Archive for September, 2008

CHMP nod to Eli Lilly’s Zypadhera

Eli Lilly and Company has announced that the Committee for Medicinal Products for Human Use (CHMP) has expressed a positive opinion in recommending the approval of Zypadhera (olanzapine long-acting injection) for maintenance treatment of schizophrenia in adult patients. The stand taken by the CHMP will have to be confirmed by the European Commission for the new indication to be considered as approved. The CHMP formed its opinion on the basis of data derived from eight studies, involving 2,054 patients.

OmniGuide’s BeamPath NEURO facilitates neurosurgery

OmniGuide Inc., has introduced the the first flexible CO2 laser scalpel for neurosurgery, the new BeamPath NEURO fiber. It provides surgeons with a precise, no-touch microsurgical tool for various central nervous system (CNS) procedures. It is designed for operating near structures that are critical and difficult to access. Besides, it minimizes thermal injury to adjoining healthy tissues of spine or brain. Neurosurgeons can, now, perform dissection, debulking and micro-vascular coagulation with precision.

Tysabri can treat MS effectively

Recent tests of Tysabri (developed by the Irish company Elan) have come up with positive results which were put before the World Congress on Treatment and Research in Multiple Sclerosis in Montreal. The doctors have concluded that the drug has the potential to come up as an effective treatment for patients suffering with multiple sclerosis. The medication is also useful in slowing down the progression of disability.

European commission grants Cethrin orphan drug designation

The European Commission has granted orphan drug designation to Cethrin developed by Alseres Pharmaceuticals, Inc., for the treatment of traumatic spinal cord injury (SCI). The drug had received the same status from FDA in 2005. Currently being tested for restoration of sensory and motor function, Cethrin is in Phase-II of its clinical trial.
The designation provides the drug with market exclusivity for a period of 10 years in the EU (7 years in the U.S). The Commission considered SCI as one of the rare and critical conditions lacking effective therapies.

Bayer develops thinnest needle for MS

Bayer HealthCare Pharmaceuticals Inc. has come up with a new 30-gauge needle, Betaseron (interferon beta-1b), its treatment for relapsing forms of multiple sclerosis (MS). It will be the thinnest needle (as thin as for insulin and pediatric injections) of any injectable therapy for MS patients. This will tackle the injection anxiety that many MS patients face during the treatment. They will now be more comfortable taking injections. The new needle causes lesser pain.

FDA approves ThermoSuit(R) System for clinical study

The U.S. Food and Drug Administration has approved Life Recovery Systems‘ ThermoSuit(R) System, a rapid patient cooling device for use in a clinical study of patients suffering from traumatic brain injury. Till now, the system has been in use to induce rapid cooling of heart patients only.The study which will be conducted at the University of Texas Health Science Center in Houston will investigate whether the induction of hypothermia will result in higher number of patients coming up with good outcomes at six months and 12 months after injury as compared to patients who were randomized to normothermia.


Medivation agrees to co-develop Dimebon with Pfizer

Pfizer Inc. and Medivation Inc. have entered into an agreement for development and commercialization of Dimebon. Dimebon is Medivation’s investigational drug to be used in the treatment of Alzheimer’s disease and Huntington’s disease, currently in Phase III of its trial involving patients with mild-to-moderate Alzheimer’s disease. The companies will share all U.S. development and commercialization expenses along with U.S. profits/losses with Pfizer assuming the larger share (60%). In addition, Medivation will co-promote Dimebon to specialty physicians in the U.S.

Novel Imaging Approach Detects Tumors Earlier

Researchers at Barrow Neurological Institute (St. Joseph’s Hospital) and the Montreal Neurological Institute recently carried out a pilot study which suggests that a certain type of MRI scanning can proactively detect whether a patient is failing brain tumor treatment. It assesses the response before symptoms appear. Patients with recurring malignant brain tumors received scans through an imaging device known as MR spectroscopy. This device identifies metabolic changes. The study concluded that the use of metabolic imaging can identify chemical changes earlier than the technology of structural imaging such as CT scan or a conventional MRI. This imaging can be done frequently. It is non-invasive and poses no radiation hazards.