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 XenoPort, GSK’s Horizant ER tablets for management of PHN

GlaxoSmithKline plc (GSK) and XenoPort, Inc. announced today that the United States (US) Food and Drug Administration (FDA) has approved Horizant (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.

7 Jun 2012

New immune response data from Generex’s AE37 Phase II trial on breast cancer

Generex Biotechnology Corporation announced today that new immune response data from the on-going Phase II clinical trial of the AE37 breast cancer vaccine undertaken by Generex wholly-owned subsidiary Antigen Express, Inc. was presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 2, 2012 in Chicago, IL.

6 Jun 2012

Results from Celgene’s ABRAXANE plus gemcitabine clinical study on resectable pancreatic cancer

Celgene International Sàrl, a subsidiary of Celgene Corporation today announced results from a study of ABRAXANE(paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in patients with resectable pancreatic cancer.

5 Jun 2012

Positive results from BioSpecifics’ XIAFLEX Phase III clinical program on Peyronie's disease

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX in the U.S. and XIAPEX in Europe and Eurasia, today announced positive top-line results from the IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program of XIAFLEX for the treatment of Peyronie's disease, which was conducted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc.

5 Jun 2012

Positive results from Auxilium’s XIAFLEX phase III studies on Peyronie's disease

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line results from its IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III studies that assessed XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office, first-in-class biologic therapy for the potential treatment of Peyronie's disease (PD).

4 Jun 2012

Lilly, Kowa announce results from PREVAIL U.S. study

Kowa Pharmaceuticals America, Inc. and Eli Lilly and Company today announced results of the PREVAIL U.S. study (Pitavastatin compaREd with praVAstatin In Lowering LDL-C in the U.S.) which evaluated the efficacy of LIVALO (pitavastatin) 4 mg compared with pravastatin 40 mg in reducing low-density lipoprotein cholesterol (LDL-C), the primary endpoint, as well as effects on other lipid parameters and lipoprotein particles in adult patients with primary hyperlipidemia or mixed dyslipidemia.

2 Jun 2012

Researchers identify mechanism key in drug allergy

Adverse drug reactions are a major issue that cause harm, are costly and restrict treatment options for patients and the development of new drugs. A groundbreaking finding by researchers from the La Jolla Institute for Allergy & Immunology could lead to a new way to dramatically improve drug safety by identifying drugs at risk to cause potentially fatal genetic-linked hypersensitivity reactions before their use in man.

30 May 2012

Intensity of itching in eczema linked to depression

Itch intensity in atopic dermatitis is related to the stress level and emotional wellbeing of patients, say researchers.

30 May 2012

Merck welcomes launch of ROTATEQ in Rwanda of Africa’s rotavirus vaccination program

Merck, known as MSD outside the United States and Canada, welcomes today's launch in Rwanda of Africa's first national rotavirus vaccination program with ROTATEQ (rotavirus vaccine, live, oral, pentavalent), Merck's vaccine for the prevention of rotavirus disease.

25 May 2012

Study reveals why people develop life-threatening drug allergies

A research team led by the University of Melbourne and Monash University, Australia, has discovered why people can develop life-threatening allergies after receiving treatment for conditions such as epilepsy and AIDS.

25 May 2012

UCSF scientists aim to use embryonic stem cells for treatment of neuropathic pain

Chronic pain, by definition, is difficult to manage, but a new study by UCSF scientists shows how a cell therapy might one day be used not only to quell some common types of persistent and difficult-to-treat pain, but also to cure the conditions that give rise to them.

25 May 2012

Severe hypersensitivity reactions to anti-HIV drug occur through autoimmune mechanism

Potentially severe hypersensitivity reactions to the anti-HIV drug abacavir occur through an autoimmune mechanism, resulting from the creation of drug-induced immunogens that are attacked by the body's immune system, according to a study published online by the journal AIDS, official journal of the International AIDS Society.

23 May 2012

Researchers identify new mechanism for drug-related autoimmune reactions

A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions.

23 May 2012

Pernix Therapeutics introduces Omeclamox-Pak® for the treatment of H. pylori infection and duodenal ulcer disease

Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company, today announced the introduction of Omeclamox-Pak®, a ten-day therapy of omeprazole delayed-release capsules (20 mg), clarithromycin tablets (500 mg) and amoxicillin capsules (500 mg) for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adult patients.

21 May 2012

Data from Purdue Pharma’s Butrans clinical trials to be presented at APS annual meeting

Purdue Pharma L.P. will present an analysis of data from completed clinical trials for Butrans® (buprenorphine) Transdermal System CIII at the American Pain Society's (APS) 31st Annual Scientific Meeting.

19 May 2012

Pfizer announces results from Lyrica clinical studies on fibromyalgia

Pfizer Inc. announced the results of studies on Lyrica (pregabalin) capsules CV presented at the American Pain Society Annual Meeting in Honolulu.

19 May 2012

Janssen’s NUCYNTA ER tablets more effective in providing pain management in adults with DPN

Janssen Pharmaceuticals, Inc. today announced the results of an investigational Phase 3 study suggesting NUCYNTA ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy.

18 May 2012

Chinese sFDA approves Baxter's ADVATE to treat hemophilia A

Baxter International Inc. today announced the approval of ADVATE [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes in individuals with hemophilia A (congenital factor VIII deficiency) in China by the State Food and Drug Administration.

From Baxter International Inc. 17 May 2012

Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

Pfizer Inc announced that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL(temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib.

16 May 2012

NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

Celgene International Sàrl, a subsidiary of Celgene Corporation, today announced that results from three phase III studies evaluating the use of continuous REVLIMID(lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine.

11 May 2012

Hypersensitivity News and Research

FDA approves XenoPort, GSK’s Horizant ER tablets for management of PHN

New immune response data from Generex’s AE37 Phase II trial on breast cancer

Results from Celgene’s ABRAXANE plus gemcitabine clinical study on resectable pancreatic cancer

Positive results from BioSpecifics’ XIAFLEX Phase III clinical program on Peyronie's disease

Positive results from Auxilium’s XIAFLEX phase III studies on Peyronie's disease

Lilly, Kowa announce results from PREVAIL U.S. study

Researchers identify mechanism key in drug allergy

Intensity of itching in eczema linked to depression

Merck welcomes launch of ROTATEQ in Rwanda of Africa’s rotavirus vaccination program

Study reveals why people develop life-threatening drug allergies

UCSF scientists aim to use embryonic stem cells for treatment of neuropathic pain

Severe hypersensitivity reactions to anti-HIV drug occur through autoimmune mechanism

Researchers identify new mechanism for drug-related autoimmune reactions

Pernix Therapeutics introduces Omeclamox-Pak® for the treatment of H. pylori infection and duodenal ulcer disease

Data from Purdue Pharma’s Butrans clinical trials to be presented at APS annual meeting

Pfizer announces results from Lyrica clinical studies on fibromyalgia

Janssen’s NUCYNTA ER tablets more effective in providing pain management in adults with DPN

Chinese sFDA approves Baxter's ADVATE to treat hemophilia A

Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

NEJM publishes results from Celgene’s REVLIMID phase III studies on MM

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