Anaphylaxis News and Research

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Anaphylaxis is an acute multi-system severe type I hypersensitivity reaction. Due in part to the variety of definitions, between 1% and 15% of the population of the United States can be considered "at risk" for having an anaphylactic reaction if they are exposed to one or more allergens. Of those people who actually experience anaphylaxis, up to 1% may die as a result.

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

Grifols receives FDA approval for Alphanate to treat vCJD

Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain today announced that it received approval from the US Food and Drug Administration for revised labeling for Alphanate Antihemophilic Factor/von Willebrand Factor Complex indicating that certain manufacturing steps have been shown to reduce the infectivity of a experimental TSE agent that is a model for variant Creutzfeldt Jakob Disease.

5 Mar 2011

Scientists devise new on-line calculator to predict food allergies in children

An on-line calculator that predicts, within seconds, the presence of the three major food allergies in children has been developed by researchers at University College Cork.

2 Mar 2011

Experts offer myth-busting advice to fight against spring allergies

Millions of Americans sneeze and wheeze March through June when they use misinformation to manage their spring allergies.

27 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011

New guidelines recommend routine use of allergy tests to improve quality of care in children

The first guidelines for food allergy in children and young people issued by NICE, National Institute for health and Clinical Excellence, recommend routine use of allergy tests in NHS primary care and community settings to confirm suspected food allergy.

24 Feb 2011

ASC launches ACT NOW to offer support, education about asthma and respiratory allergies

In response to increasing public enquiries for information on respiratory allergies, the Asthma Society of Canada announced today the launch of Allergies Count Too, NOW a program that will fill the gap in allergy education and provide critical information to Canadians.

9 Feb 2011

AMAG receives Health Canada Notice of Non-Compliance for Feraheme NDS

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has received a Notice of Non-Compliance (NON) from Health Canada regarding its New Drug Submission (NDS) for Feraheme® (ferumoxytol) injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients.

9 Feb 2011

Dermatologists advise parents of young children about atopic dermatitis, food allergies

Atopic dermatitis, one of the most common forms of eczema in this family of inflammatory skin diseases, is a chronic disease marked by red, cracked and itchy skin. Now, increasing evidence indicates atopic dermatitis is a precursor to allergic diseases rather than a consequence. Dermatologists are advising parents of infants and young children affected by this common skin condition to be aware of the potential for future food allergies.

5 Feb 2011

Canadian government urged to approve proposed federal food labelling regulations

Prime Minister Stephen Harper is being asked to act on the concerns of millions of Canadians with food allergies and celiac disease and listen to the advice of prominent national medical, consumer and health organizations and pass proposed federal food labelling regulations now. The Prime Minister is also encouraged to heed the results of a new public opinion poll showing close to 70% of Canadians want regulations to affect all pre-packaged food and beverages and not grant a special exemption for the beer industry.

3 Feb 2011

Merck announces publication of GARDASIL pivotal Phase III study data in NEJM

Merck announced today that data from the pivotal Phase III study with GARDASIL in males were published in the February 3 issue of the New England Journal of Medicine.

3 Feb 2011

Anaphylaxis through the eyes of the food-allergic child

New research shows young people who have experienced life-threatening anaphylactic shock from specific food exposures have significantly different views of the risks associated with their allergies based on their age and can benefit from discussing their perceptions of the safety of their school environment in improving their ability to cope.

27 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Studies show XIFAXAN 550 mg tablets demonstrate significant relief of global IBS symptoms

Salix Pharmaceuticals, Ltd. today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company's two pivotal Phase 3 efficacy and safety studies of XIFAXAN (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS.

6 Jan 2011

DBV Technologies secures $25.5 million in Series C financing round

DBV Technologies, an emerging biotechnology company, announced today that it has secured $25.5 million (€19,4 million) in a Series C financing round. The round was co-led by new investors InnoBio Fund (managed by CDC Entreprises within FSI France Investment program) and Lundbeckfond Ventures.

5 Jan 2011

Meda gains exclusive marketing and distribution rights for EpiPen Auto-Injector in Europe

Meda has signed a long-term license agreement with the specialty division of Mylan Inc., Dey Pharma, L.P., for exclusive marketing and distribution rights of EpiPen® (epinephrine) Auto-Injector in Europe. EpiPen is used for emergency treatment of severe allergic reactions (anaphylaxis). Anaphylaxis can occur quickly (often within a couple of minutes) and may be life-threatening.

23 Dec 2010

Merck announces FDA approval for GARDASIL against HPV-related anal cancer

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for the prevention of anal cancer caused by human papillomavirus (HPV) types 16 and 18 and for the prevention of anal intraepithelial neoplasia (AIN) grades 1, 2 and 3 (anal dysplasias and precancerous lesions) caused by HPV types 6, 11, 16 and 18, in males and females 9 through 26 years of age.

23 Dec 2010

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Biogen Idec and Elan Corporation, plc announced that the companies have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics.

22 Dec 2010

Official guidelines for diagnosis, treatment and management of food allergies released

A collaborative, government-led effort to guide and standardize diagnosis, treatment and management of food allergies has resulted in the release of an official set of recommendations for physicians.

10 Dec 2010