Hypersensitivity News and Research

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

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

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 High-Dose (Influenza Vaccine) to include efficacy data in the 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

Researchers receive NIH grant to study mechanisms of auditory hypersensitivity in fragile X syndrome

Fragile X syndrome (FXS) is a genetic disorder in humans that causes social impairments and repetitive behaviors, and other behaviors on the autistic spectrum, as well as cognitive deficits.

17 Oct 2014

Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Helsinn Group and Eisai Inc. announced today that the Food and Drug Administration (FDA) approved AKYNZEO® for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

13 Oct 2014

Preoperative IV ibuprofen improves quality of recovery after laparoscopic cholecystectomy surgery

Cumberland Pharmaceuticals Inc. today announced that preoperative intravenous ibuprofen improved overall quality of recovery in patients undergoing laparoscopic cholecystectomy surgery. These results will be presented at the American Anesthesiology 2014 Annual Meeting in New Orleans, Louisiana.

12 Oct 2014

Pediatric specialist in EGIDs helps lead $6.25 million NIH clinical research project

A pediatric specialist in eosinophilic gastrointestinal diseases (EGIDs) at the University of Colorado School of Medicine and Children's Hospital Colorado will help lead a five-year, $6.25 million clinical research project recently funded by the National Institutes of Health.

9 Oct 2014

Boehringer Ingelheim announces availability of Striverdi Respimat Inhalation Spray 5 mcg in the U.S.

Boehringer Ingelheim today announced that Striverdi Respimat (olodaterol) Inhalation Spray 5 mcg is now available by prescription in pharmacies across the United States.

8 Oct 2014

Medac Pharma launches Rasuvo (methotrexate) injection for patients with RA, pJIA and psoriasis

Medac Pharma, Inc., a privately held pharmaceutical company, has announced the launch of its lead product Rasuvo (methotrexate) injection for patients with rheumatoid arthritis (RA), poly-articular-course juvenile idiopathic arthritis (pJIA) and psoriasis in the U.S.

6 Oct 2014

Mission Pharmacal adds Ovace Plus Lotion to its range of product offerings

Itch. Scratch. Repeat. Irritating skin conditions, such as seborrheic dermatitis (SD), can create a distracting, uncomfortable vicious circle for those affected.

1 Oct 2014

Par Pharmaceutical starts shipping generic version of Exforge

Par Pharmaceutical Companies, Inc. today announced that it has begun shipping all four strengths of amlodipine and valsartan tablets, the generic version of Novartis' Exforge. Par received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for amlodipine and valsartan and was granted 180 days of marketing exclusivity.

30 Sep 2014

Understanding ways to treat, cure eosinophilic gastritis

Investigators at Cincinnati Children's Hospital Medical Center have published the first study to extensively characterize eosinophilic gastritis (EG).

24 Sep 2014

Elusys completes phase 3 clinical program of obiltoxaximab in healthy adult volunteers

Elusys Therapeutics, Inc., a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204).

23 Sep 2014

Janssen announces availability of PREZCOBIX for Canadians living with HIV

Janssen Inc. announced today that PREZCOBIX (darunavir/cobicistat), a once-daily, oral medication for the treatment of HIV infection in combination with other antiretroviral agents, is now available in Canada. It is the first HIV treatment option available to patients that provides boosted darunavir in a single tablet.

17 Sep 2014