Hypersensitivity News and Research

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

NDA for Lubiprostone to treat irritable bowel syndrome with constipation

Sucampo Pharmaceuticals, Inc., has announced that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration to seek market approval of a lower strength of lubiprostone (8 mcg) to treat irritable bowel syndrome with constipation (IBS-C).

13 Jul 2007

Baxter presents findings from the ADAPT study

Baxter Healthcare Corporation has announced the presentation of findings from the ADAPT (Analysis of Data from ADVATE Prospective Trials) study program database showing a statistically significant relationship between the duration of time spent with factor VIII blood levels below one international unit per deciliter (1 IU/dL, one percent of normal factor VIII level) and an increase in the annual bleed rate in people with hemophilia A.

11 Jul 2007

Early diagnosis and prevention of the effects of tooth erosion are fundamental to keeping teeth healthy for life

Fruit, yogurt, citric and soft drinks, may seem like harmless snacks and beverages, but improper consumption and overuse may lead to devastating and permanent damage to teeth. It's known as tooth erosion, the break down of tooth structure caused by the effect of acid on the teeth that leads to decay.

26 Jun 2007

Greater understanding of fibromyalgia as a true medical condition

Fibromyalgia, a chronic, widespread pain in muscles and soft tissues accompanied by fatigue, is a fairly common condition that does not manifest any structural damage in an organ.

26 Jun 2007

Novel method of drug delivery to inhibit the growth of prostate cancer cells

Prostate cancer is the second leading cause of cancer-related death for men in the U.S. Present treatments for metastatic prostate cancer (cancer cells that spread to other parts of the body) include hormonal therapy, chemotherapy and radiotherapy, which frequently have serious side effects.

23 Jun 2007

Genzyme files for FDA approval of single-treatment Synvisc-One

Genzyme Corp. has announced that it has filed with the U.S. Food and Drug Administration (FDA) for approval of Synvisc-One, the single treatment of Synvisc (hylan G-F 20) that provides up to six months of pain relief from osteoarthritis (OA) of the knee.

23 Jun 2007

FDA approves Norditropin for short stature in children with Noonan syndrome

Novo Nordisk has announced that Norditropin (somatropin[rDNA origin] injection) received U.S. Food and Drug Administration (FDA) approval for the treatment of short stature in children with Noonan syndrome.

3 Jun 2007

Diagnosis of aspirin hypersensitivity

A position paper on the diagnosis of aspirin hypersensitivity by a team of European scientists from the Global Allergy and Asthma European Network (GA2LEN) has just been published on the Allergy Journal website.

1 Jun 2007

FDA completes review of FluMist

MedImmune, Inc. has announced that the U.S. Food and Drug Administration (FDA) has stated the agency has completed its review of all submissions made related to the supplemental biologics license application (sBLA) to extend the age indication of FluMist (Influenza Virus Vaccine Live, Intranasal).

28 May 2007

Ramelteon does not impair balance, mobility or memory performance in older adults with insomnia

A new study presented today showed that ramelteon did not impair middle-of-the-night balance, mobility or memory performance in older adults with insomnia, relative to placebo.

24 May 2007

Lubiprostone may improve symptom relief rates in adults with irritable bowel syndrome with constipation

A new study demonstrated that the active ingredient in AMITIZA (lubiprostone), given 8 mcg twice a day, may improve symptom relief rates in adults with irritable bowel syndrome with constipation (IBS-C).

22 May 2007

Lubiprostone may improve symptom relief rates in adults with irritable bowel syndrome

22 May 2007

Theophylline offers relief for unexplained chest pain

The discomfort caused by esophageal (non-cardiac) chest pain is often severe, driving many patients to emergency rooms and physicians' offices despite the fact that the ailment has no definable pathology.

10 May 2007

FluMist may help reduce the burden of seasonal influenza

MedImmune, Inc. has announced research results showing that use of FluMist(R) (Influenza Virus Vaccine Live, Intranasal) in daycare and school settings may help reduce the burden of seasonal influenza.

9 May 2007

FDA approves new indication for FRAGMIN for the extended treatment of symptomatic venous thromboembolism

The U.S. Food and Drug Administration (FDA) has approved a new indication for FRAGMIN (dalteparin sodium injection), for the extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in patients with cancer.

4 May 2007

Gleevec available to patients in post-surgical GIST study

Investigators will begin offering Gleevec(R) (imatinib mesylate)* tablets to patients receiving placebo in a major North American clinical trial after an interim analysis showed participants with Kit-positive gastrointestinal stromal tumors treated with Gleevec following surgery were significantly less likely to experience a return of their cancer compared to those not taking this innovative therapy.

15 Apr 2007

Mediterranean diet for children means fewer allergic symptoms

The benefits of a Mediterranean diet have been further enhanced with the latest research by scientists from Greece, Spain and the United Kingdom.

8 Apr 2007

Mums who eat apples decrease likelihood of kids having asthma

Eating apples while pregnant may give new meaning to an apple a day keeping the doctor away.

7 Apr 2007

Cephalon provides update on Nuvigil NDA

Cephalon has announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for NUVIGIL (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).

2 Apr 2007