Hypersensitivity News and Research

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

Positive results from Astellas Pharma's mirabegron phase III trial in overactive bladder

Astellas Pharma US, Inc., U.S. subsidiary of Astellas Pharma Inc., today announced the results of a pivotal phase III clinical trial for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder (OAB), which show mirabegron significantly improves key OAB symptoms – urinary incontinence and frequency of micturition compared with placebo.

18 May 2011

Daiichi Sankyo, Regency Therapeutics launch SPRIX Nasal Spray for severe pain

Regency Therapeutics, a newly established division of Luitpold Pharmaceuticals, Inc., and its co-promotion partner Daiichi Sankyo, Inc., announced today that they have launched SPRIX® (ketorolac tromethamine) Nasal Spray and that it is now commercially available.

17 May 2011

Journal of Burn Care & Research publishes Caldolor clinical study data in hospitalized patients

Cumberland Pharmaceuticals Inc. today announced that results from a clinical study evaluating the safety and efficacy of Caldolor Injection in treating fever and pain in hospitalized burn patients was published in Volume 32, Number 1 of the Journal of Burn Care & Research.

16 May 2011

Australian TGA approves Biogen Idec's FAMPYRA to improve walking ability in patients with MS

The Australian Therapeutic Goods Administration (TGA) has granted approval for FAMPYRA, (fampridine) 10 mg Modified Release (MR) tablet, for the symptomatic improvement of walking ability in adult patients with multiple sclerosis (MS) who have shown improvement after eight weeks of treatment.

16 May 2011

ViroPharma, Halozyme sign license deal to develop Cinryze against hereditary angioedema

Halozyme Therapeutics, Inc. and ViroPharma Incorporated, today announced the signing of a worldwide exclusive licensing agreement for the use of rHuPH20 in the development of a subcutaneous formulation of Cinryze .

12 May 2011

Journal of Rheumatology publishes positive results from Cimzia Phase III trial in RA

UCB announced today results from a post hoc analysis of the RAPID 1 study published in the Journal of Rheumatology. The results suggest moderate to severe rheumatoid arthritis patients treated with Cimzia, the only approved PEGylated anti-TNF, together with methotrexate, achieved a rapid response associated with improved long-term outcomes one year after treatment began.

11 May 2011

Ipsen first quarter sales increase 6.1% to €285.8 million

Ipsen reported today its sales for the first quarter 2011.

3 May 2011

AstraZeneca receives FDA approval for NEXIUM I.V. to treat GERD with erosive esophagitis

AstraZeneca announced today that the U.S. Food and Drug Administration has approved the use of NEXIUM I.V. for Injection for children ages greater than 1 month old for the short-term treatment of gastroesophageal reflux disease with erosive esophagitis when oral therapy is not possible or appropriate.

3 May 2011

Temsirolimus with chemotherapy may serve as promising therapy for mesothelioma

A drug commonly used to treat kidney cancer may increase the effectiveness of chemotherapy for mesothelioma, according to a study published in the May issue of the Journal of Thoracic Oncology.

2 May 2011

Bayer expands sponsorship agreement with World Federation of Hemophilia

Bayer HealthCare Pharmaceuticals and the World Federation of Hemophilia are announcing a three-year extension of Bayer's sponsorship agreement with WFH.

29 Apr 2011

The Lancet publishes phase 3 clinical study data on VIVITROL for treatment of opioid dependence

Alkermes, Inc. today announced that results from the phase 3 clinical study of VIVITROL® (naltrexone for extended-release injectable suspension) in opioid dependence have been published by The Lancet. The six-month, phase 3 trial met its primary endpoint and showed significantly greater opioid-free weeks among patients treated with VIVITROL, compared to placebo.

28 Apr 2011

Millennium submits two VELCADE sNDAs to FDA

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that it has submitted two supplemental new drug applications (sNDAs) for VELCADE® (bortezomib) for Injection to the U.S. Food and Drug Administration. The first application seeks to add a subcutaneous route of administration for VELCADE. The second application is for the use of VELCADE in combination with rituximab in patients with relapsed follicular non-Hodgkin lymphoma (NHL).

26 Apr 2011

FDA approves Bayer's new Kogenate FS storage option for hemophilia A treatment

Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved a new storage option for Kogenate FS, antihemophilic factor, now allowing the product to be stored at room temperature for up to one year.

26 Apr 2011

Nausea and vomiting are most feared of all chemotherapy-related side effects

PediatRx, Inc. today commented on studies which reveal that chemotherapy-induced nausea and vomiting is one of the most feared of all chemotherapy-related side effects. The fear of nausea and subsequent vomiting is many times so significant that patients can develop a condition known as 'anticipatory' nausea, where the patient becomes nauseous primarily as a result of the fear of becoming nauseous.

25 Apr 2011

Rwanda, QIAGEN and Merck launch comprehensive national cervical cancer prevention program

The Government of Rwanda, together with QIAGEN N.V. and Merck, known as MSD outside the United States and Canada, today announced the launch, in Kigali, Rwanda, of a comprehensive national cervical cancer prevention program that includes vaccination with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls 12 to 15 years of age and modern molecular diagnostic screening for women between the ages of 35 and 45.

From QIAGEN Manchester Limited 25 Apr 2011

FDA approves Sanofi Pasteur's meningococcal vaccine

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration has granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra, to include a two-dose schedule for infants and children 9 months through 23 months of age.

25 Apr 2011

Salix Pharmaceuticals receives three U.S. patents relating to rifaximin

Salix Pharmaceuticals, Ltd. today announced that the U.S. Patent and Trademark Office has issued three patents relating to rifaximin.

21 Apr 2011

Baxter enters definitive agreement to acquire Prism

Baxter International Inc. announced today that it has entered into a definitive agreement to acquire privately-held Prism Pharmaceuticals, Inc., a specialty pharmaceutical company based in King of Prussia, PA. Prism Pharmaceuticals has developed and received U.S. Food and Drug Administration (FDA) approval for multiple presentations of NEXTERONE® (amiodarone HCl), an antiarrhythmic agent.

From Baxter International Inc. 18 Apr 2011

CHMP adopts EU positive opinion for TYSABRI labeling with anti-JCV antibody status

Biogen Idec and Elan Corporation, plc today announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion for inclusion of an additional risk factor, anti-JC virus (JCV) antibody status, to the product label for TYSABRI in the European Union.

18 Apr 2011

Baxter's ARTISS phase III study results in face lift surgery presented at AAPS meeting

Baxter International Inc. announced today the results of a phase III study evaluating the safety and efficacy of ARTISS in 75 patients.

From Baxter International Inc. 12 Apr 2011