Specialty Pharmacy

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

CAMBRIDGE, Mass. A company that develops drugs for treating autoimmune diseases and cancer has created a scientific advisory board as part of its efforts to create treatments for Type 1 diabetes.

Tolerx said the four-member board would support the development of its lead drug candidate, otelixizumab, and guide future research and development in the Type 1 diabetes area.

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.” 

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.