Hypersensitivity News and Research

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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.

FDA approves LILETTA (levonorgestrel-releasing intrauterine system) to prevent pregnancy

Actavis plc, a leading global specialty pharmaceutical company, and Medicines360, a nonprofit women's health pharmaceutical company, today announced the approval of LILETTA (levonorgestrel-releasing intrauterine system) by the U.S. Food and Drug Administration for use by women to prevent pregnancy for up to three years.

27 Feb 2015

Hospira announces launch of first biosimilar monoclonal antibody in Europe

Hospira, Inc., a world leader in the development of biosimilar therapies, today announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets.

16 Feb 2015

Jazz Pharmaceuticals to present defibrotide results for hepatic VOD at BMT Tandem meetings

Jazz Pharmaceuticals plc announced today that researchers will present data on the use of defibrotide, an investigational medicine being studied in the United States (U.S.) for the treatment of hepatic veno-occlusive disease (VOD), a rare, potentially life-threatening, early complication in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy.

13 Feb 2015

Stomach ulcer bug H. pylori may reduce risk of developing multiple sclerosis

A West Australian team has found evidence that the stomach ulcer bacterium, Helicobacter pylori, is associated with a lower risk of multiple sclerosis (MS), bolstering evidence for the role of the ‘hygiene hypothesis’ in autoimmune disorders.

21 Jan 2015

FDA approves Hospira's Dyloject (diclofenac sodium) Injection for pain management

Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, has received approval from the U.S. Food and Drug Administration for Dyloject (diclofenac sodium) Injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic.

30 Dec 2014

FDA approves Novo Nordisk’s weight loss injection, Saxenda

Novo Nordisk today announced that the Food and Drug Administration (FDA) has approved the new drug application (NDA) for Saxenda® (liraglutide [rDNA origin] injection), the first once-daily glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management.

25 Dec 2014

FDA approves intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi)

Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration approved the intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi). Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.

19 Dec 2014

Secrets of success for pioneering research revealed

The British Pharmacological Society has announced the secrets of success for pioneering research along with the outcome of its annual 'Putting UK Pharmacology on the Map' vote. The vote selects sites of special scientific interest linked to achievements in pharmacology based on a ballot of MPs, peers and senior members of the scientific community.

18 Dec 2014

Crealta publishes review of post-hoc safety analysis completed for Krystexxa

Crealta Pharmaceuticals LLC, today announced that the Journal of Clinical Rheumatology published a comprehensive review of a post-hoc safety analysis that was completed for Krystexxa (pegloticase), including data from the two pivotal randomized Phase III trials and one open-label extension trial.

14 Dec 2014

FDA approves Fluzone Intradermal Quadrivalent vaccine to prevent four strains of influenza virus

Sanofi Pasteur, the vaccines division of Sanofi, today announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine.

13 Dec 2014

Study: Obese children's brains light up differently when tasting sugar

A new study led by researchers at University of California, San Diego School of Medicine finds that the brains of obese children literally light up differently when tasting sugar.

12 Dec 2014

Amgen announces new data from BLINCYTO Phase 2 study for treatment of patients with ALL

Amgen today announced that new data from a pivotal Phase 2 study evaluating BLINCYTO (blinatumomab) for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL) was presented at the 56th American Society of Hematology Annual Meeting and Exposition.

9 Dec 2014

Amgen's XGEVA (denosumab) receives FDA approval for treatment of hypercalcemia of malignancy

Amgen today announced that the U.S. Food and Drug Administration has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

8 Dec 2014

Mylan gets tentative approval from FDA for two pediatric dosages of abacavir/lamivudine tablets

Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its New Drug Applications (NDAs) for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.

4 Dec 2014

Baxter seeks FDA approval of BAX 855 for treatment of people with hemophilia A

Nektar Therapeutics reported that partner Baxter International Inc. today announced that the company has submitted a biologics license application (BLA) to the United States Food and Drug Administration for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on ADVATE [Antihemophilic Factor (Recombinant)].

From Baxter International Inc. 1 Dec 2014

Researchers examine genomic landscapes of humans and mice

Looking across evolutionary time and the genomic landscapes of humans and mice, an international group of researchers has found powerful clues to why certain processes and systems in the mouse - such as the immune system, metabolism and stress response - are so different from those in people. Building on years of mouse and gene regulation studies, they have developed a resource that can help scientists better understand how similarities and differences between mice and humans are written in their genomes.

23 Nov 2014

Janssen announces submission of NDA for three-month paliperidone palmitate

Janssen Research & Development, LLC today announced the submission of a New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate to the U.S. Food and Drug Administration. The NDA seeks approval for the medication as a treatment for schizophrenia in adults.

19 Nov 2014

Hospira launches Paricalcitol Injection

Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, today announced the launch of Paricalcitol Injection, a generic version of AbbVie's Zemplar. Hospira obtained U.S. Food and Drug Administration approval of paricalcitol on Oct. 21 and launched the product Nov. 1.

5 Nov 2014

FDA approves Fluzone High-Dose vaccine sBLA to include efficacy data in Prescribing Information

3 Nov 2014

Novel way for treating non-cardiac chest pain due to esophageal hypersensitivity

Chest pain doesn't necessarily come from the heart. An estimated 200,000 Americans each year experience non-cardiac chest pain, which in addition to pain can involve painful swallowing, discomfort and anxiety. Non-cardiac chest pain can be frightening for patients and result in visits to the emergency room because the painful symptoms, while often originating in the esophagus, can mimic a heart attack.

22 Oct 2014