Hypersensitivity News and Research

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

Some public health advocates disagree with Indian government's decision to roll out pentavalent vaccines, IPS reports

"Ignoring widespread concern over the safety, efficacy and cost of pentavalent vaccines" -- which provide protection against diphtheria, pertussis, tetanus, hepatitis B and haemophilus influenza type b (Hib) -- "India's central health ministry has, this month, approved inclusion of the prophylactic cocktail in the universal immunization program in seven of its provinces," Inter Press Service reports.

30 Apr 2012

Allergies may provide benefit by keeping away noxious environmental toxins

Yale researchers suggested Wednesday that allergies may be an outgrowth of the protective mechanism of the body to protect itself from noxious substances in the environment.

26 Apr 2012

FDA extends review period for linaclotide NDA to treat constipation

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) notified the companies that it will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).

23 Apr 2012

EMA CHMP recommends approval of AMAG’s ferumoxytol

AMAG Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease.

21 Apr 2012

Coronary stents do not increase risk of heart attack, death in people with metal allergies

Cardiologists have long grappled with how to best manage patients with coronary artery disease who report skin hypersensitivity to nickel or other metal components found in stents -- small tubes placed in narrowed or weakened arteries to help improve blood flow to the heart. But new Mayo Clinic research, published in the April 16, 2012, issue of Circulation: Cardiovascular Interventions, may help allay these concerns.

17 Apr 2012

Mylan receives final FDA approval for generic Lescol Capsules ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluvastatin Capsules USP, 20 mg and 40 mg, the first generic version of Novartis' Lescol Capsules.

16 Apr 2012

New compound reverses major symptoms associated with FXS

A recent study finds that a new compound reverses many of the major symptoms associated with Fragile X syndrome (FXS), the most common form of inherited intellectual disability and a leading cause of autism. The paper, published by Cell Press in the April 12 issue of the journal Neuron, describes the exciting observation that the FXS correction can occur in adult mice, after the symptoms of the condition have already been established.

12 Apr 2012

Biogen Idec launches FAMPYRA in Canada

Today, Biogen Idec Canada announces that FAMPYRA (fampridine sustained release tablets or fampridine SR) is now available for prescription for patients living with multiple sclerosis (MS) in Canada.

12 Apr 2012

Par Pharmaceutical commences shipment of modafinil tablets

Par Pharmaceutical Companies, Inc. today announced that it began shipping all strengths of modafinil tablets, a generic version of Teva's Provigil brand.

7 Apr 2012

Purdue Pharma launches Intermezzo for middle-of-the-night insomnia

Purdue Pharma L.P. announced today that Intermezzo (zolpidem tartrate) sublingual tablet CIV is now available in 1.75 mg and 3.5 mg dosage strengths by prescription in retail pharmacies nationwide.

6 Apr 2012

Vaccination most promising against asthma

Asthma is a chronic inflammatory and respiratory disease caused by an abnormal reactivity to allergens in the environment. Of the several avenues of exploration that are currently being developed, vaccination appears to be the most promising approach.

5 Apr 2012

UCB receives FDA approval for Neupro to treat idiopathic Parkinson's, RLS

UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro (Rotigotine Transdermal System) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson's disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome.

3 Apr 2012

New ACR guidelines recommend use of topical NSAIDs for older patients with knee OA

The American College of Rheumatology (ACR) Subcommittee on Osteoarthritis Guidelines has approved and issued several updates to clinical practice guidelines for the treatment of osteoarthritis (OA).

31 Mar 2012

Hapten licenses HPT-721 to prevent poison ivy dermatitis

Hapten Sciences Inc. of Memphis, Tenn., has licensed a compound developed by ElSohly Laboratories Inc. and University of Mississippi pharmaceutical researchers to prevent reactions to poison ivy, oak and sumac.

27 Mar 2012

CSL Behring commences enrollment in SCIg PATH trial for CIDP

CSL Behring has announced that the first patient has been enrolled in the PATH study, an international clinical trial designed to evaluate the efficacy, safety, and tolerability of two different doses of subcutaneous immunoglobulin (SCIg), compared with placebo, in maintenance treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

26 Mar 2012

Australian TGA approves Bayer's EYLEA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that Bayer HealthCare has received approval from the Australian Therapeutic Goods Administration (TGA) for EYLEA (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 milligrams (mg) via intravitreal injection per month for three consecutive months, followed by 2 milligrams via intravitreal injection every two months.

8 Mar 2012

Fera introduces Sulfacetamide Ointment for conjunctivitis

Fera Pharmaceuticals is pleased to announce the launch of Sulfacetamide Sodium Ophthalmic Ointment USP, 10%.

7 Mar 2012

Shire to commence two Vyvanse and Concerta Phase 4 comparison trials for ADHD

As part of its continued commitment to ADHD research, Shire plc, the global specialty biopharmaceutical company, today announced it is initiating two Phase 4 clinical trials to compare Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta (methylphenidate HCl) Extended-Release Tablets.

7 Mar 2012

AMAG fourth quarter total revenues decrease to $14.9 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2011. As of December 31, 2011, the company's cash, cash equivalents and investments totaled approximately $230 million.

5 Mar 2012

Study: Bioavailability similar among four subcutaneous IgG preparations

Data presented by CSL Behring today suggest that the bioavailability of immunoglobulin G (IgG) therapies is consistent when patients with primary immunodeficiencies switch from one IgG product to another by the subcutaneous route.

5 Mar 2012