Sepsis News and Research

Latest Sepsis News and Research

Morphotek announces preliminary data from Phase II trial of farletuzumab

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, today announced preliminary data from a Phase II trial evaluating the safety and efficacy of farletuzumab in platinum-sensitive epithelial ovarian cancer subjects experiencing their first relapse. Farletuzumab (MORAb-003) is a humanized monoclonal antibody that targets the Folate Receptor Alpha (FRA).

26 Sep 2009

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.

26 Sep 2009

Merck, QIAGEN to collaborate to increase access to HPV vaccination and HPV DNA testing in developing countries

Merck & Co., Inc. and QIAGEN N.V. today announced their intent to collaborate on a new program to increase access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world.

From QIAGEN Manchester Limited 24 Sep 2009

Results of Phase 3 CRYSTAL study of mCRC patients announced

The retrospective CRYSTAL analysis was conducted as a result of an effort to increase the tissue ascertainment rate to determine the K-ras status of patients’ tumors. The analysis included extended patient follow up of nearly 1.5 years and doubled the tissue ascertainment rate from 45% to 89%. These data are an update from the overall survival results from CRYSTAL that were published in the April 2009 issue of the New England Journal of Medicine.

23 Sep 2009

Amgen announces Phase 3 results evaluating Vectibix in combination with FOLFIRI chemotherapy

Amgen (Nasdaq: AMGN) today announced detailed results from the Phase 3 '181' trial evaluating Vectibix((R)) (panitumumab) in combination with FOLFIRI (an irinotecan based chemotherapy), as a second-line treatment for metastatic colorectal cancer (mCRC). In this trial, Vectibix significantly improved progression-free survival (PFS) in patients with KRAS wild-type mCRC.

22 Sep 2009

Amgen to present its four Phase 3 clinical trial results

Amgen today announced it will present detailed data from four Phase 3 studies as well as other data at the ECCO 15 - ESMO 34 European Multidisciplinary Congress, September 20 - 24, 2009 in Berlin, Germany.

16 Sep 2009

Clinical study results of DAS181 against H1N1 influenza presented

NexBio, Inc. announced today the presentation of two studies of DAS181 activity against H1N1 influenza and NAI-resistant influenza at the 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting on Sunday, September 13, 2009, in San Francisco, CA.

14 Sep 2009

FAB Pharma to develop new class of anti-MRSA drugs

FAB Pharma today announced the completion of a €2.3 million round of series A funding led by CDC innovation and co-led by Bioam Gestion.

14 Sep 2009

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Therapeutic principles of monoclonal antibodies

Professor Joachim R. Kalden, Member of the Department for Molecular Immunology, Nikolaus-Fiebiger-Zentrum, University Medical School Erlangen-Nuremberg, presents therapeutic principles based on monoclonal antibodies.

10 Sep 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

10 Sep 2009

Thermo Fisher Scientific to acquire B.R.A.H.M.S. for $470 million

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, has signed a definitive agreement to acquire B.R.A.H.M.S. AG for €330 million (approximately $470 million USD). B.R.A.H.M.S. is a leading provider of specialty in-vitro diagnostic tests based on its patented biomarkers for sepsis, cardiovascular and pulmonary diseases, as well as intensive care treatments and prenatal screening.

From Thermo Fisher Scientific Inc. 3 Sep 2009

FDA: Randomized clinical trial necessary to better interpret Clolar’s efficacy and safety in adult AML

Genzyme Corporation (Nasdaq: GENZ) announced today that the FDA’s Oncologic Drugs Advisory Committee voted 9 to 3 that a randomized, controlled trial is needed to support the currently proposed label expansion for Clolar® (clofarabine) in adult myeloid leukemia (AML). The committee found that the single-arm clinical study results submitted to support the label expansion showed Clolar was an active agent in acute AML patients, but concluded that a randomized clinical trial should be necessary to better interpret Clolar’s efficacy and safety in the proposed patient population.

2 Sep 2009

Pathogenic microbes can suppress immune system in newborns

Group B Streptococcus (GBS), a bacterial pathogen that causes sepsis and meningitis in newborn infants, is able to shut down immune cell function in order to promote its own survival, according to researchers at the University of California, San Diego School of Medicine and the Skaggs School of Pharmacy and Pharmaceutical Sciences.

2 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009

Genzyme’s supplemental NDA for treating adult AML with Clolar to be discussed by the FDA

Genzyme Corporation (Nasdaq: GENZ) announced today that its supplemental New Drug Application for Clolar® (clofarabine) will be discussed Tuesday, September 1 at a public meeting of the FDA’s Oncologic Drugs Advisory Committee in Silver Spring, Maryland. The panel is expected to consider the clinical trial results Genzyme submitted to support the approval and labeling of Clolar to treat older adult patients with acute myeloid leukemia (AML), the most common type of acute leukemia in adults.

29 Aug 2009

DAS181 inhibits H5N1 Influenza lung virus infection of human lung tissues

NexBio, Inc. announced today the publication "DAS181 Inhibits H5N1 Influenza Lung Virus Infection of Human Lung Tissues" in the September, 2009 issue of the journal Antimicrobial Agents and Chemotherapy (AAC).

26 Aug 2009

MRSA Survivors Network founder organizes the first Inaugural World MRSA Day

MRSA Survivors Network founder, Jeanine Thomas has organized the first Inaugural World MRSA Day Kick-off event on October 1st in Chicago at Loyola University. Other events will be held across the globe and in the U.S. on October 2nd and throughout the month of October, World MRSA Awareness Month.

26 Aug 2009

Study reveals factors associated with higher mortality rate in haematological malignancy

A study of 7,689 admissions from 178 adult intensive care unit s in England, Wales and Northern Ireland has revealed the factors associated with a higher mortality rate in haematological malignancy. Researchers writing in BioMed Central's open access journal Critical Care found that certain factors have a significant impact on the risk of death.

25 Aug 2009

USDA donates funds for teaching food safety awareness to AIDS patients

Researchers at the University of Illinois at Chicago School of Public Health have received a grant from the U.S. Department of Agriculture to educate AIDS patients on food safety.

25 Aug 2009