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Daily news and top headlines for drug research professionals

Ariad's Lung Cancer Drug Receives FDA Breakthrough Therapy Designation

October 2, 2014 3:21 pm | News | Comments

Ariad Pharmaceuticals, Inc. announced that its investigational cancer medicine, AP26113, has received Breakthrough Therapy designation by the FDA for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib. Read more...

NKT Therapeutics’ Sickle Cell Disease Drug Receives FDA Fast Track

October 2, 2014 2:42 pm | News | Comments

NKT Therapeutics announced that FDA has granted Fast Track designation to NKTT120, the company’s lead therapeutic being developed for the treatment of sickle cell disease. Read more...

Lilly Discontinues Development of Lupus Drug

October 2, 2014 2:33 pm | News | Comments

Eli Lilly and Company announced it will discontinue development of tabalumab­ -- being studied for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus) -- due to insufficient efficacy in two pivotal Phase 3 trials. Read more...

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Amgen Announces Positive Data for Cholesterol-Lowering Medication

October 2, 2014 2:12 pm | News | Comments

Amgen announced The Lancet published data from two Phase 3 studies, RUTHERFORD-2 and TESLA, that showed treatment with evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication, resulted in a statistically significant reduction in LDL-C compared to placebo in patients with different types of familial hypercholesterolemia (FH). Read more...

Takeda Announces Phase 3 Data for UC, Crohn's Drug

October 2, 2014 10:29 am | News | Comments

Takeda announced that new data from GEMINI LTS, a Phase 3, ongoing, open-label extension study of Entyvio (vedolizumab) for the treatment of adults with moderately to severely active UC and CD will be presented as oral presentations during the 21st United European Gastroenterology Week in Vienna, Austria. Read more...

Japan Starts World-First Stem Cell Trial, Plans More

October 2, 2014 10:20 am | by Cynthia Fox, Science Editor | Articles | Comments

The first patient has been treated, by Japan’s Riken Institute, in the world’s first clinical study of stem cells made from ordinary mature cells. The cells were retinal pigment epithelial (RPE) cells, but they began as a macular-degeneration patient’s skin cells.

High-Cholesterol Drug Data Lifts Esperion

October 2, 2014 10:13 am | News | Comments

Shares of Esperion Therapeutics surged in aftermarket trading after the company reported positive clinical trial results for its experimental high-cholesterol drug ETC-1002. Read more...                   

Nine-Valent HPV Vaccine May Prevent Nearly 90% of Cervical Cancers

October 1, 2014 3:59 pm | News | Comments

Because nine human papillomavirus (HPV) subtypes were found to cause the majority of cervical precancers, a nine-valent HPV vaccine currently being investigated may be able to prevent more cervical cancers than current vaccines, according to new research. Read more...

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Portola Pharmaceuticals Announces Phase 3 ANNEXA-A Data

October 1, 2014 3:45 pm | News | Comments

Portola Pharmaceuticals announced that its first Phase 3 study of andexanet alfa, a potential universal Factor Xa inhibitor antidote and U.S. Food and Drug Administration-designated breakthrough therapy, met its primary and secondary endpoints with high statistical significance. Read more...

Immunovaccine Announces Plans for Phase 2 Clinical Trial of DPX-Survivac

October 1, 2014 11:14 am | News | Comments

Immunovaccine Inc. (“Immunovaccine” or “IMV”), a clinical stage vaccine and immunotherapy company, provided a clinical development program update for DPX-Survivac, the company’s lead cancer vaccine candidate. Read more...

Targeted Treatment Could Halt Womb Cancer Growth

October 1, 2014 10:06 am | News | Comments

A drug which targets a key gene fault could halt an aggressive womb cancer and shrink tumours, according to research published in the British Journal of Cancer. Read more...

Sanofi, Regeneron Announce Positive Dupilumab Results

September 30, 2014 11:00 am | News | Comments

Regeneron Pharmaceuticals and Sanofi announced that a Phase 2a study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps (CSwNP) who did not respond to intranasal corticosteroids. Read more...

Pfizer, Kyowa Hakko Kirin Partner on Immuno-Oncology Combo Study

September 30, 2014 10:49 am | News | Comments

Pfizer Inc. and Kyowa Hakko Kirin announced that they've entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s PF-05082566 with Kyowa Hakko Kirin’s anti-CCR4 antibody mogamulizumab. Read more...         

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Takeda, Seattle Genetics Receive Positive Data from Lymphoma Trial

September 30, 2014 10:02 am | News | Comments

Seattle Genetics and Takeda Pharmaceutical Co. Ltd. announced that patients with Hodgkin lymphoma (HL) who received Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplantation (ASCT) lived significantly longer without disease progression compared to patients who received placebo. Read more...

Array's Melanoma Drug Promising in Phase 2

September 29, 2014 3:46 pm | News | Comments

Final results from a Phase 2 trial of binimetinib in patients with advanced NRAS mutant melanoma were presented at the European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, Spain. Invented by Array BioPharma Inc. and licensed to Novartis in 2010, binimetinib is a small molecule selective inhibitor of the kinases MEK1 and MEK2. Read more...

Tonix Fibromyalgia Pain Drug Misses Endpoint in Phase 2b

September 29, 2014 3:28 pm | News | Comments

Tonix Pharmaceuticals announced results of the Phase 2b BESTFIT study of TNX-102 SL as a chronic bedtime treatment for fibromyalgia. The study did not achieve statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12. Read more...

Combo Treatment Ups PFS in Advanced Melanoma Patients

September 29, 2014 3:07 pm | News | Comments

Shares of Exelixis jumped Monday before markets opened and after the drugmaker said its treatment for a deadly form of skin cancer fared better than another drug in a late-stage clinical study. Read more...

Bristol-Myers Squibb Gets Positive Results for Nivoluma

September 29, 2014 2:58 pm | News | Comments

Bristol-Myers Squibb Co. announced positive results from CheckMate-037, a Phase 3 randomized, controlled open-label study of Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, versus investigator’s choice chemotherapy (ICC) in patients with advanced melanoma. Read more...

Cancer Research UK Increases Drug Development Investment

September 29, 2014 10:21 am | News | Comments

Cancer Research UK is to increase investment by nearly 50% over the next five years in its Drug Development Office, which is also changing its name to the Center for Drug Development (CDD). Read more...              

Genentech’s Perjeta Regimen Extended Lives

September 29, 2014 9:59 am | News | Comments

Genentech announced final survival results from the Phase 3 Cleopatra study, which showed that adding Perjeta to Herceptin and docetaxel chemotherapy extended the lives of people with previously untreated HER2-positive metastatic breast cancer by 15.7 months compared to Herceptin and chemotherapy. Read more...

MicroBiome Therapeutics' Drug May Limit Metformin Side Effects

September 26, 2014 3:47 pm | News | Comments

MicroBiome Therapeutics reported positive topline results from a proof-of-concept study testing whether its investigational drug, NM 505, can improve the tolerability of metformin, the first-line therapy for Type 2 diabetes worldwide. Read more...

Bausch + Lomb Receives Successful Results from Phase 3 Study

September 26, 2014 10:59 am | News | Comments

Bausch + Lomb announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase 3 study. Read more...

Gilead Gets Positive Opinion for HCV Tablet

September 26, 2014 10:48 am | News | Comments

Gilead Sciences Inc. announced that the CHMP, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company's Marketing Authorization Application (MAA) for Harvoni, an investigational once-daily tablet combining the NS5A inhibitor (LDV) 90 mg and the nucleotide analog polymerase inhibitor (SOF) 400 mg for the treatment of HCV infection in adults. Read more...

MabVax Neuroblastoma Vaccine Gets Orphan Drug Designation

September 25, 2014 2:51 pm | News | Comments

MabVax Therapeutics Holdings Inc. announced that the FDA has granted orphan drug designation to the company's vaccine intended for the treatment of the childhood cancer neuroblastoma. Read more...               

Boehringer Ingelheim Announces FDA Approval of COPD Drug

September 25, 2014 1:31 pm | News | Comments

Boehringer Ingelheim Pharmaceuticals, Inc. announced that the FDA approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Read more...

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