Lilly Stops FLEX-M, Isis Gets Fast Track: Healthcare Business Recap
Eli Lilly and Company (NYSE:LLY) will cease FLEX-M, one of three late-stage trials of its rheumatoid arthritis drug tabalumab, due to insufficient efficacy, saying that the decision was not based on worries regarding safety and patients currently enrolled in other tabalumab rheumatoid arthritis evaluations will continue treatment. The move to stop the study should result in an after-tax charge of around 2 cents per share in the fourth quarter.
On Thursday, Isis Pharmaceuticals (NASDAQ:ISIS) announced that ISIS-TTR, a treatment of familial amyloid polyneuropathy, has been granted fast track designation by the FDA. The antisense drug is in development with GlaxoSmithKline (NYSE:GSK) for the treatment of transthyretin amyloidosis, which is a severe and rare genetic disease marked by progressive dysfunction of peripheral nerve and/or heart tissues. The firms recently amended the clinical development plan and financial terms linked with the treatment in support of a registration-directed Phase 2/3 clinical study on the drug which will begin in December.
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Cerus Corporation (NASDAQ:CERS) said Thursday that the FDA has accepted its proposed modular pre-market approval application shell for review of the INTERCEPT Blood System for plasma. A PMA shell is an outline of the application process which describes the structure, content and timing of each module. However, the FDA and the applicant must agree on a shell prior to initiation of a modular PMA submission.
BioScrip (NASDAQ:BIOS) will acquire HomeChoice Partners, a majority-owned subsidiary of DaVita HealthCare Partners, at a price of $70 million in cash which is subject to adjustment through the terms of the agreement. The buyer also expects to realize the value of a future tax benefit calculated at $3.9 million as a result of the deal. BioScrip is a top supplier of alternate-site infusion pharmacy services.
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