Hypersensitivity News and Research

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

Pfizer announces approval of Lyrica capsules for peripheral neuropathic pain

Pfizer Inc announced that the Japanese Ministry of Health, Labour and Welfare approved Lyrica (pregabalin) capsules for the treatment of peripheral neuropathic pain. This follows the recent approval in Japan of Lyrica for the treatment of postherpetic neuralgia on April 16, 2010. Lyrica is the first medication approved for peripheral neuropathic pain in Japan where it is co-promoted with Eisai Co., Ltd.

29 Oct 2010

Sandoz initiates voluntary recall of Methotrexate Injection

Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots.

28 Oct 2010

ENDOMETRIN Vaginal Insert offers effective luteal support in IVF procedures

Ferring Pharmaceuticals Inc. presented study results demonstrating that ENDOMETRIN (progesterone) Vaginal Insert provides effective luteal support compared to intramuscular (IM) progesterone-in-oil (PIO) in patients undergoing in vitro fertilization (IVF) using gonadotropin releasing hormone (GnRH) antagonist.

27 Oct 2010

Baxter announces launch of GLASSIA in the U.S.

Baxter International Inc. today announced the commercial launch of GLASSIATM [Alpha1-Proteinase Inhibitor (Human)] in the United States. GLASSIATM is the first available ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1 antitrypsin (AAT), an under-diagnosed hereditary condition characterized by a low level of alpha-1 protein in the blood.

From Baxter International Inc. 26 Oct 2010

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

ViroPharma Incorporated today announced that it has completed enrollment in its Phase 2 study evaluating subcutaneous delivery of Cinryze™ (C1esterase inhibitor [human]). This multi-center, open-label, multi-dose Phase 2 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze in adolescent and adult subjects with hereditary angioedema (HAE).

25 Oct 2010

FDA issues complete response letter for ViroPharma's Cinryze

ViroPharma Incorporated today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding Cinryze (C1 Esterase Inhibitor [Human]) industrial scale manufacturing expansion activities. The FDA has requested additional information related to observations from the pre-approval inspection and review of the technical processes.

25 Oct 2010

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Cephalon, Inc. today announced that Risk Evaluation and Mitigation Strategies (REMS) for its medications NUVIGIL (armodafinil) Tablets [C-IV] and PROVIGIL (modafinil) Tablets [C-IV] have been approved by the U.S. Food and Drug Administration (FDA).

25 Oct 2010

Talecris announces publication of PROLASTIN-C study results for AAT deficiency in BML journal

Talecris Biotherapeutics today announced the publication of results from a study showing that PROLASTIN-C (Alpha1-Proteinase Inhibitor [Human]) (A1PI) is as effective as PROLASTIN (Alpha1-Proteinase Inhibitor [Human]) in raising levels of alpha-1 protein in patients with alpha1-antitrypsin (AAT) deficiency.

22 Oct 2010

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Results of a new international phase 4 study of patients with nosocomial pneumonia due to proven methicillin-resistant Staphylococcus aureus (MRSA) demonstrated that the antibiotic Zyvox® (linezolid) achieved a statistically significantly higher clinical success rate compared with vancomycin for the primary endpoint. The ZEPHyR (Linezolid in the treatment of subjects with nosocomial pneumonia proven to be due to methicillin-resistant Staphylococcus aureus) study was the largest ever conducted in this population.

21 Oct 2010

Pradaxa capsules receive FDA approval for reducing stroke and systemic embolism risk in AFib patients

The U.S. Food and Drug Administration (FDA) has approved Pradaxa (dabigatran etexilate) capsules to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AFib).

20 Oct 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

UCB presents P3, P4 clinical trial data for Crohn's disease at ACG Scientific Meeting

Findings from the PRECiSE 3 (P3) open label extension study for Cimzia, demonstrating the longest continuously running maintenance trial for an anti-TNF in Crohn's disease, will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology (ACG), taking place in San Antonio from October 15 – 20. Additionally, long-term efficacy data from the PRECiSE 4 (P4) clinical trial also will be presented at the meeting.

19 Oct 2010

ACG meeting to exhibit Cimzia data for Crohn's disease treatment

Studies and analyses of the Crohn's disease (CD) treatment Cimzia (certolizumab pegol) will be exhibited at the 2010 Annual Scientific Meeting of the American College of Gastroenterology, taking place in San Antonio from October 15 – 20.

18 Oct 2010

Biogen, Elan announce clinical utility data of two-step ELISA to detect anti-JCV antibodies

Biogen Idec and Elan Corporation, plc today announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum.

18 Oct 2010

Genentech and Biogen Idec announce positive results from ocrelizumab phase II RRMS study

Genentech, Inc., a member of the Roche Group, and Biogen Idec today announced 24-week results from a phase II study of ocrelizumab in patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of the disease. Ocrelizumab demonstrated a significant reduction in disease activity as measured by brain lesions and relapse rate.

15 Oct 2010

FDA approves Gamunex-C for primary immunodeficiency treatment

Talecris Biotherapeutics announced today that the U.S. Food and Drug Administration (FDA) approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).

15 Oct 2010

Acetadote Injection is now commercially available in Australia

Cumberland Pharmaceuticals Inc. and Phebra Pty Ltd. today announced that Acetadote (acetylcysteine) Injection, an injectable product used to treat acetaminophen (paracetamol) overdose, is now commercially available in the Australian market. Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, has an exclusive license from U.S.-based Cumberland Pharmaceuticals to market and distribute the product in Australia.

15 Oct 2010

Alkermes' VIVITROL medication for treatment of opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VIVITROL(naltrexone for extended-release injectable suspension) for the prevention of relapse to opioid dependence, following opioid detoxification.

13 Oct 2010

Erbitux-based therapy helps in early tumor shrinkage, long-term survival in mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany has announced that new data presented today at the 35th Congress of the European Society for Medical Oncology (ESMO) have shown that patients with KRAS wild-type metastatic colorectal cancer (mCRC) who experienced early tumor shrinkage (within 8 weeks) during 1st line Erbitux (cetuximab) based treatment lived a median of 28.3 months.

12 Oct 2010

Hypersensitivity News and Research

Pfizer announces approval of Lyrica capsules for peripheral neuropathic pain

Sandoz initiates voluntary recall of Methotrexate Injection

ENDOMETRIN Vaginal Insert offers effective luteal support in IVF procedures

Baxter announces launch of GLASSIA in the U.S.

Enrollment complete in ViroPharma's Phase 2 study evaluating subcutaneous delivery of Cinryze

FDA issues complete response letter for ViroPharma's Cinryze

FDA approves REMS for NUVIGIL and PROVIGIL tablets

Talecris announces publication of PROLASTIN-C study results for AAT deficiency in BML journal

Zyvox achieves higher clinical success rate than vancomycin in MRSA nosocomial pneumonia study

Pradaxa capsules receive FDA approval for reducing stroke and systemic embolism risk in AFib patients

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

UCB presents P3, P4 clinical trial data for Crohn's disease at ACG Scientific Meeting

ACG meeting to exhibit Cimzia data for Crohn's disease treatment

Biogen, Elan announce clinical utility data of two-step ELISA to detect anti-JCV antibodies

Genentech and Biogen Idec announce positive results from ocrelizumab phase II RRMS study

FDA approves Gamunex-C for primary immunodeficiency treatment

Acetadote Injection is now commercially available in Australia

Alkermes' VIVITROL medication for treatment of opioid dependence

Erbitux-based therapy helps in early tumor shrinkage, long-term survival in mCRC patients with KRAS wild-type tumors

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