Hypersensitivity News and Research

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

BrainTrust Canada and CSPS partner to distribute Concussion Cards to all CSPS ski patrollers

During this week - National Learn to Ski & Snowboard Week - BrainTrust Canada and the Canadian Ski Patrol System (CSPS) have launched a partnership which includes the distribution of Concussion Cards as a prevention and management tool to all 5,000 CSPS ski patrollers across the country.

20 Jan 2010

Health Canada approves Novartis' Afinitor to treat patients with mRCC

Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Afinitor(R) (everolimus), a once-daily oral cancer treatment, has been approved by Health Canada for patients with metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer, after failure of initial treatment with VEGF-receptor targeted therapies Sutent(R) (sunitinib) or Nexavar(R) (sorafenib).

20 Jan 2010

Antibiotic drops are safe and effective for treating swimmer's ear

When treating the pain and inflammation of swimmer's ear, antibiotic drops are the most effective — and safest - therapy, finds a new review of studies.

20 Jan 2010

FDA grants orphan drug exclusivity approval for Octapharma AG's wilate

Octapharma AG, one of the largest manufacturers of plasma products in the world, today announced that it has received orphan drug exclusivity approval for wilate® from the U.S. Food and Drug Administration (FDA).

18 Jan 2010

First sulfite-free rectal suspension for UC

sfRowasa™ (mesalamine) Rectal Suspension 4g/60mL –Sulfite-Free Formulation, is the first sulfite-free rectal suspension available for Ulcerative colitis (UC). According to a study published in The American Journal of Gastroenterology, products containing sulfites may exacerbate natural sulfide levels in the colon and may increase inflammation in UC patients. With its sulfite-free preparation, sfRowasa™ offers a new treatment option for the treatment of active, mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

13 Jan 2010

Cardene I.V. more effective than intravenous labetalol for BP management in acute stroke patients

EKR Therapeutics, Inc., a specialty pharmaceutical company commercializing acute-care hospital products, today said that interim study data1 demonstrate that Cardene® I.V. (nicardipine hydrochloride) is significantly more effective than intravenous labetalol for the management of blood pressure (BP) in stroke patients.

12 Jan 2010

ViroPharma signs agreement with Sanquin Blood Supply Foundation to develop and commercialize Cinryze

ViroPharma Incorporated today announced that it has signed an agreement with Sanquin Blood Supply Foundation for rights to develop, file regulatory dossiers, and commercialize Cinryze(TM) (C1 esterase inhibitor [human]) for hereditary angioedema (HAE) as well as for potential new indications in certain European and rest of world (ROW) territories.

12 Jan 2010

AMAG Pharmaceuticals provides update on the commercial launch of Feraheme Injection

AMAG Pharmaceuticals, Inc. today provided an update on the commercial launch of Feraheme® (ferumoxytol) Injection for intravenous (IV) use, including preliminary fourth quarter 2009 Feraheme net product revenues estimates, as well as an update on the Company’s international and label expansion efforts.

10 Jan 2010

Genentech's ACTEMRA approved to treat RA

Genentech, Inc., a wholly owned member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Rituximab treatment reduces patients' response to pneumonia vaccine

Researchers from Johns Hopkins University determined that immune responses to the tetanus vaccine were not changed when rituximab in combination with methotrexate (MTX) was compared with MTX alone in patients with rheumatoid arthritis (RA).

7 Jan 2010

VELCADE sNDA receives FDA approval

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

5 Jan 2010

Pfizer provides update on Prevnar 13

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13™, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company’s candidate 13-valent pneumococcal conjugate vaccine.

31 Dec 2009

Eli Lilly and Kowa Pharmaceuticals America to co-promote LIVALO in the U.S

Eli Lilly and Company (NYSE: LLY), Kowa Company, Limited, and Kowa's U.S. subsidiary, Kowa Pharmaceuticals America, Inc., today announced that Lilly and Kowa Pharmaceuticals America have entered into a co-promotion agreement in the United States to commercialize LIVALO® (pitavastatin). Lilly and Kowa have also entered into a licensing agreement in Latin America. LIVALO is a statin approved by the U.S. Food and Drug Administration (FDA) in August 2009 for the treatment of primary hyperlipidemia and mixed dyslipidemia.

24 Dec 2009

Fluzone High-Dose inactivated influenza virus vaccine receives FDA approval

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B.

24 Dec 2009

ZEGERID OTC approval triggers $20M milestone payment to Santarus

Santarus, Inc., a specialty biopharmaceutical company, today announced that it has received the $20 million milestone payment previously announced on December 1, 2009 relating to the approval of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co., Inc. Schering-Plough and Merck merged on November 3, 2009.

22 Dec 2009

New study suggests nasal allergy may be involved in chronic sinus disease

Exposing patients with chronic sinus disease to allergens and then obtaining repeated images by X-ray or ultrasound reveals that nasal allergies may be involved in some cases of chronic sinus disease, according to a report in the December issue of Archives of Otolaryngology-Head & Neck Surgery, one of the JAMA/Archives journals.

22 Dec 2009

ZymoGenetics restructures license and collaboration agreements on RECOTHROM

ZymoGenetics, Inc. today announced a restructuring of the U.S. co-promotion and ex-U.S. license and collaboration agreements with Bayer Schering Pharma AG and Bayer HealthCare relating to RECOTHROM® Thrombin, topical (Recombinant).

21 Dec 2009

Initial data from REVLIMID Phase III trial in multiple myeloma patients announced

Celgene Corporation today announced the National Cancer Institute (NCI), a part of the National Institutes of Health, reported initial data from a Phase III, randomized, double-blind, multi-center clinical study led by the Cancer and Leukemia Group B (CALGB).

18 Dec 2009

Positive results from Onset Therapeutics' BenzEFoam Emollient Foam skin moisturization study

Onset Therapeutics, a specialty pharmaceutical company focused in dermatology, today announced positive results from a skin moisturization study that compared the Company’s recently launched BenzEFoam™ (benzoyl peroxide 5.3%) Emollient Foam to a market leading combination gel containing clindamycin 1% - benzoyl peroxide 5%. BenzEFoam™ Emollient Foam is indicated for the topical treatment of mild to moderate acne vulgaris and is the first prescription foam formulation containing benzoyl peroxide as the active ingredient.

16 Dec 2009