Hypersensitivity News and Research

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

UCB presents data on Vimpat AED at AES meeting

UCB today announced new findings on its antiepileptic drug (AED) Vimpat® that offer additional clinical evidence supporting the use of this AED as adjunctive therapy in adult patients with partial-onset seizures. Results of presented research demonstrate sustained efficacy in adult patients taking Vimpat® for up to three years, and a consistent long-term tolerability profile.

7 Dec 2009

VELCADE based regimens are cost-effective for payers and patients, finds study

Millennium: The Takeda Oncology Company today announced that two studies presented at the 51st American Society of Hematology (ASH) Annual Meeting found that VELCADE based regimens are more cost-effective for payers and reduced out-of-pocket costs for patients than other commonly used multiple myeloma treatments.

7 Dec 2009

FDA approves Santarus’ NDA for immediate-release prescription tablet product

Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole.

5 Dec 2009

Results from Phase III pivotal study of FIRMAGON presented

Drs. Neal Shore and E. David Crawford presented results for prostate-specific antigen (PSA) recurrence from the additional analysis of secondary end points of biochemical recurrence rate in a Phase III pivotal study of FIRMAGON® (monthly degarelix for injection) or monthly leuprolide in prostate cancer patients during the first year of treatment.

4 Dec 2009

Pfizer to present study findings from its expanded breast cancer portfolio

Pfizer Oncology announced today that it will be presenting study findings evaluating several compounds including those from its newly expanded breast cancer portfolio following the recent acquisition of Wyeth, focusing on the needs of multiple breast cancer patient populations at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) being held December 9 – 13.

4 Dec 2009

Data from recent clinical trial for Caldolor Injection to be presented

Cumberland Pharmaceuticals Inc. announced today that data from a recent clinical trial for Caldolor® (ibuprofen) Injection, an intravenous treatment for pain and fever, will be presented at the 44th American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting in Las Vegas, Nevada, in December.

4 Dec 2009

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in its phase II clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate).

3 Dec 2009

New data demonstrating the strength of Novartis' hematology portfolio to be presented

Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company's hematology portfolio in advancing the care of patients.

2 Dec 2009

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