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 Schering-Plough's New Drug Application for ZEGERID OTC capsules

Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.’s, New Drug Application (NDA) for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn.

2 Dec 2009

Study of Acetadote Injection as a cost-saving treatment for acetaminophen poisoning published

Cumberland Pharmaceuticals Inc. announced today that an independently conducted study of Acetadote (acetylcysteine) Injection, or intravenous N-acetylcysteine, as a cost-saving treatment for acetaminophen poisoning was published in Volume 12, Number 4 of the peer-reviewed Journal of Medical Economics, distributed in December.

2 Dec 2009

FDA grants approval for Dyax' KALBITOR for treating HAE patients

Dyax Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for KALBITOR® (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

2 Dec 2009

Bioequivalence and comparable toxicity of ADVENTRX Pharmaceuticals' ANX-514 and Taxotere affirmed

ADVENTRX Pharmaceuticals, Inc. today announced that a new, recently completed preclinical study has affirmed the bioequivalence and comparable toxicity of ANX-514 and Taxotere® (docetaxel). Shin Poong Pharmaceuticals, ADVENTRX's partner for ANX-514 in South Korea, independently conducted the study and data analysis.

1 Dec 2009

Article on TYSABRI for treating patients with multiple sclerosis published

Best-practice recommendations for the selection and management of patients with multiple sclerosis (MS) who may benefit from, or are receiving treatment with TYSABRI- (natalizumab) were published today in a supplement to the medical journal Multiple Sclerosis.

1 Dec 2009

Findings show the relationship between neurotransmitter dopamine and ADHD

Scientists at the California Institute of Technology (Caltech) have uncovered evidence of a primitive emotion-like behavior in the fruit fly, Drosophila melanogaster.

26 Nov 2009

Tibotec Therapeutics' INTELENCE granted FDA traditional approval

The FDA granted traditional approval for INTELENCE® (etravirine) tablets, a non-nucleoside reverse transcriptase inhibitor (NNRTI). INTELENCE is the only NNRTI specifically indicated for use in treatment-experienced adults who are experiencing virologic failure with HIV-1 strains resistant to an NNRTI and other antiretroviral (ARV) agents.

25 Nov 2009

U.S. Court rules in Merck's favor in Flemings case involving FOSAMAX

Merck said today that U.S. District Court Judge John F. Keenan granted summary judgment in Merck's favor in Flemings v. Merck. Flemings is the second of three cases involving FOSAMAX (alendronate sodium) designated by the federal MDL court as a bellwether trial case.

24 Nov 2009

Caldolor Injection effective in treating fever in hospitalized burn patients

Cumberland Pharmaceuticals Inc. today announced positive new top-line results from a study evaluating the safety and efficacy of Caldolor (ibuprofen) Injection in treating fever in hospitalized burn patients.

23 Nov 2009

FDA approves sNDA for pediatric autism drug ABILIFY

Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

20 Nov 2009

FDA Advisory Committee votes in support of Pfizer's Prevnar 13

Pfizer Inc announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 10 to 1 that the data presented support the safety and effectiveness of its 13-valent pneumococcal conjugate candidate vaccine, Prevnar 13™ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for the prevention of invasive pneumococcal disease in infants and young children.

19 Nov 2009

Millennium commences Phase I clinical trial for its second-generation proteasome inhibitor

Millennium: The Takeda Oncology Company today announced it has further expanded its protein homeostasis program with the initiation of a Phase I clinical trial for an oral formulation of MLN9708, the Company’s second-generation proteasome inhibitor. An intravenous formulation of MLN9708 entered clinical trials in March.

18 Nov 2009

Shire publishes new study results on INTUNIV Extended-Release Tablets

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended-Release Tablets published in the October Journal of Child and Adolescent Psychopharmacology. In this open-label safety study, there was no evidence of unique adverse effects with the combination of INTUNIV and amphetamine or methylphenidate relative to what was observed with either medication alone.

17 Nov 2009

FDA approves Par Pharmaceutical's new painkiller drug

Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for the 100mg and 200mg strengths of tramadol ER.

17 Nov 2009

Erbitux recognized as one of the major clinical cancer advances of 2009

The American Society of Clinical Oncology (ASCO) has once again recognized Erbitux® (cetuximab) as one of the major clinical cancer advances of 2009. This year Erbitux was selected by ASCO for providing the first significant increase in survival for 30 years in the treatment of patients with 1st-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

16 Nov 2009

Alkermes' phase 3 trial of naltrexone XR-NTX meets primary endpoint

Alkermes, Inc. today announced positive preliminary results from a phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence. The six-month phase 3 study met its primary efficacy endpoint and data showed that patients treated once-monthly with XR-NTX demonstrated statistically significant higher rates of clean (opioid-free) urine screens, compared to patients treated with placebo, as measured by the cumulative distribution of clean urine screens (p<0.0002).

16 Nov 2009

Findings from post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse announced

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse-. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

16 Nov 2009

Shire announces findings from Phase 3 study data with Vyvanse

Shire plc, the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.

13 Nov 2009

FDA approves CSL Biotherapies' seasonal flu vaccine, Afluria for children

CSL Biotherapies, a subsidiary of CSL Limited, one of the world’s leading manufacturers of influenza vaccine, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s application for accelerated approval of its seasonal flu vaccine, Afluria® (Influenza Virus Vaccine) for use in the pediatric population aged 6 months and older.

12 Nov 2009

Occupational contact dermatitis and asthma are most common work-related health issues, says new research

Occupational contact dermatitis and asthma are two of the most common work-related health issues facing workers worldwide, according to experts presenting the latest research at the annual meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Miami Beach, Fla.

11 Nov 2009