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First-line sunitinib superior to everolimus for metastatic RCC

Results for the RECORD-3 trial support the current strategy of first-line sunitinib followed by second-line everolimus for the treatment of patients with metastatic renal cell carcinoma.

11 Aug 2014

Access Pharmaceuticals enters into exclusive license agreement with Norgine

ACCESS PHARMACEUTICALS, INC., an emerging biopharmaceutical company, today announced that it had entered into an exclusive license agreement with Norgine B.V., a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in Europe.

7 Aug 2014

Phase 3 trial: NEXAVAR tablets fail to meet primary endpoint in HER2-negative breast cancer patients

Bayer HealthCare and Onyx Pharmaceuticals Inc., an Amgen subsidiary, today announced that an investigational Phase 3 trial of NEXAVAR (sorafenib) tablets in patients with advanced breast cancer did not meet its primary endpoint of improving progression-free survival (PFS).

25 Jul 2014

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.

14 Jul 2014

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.

28 Jun 2014

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.

23 Jun 2014

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.

9 Jun 2014

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).

31 May 2014

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.

8 Apr 2014

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.

8 Apr 2014

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).

25 Mar 2014

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.

11 Mar 2014

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.

20 Feb 2014

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.

17 Feb 2014

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.

17 Feb 2014

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.

11 Feb 2014

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.

28 Jan 2014

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.

12 Dec 2013

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.

3 Dec 2013

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.

23 Nov 2013