Inside This Issue: Parkinson's Disease
Top News Alerts: Product Updates, Deals & Financings
Company Spotlight: Biotie
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Market Highlights: FDA Gives an Inch to Companies Striving for Approval
Several companies prevailed in negotiations with the FDA to reconsider rejections and provide clear and reasonable guidance for a path to approval. Transcept rebounded dramatically after finding a way forward for their insomnia treatment with modified dosing instructions (see story, page 7). Vivus is being permitted to resubmit their obesity NDA with label changes to omit the patient population of concern to the FDA (see story, page 5). Orexigen also prevailed on the agency to accept interim, rather than complete, data from a cardiovascular safety trial (see story, page 5). A similar request had been rejected by the FDA in June. Importantly the agency also stated that outcomes from a planned committee meeting next year to discuss weight-loss drugs “will not impact on the advice provided in this letter and the agency will honor the advice provided." ....
Parkinson's: Slow and Steady Progress in Development of Novel Therapies
PD is the fourth most common neurodegenerative disease of the elderly. It affects about 1% of those over 65 years of age with mean onset at age 57. Although PD is associated with old age, a juvenile form with onset in childhood or adolescence also exists. Worldwide the prevalence is estimated at 4 million individuals. Parkinson's disease is an idiopathic, slowly progressive neurodegenerative disease affecting the substantia nigra. The hallmark of PD is the gradual disappearance of the dark staining nucleus, which is visible macroscopically upon dissection of the brain stem. Microscopically one finds neuronal protein aggregates called Lewy bodies, consisting of phosphorylated alpha-synuclein . This article outlines current treatment in development for Parkinson's...
Biotie Snaps up Newron, Expands Pipeline
Biotie is a Finnish pharmaceutical company headed by Timo Veromaa. According to Veromaa, the company was founded in the mid-1990's as a classical biotech with a focus on inflammation. It went public on the Helsinki market in 2000. Dr. Veromaa joined the company as VP in 1999, just before the IPO and he has been CEO since 2005. Biotie has a simple strategy, says Veromaa, "There are too many companies in the biotech space, too many projects disguised as companies, too many poorly financed entities." He continues,"Biotie is on an M&A path to acquire late stage assets. The path has taken us to a point where we now have a very different market cap than say two years ago...
Companies Covered In This Issue Include: Transcept, Orexigen, Vivus, Pfizer, Brainsway, Merck, SAgent Pharma, St. Jude Medical, Medicis, NeurogesX, Novartis, Teva, Alcobra, eNeuras, Roche, Innocoll, Cochlear, Med-El, Advanced Bionics, AxoGen, Alexion Pharma, MindSparke, Pearson, Takeda, Nektar, Trophos, StemCells, GlaxoSmithKline, Bioness, Transition Therapeutics, Adamas, Extab, BioDelivery Sciences, Synapse Biomedical, Evotec, Roche, Neuropace, GI Dynamics, BioLineRx, Aestus, Prosidion, EmSense, NeuroFocus, InnerScope, BioBehavioral Diagnostics, Zafgen, Ipierian, Jazz Pharma, Neurosearchy, Lundbeck, Proximagen, Addex, VErnalis, Biogen Idec, AFFiRis, Alnylam, ReMYND, MedGenesis, Medtronic, Eli Lilly, Amgen, Ceregene, Link Medicine, Neuropore, Tital, Sapiends Steering Brain Stimulation, Philips, NeuroNexus, Aleva Neurotherapeutics
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