It is but axiomatic to believe that the promise of expensive
biologics cannot be fully realized without the cooperation, endorsement and support of payers responsible for enabling vital provider and patient access to them.
At issue in the
biologics debate is the length of a data-exclusivity period for developers of a drug.
"The MTF is a world leader in tissue research and development, and has been both a financial and strategic partner to Bone
Biologics over the past four years," noted Bruce A.
Competition may eventually emerge if a regulatory pathway is approved for the manufacturing of generic
biologics, which may reduce prices 20% to 30% and will play an important role in the specialty-drug environment.
Government: The FDA approved 119 medicines in 2004, consisting of 113 drugs and 6
biologics, 29 of which received priority reviews, according to the FDA Center for Drug Evaluation and Research's "2004 Report to the Nation." Of these medicines, 31 were new molecular entities (NMEs) and five were new
biologic license applications (BLAs).
Research conducted at FDA (in particular at the Center for
Biologics Evaluation and Research) contributing to biological warfare defense and other counterbioterrorism efforts is in the following areas: design of new vaccines (e.g., pox viruses); pathogenesis and mechanism of replication of biological warfare agents; new methods and standards to expedite the review of new vaccines and immunoglobulins (e.g., mucosal protection against a pathogen); and stem cell protection and chemokine/cytokine and angiogenic agent defense mechanisms.
M2 EQUITYBITES-May 21, 2019-WuXi
Biologics announces launch of LOI for the manufacture and supply of vaccine products
Global Banking News-May 21, 2019-WuXi
Biologics announces launch of LOI for the manufacture and supply of vaccine products
M2 PHARMA-May 3, 2019-Samsung
BioLogics signs contract with GI Innovation
Gustavo Mahler has decided to leave his position as chief executive officer effective April 30th, 2019 after a 10 year tenure with CMC
Biologics and AGC
Biologics.