Hypersensitivity News and Research

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

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Merck announced a non-exclusive license agreement with Laboratory Corporation of America Holdings for the commercialization of a genetic test that may help predict the response of patients with Hepatitis C virus infection to peginterferon alpha-based therapy.

28 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010. The Company reported total revenue of $164.4 million for the quarter ended June 30, 2010, which includes net product sales of $162.5 million. Net loss, excluding a restructuring charge of $3.4 million, was $40.8 million, or $0.28 per share.

22 Jul 2010

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Dyax Corp. today announced that it has launched its newly enhanced product website, www.KALBITOR.com, featuring its comprehensive financial assistance program. KALBITOR (ecallantide) is approved for the treatment of acute attacks of hereditary angioedema in patients 16 years of age and older.

20 Jul 2010

Eisai's NDA for BANZEL Oral Suspension accepted for FDA review

Eisai Inc., a U.S. subsidiary of Eisai Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's NDA for BANZEL® (rufinamide) Oral Suspension (40 mg/mL).

19 Jul 2010

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

GTC Biotherapeutics, Inc. announced today that it has signed a definitive agreement whereby the Company has regained US commercialization rights to ATryn from Lundbeck, Inc., a wholly owned subsidiary of H. Lundbeck A/S in Denmark.

17 Jul 2010

First-of-its-kind patient, healthcare provider support program for management of HE

Concentric Pharma Advertising, an independent healthcare advertising and marketing agency, announces the creation of Salix Pharmaceuticals' Hepatic Encephalopathy Living Program. H.E.L.P. launched May 24, 2010, and coincides with the launch of Xifaxan550 (rifaximin) for the management of patients 18 or older at risk for overt hepatic encephalopathy recurrence.

16 Jul 2010

Lantheus Medical Imaging, JBCPL partner to launch DEFINITY ultrasound contrast imaging agent in India

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the launch of its ultrasound contrast imaging agent, DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, in India. The company has signed a multi-year agreement with Mumbai-based J.B. Chemicals & Pharmaceuticals, Ltd. for the distribution and marketing of DEFINITY® in the Indian marketplace.

15 Jul 2010

New REMESENSE TOOTH DESENSITIZER for treating tooth hypersensitivity

Nuline Pharmaceuticals, LLC announces the introduction of REMESENSE (dipotassium oxalate 3%) TOOTH DESENSITIZER, an Rx Class II medical device now available in the U.S. REMESENSE was introduced globally in 2008. It is presently sold in 16 countries, ranging from England and the European Union to Asia and Africa. Nuline expects to launch REMESENSE in Canada and other countries later this year or by early 2011.

15 Jul 2010

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

Cumberland Pharmaceuticals Inc. today announced that data supporting the efficacy of Caldolor in treating fever associated with falciparum malaria was published in the July edition of the peer-reviewed American Journal of Tropical Medicine and Hygiene. The study, which is the first to document an antipyretic effect of an injectable non-steroidal anti-inflammatory drug on fever caused by malaria, demonstrated that patients who received intravenous ibuprofen experienced a greater reduction in their temperatures than those who received placebo.

13 Jul 2010

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

GE Healthcare Medical Diagnostics today announced the market reintroduction of Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a diagnostic ultrasound contrast agent for use in select echocardiograms. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve the delineation of the left ventricular endocardial borders. The safety and efficacy of Optison with exercise stress or pharmacologic stress testing have not been established.

12 Jul 2010

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Pfizer Inc, the world's leading biopharmaceutical company, today announced that the results of a number of hemophilia studies will be presented at the World Federation of Hemophilia 2010 Congress taking place July 10-14, 2010, in Buenos Aires, Argentina. Key research includes a pre-clinical evaluation of recombinant factor Xa as a potential new approach to restoring hemostasis, as well as a study assessing the potential for an engineered recombinant factor VIIa molecule to improve therapeutic outcomes in mouse models of hemophilia.

9 Jul 2010

Ethicon launches OMNEX Surgical synthetic sealant

Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON™ OMNEX™ Surgical Sealant, ETHICON™ Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON™ OMNEX™ Surgical Sealant.

8 Jul 2010

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, in collaboration with APR Applied Pharma Research s.a. of Switzerland and Labtec GmbH of Germany, today announced that its partner, Strativa Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Zuplenz® oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

8 Jul 2010

European Commission approves new indication for ORENCIA in combination with MTX for RA

Bristol-Myers Squibb Company has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.

7 Jul 2010

US WorldMeds launches Revonto for malignant hyperthermia

US WorldMeds is proud to announce the launch of Revonto™ (dantrolene sodium for injection), the first patented scientific advancement in the treatment of malignant hyperthermia (MH). The time to reconstitute dantrolene sodium for injection has been dramatically reduced to approximately 20 seconds or until the solution is clear. Revonto™ retains the cost-savings of the original dantrolene sodium for injection product while offering a significant improvement in pharmacotherapy.

7 Jul 2010

Fera Pharmaceuticals launches Neptazanetm tablets for reducing intraocular pressure

Fera Pharmaceuticals is pleased to announce the launch of Neptazane (Methazolamide) 25 mg and 50 mg tablets. Both strengths are available in 90 count bottles.

3 Jul 2010

Strativa receives FDA approval for Zuplenz oral soluble film

Strativa Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved Zuplenz® (ondansetron) oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. Zuplenz, a unique formulation of ondansetron, is the first oral soluble film approved by the FDA as a prescription medication.

3 Jul 2010

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

Shire plc, the global specialty biopharmaceutical company, today announced positive data from its long-term extension to its open label Phase I/II study (TKT-025 EXT) for VPRIV® (velaglucerase alfa), the company's enzyme replacement therapy for patients with type 1 Gaucher disease. The data were presented at the 9th Annual European Working Group on Gaucher Disease (EWGGD) in Cologne, Germany, and add to the growing body of clinical evidence which supports the safety and sustained efficacy of VPRIV.

2 Jul 2010

FDA approves Purdue's Butrans Transdermal System CIII for management of chronic pain

Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Butrans™ (buprenorphine) Transdermal System CIII for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid analgesic for an extended period of time. Butrans Transdermal System is an analgesic product that delivers continuous release of medication for seven days.

2 Jul 2010

Hypersensitivity News and Research

Merck signs non-exclusive license agreement with LabCorp for commercialization of genetic test

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Dyax launches newly enhanced product website featuring comprehensive financial assistance program

Eisai's NDA for BANZEL Oral Suspension accepted for FDA review

GTC Biotherapeutics regains US commercialization rights to ATryn from Lundbeck

First-of-its-kind patient, healthcare provider support program for management of HE

Lantheus Medical Imaging, JBCPL partner to launch DEFINITY ultrasound contrast imaging agent in India

New REMESENSE TOOTH DESENSITIZER for treating tooth hypersensitivity

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

GE Healthcare Medical Diagnostics reintroduces Optison ultrasound contrast agent for echocardiograms

Pfizer to present results of hemophilia studies at WFH 2010 Congress

Ethicon launches OMNEX Surgical synthetic sealant

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

European Commission approves new indication for ORENCIA in combination with MTX for RA

US WorldMeds launches Revonto for malignant hyperthermia

Fera Pharmaceuticals launches Neptazanetm tablets for reducing intraocular pressure

Strativa receives FDA approval for Zuplenz oral soluble film

Shire presents positive data from TKT-025 EXT Phase I/II study for VPRIV in type 1 Gaucher disease patients

FDA approves Purdue's Butrans Transdermal System CIII for management of chronic pain

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