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.

Positive results from Santarus and Pharming’s RUCONEST Phase III trial on HAE

Santarus, Inc. and Pharming Group NV today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.

7 Nov 2012

AstraZeneca commences FASLODEX Phase III study for hormone receptor-positive metastatic breast cancer

AstraZeneca today announced the start of a Phase III study (FALCON), a global clinical trial which will involve 450 postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy. The Phase III study is designed to evaluate the efficacy and tolerability of fulvestrant 500 mg compared to anastrozole 1 mg in this patient population.

29 Oct 2012

Sanofi presents overview of Phase II and III trials for quadrivalent influenza vaccine

Sanofi Pasteur, the vaccines division of Sanofi, presented today an overview of Phase II and Phase III clinical trials for its investigational quadrivalent influenza vaccine (QIV).

23 Oct 2012

Sanofi Pasteur files Fluzone sBLA with FDA for treatment of influenza

Sanofi Pasteur, the vaccines division of Sanofi, announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for a quadrivalent formulation of its Fluzone (Influenza Virus Vaccine).

20 Oct 2012

EMA CHMP issues positive opinion to Savient's KRYSTEXXA for treatment of chronic gout

Savient Pharmaceuticals, Inc. and its wholly owned subsidiary, Savient Pharma Ireland Limited, announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has completed its scientific assessment and has issued a positive opinion recommending approval of a marketing authorization in the European Union for KRYSTEXXA for the treatment of severe debilitating chronic tophaceous gout in adult patients who may also have erosive joint involvement and who have failed to normalize serum uric acid with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these medicines are contraindicated.

19 Oct 2012

Longer looks: Mitt Romney's health care legacy; Closing of Philly hospitals brings 'grim consequences;' Young doctors and their apps

A journey into the places, people, and decisive moments that made the men who are competing for the presidency. ...As governor, Romney knew he needed what political pros called a "legacy issue" if he wanted to run for president one day. He devoted his energy towards reforming health care, an issue that Democrats had been grappling with and a problem that cost the state dearly as taxpayers bore the brunt of covering the uninsured.

11 Oct 2012

Takeda, Seattle Genetics announce preliminary data from brentuximab vedotin phase I study on sALCL

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, and Seattle Genetics, Inc., today announced preliminary data from one arm of a three arm phase I, open-label, multicenter study designed to determine the safety and activity of sequential and combination treatment approaches of brentuximab vedotin with CHOP or CH-P chemotherapy in newly diagnosed patients with CD30-positive mature T- and NK- cell lymphomas.

1 Oct 2012

Positive results from Sobi, Biogen Idec's rFIXFc Phase 3 trial on hemophilia B

Biogen Idec and Swedish Orphan Biovitrum (Sobi) today announced positive results from B-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia B. Hemophilia B is a rare inherited disorder that impairs blood coagulation.

27 Sep 2012

Severe egg allergy treatment shows promise

Specific oral tolerance induction with raw hen’s egg can reduce the severity of egg allergy in affected children, show study findings.

14 Sep 2012

Antibiotics: facts and fictions: an interview with Dr Philippa Binns, clinical adviser at NPS MedicineWise

Antibiotics are medicines used to treat infections or diseases caused by bacteria, such as some respiratory tract infections (including pneumonia and whooping cough), urinary tract infections, skin infections and infected wounds.

6 Sep 2012

AMAG receives Swiss marketing authorization for ferumoxytol to treat iron deficiency anemia

AMAG Pharmaceuticals, Inc. today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease.

6 Sep 2012

EC grants marketing authorization for Pfizer’s INLYTA to treat renal cell carcinoma

Pfizer Inc. announced today that the European Commission (EC) has granted marketing authorization for INLYTA (axitinib) for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

4 Sep 2012

Mallinckrodt receives FDA approval for 32 mg tablet strength of EXALGO

The U.S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of Covidien, that it has approved a 32 mg tablet strength of EXALGO (hydromorphone HCI) Extended-Release Tablets (CII) for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

FDA approves Intelliject's Auvi-Q for anaphylaxis

Intelliject, Inc. announced that the U.S. Food and Drug Administration approved Auvi-Q (epinephrine injection, USP) for the emergency treatment of life-threatening allergic reactions in people who are at risk or have a history of anaphylaxis. This is the first-and-only compact auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.

13 Aug 2012

Combination therapy does not change safety and efficacy relationship of TORISEL for advanced RCC

Pfizer Inc. announced that the Phase 3 INTORACT trial (B1771006), evaluating the combination of bevacizumab plus TORISEL (temsirolimus) compared with bevacizumab plus interferon-alfa-2a (IFN-α-2a) in the first-line treatment of patients with advanced renal cell carcinoma (RCC) across risk groups, did not meet its primary endpoint of superiority in extending progression free survival (PFS) in the study population.

12 Aug 2012

Alfa Wassermann, Salix enter license agreement for EIR formulation of rifaximin

Salix Pharmaceuticals, Ltd. and Alfa Wassermann S.p.A. today announced that they have entered into an exclusive agreement by which Salix has licensed rights in the United States and Canada to an extended intestinal release (EIR) formulation of rifaximin for gastrointestinal and respiratory indications, including Crohn's disease.

9 Aug 2012

UMass Medical, Serum Institute of India partner on anti-rabies monoclonal antibody pivotal trial

A pivotal clinical trial for an anti-rabies human monoclonal antibody (RMAb) being developed through a collaborative partnership between MassBiologics of the University of Massachusetts Medical School and the Serum Institute of India, Ltd., is starting to enroll patients.

8 Aug 2012

NCH conducts workshop to teach participants how and when to use EpiPen

Many children with severe allergies carry injectable epinephrine (EpiPens) - syringes filled with epinephrine to delay an allergic reaction - but the EpiPens sometimes require the help of an adult to dispense. School nurses are often the only school officials authorized to handle medications, leaving the educators who are with the children most of the day untrained. According to doctors at Nationwide Children's Hospital, this lack of training is exactly what becomes most dangerous for children with severe allergies.

7 Aug 2012

GSK begins shipping the first lots of 2012-2013 seasonal influenza vaccines

GlaxoSmithKline announced today it has begun shipping the first lots of 2012-2013 FluLaval (Influenza virus vaccine) and Fluarix (Influenza Virus Vaccine) to CDC distribution centers and U.S. healthcare providers.

1 Aug 2012

Steak and ticks: A potentially life-threatening experience

Tick bites can trigger a severe, delayed allergic reaction to red meat, suggest findings published in the Journal of General Internal Medicine.

27 Jul 2012