GPhA praises FDA for roundtable talks discussing affordable biogenerics
ARLINGTON, Va. The Generic Pharmaceutical Association praised a Federal Trade Commission’s roundtable that included a discussion about biogenerics in a statement Friday.
“The mere fact that the FTC is conducting this roundtable demonstrates the growing momentum behind ensuring that consumers have access to safe and affordable biogenerics sooner rather than later,” GPhA president and chief executive Kathleen Jaeger said. “As our elected officials grapple with issues like market exclusivity and patent resolution measures, they must do so recognizing that competition will unleash innovation, while at the same time assuring that affordable, lifesaving medicines are available for patients in need.”
The organization, which represents manufacturers of generic drugs, has pushed hard for a regulatory pathway to allow the approval of generic biologic drugs.
Amgen, Takeda cancer drug trials stopped after deaths
NEW YORK Several deaths have brought phase 3 clinical trials of a cancer drug by Amgen and Takeda Pharmaceutical to a halt.
The two companies are investigating the drug, motesanib, as an initial treatment for small-cell lung cancer, to be used in conjunction with chemotherapy.
A committee monitoring the 600-patient study found more had died early using the drug than those receiving placebo.
“While we are disappointed in the outcome, it is consistent with data seen with some other anti-VEGF therapies and appears to constitute a class effect of these types of agents,” Amgen executive vice president for research and development Roger Perlmutter said in a statement.
Elan appoints Paya as president
SOUTH SAN FRANCISCO, Calif. Elan Corp. has appointed Carlos Paya as president, the company announced Thursday.
Paya will work from Elan?s South San Francisco, Calif., campus, focusing on leading the company’s scientific, clinical and medical initiatives.
“As an immunologist, a former vice dean of clinical investigation at the Mayo Clinic and as a successful industry executive, Dr. Paya has a unique set of attributes and experiences that perfectly match the opportunities and challenges facing Elan,” said Elan chairman of the board Kyran McLaughlin in a statement.
Paya previously worked at Eli Lilly & Co. as vice president of Lilly Research Labs and global leader of the Diabetes and Endocrine Platform. He had served as an executive at Lilly since 2001. He also worked for six years at the Mayo Clinic as professor of medicine, immunology and pathology, in addition to his position as vice dean.