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FDA Grants Orphan Status for Halo's DMD Drug Candidate
January 4, 2012
Halo Therapeutics, the do-it-yourself biotech founded by two American families with children diagnosed with Duchenne's Muscular Dystrophy (DMD), has received orphan drug status for HT-100 for the treatment of DMD. Halo licensed HT-100 from Collard and plans to launch a clinical trial this year with support from nonprofits and patients groups. The candidate drug is thought to promote healthy muscle fiber regeneration and may broadly benefit other neuromuscular diseases including ALS.


Teva Engages New CEO, New Prospects for ALS?
January 3, 2012
The Israeli drug giant has announced former Bristol-Myers Squibb co-Executive Director Jeremy Levin will assume the reins as Teva’s new CEO. The choice of Levin underscores Teva's interest to move beyond generics and acquire companies developing novel treatments. At BMS, Levin spearheaded no less than 17 highly successful strategic acquisitions in the past few years. Both Teva and BMS have shown interest in orphan diseases including ALS, which makes Levin's next moves worth watching closely.


Financing Presents Obstacle for Clinical Development of Cytokinetics' ALS Drug
December 29, 2011
San Francisco's Cytokinetics is struggling to bring its ALS drug to market. After shedding its cancer program, the company has focused its activity on its ALS drug candidate, CK-2017357, now in its second phase II clinical trial. While the drug shows promise, it is not yet clear how the company will manage to finance the all-important Phase III efficacy trial.


Diagnostics: The New Gatekeepers to Drugs
December 26, 2011
After Trophos' recent ALS drug failure (http://www.researchals.org/page/4746/8296/), the importance of diagnostics was made clear. Trophos' drug failed in a Phase III clinical trial and one of the suspected reasons for the failure was the advanced stage of disease in many of the participants. This recent New York Times story discusses a growing trend towards the co-development of "companion diagnostics" together with new drugs; the next phase of personalized medicine.


ALS TDI Announces Research Agreement with Biogen Idec and UCB
December 19, 2011
The nonprofit biotech, ALS Therapy Development Institute has formed a new partnership with Biogen Idec and UCB to further the development of compounds targeting the CD40 Ligand pathway in ALS. The terms of the agreement call for TDI to perform preclinical testing, in the SOD1 model, of a murine surrogate of CDP7657, a anti-CD40L biologic that UCB is currently clinically exploring in systemic lupus erythematosus in a phase I trial. As this partnership signals, immunomodulation could be a very promising therapeutic area for ALS, one which may greatly benefit from several current industry-led efforts to develop immunomodulatory drugs for multiple sclerosis (discussed in Nature Reviews Drug Discovery: http://www.nature.com/nrd/journal/v10/n12/full/nrd3610.html).