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Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen submits supplemental New Drug Application for IMBRUVICA to the U.S. FDA

Janssen Research & Development, LLC ("Janssen") today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA™ (ibrutinib) to the U.S. Food and Drug Administration (FDA) by its collaboration partner Pharmacyclics, Inc. [More]
Access provides update on new formulation of anti-inflammatory drug amlexanox

Access provides update on new formulation of anti-inflammatory drug amlexanox

ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP) provided an update on a new formulation of the anti-inflammatory drug amlexanox, called LexaGard™, for the treatment of inflammatory and ulcerative conditions of the esophagus. [More]
European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

European Commission approves Exelixis' COMETRIQ for treatment of progressive, metastatic MTC

Exelixis, Inc. today announced that the European Commission has approved COMETRIQ (cabozantinib) for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma (MTC). [More]
Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Bayer and Onyx announce Phase 3 trial evaluating use of NEXAVAR for patients with HCC after local ablation

Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals, Inc., an Amgen subsidiary (Nasdaq: AMGN), today announced that a Phase 3 trial evaluating the investigational use of NEXAVAR® (sorafenib) tablets as an adjuvant treatment for patients with hepatocellular carcinoma (HCC), or liver cancer, who had no detectable disease after surgical resection or local ablation, did not meet its primary endpoint of improving recurrence-free survival. [More]
Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics total revenue for fourth quarter 2013 increases 113% to $123.6 million

Pharmacyclics, Inc. today reported financial results and recent developments for the quarter and year ended December 31, 2013. [More]

Afatinib ‘first line’ for advanced mutation-positive lung cancer

Afatinib should be given as a first-line treatment for Asian patients with advanced, epidermal growth factor receptor mutation-positive, non-small-cell lung cancer, researchers recommend. [More]
BMG Pharma signs agreement with Samyang Biopharmaceutical to market GelX in South Korea

BMG Pharma signs agreement with Samyang Biopharmaceutical to market GelX in South Korea

BMG Pharma S.r.l. today is pleased to announce that it has signed an exclusive distribution agreement with Samyang Biopharmaceutical Corporation granting them the rights to promote, sell and market its novel mucositis management product GelX in the territory of South Korea. [More]
Long-distance signaling molecules tell brain to produce anti-viral interferon

Long-distance signaling molecules tell brain to produce anti-viral interferon

The brain contains a defense system that prevents at least two unrelated viruses-and possibly many more-from invading the brain at large. The research is published online ahead of print in the Journal of Virology. [More]

Everolimus fails to boost advanced NSCLC response

Phase II trial findings have ruled out a combination of erlotinib and everolimus for advanced non-small-cell lung cancer patients with progression after chemotherapy. [More]
Emergent BioSolutions enters into definitive agreement to acquire Cangene

Emergent BioSolutions enters into definitive agreement to acquire Cangene

Emergent BioSolutions Inc.announced that it has entered into a definitive agreement with Cangene Corporation (TSX: CNJ) under which Emergent will acquire all of the outstanding common shares of Cangene in an all-cash transaction valued at $3.24 per share on a fully diluted basis for an aggregate purchase price of $222 million. [More]

Investigational c-Met inhibitor shows early promise in NSCLC

A first-in-class drug that inhibits c-Met, a receptor tyrosine kinase, has demonstrated good tolerability when combined with erlotinib in the treatment of Japanese patients with advanced/metastatic non-small-cell lung cancer. [More]
NEXAVAR tablets receive FDA approval for treatment of patients with thyroid cancer

NEXAVAR tablets receive FDA approval for treatment of patients with thyroid cancer

Bayer HealthCare and Onyx Pharmaceuticals, Inc., an Amgen subsidiary, today announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for the oral multi-kinase inhibitor NEXAVAR (sorafenib) tablets for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment. [More]
Results announced for Phase II PRECEDENT trial of vintafolide for treatment of platinum-resistant ovarian cancer

Results announced for Phase II PRECEDENT trial of vintafolide for treatment of platinum-resistant ovarian cancer

Merck, known as MSD outside the United States and Canada, (NYSE: MRK) and Endocyte, Inc. (NASDAQ: ECYT) today announced the online publication of results from the randomized Phase II PRECEDENT trial for vintafolide (MK-8109/EC145), an investigational folate small molecule drug conjugate (SMDC), in the Journal of Clinical Oncology (JCO), the official journal of the American Society of Clinical Oncology. [More]

Exelixis starts phase 3 pivotal trial of cabozantinib for treatment of metastatic renal cell carcinoma

Exelixis, Inc. today announced it has initiated METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with at least one prior VEGFR tyrosine kinase inhibitor. [More]
Findings highlight importance of IL-21 in the development of antiviral vaccines

Findings highlight importance of IL-21 in the development of antiviral vaccines

Scientists at Emory Vaccine Center have shown that an immune regulatory molecule called IL-21 is needed for long-lasting antibody responses in mice against viral infections. [More]
Vesicular stomatitis virus spares non-cancerous cells and kills melanoma cells

Vesicular stomatitis virus spares non-cancerous cells and kills melanoma cells

Researchers from Yale University School of Medicine have demonstrated that vesicular stomatitis virus (VSV) is highly competent at finding, infecting, and killing human melanoma cells, both in vitro and in animal models, while having little propensity to infect non-cancerous cells. [More]

Oral toxicity is frequent limitation of mTOR therapy

Oral mucositis is a frequent complication in patients taking mTOR inhibitors and a major reason for dose reductions and discontinuations in clinical trials, according to a review of this class of cancer drugs. [More]

Everolimus treatment option for tuberous sclerosis patients

Researchers have shown that the immunosuppressant everolimus provides a potential new treatment option for patients with tuberous sclerosis and associated angiomyolipomas. [More]
STA announces results from ABRAXANE plus gemcitabine phase III trial on pancreatic cancer

STA announces results from ABRAXANE plus gemcitabine phase III trial on pancreatic cancer

Australian biopharmaceutical company Specialised Therapeutics Australia announces that a phase III clinical trial of world leading breast cancer drug ABRAXANE (nanoparticle albumin-bound paclitaxel) in combination with current standard of care gemcitabine in patients with advanced pancreatic cancer has demonstrated substantially improved survival times, with double the number of patients surviving two years. [More]
Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Boehringer Ingelheim receives FDA Priority Review for afatinib to treat EGFR mutation-positive NSCLC

Boehringer Ingelheim today announced that the New Drug Application (NDA) for its investigational oncology compound afatinib has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). [More]