FDA seeks input from stakeholders, public on regulatory approval pathway for follow-on biologics
SILVER SPRING, Md. — The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.
The FDA plans to use the input it gets to create a user fee program for regulatory approval applications.
In addition to accepting written comments, the agency will consult with scientific and academic experts, healthcare professionals, patient and consumer advocacy groups and companies.
A Federal Register notice displayed Monday described the principles the agency proposes to develop the program, a proposed structure for it and proposed performance goals. The notice is available here.
Merck kicks off Hope Against Hepatitis C initiative
WHITEHOUSE STATION, N.J. — Drug maker Merck announced that it has kicked off an initiative that includes a wide range of public education and patient support programs, as well as research efforts to help improve care for people living with chronic hepatitis C virus infections.
Merck’s Hope Against Hepatitis C initiative includes a variety of public-private partnerships, educational programs and collaborative research efforts aimed at supporting the hepatitis C community.
The drug maker also has launched a new consumer education website, AllAboutHepC.com, to help inform patients about the risks associated with chronic HCV infection and to address common questions about the disease.
"Winning the battle against viral hepatitis C requires improved public awareness and education to ensure that those at risk speak to their physicians about getting tested," said Patrick Bergstedt, SVP and general manager, infectious diseases, global human health at Merck. "Merck is committed to supporting these efforts, which are critical to managing this serious public health issue.”
Sanofi bids adieu to Aventis moniker
PARIS — French drug maker Sanofi-Aventis has shortened its name to Sanofi, the company said.
The company, which acquired Cambridge, Mass.-based biotech giant Genzyme for $20.1 billion earlier this year, had planned to vote at its shareholder meeting Friday.
According to published reports, the previous name was difficult to pronounce for people in many countries.