Hypersensitivity News and Research

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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

Celgene International Sàrl today announced that researchers presented data from an investigator-initiated Phase II study of lenalidomide (REVLIMID) in untreated patients with chronic lymphocytic leukemia at the annual meeting of the American Society of Clinical Oncology.

8 Jun 2010

EDEMA4 study results of KALBITOR for treatment of acute attacks of HAE published

Dyax Corp. announced today the publication of results from its second Phase 3, placebo-controlled trial, known as EDEMA4, evaluating KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema. The results, published in the June 2010 issue of the Annals of Allergy, Asthma, and Immunology, indicate that KALBITOR is effective in ameliorating HAE attacks, resolving associated symptoms and preventing attack progression.

7 Jun 2010

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Novartis Pharmaceuticals Corporation announced today that results from a Phase II study show Afinitor® (everolimus) tablets is the first medication in a clinical trial to decrease the size of subependymal giant cell astrocytomas (SEGAs), benign brain tumors associated with tuberous sclerosis (TS). In this study of 28 patients presented today at the 46th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, 75% of patients experienced a reduction of 30% or greater in the size of their brain tumors from baseline to six months (p<0.001).

7 Jun 2010

Millennium reports on data of VELCADE for multiple myeloma from 2010 ASCO oral presentations

Millennium: The Takeda Oncology Company today reported on data from oral presentations of VELCADE® (bortezomib) for Injection based therapy in multiple myeloma presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO). These data highlight VELCADE based therapy in both transplant and non-transplant eligible previously untreated multiple myeloma patients, as well as VELCADE used as induction and/or maintenance therapy.

7 Jun 2010

Phase I study results of Pharmacyclics' PCI-32765 Btk inhibitor for B cell NHL presented at ASCO

Pharmacyclics, Inc. today announced results from a Phase I study of its novel orally administered Bruton's tyrosine kinase (Btk) inhibitor, PCI-32765, in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukemia (CLL) and Waldenstroms Macroglobulinemia (WM). These data are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place this week in Chicago, IL.

7 Jun 2010

GE Healthcare highlights molecular imaging technologies to help clinicians improve patient experiences

Focusing on helping clinicians improve experiences for their patients, GE Healthcare is highlighting an innovative portfolio of molecular imaging technologies and agents at the 57th annual meeting of the Society of Nuclear Medicine, June 5-9, in Salt Lake City.

7 Jun 2010

Celldex reports interim positive results from rindopepimut Phase 2b study for GBM at ASCO

Celldex Therapeutics, Inc. today announced that interim results from a Phase 2b study evaluating rindopepimut (formerly PF-04948568 or CDX-110) in newly-diagnosed glioblastoma multiforme (GBM) patients were presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO).

7 Jun 2010

Celgene reports initial data from investigator-initiated study of REVLIMID

Celgene International Sàrl today announced that initial data from an investigator-initiated study of REVLIMID (lenalidomide) plus Rituxan (rituximab) in patients with newly diagnosed indolent B-cell non-Hodgkin's lymphoma (NHL) were presented at the annual meeting of the American Society of Clinical Oncology.

5 Jun 2010

Millennium announces data on VELCADE in treatment of patients with amyloidosis

Millennium: The Takeda Oncology Company today announced data examining the use of VELCADE in the treatment of patients with relapsed or refractory light chain (AL) amyloidosis. Amyloidosis is a rare condition in which excessive proteins build up in organs or tissues, such as the heart, kidney or liver. These data were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Illinois, June 4-8, 2010.

5 Jun 2010

Researchers present clinical outcomes of lenalidomide in patients with large B-cell lymphoma

Celgene International Sàrl today announced researchers at the annual meeting of the American Society of Clinical Oncology presented data from an evaluation of lenalidomide (REVLIMID) in patients with diffuse large B-cell lymphoma either with a germinal center B-cell or non-germinal center B-cell phenotype.

5 Jun 2010

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Merck announced today results from a new non-inferiority trial of an antiemetic regimen containing fosaprepitant dimeglumine administered as a single intravenous (IV) 150-mg dose in combination with a 5-HT3 antagonist and dexamethasone compared with a three-day regimen of aprepitant with a 5-HT3 antagonist and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.

4 Jun 2010

Promising results of ABRAXANE for bladder cancer support efficacy of nab-driven chemotherapy

Abraxis BioScience, Inc. announced today that findings from a phase 1 randomized trial demonstrated that the nanoparticle albumin bound (nab®) driven chemotherapy, nab-paclitaxel (ABRAXANE® for Injectable Suspension; paclitaxel albumin protein-bound particles for injectable suspension) is well-tolerated and active in the second-line treatment of high-grade, non-muscle-invasive bladder cancer that has been refractory to standard intra-bladder infusion (intravesical) therapy.

4 Jun 2010

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

Novartis Pharmaceuticals Corporation announced today that a Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint, showing the drug significantly extended progression-free survival, or time without tumor growth, in patients with advanced pancreatic neuroendocrine tumors.

3 Jun 2010

FAIR-HF study: Ferinject improves renal function in patients with CHF and iron deficiency

Results of a subanalysis from the FAIR-HF study demonstrate that correcting iron deficiency with Ferinject (ferric carboxymaltose) can improve renal function in chronic heart failure patients. Ferinject is an intravenous iron product used to treat iron deficiency and iron deficiency anaemia.

From CSL Ltd 31 May 2010

FDA approves Cysview for detection of non-muscle-invasive papillary cancer of bladder

GE Healthcare, a unit of General Electric Company, today announced that the US Food and Drug Administration has approved Cysview (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer.

29 May 2010

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder in adolescents aged 13 to 17 years.

26 May 2010

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

Biogen Idec to join global MS community to commemorate the second annual World MS Day

On May 26, Biogen Idec will join the global multiple sclerosis community to commemorate the second annual World MS Day. Biogen Idec is a leader in the fight against MS, bringing hope to the thousands of patients across the globe who benefit from the company's MS therapies and ongoing research programs.

25 May 2010

Hypersensitivity News and Research

Researchers present data from Phase II study of lenalidomide in patients with untreated CLL at ASCO

EDEMA4 study results of KALBITOR for treatment of acute attacks of HAE published

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Millennium reports on data of VELCADE for multiple myeloma from 2010 ASCO oral presentations

Phase I study results of Pharmacyclics' PCI-32765 Btk inhibitor for B cell NHL presented at ASCO

GE Healthcare highlights molecular imaging technologies to help clinicians improve patient experiences

Celldex reports interim positive results from rindopepimut Phase 2b study for GBM at ASCO

Celgene reports initial data from investigator-initiated study of REVLIMID

Millennium announces data on VELCADE in treatment of patients with amyloidosis

Researchers present clinical outcomes of lenalidomide in patients with large B-cell lymphoma

Antiemetic-regimen with fosaprepitant injection provides similar protection against CINV as oral EMEND

Promising results of ABRAXANE for bladder cancer support efficacy of nab-driven chemotherapy

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

FAIR-HF study: Ferinject improves renal function in patients with CHF and iron deficiency

FDA approves Cysview for detection of non-muscle-invasive papillary cancer of bladder

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Biogen Idec to join global MS community to commemorate the second annual World MS Day

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Expanding research and clinical options for children with cancer

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