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Dabigatran decreases risk of recurrent venous thromboembolism

New findings from two double-blind, randomized trials, RE-MEDY and RE-SONATE, show that dabigatran 150 mg twice daily reduces the risk of recurrent venous thromboembolism (VTE).

21 Feb 2013

UCB seeks FDA and EMA marketing authorization for Cimzia to treat active psoriatic arthritis

UCB announced today two new regulatory filings with the US Food and Drug Administration (FDA) and with the European Medicines Agency (EMA) to extend the marketing authorization for Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis (PsA) and for adult patients with active axial spondyloarthritis (axSpA).

20 Feb 2013

rEVO Biologics announces results from Atryn phase 3 studies on pregnant AT-deficient women

rEVO Biologics announced today the results of a major retrospective study analysis of its pivotal phase 3 studies which demonstrate that pregnant patients with hereditary antithrombin deficiency (HD) benefit from ATryn Antithrombin (Recombinant) therapy to prevent venous thromboembolic events (VTE).

16 Feb 2013

Diastolic hypotension key predictor of admission in pediatric asthma

Results from a large study show that diastolic hypotension is a consistent predictor of admission to hospital in all children with asthma.

12 Feb 2013

Fish-related ciguatoxin danger highlighted

Researchers report that 28 cases of ciguatera fish poisoning occurred in New York City during 2010–2011, a greater number than were reported during the preceding 10-year period.

6 Feb 2013

Dual renin angiotensin system blockade: too many cons

Any benefit of dual blockade of the renin angiotensin system is limited to its effects on surrogate endpoints, and outweighed by an excessive risk for adverse events such as hypotension, hyperkalemia, and renal failure, argue hypertension experts.

31 Jan 2013

Childhood adversity raises comorbidity risk in bipolar disorder

Childhood adversity, including verbal, physical, or sexual abuse, is associated with the later development of multiple medical comorbidities in patients with bipolar disorder, researchers report.

29 Jan 2013

GE Healthcare submits Optison sNDA to aid in detection of cardiovascular diseases

GE Healthcare today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.

16 Jan 2013

Taking early and repeated WBC is critical in determining infants at high risk of pertussis

A study released today from the upcoming issue of the Journal of the Pediatric Infectious Diseases Society (JPIDS) found that taking early and repeated white blood cell counts (WBC) is critical in determining whether infants have pertussis and which of those children are at highest risk of death from the disease.

11 Jan 2013

Merck’s resubmission of the NDA for suggammadex sodium injection accepted for review by the FDA

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the resubmission of the New Drug Application (NDA) for sugammadex sodium injection has been accepted for review by the U.S. Food and Drug Administration (FDA). Merck expects the FDA’s review to be completed in the first half of 2013.

7 Jan 2013

New insights into devastating second impact syndrome

Physicians at Indiana University School of Medicine and the Northwest Radiology Network (Indianapolis, Indiana) report the case of a 17-year-old high school football player with second impact syndrome (SIS). A rare and devastating traumatic brain injury, SIS occurs when a person, most often a teenager, sustains a second head injury before recovery from an earlier head injury is complete.

2 Jan 2013

AMAG seeks FDA sNDA approval for Feraheme Injection

AMAG Pharmaceuticals, Inc. today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme (ferumoxytol) Injection for Intravenous (IV) use.

25 Dec 2012

Updated U.S. prescribing information for Boehringer Ingelheim’s Pradaxa

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.

21 Dec 2012

AMAG presents new data from two ferumoxytol phase III trials on IDA at ASH annual meeting

AMAG Pharmaceuticals, Inc. today announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia.

11 Dec 2012

Study: Controversial treatment for autism spectrum disorder may be harmful

A controversial treatment for autism spectrum disorder (ASD) is not only ineffective but may be harmful, according to a study conducted by Baylor University researchers.

30 Nov 2012

Ultrasound-guided transbronchial needle aspiration complication rate ‘reassuring’

Multisite findings support the use of endobronchial ultrasound-guided transbronchial needle aspiration for mediastinal lymph node sampling.

12 Nov 2012

Pradaxa use does not appear to increase serious bleeding

The U.S. Food and Drug Administration (FDA) today announced the results of a Mini-Sentinel assessment that indicates bleeding rates associated with new use of Pradaxa (dabigatran etexilate mesylate) capsules do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the pivotal RE-LY trial.

4 Nov 2012

NICE decides to recommend Bristol-Myers Squibb’s YERVOY for treatment of advanced melanoma

Bristol-Myers Squibb Company is pleased to announce that today the National Institute of Health and Clinical Excellence (NICE) has decided to recommend YERVOY (ipilimumab), which is approved in the European Union for the treatment of previously-treated metastatic (advanced) melanoma, within the Final Appraisal Determination (FAD).

3 Nov 2012

FDA accepts Sunovion’s two LATUDA sNDAs for review

Sunovion Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental New Drug Applications (sNDAs) for the use of LATUDA as 1) monotherapy and 2) adjunctive therapy to lithium or valproate, both to treat adult patients with depressive episodes associated with bipolar I disorder (bipolar depression).

31 Oct 2012

$Most refractory status epilepticus patients have poor functional outcome$

Most refractory status epilepticus patients have poor functional outcome

Three-quarters of refractory status epilepticus patients have a poor functional outcome, which is linked to drug-induced coma and severe encephalographic suppression, say US scientists.

30 Oct 2012