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.

FDA grants 12-year exclusivity to RUCONEST (C1 esterase inhibitor [recombinant])

Salix Pharmaceuticals and Pharming Group NV announced today that the U.S. Food and Drug Administration has granted 12 years of exclusivity to RUCONEST (C1 esterase inhibitor [recombinant]) 50 IU/kg.

8 Oct 2015

Allergan's anti-infective portfolio to be highlighted at IDWeek 2015

Allergan plc today announced that its infectious disease portfolio will be featured in 13 abstracts highlighting data at IDWeek 2015, which takes place from October 7-11, 2015, in San Diego.

8 Oct 2015

Allergan receives FDA approval to market JUVEDERM ULTRA XC for use in lips

Allergan plc, a leading global pharmaceutical company, today announced that the company has received approval from the U.S. Food and Drug Administration to market JUVEDERM ULTRA XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21. JUVEDERM ULTRA XC instantly adds fullness to the lips and is the only dermal filler that has proven results lasting up to one year for lip augmentation.

1 Oct 2015

Novo Nordisk announces FDA approval of Tresiba (insulin degludec injection) for diabetes treatment

Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration approved the new drug application for Tresiba (insulin degludec injection), a once-daily, long-acting basal insulin. Tresiba is indicated for use alone, or in combination with oral antidiabetic medicines or bolus insulin, and is approved for glycemic control in adults with type 1 and type 2 diabetes. Tresiba provides a long duration of action beyond 42 hours.

From Novo Nordisk 26 Sep 2015

New cell type appears to drive life-threatening food allergies

Researchers have discovered a new cell type that appears to drive life-threatening food allergies and may help explain why some people get severe allergic reactions and others do not.

22 Sep 2015

FDA approves Allergan's sNDA to update label for TEFLARO (ceftaroline fosamil)

Allergan plc today announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application (sNDA) to update the label for TEFLARO (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

2 Sep 2015

Shire enters into agreement with Sanquin for CINRYZE

Shire plc announced today it has entered into an agreement with Sanquin Blood Supply, the manufacturer of CINRYZE (C1 esterase inhibitor [human]), providing Shire access to its manufacturing technology and allowing Shire to source additional manufacturers to meet the growing demand for CINRYZE.

25 Aug 2015

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

13 Aug 2015

Turing Pharmaceuticals acquires rights to market Daraprim (pyrimethamine) in the U.S.

Turing Pharmaceuticals AG today announced that it has acquired the exclusive rights to market Daraprim (pyrimethamine) in the U.S. from Impax Laboratories, Inc. The acquisition by Turing is part of a strategic effort focused on treatments for toxoplasmosis and other serious infectious diseases. The company also announced plans to invest in the development of new drug candidates for toxoplasmosis.

10 Aug 2015

Experts discuss ways to encourage appropriate use of epinephrine for all severe allergic reactions

There are times when emergency physicians can't be 100 percent sure a person is suffering from a severe allergic reaction, known as anaphylaxis, and may hesitate to use epinephrine. A new article says when in doubt - administer the epinephrine.

7 Aug 2015

Pennsylvania physicians examine back-to-school health, offer tips for parents and students

As students start heading back to classes for the upcoming academic year, Pennsylvania physicians take a close look at back-to-school health and offer some tips for parents and students who strive to stay in class and not home in bed sick.

7 Aug 2015

Astellas reports topline results from isavuconazole Phase 3 study in candidemia and other invasive Candida infections

Astellas today announced topline results from the Phase 3 ACTIVE study evaluating the efficacy and safety of intravenous (IV) and oral isavuconazole, commercially known as CRESEMBA (isavuconazonium sulfate), under development for adults with candidemia and other invasive Candida infections.

30 Jul 2015

GSK starts shipping FLUARIX QUADRIVALENT (Influenza Vaccine) to US healthcare providers

GSK announced today it has begun shipping FLUARIX QUADRIVALENT (Influenza Vaccine) doses to US healthcare providers, following licensing and lot-release approval from the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research.

16 Jul 2015

New research reveals why some kids can have severe allergic reaction hours later

Parents of kids with severe allergies know how scary a severe allergic reaction (anaphylaxis) is. New research offers clues as to why some kids can have a second, related reaction hours later - and what to do about it.

8 Jul 2015

Emergency room visits, hospitalizations of children with food allergy reactions increase in Illinois

Emergency room visits and hospitalizations of children with severe, potentially life-threatening food allergy reactions increased nearly 30 percent in Illinois over five years, reports a Northwestern Medicine study.

26 Jun 2015

Pediatric study looks at evidence-based predictors of biphasic allergic reactions

Children are more likely to have a repeat, delayed anaphylactic reaction from the same allergic cause, depending on the severity of the initial reaction. The first pediatric study to look at the predictors for this phenomenon was published today in Annals of Allergy, Asthma & Immunology.

22 Jun 2015

Phase 2 study of AR101 meets primary endpoint in patients with peanut allergy

Aimmune Therapeutics, Inc., a privately held biopharmaceutical company developing desensitization treatments for food allergies, announced today that a Phase 2 study (ARC001) evaluating the company's lead investigational product, AR101 for the treatment of peanut allergy, met its primary endpoint and additional endpoint of desensitizing patients to cumulative amounts of peanut protein of 443 mg and 1,043 mg, respectively.

10 Jun 2015

Pennsylvania physicians urge residents to take precautions against bug bites, bee stings

For many people, bug bites and bee stings aren't a big deal beyond a small irritation. But for some, it could mean the start of a painful - possibly long-term or even deadly - experience.

1 Jun 2015

FDA approves Humalog 200 units/mL KwikPen to improve glycemic control in diabetic patients

The U.S. Food and Drug Administration (FDA) has approved Humalog® 200 units/mL KwikPen® (insulin lispro 200 units/mL; U-200), a pre-filled pen containing a concentrated formulation of Lilly's rapid-acting insulin Humalog® (insulin lispro 100 units/mL) to improve glycemic control in people with type 1 and type 2 diabetes, Eli Lilly and Company announced today. Humalog U-200 KwikPen marks the first FDA approval of a concentrated mealtime insulin analog.

29 May 2015

Salix Pharmaceuticals receives FDA approval for Xifaxan 550 mg to treat IBS-D in adults

Valeant Pharmaceuticals International, Inc. announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration for Xifaxan 550 mg for the treatment of IBS-D in adults.

28 May 2015