Hypersensitivity News and Research

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

FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

12 Oct 2011

DARA BioSciences' KRN5500 reduces neuropathic pain in patients with cancer

DARA BioSciences, Inc. today announced the Journal of Pain and Symptom Management, an internationally respected, peer-reviewed journal, has published results of a Phase II safety and efficacy study of KRN5500 for the treatment of neuropathic pain in patients with cancer.

11 Oct 2011

Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler.

10 Oct 2011

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved JUVISYNC(sitagliptin and simvastatin), a new treatment for type 2 diabetes that combines the glucose-lowering medication sitagliptin, the active component of JANUVIA (sitagliptin), with the cholesterol-lowering medication ZOCOR.

10 Oct 2011

JCO publishes data from Celgene's ABRAXANE Phase II combination trial on pancreatic cancer

Celgene International Sàrl today announced that results from a clinical study of ABRAXANE in combination with gemcitabine in 67 patients with previously untreated advanced pancreatic cancer were published in an online article by the Journal of Clinical Oncology ahead of print.

7 Oct 2011

Almirall seeks European approval for linaclotide to treat irritable bowel syndrome with constipation

Almirall, S.A. announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for linaclotide, an investigational guanylate cyclase-C (GC-C) receptor agonist for the treatment of irritable bowel syndrome with constipation (IBS-C). Once approved, linaclotide will be marketed in Europe under the trademark Constella®.

29 Sep 2011

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

Ironwood Pharmaceuticals, Inc. today announced that its European partner Almirall, S.A. submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the treatment of irritable bowel syndrome with constipation.

29 Sep 2011

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Butrans (Buprenorphine) Transdermal System CIII 20 mcg/hour provided significantly lower "average pain over the last 24 hours" scores compared to Butrans 5 mcg/hour when used in opioid-experienced patients with moderate-to-severe chronic low back pain, according to a pivotal Phase 3 clinical study published in the online, August issue of The Journal of Pain.

26 Sep 2011

Data from Amgen's XGEVA and Vectibix studies to be presented at EMCC 2011

Amgen announced today that data from XGEVA (denosumab) and Vectibix (panitumumab) studies will be presented at the 2011 European Multidisciplinary Cancer Congress, Sept. 23 - 27, 2011, in Stockholm, Sweden.

23 Sep 2011

Helsinn commences Netupitant/Palonosetron Phase III combination study in CINV

Helsinn Group and Eisai Inc. announced today that Helsinn has commenced a multi-centered Phase III clinical study program investigating the Netupitant/Palonosetron (300mg/0.50mg) oral fixed-dose combination for the prevention of chemotherapy-induced nausea and vomiting.

23 Sep 2011

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Celgene International Sàrl was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

23 Sep 2011

Spinifex initiates EMA401 Phase 2 trial in postherpetic neuralgia

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced the first patients have been treated in its Phase 2 clinical trial of EMA401 in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

19 Sep 2011

DARA's KRN5500 meets primary end-points in Phase II study for chemotherapy-induced neuropathic pain

Thanks to greater awareness, earlier detection and improving therapeutic agents, people with cancer are living longer than ever before. One of the consequences of living longer is the symptom burden of cancer survivorship, which may have a substantial impact on quality of life for many survivors. One such burden is the pain syndromes resulting from cancer treatments.

17 Sep 2011

Spanish research establishes factors associated with tiredness in breast cancer survivors

In Spain, 5-year survival following breast cancer diagnosis is more than 83%. Around 66% suffer fatigue following treatment. A Spanish research establishes the factors associated with tiredness in cancer survivors to improve their quality of life and rehabilitation.

15 Sep 2011

Jefferson neurologist receives Harold G. Wolff Lecture Award for migraine headache model

Michael L. Oshinsky, Ph.D., assistant professor of Neurology at Jefferson Medical College of Thomas Jefferson University, and a member of the Jefferson Headache Center team, was recently named the 2011 Harold G. Wolff Lecture award recipient for creating a new animal model of migraine headache.

14 Sep 2011

New data from Pfizer's investigational oncology compounds to be presented at EMCC 2011

Pfizer Oncology announced today that data evaluating crizotinib in anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), as well as data from Pfizer's renal cell carcinoma (RCC) portfolio on axitinib, an investigational compound, and SUTENT(sunitinib malate) will be presented at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden, September 23 - 27, 2011.

14 Sep 2011

Merck issues statement on GARDASIL human papillomavirus vaccine

Merck, known as MSD outside the United States and Canada, issued the following statement on GARDASIL, Merck's vaccine to protect against certain diseases caused by human papillomavirus (HPV) types 6, 11, 16 and 18.

14 Sep 2011

ViroPharma initiates Cinryze Phase 2 subcutaneous trial in patients with HAE

ViroPharma Incorporated and Halozyme Therapeutics announced today that ViroPharma has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous administration of Cinryze in combination with Halozyme's Enhanze technology, a proprietary drug delivery platform using Halozyme's recombinant human hyaluronidase enzyme, in subjects with hereditary angioedema.

14 Sep 2011

Chronic pain gene discovered

Scientists have found the gene responsible for chronic pain. It said that this could lead to drugs for treating long-lasting back pain.

12 Sep 2011

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

9 Sep 2011

Hypersensitivity News and Research

FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

DARA BioSciences' KRN5500 reduces neuropathic pain in patients with cancer

Boehringer Ingelheim receives FDA approval for COMBIVENT RESPIMAT to treat COPD

Merck receives FDA approval for JUVISYNC to treat type 2 diabetes

JCO publishes data from Celgene's ABRAXANE Phase II combination trial on pancreatic cancer

Almirall seeks European approval for linaclotide to treat irritable bowel syndrome with constipation

Almirall submits linaclotide MAA to EMA for treatment of IBS-C

The Journal of Pain publishes results from Butrans Transdermal System Phase 3 clinical study

Data from Amgen's XGEVA and Vectibix studies to be presented at EMCC 2011

Helsinn commences Netupitant/Palonosetron Phase III combination study in CINV

E.U. CHMP issues positive opinion for use of Celgene's REVLIMID/dexamethasone MM drug

Spinifex initiates EMA401 Phase 2 trial in postherpetic neuralgia

DARA's KRN5500 meets primary end-points in Phase II study for chemotherapy-induced neuropathic pain

Spanish research establishes factors associated with tiredness in breast cancer survivors

Jefferson neurologist receives Harold G. Wolff Lecture Award for migraine headache model

New data from Pfizer's investigational oncology compounds to be presented at EMCC 2011

Merck issues statement on GARDASIL human papillomavirus vaccine

ViroPharma initiates Cinryze Phase 2 subcutaneous trial in patients with HAE

Chronic pain gene discovered

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

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