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.

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.

1 Mar 2013

FDA alerts patients and health care providers of voluntary recall of Omontys by Affymax

The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill.

25 Feb 2013

rEVO Biologics announces results from Atryn phase 3 studies on pregnant AT-deficient women

rEVO Biologics announced today the results of a major retrospective study analysis of its pivotal phase 3 studies which demonstrate that pregnant patients with hereditary antithrombin deficiency (HD) benefit from ATryn Antithrombin (Recombinant) therapy to prevent venous thromboembolic events (VTE).

16 Feb 2013

Dyax fourth quarter total revenues increase to $16.0 million

Dyax Corp. today announced financial results for the fourth quarter and year ended December 31, 2012.

14 Feb 2013

Elan agrees to restructure Tysabri collaboration with Biogen Idec

Elan Corporation, plc today announced that it has agreed to restructure the Tysabri® collaboration with Biogen Idec.

6 Feb 2013

Sanofi announces availability of Auvi-Q in U.S. retail pharmacies

Sanofi announced today that Auvi-Q (epinephrine injection, USP) is now available in U.S. retail pharmacies nationwide with a prescription from a healthcare provider.

29 Jan 2013

Millennium, Seattle Genetics commence ADCETRIS plus chemotherapy phase III trial in MTCL

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced the initiation of a global phase III clinical trial evaluating ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the treatment of newly diagnosed CD30-positive mature T-cell lymphoma (MTCL) patients, including patients with systemic anaplastic large cell lymphoma (sALCL) and other types of peripheral T-cell lymphomas.

28 Jan 2013

Sanofi Canada announces new option for emergency treatment of anaphylaxis

Sanofi Canada announces a new option for the emergency treatment of anaphylaxis. Allerject is the first and only 'talking' epinephrine auto-injector in Canada.

28 Jan 2013

FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

28 Jan 2013

Results from Amgen’s Neulasta plus bevacizumab Phase 3 trial on colorectal cancer

Amgen announced today results from Pegfilgrastim and Anti-VEGF Evaluation Study (PAVES), a Phase 3 trial which evaluated Neulasta (pegfilgrastim) in 845 patients receiving FOLFOX or FOLFIRI and bevacizumab for the first-line treatment of locally-advanced or metastatic colorectal cancer.

28 Jan 2013

Single dose of seasonal flu vaccine is safe for egg allergic children

Egg allergic children, including those with a history of anaphylaxis to egg, can safely receive a single dose of the seasonal influenza vaccine, according to a new study from the University of Michigan.

23 Jan 2013

Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

Today Biogen Idec and Elan Corporation, plc announced that they have submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) requesting updates to the TYSABRI (natalizumab) labels.

16 Jan 2013

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA’s review to be completed in the first half of 2013.

7 Jan 2013

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

GSK receives FDA approval for FLUARIX QUADRIVALENT to treat seasonal flu

GlaxoSmithKline plc announced today that the U.S. Food and Drug Administration (FDA) has approved FLUARIX QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained in the vaccine.

17 Dec 2012

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.

11 Dec 2012

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

Genentech, a member of the Roche Group, today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.

10 Dec 2012

New data from AstraZeneca's FASLODEX studies on breast cancer to be presented at SABSC

AstraZeneca today announced the presentation of important new data from studies of FASLODEX (fulvestrant) Injection at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium taking place from 4-8 December at the Henry B. Gonzalez Convention Center, San Antonio, Texas.

5 Dec 2012

New study finds chemicals used for water purification can lead to food allergies

Food allergies are on the rise, affecting 15 million Americans. And according to a new study published in the December issue of Annals of Allergy, Asthma and Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI), pesticides and tap water could be partially to blame.

3 Dec 2012

Tdap well tolerated in over-65s

Off-label use of tetanus–diptheria–acellular pertussis vaccine in senior patients results in no more adverse events than the tetanus and diphtheria vaccine, a US study shows.

30 Nov 2012

Anaphylaxis News and Research

Further Reading

Otsuka receives FDA approval for ABILIFY MAINTENA to treat schizophrenia

FDA alerts patients and health care providers of voluntary recall of Omontys by Affymax

rEVO Biologics announces results from Atryn phase 3 studies on pregnant AT-deficient women

Dyax fourth quarter total revenues increase to $16.0 million

Elan agrees to restructure Tysabri collaboration with Biogen Idec

Sanofi announces availability of Auvi-Q in U.S. retail pharmacies

Millennium, Seattle Genetics commence ADCETRIS plus chemotherapy phase III trial in MTCL

Sanofi Canada announces new option for emergency treatment of anaphylaxis

FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

Results from Amgen’s Neulasta plus bevacizumab Phase 3 trial on colorectal cancer

Single dose of seasonal flu vaccine is safe for egg allergic children

Elan, Biogen Idec submit applications to FDA and EMA for updation of TYSABRI labels

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

AMAG seeks FDA sNDA approval for Feraheme Injection

GSK receives FDA approval for FLUARIX QUADRIVALENT to treat seasonal flu

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

New survival results from Genentech’s Perjeta Phase III combination study on HER2-positive mBC

New data from AstraZeneca's FASLODEX studies on breast cancer to be presented at SABSC

New study finds chemicals used for water purification can lead to food allergies

Tdap well tolerated in over-65s

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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