Oral Therapies for Multiple Sclerosis – Fingolimod (FTY 720) and Cladribine: How Close are Novartis and Merck KGaA to FDA Approval?

These are interesting days for the first oral therapies targeting multiple sclerosis (cladribine and  fingolimod or FTY720) indeed, with both positive and negative events making news over the last several weeks.  On November 30th 2009,  Reuters reported that the FDA had issued Merck KGaA a ‘refuse to file’ letter, which in effect is the FDA’s way [...]

Elan/Biogen Idec’s Antegren (Natalizumab) for Treatment of Multiple Sclerosis

On July 26, 2004 Elan Corp.’s application for approval of its multiple sclerosis (MS) drug Antegren was accepted for review by the FDA. Elan has developed Antegren with U.S. partner Biogen Idec. The company has stated that this therapy represents a new approach in the treatment of MS and is expected to eventually generate annual [...]

Neurochem’s Alzhemed for treatment of Alzheimer’s

On July 18, 2004, Neurochem Inc. released interim data pertaining to a Phase II open-label extension study of the effects of Alzhemed on cognitive function and global measure of performance in patients with mild-to-moderate Alzheimer’s Disease. According to Neurochem, the study showed that approximately 70% of the mild AD patients had stabilized or improved cognitive [...]

Xenova Group’s TA-NIC for the Treatment of Nicotine Addiction

On July 14, 2004 Xenova Group plc released results of a second clinical trial with TA-NIC, a therapeutic vaccine under development for the treatment of nicotine addiction. The company reported that this randomized, placebo controlled, double-blinded study involved a total of 60 smokers and was designed to prove safety and tolerability data while measuring anti-nicotine [...]

Dexanabinol

On March 15, 2004 Pharmos Corporation announced that it had completed patient enrollment in its pivotal Phase III study of dexanabinol for the treatment of severe traumatic brain injury (TBI). A total of 86 trauma centers recruited 860 patients. Pharmos expects to unblind the study data and announce initial results toward the end of [...]

Indiplon

Indiplon
On February 18, 2004 Neurocrine Biosciences said that preliminary results from a late-stage clinical trial showed that its experimental sleeping pill, being developed in conjunction with Pfizer, works in elderly patients with chronic insomnia. Results from its Phase III clinical trial with two doses (5 mg and 10 mg) of the immediate release formulation of [...]

Visudyne

On January 29, 2004, U.S. health authorities expanded patient reimbursement for QLT’s Visudyne therapy to treat Wet Age Related Macular Degeneration (AMD). The changes, which could take effect by October 2004, will make 40,000 to 60,000 new patients eligible for reimbursement, potentially doubling QLT’s current patient pool of about 60,000. Until now, Medicaid [...]

Namenda

In October of 2003, Forest Laboratories announced FDA approval of Namenda™ (memantine HCL) for moderate-to-severe Alzheimer’s disease. This new therapy is the first of a new class of drugs for Alzheimer’s disease known as NMDA antagonists. Namenda is thought to decrease the affinity of the NMDA receptor for a neurotransmitter known as glutamate, which plays [...]