WASHINGTON - Language to establish a pathway for approving follow-on biologics will be incorporated into a comprehensive FDA bill advancing through the Senate, the "Food and Drug Administration Revitalization Act," Sen. Edward Kennedy (D-Mass.) said late Wednesday. (BioWorld Today)
WASHINGTON - Rep. Henry Waxman (D-Calif.) Tuesday urged that follow-on biologics language be incorporated into a bill to renew the Prescription Drug User Fee Act (PDUFA) at a House subcommittee hearing, during which one witness also spoke in favor of a Senate proposal to markedly increase the amount of user fees dedicated to drug safety. (BioWorld Today)
WASHINGTON - Rep. Henry Waxman (D-Calif.) Tuesday urged that follow-on biologics language be incorporated into a bill to renew the Prescription Drug User Fee Act (PDUFA) at a House subcommittee hearing, during which one witness also spoke in favor of a Senate proposal to markedly increase the amount of user fees dedicated to drug safety. (BioWorld Today)
WASHINGTON - Wide-ranging FDA legislation is scheduled for Senate review on Wednesday, but notably, the bill does not include a provision related to follow-on biologics. (BioWorld Today)
WASHINGTON - Wide-ranging FDA legislation is scheduled for Senate review on Wednesday, but notably, the bill does not include a provision related to follow-on biologics. (BioWorld Today)
Shares in ImClone Systems Inc. took a 6.4 percent dip on word that Erbitux (cetuximab) missed the primary endpoint in a Phase III pancreatic cancer study, a backslide that follows a month of significant gains. (BioWorld Today)
