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Merck, NewLink Genetics sign exclusive worldwide license agreement for Ebola vaccine candidate

Merck, NewLink Genetics sign exclusive worldwide license agreement for Ebola vaccine candidate

Merck, known as MSD outside the United States and Canada, and NewLink Genetics Corporation, announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink's investigational rVSV-EBOV (Ebola) vaccine candidate. [More]
Toxicity profiles for everolimus, temsirolimus differ in advanced RCC

Toxicity profiles for everolimus, temsirolimus differ in advanced RCC

Non-infectious pneumonitis and stomatitis occur more frequently in patients with advanced renal cell carcinoma treated with everolimus than temsirolimus, whereas temsirolimus is associated with a higher incidence of fatigue, rash and asthenia, a retrospective study reports. [More]
FDA approves CYRAMZA in combination with paclitaxel for advanced adenocarcinoma

FDA approves CYRAMZA in combination with paclitaxel for advanced adenocarcinoma

Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA (ramucirumab) in combination with paclitaxel (a type of chemotherapy) as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. [More]
Human trial of second investigational Ebola vaccine candidate under way

Human trial of second investigational Ebola vaccine candidate under way

Human testing of a second investigational Ebola vaccine candidate is under way at the National Institutes of Health's Clinical Center in Bethesda, Maryland. [More]
ADI develops ELISA test kits for detection of Ebola viral protein antibodies

ADI develops ELISA test kits for detection of Ebola viral protein antibodies

San Antonio, Texas-based Biotech Company Alpha Diagnostic Int'l has developed and released several convenient, rapid, and sensitive ELISA test kits for the detection of major Ebola viral protein antibodies (Glycoprotein, GP; Nucleoprotein, NP, and Viral Protein 40 or VP40). [More]
Medac Pharma launches Rasuvo (methotrexate) injection for patients with RA, pJIA and psoriasis

Medac Pharma launches Rasuvo (methotrexate) injection for patients with RA, pJIA and psoriasis

Medac Pharma, Inc., a privately held pharmaceutical company, has announced the launch of its lead product Rasuvo (methotrexate) injection for patients with rheumatoid arthritis (RA), poly-articular-course juvenile idiopathic arthritis (pJIA) and psoriasis in the U.S. [More]
NIH to start initial human testing of investigational Ebola vaccine next week

NIH to start initial human testing of investigational Ebola vaccine next week

Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. [More]
Zebrafish and virus help scientists map the living brain

Zebrafish and virus help scientists map the living brain

A virus and a zebrafish are helping scientists map the living brain. "You can kinda draw a diagram and see how cells within it are connected in a functioning brain," said Dr. Albert Pan, neuroscientist at the Medical College of Georgia at Georgia Regents University. [More]
First-line sunitinib superior to everolimus for metastatic RCC

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. [More]
Access Pharmaceuticals enters into exclusive license agreement with Norgine

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

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). [More]
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]