Hypersensitivity News and Research

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

Positive results from XIAFLEX phase IIIb multicord trial for Dupuytren's contracture

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The Company enrolled 60 patients at eight sites throughout the U.S. and Australia.

30 Jul 2012

EC approves Vertex's KALYDECO for treatment of cystic fibrosis

Vertex Pharmaceuticals Incorporated announced today that the European Commission has approved KALYDECOTM (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

28 Jul 2012

FDA approves Horizon Pharma's RAYOS to treat key IL-6 mediated diseases

Horizon Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved RAYOS (prednisone) delayed-release tablets (1 mg, 2 mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD).

26 Jul 2012

Pfizer’s Lyrica does not affect reproductive function in healthy males

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules CV Study A0081104 - Assessment of the Impact of Lyrica on Sperm Production in Healthy Volunteers - demonstrate that Lyrica does not affect the reproductive function in healthy males when compared to placebo.

24 Jul 2012

FDA approves Forest Laboratories’ Tudorza Pressair to treat COPD

Forest Laboratories, Inc. and Almirall, S.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Tudorza Pressair (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

24 Jul 2012

Once-daily Gralise significantly reduces pain intensity in PHN patients

Depomed, Inc. today announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN).

23 Jul 2012

Top-line results in Pfizer's Lyrica long term safety study for Generalized Anxiety Disorder

Pfizer Inc. announced today that top-line results for Lyrica (pregabalin) capsules Study A0081147 - Long Term Safety and Efficacy of Pregabalin in Subjects with Generalized Anxiety Disorder (GAD) - demonstrate that drug discontinuation symptoms were low after tapering Lyrica treatment following three months and six months in GAD patients.

23 Jul 2012

Regeneron, Sanofi initiate enrollment in SAR236553/REGN727 Phase 3 program

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that several trials within ODYSSEY, the Phase 3 clinical program of SAR236553/REGN727, have initiated patient enrollment.

21 Jul 2012

Delaware district court upholds Pfizer's patents for LYRICA to treat pain and seizures

Pfizer Inc. announced today that the United States District Court for the District of Delaware upheld its composition of matter patent and pain and seizure use patents covering LYRICA (pregabalin) capsules CV. With this decision, Pfizer will exclusively provide pregabalin as LYRICA to patients through December 30, 2018 in the U.S., pending generic company appeal and further litigation.

20 Jul 2012

Dyax second quarter 2012 total revenues increase to $14.0 million

Dyax Corp. today announced financial results for the second quarter ended June 30, 2012.

20 Jul 2012

Positive preliminary results from Feraheme phase III study on iron deficiency anemia

AMAG Pharmaceuticals, Inc. today reported preliminary results from the second phase III study from its global registrational program for Feraheme (ferumoxytol) in patients with iron deficiency anemia (IDA) regardless of the underlying cause.

19 Jul 2012

UCB’s Neupro now available in U.S. pharmacies

UCB announced today that Neupro (Rotigotine Transdermal System) is now available in U.S. pharmacies. Neupro was approved by the U.S Food and Drug Administration in April to treat the signs and symptoms of early and advanced stage idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome.

16 Jul 2012

USPTO issues notice of allowance to Avanir for NUEDEXTA

Avanir Pharmaceuticals, Inc. announced today that the United States Patent and Trademark Office (USPTO) has allowed a new patent that covers Avanir's product NUEDEXTA, further expanding the intellectual property portfolio for the company's lead commercial asset.

2 Jul 2012

Flavocoxid liver damage reported

A prescription medical food used to treat osteoarthritis may induce reversible liver damage in some users, suggests research published in the Annals of Internal Medicine.

25 Jun 2012

FDA approves Baxter's GAMMAGARD LIQUID for multifocal motor neuropathy

Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] as a treatment for multifocal motor neuropathy (MMN). This is the first immunoglobulin treatment approved for MMN patients in the United States, and it was approved for use with MMN patients in Europe in 2011.

From Baxter International Inc. 25 Jun 2012

Genentech's Perjeta helps people with HER2-positive metastatic breast cancer live longer

Genentech, a member of the Roche Group, announced today that people with HER2-positive metastatic breast cancer (mBC) lived significantly longer (overall survival) when treated with the combination of Perjeta (pertuzumab), Herceptin (trastuzumab) and docetaxel chemotherapy, compared to Herceptin and docetaxel chemotherapy alone in the Phase III CLEOPATRA study.

23 Jun 2012

EC grants marketing authorization for AMAG's ferumoxytol to treat IDA

AMAG Pharmaceuticals, Inc. today announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD).

23 Jun 2012

Pfizer receives FDA approval for Lyrica to manage neuropathic pain associated with SCI

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) approved the use of Lyrica (pregabalin) capsules CV for the management of neuropathic pain associated with spinal cord injury.

22 Jun 2012

EAACI launches Food Allergy Campaign

Today the European Academy of Allergy and Clinical Immunology (EAACI) launched its Food Allergy Campaign. The purpose of the campaign is to raise awareness of the sharp increase of anaphylaxis in children, an allergic reaction that is severe and potentially life-threatening. It aims at educating the public to recognise the symptoms and its triggers, and to teach methods of how to react in case of emergency, e.g. by using an adrenaline pen.

18 Jun 2012

Food allergies more prevalent among urban children

Children living in urban centers have a much higher prevalence of food allergies than those living in rural areas, according to a new study, which is the first to map children's food allergies by geographical location in the United States. In particular, kids in big cities are more than twice as likely to have peanut and shellfish allergies compared to rural communities.

8 Jun 2012