Hypersensitivity News and Research

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

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

FDA approves TachoSil adjunctive hemostatic agent for use in cardiovascular surgery

Baxter International Inc. and Nycomed today announced the U.S. Food and Drug Administration (FDA) approval of TachoSil (Absorbable Fibrin Sealant Patch) for use as an adjunct to hemostasis in cardiovascular surgery. TachoSil is the first and only adjunctive hemostatic agent available in the U.S. that combines a collagen patch with a coating of human coagulation factors.

From Baxter International Inc. 7 Apr 2010

TachoSil blood-clotting patch receives FDA approval for cardiovascular surgery

The U.S. Food and Drug Administration today approved TachoSil, the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical.

6 Apr 2010

Schering-Plough HealthCare Products commences promotion of ZEGERID OTC in North America

Santarus, Inc., a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc., the consumer healthcare subsidiary of Merck & Co., Inc., has commenced promotion of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its licensing agreement with Santarus for the over-the-counter (OTC) market in North America. The OTC heartburn market in the U.S. is estimated at approximately $1.8 billion based on data from market research firm Information Resources, Inc. and Santarus estimates.

2 Apr 2010

AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited today jointly announced that the companies have entered into a license, development and commercialization agreement related to Feraheme® (ferumoxytol) Injection for intravenous (IV) use in all therapeutic indications.

1 Apr 2010

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

Genta Incorporated today announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company's newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development.

31 Mar 2010

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

ViroPharma Incorporated today announced that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze™ (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age with hereditary angioedema.

31 Mar 2010

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

30 Mar 2010

Erbitux can now be used in Japan as 1st-line treatment for mCRC: Merck Serono

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that Erbitux® (cetuximab) can now be used in Japan in combination with chemotherapy in the 1st-line treatment for patients with epidermal growth factor receptor -expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer carrying the KRAS wildtype gene.

29 Mar 2010

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Shire plc, the global specialty biopharmaceutical company, today presented positive data from a Phase III clinical trial (TKT-034) designed to evaluate the safety of switching to VPRIV (velaglucerase alfa for injection), from imiglucerase, as well as an interim analysis of safety data from an ongoing multicenter open-label treatment protocol (HGT-GCB-058) implemented to provide VPRIV to patients affected by the continuing shortage of imiglucerase.

26 Mar 2010

Biogen Idec and Elan begin comparative trial of MS treatments

Biogen Idec and Elan Corporation, plc (NYSE: ELN) today announced enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI® (natalizumab) from Copaxone® (glatiramer acetate) or Rebif® (interferon beta-1a) in patients with relapsing remitting multiple sclerosis.

25 Mar 2010

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

ViroPharma Incorporated today announced that the European Medicines Agency (EMA) has accepted the filing of its Marketing Authorization Application for Cinryze for acute treatment and prophylaxis against hereditary angioedema, which was submitted through the centralized procedure in March 2010. ViroPharma is seeking European approval for both prevention and treatment of acute attacks of hereditary angioedema.

25 Mar 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Pfizer to supply pneumococcal conjugate vaccines for infants and children

Pfizer Inc. today announced it has signed a 10-year Provisional Supply Agreement to supply Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]), the company’s 13-valent pneumococcal conjugate vaccine, for infants and young children in the world’s poorest countries under the terms of the Advance Market Commitment (AMC) pilot project against pneumococcal disease.

24 Mar 2010

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma Incorporated today announced the presentation of two abstracts relating to Cinryze™ (C1 esterase inhibitor [human]) therapy at the First International Congress of the Southern European Allergy Society in Florence, Italy.

19 Mar 2010

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

ViroPharma Incorporated today announced the launch of 'Ryze Above' (www.ryzeabove.com), an exclusive patient resources program within the company's patient support program, CINRYZESolutions®. The Ryze Above program was created for HAE patients prescribed Cinryze, the first and only drug specifically approved to help prevent swelling and/or painful attacks in teenagers and adults with HAE.

19 Mar 2010

Hypersensitivity News and Research

Survey reveals Gamunex as preferred IGIV therapy among neurologists

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

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

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

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

FDA approves TachoSil adjunctive hemostatic agent for use in cardiovascular surgery

TachoSil blood-clotting patch receives FDA approval for cardiovascular surgery

Schering-Plough HealthCare Products commences promotion of ZEGERID OTC in North America

AMAG Pharmaceuticals, Takeda Pharmaceutical announce Feraheme collaboration

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Erbitux can now be used in Japan as 1st-line treatment for mCRC: Merck Serono

Positive data from Shire's Phase III trial of TKT-034 in Type 1 Gaucher disease patients who switched to VPRIV

Biogen Idec and Elan begin comparative trial of MS treatments

EMA accepts MAA filing of ViroPharma's Cinryze for HAE

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Pfizer to supply pneumococcal conjugate vaccines for infants and children

ViroPharma to present Cinryze data at Southern European Allergy Society congress

ViroPharma launches 'Ryze Above' for patients with HAE enrolled in CINRYZESolutions support program

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