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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

Nonmotor symptoms common in early-stage PD

Nonmotor symptoms occur in nearly all individuals with Parkinson’s disease, Italian study results suggest.

17 Oct 2012

Dopaminergic treatment has ‘minor impact’ on autonomic symptoms in Parkinson’s

Norwegian researchers say that dopaminergic treatment should be considered for patients with early Parkinson’s disease after finding that dopaminergic medication only has a minor impact on autonomic symptoms after 1 year.

17 Oct 2012

Neuroprotectant success in aneurysm coiling

Treatment with the novel neuroprotective agent NA-1 reduces the number of ischemic infarcts sustained by patients undergoing coiling of cerebral aneurysms, show the ENACT results.

12 Oct 2012

Neuroprotectant success in aneurysm coiling

Treatment with the novel neuroprotective agent NA-1 reduces the number of ischemic infarcts sustained by patients undergoing coiling of cerebral aneurysms, show the ENACT results.

9 Oct 2012

Adjunctive drugs hasten sedation in the emergency department

Adding intravenous droperidol or olanzapine to midazolam shortens the time to adequate sedation in acutely agitated patients in the emergency department, show findings from a randomized controlled trial.

2 Oct 2012

Orthopedists should suspect necrotizing fasciitis in patients with out of proportion pain

Dr. Russell Russo, an Orthopedic Surgeon at LSU Health Sciences Center New Orleans, and other researchers stress that orthopedists should have a high index of suspicion for necrotizing fasciitis, or flesh-eating bacterial infection, in every patient with pain or other symptoms that are out of proportion to the initial diagnosis. Their recommendations are published in the September 2012 issue of Orthopedics Today.

17 Sep 2012

AMAG receives Swiss marketing authorization for ferumoxytol to treat iron deficiency anemia

AMAG Pharmaceuticals, Inc. today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization in Switzerland for ferumoxytol, an intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adult patients with chronic kidney disease.

6 Sep 2012

Renal denervation regenerates blood vessels and could reduce cardiovascular events

Renal denervation improves blood pressure and arterial stiffness in patients with therapy resistant hypertension, according to research presented at ESC Congress 2012 by Mr Klaas Franzen from the University Hospital of Schleswig-Holstein.

28 Aug 2012

Mallinckrodt receives FDA approval for 32 mg tablet strength of EXALGO

The U.S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of Covidien, that it has approved a 32 mg tablet strength of EXALGO (hydromorphone HCI) Extended-Release Tablets (CII) for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

Healthcare announces important changes to the U.S. product label for Optison

GE Healthcare today announced important changes to the U.S. product label for Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), a contrast agent that may improve the visualization of the left ventricular border - an area of the heart that is critical to see in order to diagnose certain heart diseases such as hypertrophic cardiomyopathy.

22 Aug 2012