Hypersensitivity News and Research

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

ViroPharma initiates multi-dose Phase 2 study of Cinryze in patients with HAE

ViroPharma Incorporated today announced that it has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze (C1 esterase inhibitor [human)] in 24 adolescents and adult subjects with hereditary angioedema.

27 Apr 2010

Nuvo Research's PENNSAID now available in U.S. pharmacies

Nuvo Research Inc., a drug development company focused on the research and development of drug products that are delivered to and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced that PENNSAID(R) (diclofenac sodium topical solution) 1.5% w/w, is now available by prescription in U.S. pharmacies.

27 Apr 2010

Covidien introduces PENNSAID to the U.S. market

Covidien, a leading global provider of healthcare products, has introduced PENNSAID (diclofenac sodium topical solution) 1.5% w/w to the U.S. market. PENNSAID is the only FDA-approved topical non-steroidal anti-inflammatory drug in a vehicle solution containing dimethyl sulfoxide, a known penetrating agent. It is indicated for treatment of the signs and symptoms of osteoarthritis of the knee(s).

26 Apr 2010

Covidien launches EXALGO Extended-Release Tablets in the US

Covidien, a leading global provider of healthcare products, today introduced EXALGO™ (hydromorphone HCI) Extended-Release Tablets, (CII), the only extended-release hydromorphone treatment available in the United States. This proven therapy, combined with an innovative delivery system, provides opioid-tolerant patients suffering from moderate-to-severe chronic pain relief for 24 hours per dose.

26 Apr 2010

Merck to market and distribute MBL's Td vaccine in the U.S.

MassBiologics of the University of Massachusetts Medical School and Merck & Co., Inc. announced today that they have entered into an agreement that provides Merck with exclusive rights to market and distribute MBL's tetanus and diphtheria toxoids adsorbed (Td) vaccine in the United States, with the exception of Massachusetts, where MBL will continue distributing the vaccine.

21 Apr 2010

ABRAXANE-bevacizumab combination therapy may exhibit potential in treatment of triple-negative breast cancers

Abraxis BioScience, Inc., a fully integrated biotechnology company, announced study results today that demonstrate a regimen of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) given in combination with bevacizumab (Avastin®) may have potential in the treatment of triple-negative breast cancers.

21 Apr 2010

Patients dismissed from hospital with noncardiac chest pain continue to experience cardiac events: Study

The growing number of Americans with cardiovascular disease has caused a heightened sensitivity in the evaluation of chest pain. In a study published in the April issue of Mayo Clinic Proceedings researchers reported that patients dismissed from the hospital with noncardiac chest pain continue to experience cardiac events, which may highlight a need for more aggressive cardiovascular risk factor management in this population.

21 Apr 2010

TYSABRI drives Biogen Idec's first-quarter revenues of $1.1 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its first quarter 2010 results.

20 Apr 2010

Study shows beneficial impact of TYSABRI on QoL in MS patients

Biogen Idec and Elan Corporation, plc today announced results from a one-year, longitudinal health outcomes studys 62nd Annual Meeting in Toronto, April 10 - 17, 2010. The AAN Annual Meeting is the world's largest gathering of neurologists.

17 Apr 2010

Strativa Pharmaceuticals: Oravig buccal tablets receive FDA approval for OPC

Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis, more commonly known as thrush, in adults and children age 16 and older.

17 Apr 2010

Ibuprofen demonstrates efficacy over acetaminophen for treatment of pain and fever

Cumberland Pharmaceuticals Inc. today announced results from a meta-analysis comparing the efficacy and safety of ibuprofen and acetaminophen, which was published in the March edition of the peer-reviewed journal The Annals of Pharmacotherapy. The publication notes that in a majority of evaluated studies ibuprofen demonstrated superior efficacy compared to acetaminophen for the treatment of pain and fever, and found no significant safety differences between the drugs.

15 Apr 2010

Patients with RLS using rotigotine achieve sustained improvements

New data presented at the 62nd American Academy of Neurology annual meeting in Toronto, Canada, showed that patients with moderate to severe Restless Legs Syndrome using rotigotine achieved sustained improvements in symptoms over 5 years of treatment.

15 Apr 2010

Phase II GAMMAGARD clinical study for Alzheimer's disease: 18-month results announced

Baxter International Inc. and New York-Presbyterian Hospital/Weill Cornell Medical Center today announced results of an 18-month Phase II clinical study of GAMMAGARD LIQUID and GAMMAGARD S/D [Immune Globulin Intravenous (Human)] (marketed as KIOVIG outside of the U.S.) for mild-to-moderate Alzheimer's disease. This marked the first announcement of clinical trial results measuring function and cognition in patients who received uninterrupted GAMMAGARD for a period of 18 months.

From Baxter International Inc. 15 Apr 2010

Alkermes submits VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that it has submitted a supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) to the U.S. Food and Drug Administration (FDA) for approval as a treatment for opioid dependence. The company requested a priority review for its sNDA and if granted by the FDA, it would mean a six month review timeline.

13 Apr 2010

MS drug TYSABRI to be highlighted at 62nd AAN Annual Meeting

Biogen Idec and Elan Corporation, plc today announced 15 company-sponsored platform and poster presentations at the American Academy of Neurology's (AAN) 62nd Annual Meeting in Toronto, April 10 - 17, 2010. The AAN Annual Meeting is the world's largest gathering of neurologists.

13 Apr 2010

Survey reveals Gamunex as preferred IGIV therapy among neurologists

Talecris Biotherapeutics, Inc., today announced results of a new survey showing that Gamunex® (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) is the preferred immune globulin intravenous (IGIV) among neurologists who indicated a brand preference. In the survey, conducted online by Harris Interactive® on behalf of Talecris, neurologists selected Gamunex over four times more often than all other available liquid IGIV therapies, with a statistically significant margin (p<0.05).

13 Apr 2010

AED Vimpat to be the subject of numerous studies and analyses at AAN meeting

The antiepileptic drug Vimpat- (lacosamide) (C-V) will be the subject of numerous studies and analyses-both UCB-sponsored and independent-at the 62nd annual American Academy of Neurology meeting, taking place at the Metro Toronto Convention Centre in Toronto from April 10-17.

9 Apr 2010

Parents lack understanding of causes, signs and symptoms of dehydration in children

Dehydration is a condition that can have a significant impact on children and, if left untreated, may lead to serious complications and hospitalization. A national survey of more than 800 parents with children between the ages of one month and 10 years found that three out of five parents reported needing to know more information about dehydration, such as when to see a physician, warning signs, and treatment, if their child became sick - pointing to a greater need for awareness and education around the condition and its treatment.

From Baxter International Inc. 8 Apr 2010

DNA barcoding-sequencing of gene in sand flies identifies two species carrying Leishmania naiffi

In the first survey of sand flies in Panama to use genetic barcoding, scientists at the Smithsonian Tropical Research Institute and Gorgas Memorial Laboratories identified 20 sand fly species from Barro Colorado Island. Two species carried Leishmania naiffi, a parasite that causes cutaneous leishmaniasis: persistent, itchy skin lesions. Three species carried Wolbachia, a bacterial parasite of insects that could contribute to a strategy to control the flies and limit disease transmission.

7 Apr 2010

FDA grants "Fast Track" designation for Genta’s advanced gastric cancer drug tesetaxel

Genta Incorporated today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.

7 Apr 2010