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Daily news and top headlines for drug research professionals

Novartis Skin Cancer Drug Hits Phase 2 Primary Endpoint

June 2, 2014 2:02 pm | News | Comments

Novartis announced the results of a pivotal Phase 2 trial demonstrating that patients with locally advanced (laBCC) or metastatic basal cell carcinoma (mBCC) taking the investigational oral compound LDE225 (sonidegib) had marked and sustained tumor shrinkage after a median follow-up of 13.9 months. Read more...

Roche Drug is FDA's First Breakthrough Therapy in Bladder Cancer

June 2, 2014 11:17 am | News | Comments

Roche announced results from a Phase 1 study that showed the investigational cancer immunotherapy MPDL3280A shrank tumors of people previously treated for metastatic urothelial bladder cancer (UBC). The FDA has granted MPDL3280A Breakthrough Therapy Designation. Read more...

GSK Breast Cancer Drug Misses Endpoint in Phase 3

June 2, 2014 11:00 am | News | Comments

GlaxoSmithKline announced that the Phase 3 study of two anti-HER2 agents, lapatinib (Tykerb/Tyverb) and trastuzumab, did not meet the primary endpoint of improved disease free survival (DFS) compared to single agent therapy with trastuzumab as adjuvant treatment for HER2 positive early breast cancer. Read more...

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inVentiv to Conduct Clinical Trials of Advaxis Immunotherapies

May 30, 2014 2:24 pm | News | Comments

inVentiv Health Clinical, a leading global CRO, and Advaxis Inc., a biotechnology company developing cancer immunotherapies, announced that they have entered into a global master services agreement for the clinical development of certain immunotherapy product candidates in Advaxis's proprietary pipeline. Read more...

Sangamo, City of Hope Land Strategic Partnership Award

May 30, 2014 2:15 pm | News | Comments

Sangamo BioSciences Inc. announced that the California Institute for Regenerative Medicine has granted a $5.6 million Strategic Partnership Award to fund clinical studies at City of Hope to develop a potentially curative ZFP Therapeutic for HIV/AIDS. Read more...

Drug Offers Potential for Endometriosis Treatment

May 30, 2014 10:34 am | News | Comments

A recent clinical study on a drug, E2MATE, also known as PGL2001, has confirmed its potential in targeting the gynecological disease endometriosis. Read more...                        

Oncothyreon, Celldex Partner on Cancer Immunotherapy

May 29, 2014 2:34 pm | News | Comments

Oncothyreon Inc. and Celldex Therapeutics Inc. announced that they have agreed to collaborate on a combined clinical trial of ONT-10 (a therapeutic vaccine targeting the tumor-associated antigen MUC1) and varlilumab (a fully human monoclonal antibody that targets CD27). Read more...

FDA Approves CINV Drug for Use in Children

May 29, 2014 2:27 pm | News | Comments

Eisai Inc. and Helsinn Group announced the FDA approval of Aloxi injection for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy, in children aged 1 month to less than 17 years. Read more...

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Eisai's Fycompa Provides Sustained Seizure Control in Study

May 29, 2014 10:39 am | News | Comments

Data from a large extension study of Eisai's seizure drug Fycompa (perampanel) demonstrate that the first-in-class epilepsy treatment reduces seizure frequency over sustained periods of time- up to two years of treatment. Read more...    

Essentialis’ Diazoxide Choline Granted Orphan Drug Designation

May 28, 2014 2:13 pm | News | Comments

Essentialis Inc. announced that the FDA's Office of Orphan Products Development has granted orphan drug designation to diazoxide choline, the patent protected active in DCCR for the treatment of Prader-Willi syndrome, a rare complex neurobehavioral/metabolic disease for which there is no FDA-approved therapy. Read more...

FDA Accepts Mallinckrodt’s Pain Med NDA

May 28, 2014 2:05 pm | News | Comments

Mallinckrodt announced that the FDA has accepted for filing the NDA for MNK-155, an investigational extended-release oral formulation of hydrocodone and acetaminophen studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. Read more...

BioCryst Posts Positive Results on Angioedema Drug

May 27, 2014 2:27 pm | News | Comments

BioCryst Pharmaceuticals Inc., announced preliminary results from its OPuS-1 proof of concept Phase 2a clinical trial of orally-administered BCX4161 in patients with hereditary angioedema, having  met the primary efficacy endpoint, several secondary endpoints and all other objectives. Read more...

BMS, Incyte Collaborate on Novel Immunotherapies

May 27, 2014 2:20 pm | News | Comments

Bristol-Myers Squibb Co. and Incyte Corp. announced the establishment of a clinical trial collaboration to evaluate a combination regimen of Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, nivolumab, and Incyte’s oral indoleamine dioxygenase-1inhibitor, INCB24360, in a Phase 1/2 study. Read more...

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Viking Signs Licensing Deal for Novel Therapeutic Programs

May 23, 2014 11:51 am | News | Comments

Viking Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders, announced that it has obtained an exclusive worldwide license to five therapeutic programs from Ligand Pharmaceuticals. Read more...

FDA Clears Kick Off of Phase 3 Alzheimer's Disease Study

May 23, 2014 11:41 am | News | Comments

AZTherapies Inc., a company developing novel treatments for Alzheimer's disease based on technology licensed from Massachusetts General Hospital, announced that it has received notice from FDA that it may proceed with the Phase 3 clinical study submitted in its IND application. Read more...

CHMP Positive About Muscular Dystrophy Drug

May 23, 2014 11:35 am | News | Comments

PTC Therapeutics Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion regarding the company's application for a conditional marketing authorization of Translarna (ataluren) for the treatment of Duchenne muscular dystrophy. Read more...

Novartis to Show Key Advances in Cancer Research

May 23, 2014 10:26 am | News | Comments

Novartis is showcasing the results of research efforts to target disease pathways at upcoming cancer-focused meetings, including updated data in ALK+ non-small cell lung cancer and the first-ever presentations of key data in polycythemia vera, multiple myeloma  and locally advanced or metastatic basal cell carcinoma. Read more...

Isis Reports Positive Phase 2 Data for Antithrombotic

May 22, 2014 2:45 pm | News | Comments

Isis Pharmaceuticals Inc. announced positive top-line data from a Phase 2 comparator-controlled study evaluating the incidence of venous thrombolic events (VTE) in patients treated with Isis-FXIRx undergoing total knee replacement surgery, or total knee arthroplasty (TKA). Read more...

AbbVie Files Canadian NDS for Hep C Regimen

May 22, 2014 2:28 pm | News | Comments

AbbVie filed a New Drug Submission (NDS) to Health Canada seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including patients with cirrhosis. Read more...

Angiox Superior to Heparins in Heart Attack Patients

May 22, 2014 10:57 am | News | Comments

Researchers reported results from the EUROMAX trial, which studied 2,198 patients with heart attacks (STEMI) during their transport on the way to urgent heart procedures (PPCI) aimed at unblocking coronary arteries occluded by blood clots– the underlying cause of heart attacks. Read more...

Boehringer Ingelheim Posts Phase 3 Data for COPD Combo

May 22, 2014 10:34 am | News | Comments

Boehringer Ingelheim presented results of the VIVACITO study, the first Phase 3 data to be reported from the TOviTO clinical trial program, evaluating the effect of the fixed-dose combination of tiotropium and olodaterol, delivered via the Respimat inhaler, on lung function in people with COPD. Read more...

Amgen Publishes Asthma Drug Proof-of-Concept in NEJM

May 21, 2014 1:32 pm | News | Comments

Amgen announced that The New England Journal of Medicine (NEJM) published positive results from a Phase 1 study adding to the growing body of evidence that inhibiting thymic stromal lymphopoietin (TSLP) could be beneficial in the treatment of asthma. Read more...

Genprex Begins Phase 2 Lung Cancer Trial

May 20, 2014 3:00 pm | News | Comments

Genprex Inc. announced that it has enrolled the first patient in a clinical trial evaluating its lead product candidate Oncoprex, a targeted biologic incorporating the pan-kinase inhibitor TUSC2, in combination with erlotinib (Tarceva) for late-stage lung cancer patients. Read more...

Isis Kicks Off Phase 1 Study of Angioedema Drug

May 20, 2014 11:24 am | News | Comments

Isis Pharmaceuticals Inc. announced that it initiated a Phase 1 clinical study of Isis-PKKRx, an antisense drug in development to treat patients with hereditary angioedemia, a rare genetic disease that is characterized by rapid and painful attacks of inflammation in the hands, feet, limbs, face, abdomen, larynx and trachea. Read more...

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...

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