FDA has lifted a clinical hold on Geron’s Investigational New Drug (IND) application – the Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may now go ahead. GRNOPC1 is the first clinical trial of a human embryonic stem cell based therapy. The Phase I trials aims to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries.

Read the full story here

Edge Therapeutics, Inc. has announced that it has entered into a feasibility agreement with SurModics, Inc. According to the agreement, SurModics will develop a novel biodegradable, site-specific, sustained-release formulation (NimoGel™, EG-1961) for treatment of delayed complications of ruptured brain aneurysms or traumatic brain injury (TBI). NimoGel, Edge’s lead drug, is a combination of the FDA-approved drug nimodipine, a calcium channel blocker, and a proprietary biodegradable delivery system.

Read the full story here

A US company is close to receiving the approval for a new scanning and dye procedure, which could revolutionise the diagnosis and treatment of Alzheimer’s. Philadelphia-based Avid Radiopharmaceuticals has been working for the past few years on a new dye designed to highlight in a PET scan the tell-tale plaque deposits associated with Alzheimer’s disease.

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has recommended approval for the novel oral agent fingolimod in the treatment of patients with relapsing-remitting multiple sclerosis (MS). The highly anticipated drug, Gilena, is the first in a new class of disease-modifying agents called sphingosine 1 phosphate receptor modulators. The drug reduces the frequency of clinical exacerbations and delays the accumulation of physical disability.

XenoPort Inc. and GlaxoSmithKline PLC have said that the FDA needs three more months to review an application to a neuropathic pain drug being developed by them. The FDA should complete its review of the drug, called gabapentin enacarbil, by Feb. 9, 2010 said the companies. The FDA wanted the companies to develop a strategy to evaluate the drug’s risks, and after GlaxoSmithKline submitted that strategy, the agency needed additional time to review it.

For the full story, Click Here

Integra LifeSciences Holdings Corporation has announced the launch of the CUSA ShearTip(TM) for its CUSA EXcel(R) Ultrasonic Surgical Tissue Ablation platform that includes the CUSA EXcel(R) and the CUSA EXcel(R)+ systems. The CUSA ShearTip(TM) has received 510(k) clearance from the United States Food and Drug Administration (FDA) and CE Mark Certification in the European Union. The new tip design will expand the use of the CUSA EXcel(R) platform in neurosurgical applications and beyond.

An FDA panel voted 12 to 1 that Acoherapeutics Inc’s Phase III trials provided substantial evidence that fampridine sustained-release was effective in improving the walking ability in patients with multiple sclerosis. The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee also voted 10 to 2, that there are conditions under which fampridine SR could be safely used as a therapy to improve walking in patients with MS.

Neuralstem Inc has received approval from the US health regulators to start an early-stage human trial of its spinal cord stem cells in Lou Gehrig’s disease, a fatal neuromuscular condition. The trial, which will test the safety of the cells and the surgery procedure, will ultimately consist of 18 patients suffering from the disease, also known as amyotrophic lateral sclerosis (ALS), the company said.

Covidien plc received the FDA approval for the use of its tissue sealant product DuraSeal for use during spine surgery. Covidien expects to start selling DuraSeal for spinal use within a few weeks. The product has been on the market since 2005 for use during brain surgery. “DuraSeal continues Covidien’s dedication to scientific, evidence-based innovation that improves patient outcomes,” Dr. Michael Tarnoff, chief medical affairs officer for Covidien’s surgical devices unit, said in a statement.

The FDA has approved BrainScope ZOOM-100DC, a handheld device for people with possible traumatic brain injury. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals. The 8-channel product, capable of recording and displaying EEG waveforms and providing conventional EEG measures displayed in tables, is designed especially for those patients who don’t have immediate access to a hospital.