Specialty Pharmacy

WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.

WOONSOCKET, R.I. In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy operations, Scott Reid, reiterated the company’s support that the FDA implement regulations necessary to approve biogeneric drugs under the Affordable Care Act.

ELMSFORD, N.Y. Specialty pharmacy provider BioScrip has promoted its COO, the company said Tuesday.

BioScrip announced that COO Rick Smith was named CEO of the company, effective Jan. 1, replacing current CEO Richard Friedman. After stepping down, Friedman will serve as non-executive chairman of BioScrip’s board.

THOUSAND OAKS, Calif. Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.

“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.” 

CRANBURY, N.J. British drug maker GlaxoSmithKline will work with U.S.-based Amicus Therapeutics to develop a drug for a rare genetic disease.

The two companies announced a deal to develop and commercialize Amigal (migalastat hydrochloride), a treatment for Fabry disease. Under the deal, GSK will pay Amicus $30 million upfront, as well as milestone payments of up to $170 million and royalties on future sales.