Codman & Shurtleff, Inc. has announced the launch of the stretch resistant XTRASOFT™ ORBIT GALAXY™ Coil (XTRASOFT), the softest endovascular finishing coil1 for use in the treatment of cerebral aneurysms. XTRASOFT is the first in a family of coils known as the ORBIT GALAXY™ Detachable Coil System, Codman’s next generation, stretch resistant coil platform. The announcement was made here at the Society of NeuroInterventional Surgery (SNIS) 7th Annual Meeting.

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RegeneRx Biopharmaceuticals, Inc. has announced that Thymosin beta 4 (TB4), administered to rats after embolic stroke, improved neurological functional outcome compared to control animals. The research was performed under a Material Transfer Agreement between RegeneRx Biopharmaceuticals, Inc. and the Henry Ford Health System. Improvement in neurological function was measured at various time intervals over a seven week period and was statistically significant.

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The FDA has approved an expanded age range for a methylphenidate transdermal system (Daytrana; Shire, under license from Noven Pharmaceuticals, Inc) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Previously approved for use in children aged 6 to 12 years, the methylphenidate patch is indicated as an integral part of a total treatment program that may include psychological, educational, and social measures.

FDA Advisory Committee affirmed the drugs positive benefit/risk profile and unanimously voted in favor of the approval of FTY720 (fingolimod) as the treatment in relapsing remitting multiple sclerosis. FTY720, potentially first in a new class of MS therapy, represents a significant advance as an efficacious oral treatment for people with relapsing remitting MS.

Data from the first phase III clinical trial of NovoCure’s NovoTTF device for treatment of patients with recurrent glioblastoma (GBM) were presented as a late breaking abstract during the Neuro-Oncology session at the American Society of Clinical Oncology (ASCO) Annual Meeting. Study results show that NovoTTF, a portable medical device, may be as or more effective than the best available chemotherapies for GBM, but without the toxicity usually associated with cytotoxic or targeted treatments.

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Synergetics USA, Inc. has announced the signing of an addendum to its three year agreement with Codman & Shurtleff, Inc. Under the terms of the revised agreement, Codman will have the exclusive right to market and distribute a Spetzler-Malis branded disposable bipolar forceps produced by Synergetics. This arrangement supports their ongoing efforts to reduce commercial expenses associated with our neurosurgery product lines.

Shire has received approval from the FDA for INTUNIV (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. The once-daily INTUNIV drug is expected to be available in the US pharmacies by November and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).

Lundbeck Inc has received approval from the FDA for its two New Drug Applications (NDA), Sabril (vigabatrin) Tablets and Oral Solution. Lundbeck will be launching Sabril in the US during the third quarter. Sabril is indicated as a monotherapy for pediatric patients, aged between one month and two years, with infantile spasms for whom the potential benefits outweigh the potential risk of vision loss. The drug is also indicated as an add-on therapy for adult patients with refractory complex partial seizures who have failed other available treatments and for whom the potential benefits outweigh the risk of vision loss.

The Food and Drug Administration (FDA) has given the approval to Neuronetics Inc.’s Neurostar [a transcranial magnetic stimulation (TMS) device] for use in the treatment of depression. The non-invasive tool stimulates the brain by transmitting magnetic pulses to the skull. The device will help the adult patients who have not benefited from anti-depressants. Also, this therapy has no risks as associated with electric shock therapy and surgically implanted electrodes.

The FDA has concluded that Teva Pharmaceutical’s bupropion XL 300 mg, a generic version of Wellbutrin XL, is a safe and effective treatment for patients suffering from depression. Questions about the safety and efficacy of Teva’s bupropion XL arose after the agency received 85 postmarketing reports of patients experiencing side effects after switching from GlaxoSmithKline’s Wellbutrin (bupropion HCl) to the generic version.