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 OZURDEX implant for uveitis treatment

Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved OZURDEX (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.

27 Sep 2010

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.

24 Sep 2010

Many antisocial boys may have malfunctioning brains

Antisocial boys who abuse drugs, break laws, and act recklessly are not just "bad" kids. Many of these boys may have malfunctioning brains, according to a new study by researchers at the University of Colorado School of Medicine.

24 Sep 2010

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Biogen Idec is committed to improving the lives of people with multiple sclerosis (MS), and no company is doing more for these patients. There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

23 Sep 2010

Talecris Biotherapeutics announces 2010 eALTA award recipients

Talecris Biotherapeutics GmbH announced yesterday the recipients of the 2010 European alpha1-antitrypsin Laurell's Training Awards (eALTA). The annual awards, sponsored by Talecris, provide two fellowships of 50,000 euros to young investigators whose research aims to enhance the understanding and treatment of alpha1-antitrypsin deficiency (AAT deficiency).

21 Sep 2010

USP PET results qualify Apricus Bio's NexACT as anti-microbial preservative

Apricus Biosciences, backed by a revenue generating CRO business and seeking to leverage its multi-route NexACT® drug delivery technology and internal pipeline through out-licensing partnerships, today announced that results from a United States Pharmacopeia Preservative Efficacy Test (USP PET) qualified NexACT as an anti-microbial preservative. The results show that NexACT was effective in killing more than 23 strains of bacteria, fungus and mold, well beyond the requirements for passing the USP PET.

21 Sep 2010

Genzyme announces Japanese approval of Synvisc viscosupplement for OA knee pain relief

Genzyme Corporation announced today that Japan's Ministry of Health, Labour and Welfare has approved Synvisc® (hylan G-F 20; 3 x 2 mL), indicated for the treatment of osteoarthritis of the knee. Reimbursement has been obtained and publicized by Japan's Central Social Insurance Medical Council.

20 Sep 2010

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL® (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.

17 Sep 2010

European Commission approves SmPC update for VIRAMUNE in HIV treatment

Boehringer Ingelheim announced today that the European Commission has approved an update to the Summary of Product Characteristics (SmPC) for VIRAMUNE (nevirapine) in the treatment of patients with HIV.

16 Sep 2010

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

ViroPharma Incorporated today announced the presentation of data from its Phase 1 study of VP20621 (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections, a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications.

16 Sep 2010

Pharmacyclics reports $9.3 million increase in total revenue for 2010 fiscal year

Pharmacyclics, Inc. today reported financial results for its fiscal year and fourth quarter which ended June 30, 2010.

14 Sep 2010

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved the 500mg dose of FASLODEX® (fulvestrant) Injection, replacing the previously approved monthly dose of 250mg, for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

13 Sep 2010

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Purdue Pharma L.P. will present data from the clinical program for Butrans™ (buprenorphine) Transdermal System CIII in a series of posters at PAINWeek®2010, September 8-10 in Las Vegas.

10 Sep 2010

Children with severe, therapy-resistant asthma more likely to have poorer lung function: SARP

A subset of children with asthma suffers from severe, treatment-resistant disease associated with more illness and greater allergic hypersensitivity, according to the results of the National Heart, Blood, and Lung Institute's Severe Asthma Research Program, presented in a recently published article in Pediatric Allergy, Immunology, and Pulmonology, a peer-reviewed journal published by Mary Ann Liebert, Inc..

10 Sep 2010

Research into role of genetic variation in drug-induced hypersensitivity reactions

The International Serious Adverse Events Consortium (SAEC) announced today it will collaborate with The University of Liverpool (www.liv.ac.uk/pharmacogenetics) to research the genetics of a form of serious adverse drug reaction called hypersensitivity. These are thought to involve the body's immune system, and mostly involve serious skin rashes.

10 Sep 2010

DARA BioSciences presents KRN5500 study results at World Congress on Pain

DARA BioSciences announced today that it presented study results from its Phase 2 multicenter, placebo controlled, double-blind, randomized dose escalation study for KRN5500 at the 13th World Congress on Pain held recently in Montreal.

9 Sep 2010

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Medicis today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 7,790,705 related to the use of SOLODYN® (minocycline HCI, USP) Extended Release Tablets. The new patent, entitled "Minocycline Oral Dosage Forms for the Treatment of Acne," relates to the use of dosage forms of SOLODYN which provide approximately 1 mg/kg dosing based on the body weight of the person, and expires in 2027.

8 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

MSD announced today that the European Commission has approved the Marketing Authorization Application (MAA) for SYCREST® (asenapine) sublingual tablets for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. Today's decision was based on recommendations from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). The Commission Decision applies to all 27 European Member States.

3 Sep 2010

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

MSD and Cardiome Pharma Corp. today announced that the intravenous (IV) formulation of BRINAVESS™ (vernakalant) has been granted marketing approval in the European Union (EU), Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.

2 Sep 2010

Hypersensitivity News and Research

FDA approves OZURDEX implant for uveitis treatment

Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Many antisocial boys may have malfunctioning brains

Biogen Idec concurs with FDA on safety monitoring for Gilenya through REMS

Talecris Biotherapeutics announces 2010 eALTA award recipients

USP PET results qualify Apricus Bio's NexACT as anti-microbial preservative

Genzyme announces Japanese approval of Synvisc viscosupplement for OA knee pain relief

FDA Advisory Committee recommends approval of Alkermes' VIVITROL for opioid dependence

European Commission approves SmPC update for VIRAMUNE in HIV treatment

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

Pharmacyclics reports $9.3 million increase in total revenue for 2010 fiscal year

FDA approves FASLODEX 500mg dose for metastatic breast cancer in postmenopausal women

Purdue Pharma to present Butrans Transdermal System CIII clinical program data at PAINWeek 2010

Children with severe, therapy-resistant asthma more likely to have poorer lung function: SARP

Research into role of genetic variation in drug-induced hypersensitivity reactions

DARA BioSciences presents KRN5500 study results at World Congress on Pain

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

European Commission approves MSD's MAA for SYCREST in manic episodes associated with bipolar I disorder

BRINAVESS IV granted marketing approval in EU for conversion of recent onset AF to sinus rhythm

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