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FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy. [More]
Experimental Ebola virus vaccine protects cynomolgus macaques against current EBOV outbreak strain

Experimental Ebola virus vaccine protects cynomolgus macaques against current EBOV outbreak strain

National Institutes of Health scientists report that a single dose of an experimental Ebola virus (EBOV) vaccine completely protects cynomolgus macaques against the current EBOV outbreak strain, EBOV-Makona, when given at least seven days before exposure, and partially protects them if given three days prior. [More]
LUX-Lung 8 supports afatinib in squamous NSCLC

LUX-Lung 8 supports afatinib in squamous NSCLC

Compared with erlotinib, treatment with afatinib leads to outcomes in previously treated patients with advanced squamous non-small-cell lung cancer, suggest the results of a head-to-head trial. [More]
Harvard Medical School scientists reveal structure of vesicular stomatitis virus protein

Harvard Medical School scientists reveal structure of vesicular stomatitis virus protein

Viruses need us. In order to multiply, viruses have to invade a host cell and copy their genetic information. To do so, viruses encode their own replication machinery or components that subvert the host replication machinery to their advantage. [More]
The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

The Lancet Oncology publishes results of CYRAMZA (ramucirumab) Phase III trial for HCC treatment

Eli Lilly and Company announced that The Lancet Oncology has published results of the Phase III REACH trial that evaluated CYRAMZA (ramucirumab) as a second-line treatment for people with hepatocellular carcinoma (HCC), also known as liver cancer. While the REACH trial's primary endpoint of overall survival favored the CYRAMZA arm, it was not statistically significant. [More]
Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Phase 3 study shows Vectibix meets primary endpoint in patients with chemorefractory wild-type KRAS mCRC

Amgen today announced that a Phase 3 study evaluating Vectibix (panitumumab) and best supportive care (BSC) met its primary endpoint, demonstrating a statistically significant improvement in overall survival (OS) in patients with chemorefractory wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC) compared to those patients treated with BSC alone. [More]
Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer announces LUX-Lung 8 data that compares efficacy of afatinib, erlotinib in patients with advanced SCC

Boehringer Ingelheim today announced overall survival (OS) results from the LUX-Lung 8 trial (NCT01523587) that directly compared the efficacy and safety of two EGFR-directed treatments, afatinib and erlotinib, in patients with advanced squamous cell carcinoma (SCC) of the lung, progressing after treatment with first-line chemotherapy. Treatment with afatinib significantly reduced the risk of death by 19%, extending the survival of patients to a median of 7.9 months compared to 6.8 months on erlotinib. [More]
Lenvatinib-everolimus combination extends PFS in patients with mRCC versus everolimus alone

Lenvatinib-everolimus combination extends PFS in patients with mRCC versus everolimus alone

Eisai Inc. announced today results from an investigational Phase 2 trial which showed that lenvatinib, when used in combination with everolimus, significantly extended progression-free survival (PFS) in patients with metastatic renal cell carcinoma (mRCC) versus everolimus alone. [More]
Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics’ Ibrutinib Phase Ib/II data show ibrutinib may be safe and effective in patients with cGVHD

Pharmacyclics LLC today announced interim results from the ongoing Phase Ib/II PCYC-1129 study suggesting that ibrutinib (IMBRUVICA) may be a safe and effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were either refractory to steroid treatment or were steroid-dependent. [More]
Eli Lilly to present Phase III PROCLAIM trial results at ASCO Annual Meeting

Eli Lilly to present Phase III PROCLAIM trial results at ASCO Annual Meeting

Eli Lilly and Company announced final results of the Phase III PROCLAIM trial that will also be discussed in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. [More]
Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Lilly receives fourth FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its fourth U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). CYRAMZA (ramucirumab injection 10 mg/mL solution) is now also indicated in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. [More]
STRIVE study to assess safety, efficacy of rVSV-ZEBOV candidate Ebola vaccine

STRIVE study to assess safety, efficacy of rVSV-ZEBOV candidate Ebola vaccine

The Centers for Disease Control and Prevention (CDC), in partnership with the Sierra Leone College of Medicine and Allied Health Sciences and the Sierra Leone Ministry of Health and Sanitation, is now enrolling and vaccinating volunteers for the Sierra Leone Trial to Introduce a Vaccine against Ebola (STRIVE). [More]
UTMB scientists develop quick-acting vaccine that is effective against Ebola strain

UTMB scientists develop quick-acting vaccine that is effective against Ebola strain

An interdisciplinary team from The University of Texas Medical Branch at Galveston and Profectus BioSciences, Inc. has developed a quick-acting vaccine that is both safe and effective with a single dose against the Ebola strain that killed thousands of people in West Africa last year. [More]
Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen today announced that the European Commission approved a new use of Vectibix (panitumumab) as first-line treatment in combination with FOLFIRI for the treatment of adult patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC). [More]
VSV-based vaccine yields promising results for rapid development of effective Ebola vaccine

VSV-based vaccine yields promising results for rapid development of effective Ebola vaccine

A live vaccine based on the "Vesicular Stomatitis Virus" (VSV) has yielded highly promising results for the rapid development of an effective vaccine against the Ebola virus. This vaccine would only need to be injected once for long-lasting immunoprotection. [More]
Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC

Eisai announces FDA approval of LENVIMA (lenvatinib) for treatment of RAI-refractory DTC

Eisai Inc. announced today that the U.S. Food and Drug Administration approved the company's receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). [More]
Large clinical trial to assess safety, efficacy of two experimental Ebola vaccines opens in Liberia

Large clinical trial to assess safety, efficacy of two experimental Ebola vaccines opens in Liberia

A large clinical trial to assess the safety and efficacy of two experimental vaccines to prevent Ebola virus infection is now open to volunteers in Liberia. The trial is being led by a recently formed Liberia-U.S. clinical research partnership and is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. [More]
BMG Pharma S.R.L Grants The Exclusive Distribution Rights For Gelx® Oral Gel And Gelx® Spray For The Treatment Of Oral Mucositis In Cancer Patients To FERRER INTERNACIONAL S.A.

BMG Pharma S.R.L Grants The Exclusive Distribution Rights For Gelx® Oral Gel And Gelx® Spray For The Treatment Of Oral Mucositis In Cancer Patients To FERRER INTERNACIONAL S.A.

BMG Pharma S.r.l. today is pleased to announce that it has signed an exclusive distribution agreement with FERRER INTERNACIONAL S.A., granting them the rights to promote, sell and market its own product GelX for the Middle East, Eastern Europe, Russia and North Africa. [More]
Lilly receives FDA approval for CYRAMZA (ramucirumab)

Lilly receives FDA approval for CYRAMZA (ramucirumab)

Eli Lilly and Company has received its third U.S. Food and Drug Administration approval for CYRAMZA (ramucirumab). [More]
First-line dacomitinib may improve advanced NSCLC survival

First-line dacomitinib may improve advanced NSCLC survival

Preliminary research suggests that the second-generation tyrosine kinase inhibitor dacomitinib may improve progression-free survival in patients with advanced non-small-cell lung cancer with epidermal growth factor receptor mutations. [More]
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