previous data. Read more...

BioDelivery Sciences: Phase 3 Trial of Diabetic Neuropathy Topical Gel

December 8, 2014 10:52 am | News | Comments

BioDelivery Sciences International, Inc. announced that it has completed the randomization of all patients in BDSI's ongoing initial pivotal Phase 3 clinical trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN). Read more...

Amgen, Onyx: Phase 3 Study Results in Myeloma Trial

December 8, 2014 10:26 am | News | Comments

Amgen and its subsidiary Onyx results of the Phase 3 ASPIRE trial, which evaluated Kyprolis (carfilzomib) for Injection plus Revlimid (lenalidomide) and dexamethasone (KRd) compared with Revlimid and dexamethasone (Rd) in patients with relapsed multiple myeloma. Read more...

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