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Medac Pharma's Rasuvo injection gets FDA approval for RA, pJIA and psoriasis

Medac Pharma's Rasuvo injection gets FDA approval for RA, pJIA and psoriasis

Medac Pharma, Inc., a privately held pharmaceutical company focused on the development of new molecules and improving the effectiveness of existing medicines, announced that the U.S. Food and Drug Administration has approved Rasuvo, a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA) and psoriasis. [More]
Taiho Oncology presents TAS-102 Phase III RECOURSE trial results in mCRC patients

Taiho Oncology presents TAS-102 Phase III RECOURSE trial results in mCRC patients

Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. (Japan), announced today detailed findings from its global Phase III RECOURSE trial of TAS-102 (nonproprietary names: trifluridine and tipiracil hydrochloride), an oral combination anticancer drug. [More]
Third-line treatment options remain elusive for advanced, EGFR wild-type NSCLC

Third-line treatment options remain elusive for advanced, EGFR wild-type NSCLC

Phase II study findings show only marginal positive effects of third-line treatment with afatinib for advanced non-small-cell lung cancer in patients with wild-type epidermal growth-factor receptor tumour status. [More]
FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

FDA accepts Pharmacyclics' IMBRUVICA sNDA for review

Pharmacyclics, Inc. today announced that the U.S. Food and Drug Administration has accepted for filing its supplemental New Drug Application (sNDA) to support the review of IMBRUVICA (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who have received at least one prior therapy for a full approval. [More]
Amgen presents extended analysis of PEAK study data at ASCO

Amgen presents extended analysis of PEAK study data at ASCO

Amgen today announced results from the Phase 2 PEAK study that reinforce the improved overall survival (OS) benefit of panitumumab (Vectibix®) when used in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, compared to bevacizumab (Avastin) plus FOLFOX as first-line treatment in patients with wild-type RAS metastatic colorectal cancer (mCRC). [More]
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 ‘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

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 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]