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Clinic Roundup
TapImmune Inc., of Seattle, said an interim safety analysis of the first five breast cancer patients treated with HER2/neu Class II antigens did not show any serious adverse events, so treatment of the remaining 17 patients in the Phase I study at the Mayo Clinic will progressBioWorld Today | Thursday, January 10, 2013 -
Clinic Roundup
Immunovaccine Inc., of Halifax, Nova Scotia, reported results from a Phase I study showing that all ovarian cancer patients receiving cancer vaccine DPX-Survivac who were evaluable by tetramer staining produced survivin-specific CD8 T cells following one or two vaccinations...The Phase Ib portion will enroll all patients with solid tumors, while the Phase IIa portion will enroll gastric and breast cancer patientsBioWorld Today | Tuesday, January 8, 2013 -
Milestone Payments From Corporate Partners: December 2012
Total: $161.9M Year to Date: $760.84M Company (Location) Partner (Location) Amt. (M) Details Date Active Biotech AB (Lund, Sweden) Ipsen SA (Paris) €10 ($12.9) For fully enrolling the Phase III trial of tacrolimus 12/11/12 Algeta ASA (Oslo, Norway) Bayer AG (Leverkusen, Germany) €50 ($65.7) For the submission of a marketing authorization application to the European Medicines Agency for Alpharadin to treat castration-resistant prostate cancer patients with bone metastases 12/13/12 AnacorBioWorld Insight | Monday, January 7, 2013 -
After a Bumpy Road, Can RNA Therapeutics Prosper in 2013?
The events-driven trial in chemotherapy-naïve castration-resistant prostate cancer patients is expected to be complete toward the end of 2013By Brian Orelli | BioWorld Insight | Monday, January 7, 2013 -
Biotech Products Approved 1992-2013
For use in combination with carboplatin for first-line treatment of locally advanced or metastatic non-small-cell lung cancer in patients who are not candidates for surgery or radiation (2/4) Isis Pharmaceuticals Inc...Oral mucositis in cancer patients (12/06) Acorda Therapeutics IncBioWorld Snapshots | Friday, January 4, 2013 -
Other News To Note
CYT-6091, which is comprised of gold nanoparticles bound with an immune avoiding molecule (PEG-Thiol) and tumor necrosis factor alpha (TNF), has been successfully tested at the National Cancer Institute in a Phase I trial in advanced-stage cancer patientsBioWorld International | Wednesday, January 2, 2013 -
Galera's Small-Molecule Shields to Protect Against Superoxide
While superoxide plays a role in many diseases, Galera has decided to initially pursue development of a dismutase mimetic in mucositis caused by radiation in head and neck cancer patientsBy Jennifer Boggs | BioWorld Today | Wednesday, January 2, 2013 -
Other News To Note
CYT-6091 , which is comprised of gold nanoparticles bound with an immune avoiding molecule (PEG-Thiol) and tumor necrosis factor alpha (TNF), has been successfully tested at the National Cancer Institute in a Phase I trial in advanced-stage cancer patientsBioWorld Today | Friday, December 28, 2012 -
Amgen Makes History with $762M Off-Label Settlement
weekly dosing for cancer patients, using dosages two to four times higher than what the FDA had approved, Marshall Miller, acting U.S...Until the FDA ordered a boxed warning in 2007 against the use of Aranesp to treat anemia in cancer patients not undergoing chemotherapy due to an increased risk of death, the company promoted that off-label use, according to the Department of Justice (DOJBy Mari Serebrov | BioWorld Today | Thursday, December 20, 2012 -
Arrowhead, Shire Ink Targeted Peptide-Drug Conjugate Deal
MDACC researchers used phage display in terminally ill cancer patients to establish a library of peptides that targeted not only tumors but also specific healthy tissueBio Perspectives | Wednesday, December 19, 2012 -
Arrowhead, Shire Ink Targeted Peptide-Drug Conjugate Deal
MDACC researchers used phage display in terminally ill cancer patients to establish a library of peptides that targeted not only tumors but also specific healthy tissueBy Marie Powers | BioWorld Today | Wednesday, December 19, 2012 -
Amgen to Pay $150M in Fines, Forfeiture; More to Come
weekly dosing for cancer patients – even though the FDA had refused to approve those regimens and the higher dosages they requiredBy Mari Serebrov | BioWorld Today | Wednesday, December 19, 2012 -
Other News To Note
Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, submitted a marketing authorization application to the European Medicines Agency for Alpharadin (radium-223 dichloride) for the treatment of castration-resistant prostate cancer patients with bone metastasesBioWorld International | Wednesday, December 19, 2012 -
Clinic Roundup
GTx Inc., of Memphis, Tenn., attained its enrollment goal for both of its pivotal Phase III studies of enobosarm to prevent and treat muscle wasting in non-small-cell lung cancer patientsBioWorld Today | Tuesday, December 18, 2012 -
Other News To Note
Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, submitted a marketing authorization application to the European Medicines Agency for Alpharadin (radium-223 dichloride) for the treatment of castration-resistant prostate cancer patients with bone metastasesBioWorld Today | Thursday, December 13, 2012 -
Other News To Note
During the collaboration, HGS conducted Phase Ia trials of AEG40826 (formerly HGS1029) in cancer patients and collaborated with Pharmascience unit Aegera Therapeutics IncBioWorld Today | Wednesday, December 12, 2012 -
Other News To Note
AstraZeneca plc, of London, said it agreed with the FDA on label changes for Faslodex (fulvestrant) injection, updating the label with results and a Kaplan-Meier plot of the final overall survival (OS) analysis from the CONFIRM pivotal study in recurrent or metastatic breast cancer patients...The four-week, repeat-dose study is designed to investigate the hypothesis that inhibition of hepcidin can raise hemoglobin levels in cancer patients with anemiaBioWorld International | Wednesday, December 12, 2012 -
Positive Breast Cancer Study Boosts Celldex Therapeutics
We are very pleased with the clinical data from what was a heavily treated breast cancer patient population," Anthony Marucci, president and CEO of Celldex, told BioWorld Today...According to estimates, about 20 percent of breast cancer patients have triple-negative disease, with about 35 percent of those patients expressing GPNMBBy Peter Winter | BioWorld Today | Tuesday, December 11, 2012 -
Pharma: Other News To Note
Janssen Pharmaceuticals Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, said the FDA approved a broader indication for oral, once-daily Zytiga (abiraterone acetate), expanding its use in combination with prednisone for earlier-stage treatment in metastatic castration-resistant prostate cancer patients before the use of chemotherapyBioWorld Today | Tuesday, December 11, 2012 -
Phase I Clinical Trials Update: November 2012
Cancer Patient dosing was initiated in a Phase I trial 11/9/12 Coronado Biosciences Inc. (Burlington, Mass.) CNDO-109 CNDO-109-activated allogeneic NK cells Acute myeloid leukemia Started a Phase I/II dose-escalation trial of allogeneic natural killer cells activated by its CNDO-109 in patients in first complete remission from and who are deemed high risk for relapse from AML 11/29/12 CytRx Corp. (Los Angeles) Aldoxorubicin Tumor-targeting doxorubicin conjugate (formerly INNO-206) Advanced softBioWorld Insight | Monday, December 10, 2012
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