Hypersensitivity News and Research

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

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

GLUMETZA tablets are now available to wholesalers and physicians

Santarus, and Depomed, today announced that supply of GLUMETZA® 500 mg to wholesalers and retailers has resumed. GLUMETZA is a once-daily, extended release formulation of metformin and is approved for use in adults with type 2 diabetes mellitus.

5 Jan 2011

Chest: January news briefs

New research suggests that subcutaneous omalizumab is safe and effective an add-on treatment to corticosteroids for moderate to severe asthma in children and adults. Researchers from Uruguay, Argentina, and Chile performed a meta-analysis on eight trials where 1,883 patients received omalizumab and 1,546 received a placebo.

4 Jan 2011

FDA approves 200 mg formulation of INTELENCE for HIV-1

The U.S. Food and Drug Administration (FDA) approved a label update to include a 200 mg formulation of INTELENCE® (etravirine), a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of human immunodeficiency virus (HIV-1) in treatment-experienced adults with resistance to an NNRTI and other antiretroviral (ARV) agents.

3 Jan 2011

Tips to prevent a hangover

Dr. Andrew Yacht, director of the division of general medicine and vice chair of medicine for education at Maimonides Medical Center in New York City said, “Alcohol clearly causes hangovers, but why it causes hangovers isn’t very well understood…Part of the suspected cause is dehydration and an electrolyte and hormonal imbalance. Some of the symptoms may be caused by low blood sugar. Or, it may be that the direct toxic effects of alcohol are causing the symptoms.”

2 Jan 2011

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Biogen Idec and Elan Corporation, plc announced that the companies have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics.

22 Dec 2010

Scientists suggest targeting ion channels could offer effective pain relief

University at Buffalo neuroscience researchers conducting basic research on ion channels have demonstrated a process that could have a profound therapeutic impact on pain.

20 Dec 2010

ADVENTRX seeks meeting with FDA to discuss ANX-514 docetaxel emulsion study findings

ADVENTRX Pharmaceuticals, Inc. today announced it has submitted a request to the U.S. Food and Drug Administration (FDA) to schedule a meeting for the purpose of discussing its product candidate ANX-514 (docetaxel emulsion for injection). The FDA is expected to set the meeting date within 60 days of receiving the request from ADVENTRX.

16 Dec 2010

BRIC researchers discover new protein that improves immune system

Researchers at BRIC, the University of Copenhagen, have discovered for the first time a protein normally found in the body that can act to prevent chronic tissue inflammation.

15 Dec 2010

DARA's KRN5500 reduces allodynia in Phase 2a study for neuropathic pain in cancer patients

DARA BioSciences, Inc. announced today additional positive results from its successfully completed KRN5500 Phase 2a Clinical Study for treatment of neuropathic pain in patients with cancer. Statistically significant primary endpoint results were released earlier.

15 Dec 2010

FDA to review Lantheus' DEFINITY sNDA for use in stress echocardiography

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension for use in stress echocardiography.

14 Dec 2010

Zogenix's SUMAVEL DosePro Needle-free Delivery System wins 2010 Most Innovative Product award

Zogenix, Inc. today announced that CONNECT, a regional San Diego nonprofit organization, selected SUMAVEL® DosePro™ (sumatriptan injection) Needle-free Delivery System as a 2010 Most Innovative Product (MIP) winner at the MIP Awards Luncheon on December 10, 2010.

13 Dec 2010

Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Talecris Biotherapeutics, Inc. announced today the initiation of a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]) (A1PI), a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to alpha(1)-antitrypsin (AAT) deficiency. AAT deficiency is a rare, genetic disorder in which low levels of the alpha(1) protein circulating in the lungs can increase an individual's risk of developing emphysema.

10 Dec 2010

FDA grants approval to manufacture Collagenase SANTYL Ointment at DPT Laboratories' facility

Healthpoint today announced that the U.S. Food and Drug Administration has granted approval to manufacture commercial supplies of Collagenase SANTYL Ointment, a biologic enzymatic debriding agent, at DPT Laboratories' Center of Excellence for Sterile & Specialty Products facility in Lakewood, New Jersey.

10 Dec 2010

Sunovion reports results of Latuda third phase 3 worldwide clinical trial for schizophrenia

Sunovion Pharmaceuticals Inc. today announced the results of the PEARL 3 study, the third phase 3 worldwide clinical trial of Latuda® (lurasidone HCl) tablets, a once-daily atypical antipsychotic agent recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with schizophrenia. In this six-week, placebo-controlled trial, both fixed doses of LATUDA 80 and 160 mg once-daily, demonstrated statistically significant improvement in symptoms of schizophrenia versus placebo across both primary and secondary efficacy measures.

9 Dec 2010

Data from comparative REVLIMID study in multiple myeloma presented at 52nd ASH

Celgene International Sàrl today announced that data from a randomised clinical study conducted by the Eastern Cooperative Oncology Group (ECOG) were presented at the 52nd Annual Meeting of the American Society of Hematology comparing REVLIMID® (lenalidomide) plus low-dose dexamethasone (Rd) to lenalidomide plus high-dose dexamethasone (RD) in both younger and older newly-diagnosed multiple myeloma patients (NDMM).

7 Dec 2010

Interim results from Cytheris CYT107 Phase I clinical trial in TCD bone marrow transplant patients

Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced interim results from a Phase I clinical trial of its investigational drug candidate, recombinant human Interleukin-7 (CYT107), in the treatment of post-transplant patients with T-cell depleted (TCD) bone marrow or peripheral blood stem cell transplants.