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.

AMAG fourth quarter total revenues decrease to $14.9 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, 2011. As of December 31, 2011, the company's cash, cash equivalents and investments totaled approximately $230 million.

5 Mar 2012

Biogen Idec receives FDA approval for two separate dosing innovations to treat MS

Today Biogen Idec announced that the U.S. Food and Drug Administration (FDA) has approved two separate dosing innovations designed to improve the treatment experience for patients receiving once-a-week AVONEX for relapsing forms of multiple sclerosis (MS).

28 Feb 2012

Dyax fourth quarter total revenues decrease to $8.5 million

Dyax Corp. today announced financial results for the fourth quarter and year ended December 31, 2011.

22 Feb 2012

Pfizer, Mylan enter settlement agreement to resolve e-cue patent litigation

Mylan Inc. and Pfizer Inc. today announced that Meridian Medical Technologies, a Pfizer subsidiary, has entered into a settlement agreement with Intelliject and Sanofi-Aventis that will resolve pending patent litigation related to Intelliject's 505(b)(2) new drug application (NDA) for its epinephrine auto-injector known as e-cue, which will be manufactured and marketed by Sanofi-Aventis.

16 Feb 2012

Merck receives FDA approval for JANUMET XR to treat type 2 diabetes

Merck, known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration approved JANUMET XR (sitagliptin and metformin hydrochloride extended-release) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of JANUVIA (sitagliptin), with extended-release metformin.

3 Feb 2012

AMAG completes enrollment in Feraheme Phase III program for iron-deficiency anemia

AMAG Pharmaceuticals, Inc. today announced the completion of patient enrollment in the second of the company's two phase III studies that comprise its global registrational program for Feraheme (ferumoxytol) in patients with iron-deficiency anemia (IDA) who are not candidates for oral iron, regardless of the underlying cause.

30 Jan 2012

Baxter to commence second GAMMAGARD LIQUID Phase III trial in Alzheimer's

Baxter International Inc. today provided an update on its clinical program evaluating the use of its GAMMAGARD LIQUID 10%, for the treatment of mild to moderate Alzheimer's disease.

From Baxter International Inc. 24 Jan 2012

FDA approves product label change for Biogen Idec's TYSABRI to treat MS

Today Biogen Idec and Elan Corporation, plc announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis.

21 Jan 2012

Baxter submits GAMMAGARD LIQUID sBLA to FDA for treatment of MMN

Baxter International Inc. today announced that the company has submitted a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) for approval of GAMMAGARD LIQUID 10% for the treatment of multifocal motor neuropathy.

From Baxter International Inc. 9 Jan 2012

ACAAI allergist available to discuss importance of immediate access to epinephrine

This week a seven-year-old elementary school student in Chesterfield County, Virginia, died after suffering an allergic reaction at school. Allergist Dr. Stanley Fineman, president of the American College of Allergy, Asthma and Immunology, (ACAAI) is available to discuss the importance of immediate access to epinephrine, the first-line treatment for an allergic emergency or anaphylactic reaction.

7 Jan 2012

CMS assigns permanent J-code for Savient's KRYSTEXXA to treat RCG

Savient Pharmaceuticals, Inc. today announced that a product-specific billing code, or permanent J-code, for KRYSTEXXA (pegloticase) became available on January 1, 2012.

7 Jan 2012

Baxter commences BAX 855 Phase I trial in hemophilia A

Baxter International Inc. today announced the dosing of the first patients in a Phase I clinical trial of its lead investigational candidate, BAX 855, a longer-acting (PEGylated) form of a full-length recombinant factor VIII (rFVIII) protein.

From Baxter International Inc. 5 Jan 2012

FDA approves CSL Behring's Berinert for treatment of HAE attacks

CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder.

4 Jan 2012

FDA approves Pfizer's Prevnar 13 pneumococcal conjugate vaccine as a single dose for adults

Pfizer Inc. announced today that the U.S. Food and Drug Administration has granted approval of the Company's pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults.

31 Dec 2011

Researchers warn food allergy blood tests should never be used as standalone diagnostics

An advisory from two leading allergists, Robert Wood of the Johns Hopkins Children's Center and Scott Sicherer of Mt. Sinai Hospital in New York, urges clinicians to use caution when ordering allergy tests and to avoid making a diagnosis based solely on test results.

26 Dec 2011

Baxter receives FDA approval for ADVATE to prevent hemophilia A

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A.

From Baxter International Inc. 17 Dec 2011

Health Alliance, Bayer sign outcomes-based contract to support MS patients

Bayer HealthCare and Health Alliance Medical Plans have entered into an outcomes-based contract for people with relapsing-remitting multiple sclerosis (MS) who are taking Betaseron (interferon beta-1b) to reduce the frequency of clinical exacerbations.

7 Dec 2011

FDA approves EUSA's orphan drug ERWINAZE for acute lymphoblastic leukemia

EUSA Pharma, a transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care, today announced that the US Food and Drug Administration (FDA) has approved its orphan drug ERWINAZE (asparaginase Erwinia chrysanthemi) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to E. coli-derived asparaginase.

19 Nov 2011

EUSA Pharma receives FDA approval for Erwinaze to treat ALL

The U.S. Food and Drug Administration today approved Erwinaze to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegaspargase chemotherapy drugs used to treat ALL.

18 Nov 2011

Feraheme as safe and effective as iron sucrose in patients with anemia, CKD

AMAG Pharmaceuticals, Inc. today announced positive new data from the FIRST head-to-head trial comparing Feraheme (ferumoxytol) Injection for intravenous (IV) use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease.

14 Nov 2011