Takeda starts phase-3 trials of vedolizumab
OSAKA, Japan — Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.
Takeda announced the start of two phase-3 trials of MLN0002 (vedolizumab) in patients with severe ulcerative colitis and Crohn’s disease. The trials are designed to find out the efficacy, safety and effects on the body of the drug, particularly to see if patients show a response after 10 weeks of treatment and disease remission after 60 weeks.
"Many patients suffering from ulcerative colitis and Crohn’s disease are eagerly awaiting new treatment options," Takeda VP general medicine Asit Parikh said. "We are striving to accelerate the development of this drug to deliver this effective and highly anticipated treatment option for patients in Japan as soon as possible."
Takeda submitted a regulatory approval application to the Food and Drug Administration for the drug in June 2013.
Mylan launches generic version of Detrol LA
PITTSBURGH — Mylan has launched a generic version of a drug made by Pfizer for treating bladder problems, the company said Tuesday.
Mylan announced the launch of tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat overactive bladder with symptoms of urinary incontinence, urgency and frequency.
The drug is a generic version of Pfizer’s Detrol LA. Tolterodine tartrate extended-release capsules had sales of about $571.5 million during the 12-month period that ended in September, according to IMS Health.
NCPA expresses support for many of the policy changes proposed by CMS
ALEXANDRIA, Va. — The National Community Pharmacists Association on Tuesday expressed support of several policy changes proposed by the Centers for Medicare and Medicaid Services, according to a document filed in the Federal Register.
"We are encouraged by CMS’ response to problems with preferred pharmacy networks," said Douglas Hoey, NCPA CEO. "CMS’ proposal to allow any willing pharmacy to offer a plan’s lowest, or ‘preferred,’ cost-sharing should help level the playing field for community pharmacies to participate in these plans and should benefit seniors by giving them more competition and choice among pharmacies in their drug plan."
Hoey commended CMS’ efforts to address concerns over maximum allowable cost pricing, "particularly in the wake of soaring costs for certain generic drugs," he said. "Giving community pharmacists both greater transparency into the MAC-setting process and more assurance that MACs should be updated frequently to reflect real-world costs is the least that prescription drug plans should do."
NCPA expressed support for CMS’ move away from "co-pay arrangements that incentivize the use of mail-order over retail."
"Research utilizing Medicare’s own data found that community pharmacies offered 90-day supplies of medication at lower cost and that these pharmacists did a better job promoting the proper use of cost-saving generic drugs compared to mail-order," Hoey noted.
NCPA also highlighted CMS’ proposed expansion of coverage of medication therapy management services. "We thank the agency for recommending a prohibition on reimbursement methods, such as prorated dispensing fees, that penalize long-term care pharmacies for adopting dispensing techniques that are intended to reduce medication waste," Hoey said.