Hypersensitivity News and Research

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

Dyax announces fourth-quarter and full-year 2009 financial results

Dyax Corp. today announced financial results for the fourth quarter and year ended December 31, 2009. Dyax will host a webcast and conference call at 10 a.m. (ET) this morning to review the financial results and corporate progress for the quarter.

17 Feb 2010

USPTO issues two new patents for EKR Therapeutics' RTU Cardene I.V. Premixed Injection

EKR Therapeutics, Inc., a specialty pharmaceutical company focused on commercializing acute-care hospital products, today announced that the US Patent and Trademark Office has issued two new patents covering methods of treatment and methods of preparation for the Company’s Ready-to-Use (RTU) Cardene® I.V. (nicardipine hydrochloride) Premixed Injection.

17 Feb 2010

Genzyme announces 2-year data from eliglustat tartrate Phase 2 trial for Gaucher disease

Genzyme Corporation announced today two-year follow-up data from patients enrolled in the phase 2 clinical trial for its investigational oral therapy for Gaucher disease type 1 known as eliglustat tartrate (formerly Genz-112638). Continued improvements were observed across all endpoints, including bone disease, at the two-year timepoint, compared with baseline. The two-year results were presented for the first time today at the Lysosomal Disease Network WORLD Symposium in Miami, Fla.

12 Feb 2010

Additional data from Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease presented

Protalix BioTherapeutics, Inc., announced today that additional data from the Company's pivotal Phase III clinical trial of taliglucerase alfa in patients with Gaucher disease was presented at the Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2010 in Miami, Florida, during an oral session titled, "Novel Enzyme Replacement Therapy for Gaucher Disease: Phase III Pivotal Clinical Trial with Plant Cell Expressed Recombinant Glucocerebrosidase (prGCD) - taliglucerase alfa."

12 Feb 2010

Critical phases of brain development may be mistimed in autistic patients, says study

Research into Fragile X Syndrome - a genetic condition that is the leading known cause of autism - has discovered that critical phases in the brain's development may be mistimed in people with the condition.

11 Feb 2010

Concomitant use of dexlansoprazole and other PPIs with Plavix: TGRD U.S. initiates trial

Takeda Global Research & Development Center, Inc., U.S., (TGRD U.S.) announced today that it has initiated a trial to study how dexlansoprazole and several other proton pump inhibitors (PPIs) affect the pharmacokinetics and pharmacodynamics of Plavix (clopidogrel bisulfate) in healthy subjects. Takeda has been evaluating all published data and communications from the U.S. Food and Drug Administration (FDA) regarding the potential risks associated with concomitant use of clopidogrel and PPIs.

10 Feb 2010

Excelsior Medical receives Canadian marketing license for new, pre-filled catheter lock syringe

Excelsior Medical Corporation, one of the leading manufacturers of pre-filled catheter flush syringes, today announced that it has received a Medical Device License from Health Canada for its new, pre-filled catheter lock syringe to be sold in the Canadian marketplace.

10 Feb 2010

FDA approves Sagent Pharmaceuticals' labetalol HCl injection for severe hypertension

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has received FDA approval of labetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension. The product will be available in two vial sizes – 100 mg per 20 mL and 200 mg per 40 mL, multi-dose vials.

9 Feb 2010

Genta commences Phase 2 trial of tesetaxel on first subject

Genta Incorporated announced that the Company has initiated treatment of the first subject in a new Phase 2 trial of tesetaxel in advanced melanoma. Tesetaxel is the Company’s newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The new trial builds on more than ten years of Genta’s experience in melanoma clinical research.

9 Feb 2010

AMAG Pharmaceuticals releases safety update on Feraheme Injection

AMAG Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease, today provided a safety update on Feraheme® (ferumoxytol) Injection for intravenous use.

6 Feb 2010

Study: Generic nifedipine product not bioequivalent to Adalat XL

An extended release generic nifedipine product (Mylan-Nifedipine extended release 60 mg formerly Gen-Nifedipine extended release 60mg, Genpharm ULC) is not bioequivalent to the Canadian originator product, Adalat(R) XL(R), according to the results of a study recently published in the International Journal of Clinical Pharmacology and Therapeutics.

4 Feb 2010

Recent clinical trials in patients with ALBP show that SOMA 250 mg reduces disability

A recent analysis of two pivotal clinical trials in patients with acute low back pain (ALBP) who were treated with SOMA® (carisoprodol) 250 mg showed significantly improved functionality and reduced disability after three days of treatment, as measured by the Roland-Morris Disability Questionnaire (RMDQ).

4 Feb 2010

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Romark Laboratories announced that it has initiated enrollment of patients in a clinical trial of Alinia® (nitazoxanide) for treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain.

1 Feb 2010

Clinical results of MedImmune's pivotal trial for motavizumab published

MedImmune today announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: Official Journal of the American Academy of Pediatrics.

30 Jan 2010

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

29 Jan 2010

Onset Therapeutics expands its sales force to create nationwide presence

Onset Therapeutics LLC, a specialty pharmaceutical company focused in dermatology, today announced that the Company’s recent growth and future opportunities have facilitated an expansion of its field sales organization to cover more than twenty-five additional major metropolitan areas.

28 Jan 2010

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) provided an improvement in overall survival (OS) when added to the standard 1st-line FOLFIRI chemotherapy regimen for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors in the CRYSTAL study.

24 Jan 2010

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients.