We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The biotechnology industry considers Democrats’ push for government negotiation of Medicare drug prices to be its biggest threat and is actively lobbying lawmakers against the move, a leading industry expert says.
The biotechnology industry considers Democrats’ push for government negotiation of Medicare drug prices to be its biggest threat and is actively lobbying lawmakers against the move, a leading industry expert says.
Advanced therapy medicinal products (ATMPs) prepared in a hospital and intended for research purposes or for the “exceptional” treatment of a specific patient would not have to comply with the European Commission’s proposed ATMP regulation, according to a new draft report prepared by Miroslav Mikolášik, rapporteur of the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI).
The average cost of developing a new therapeutic biotechnology product is more than $1.2 billion, including the costs of drugs that fail in testing and the time associated with bringing these products to market, according to a new study by the Tufts Center for the Study of Drug Development. Read More
Australias Therapeutic Goods Administration (TGA) and New Zealands Medicines and Medical Devices Safety Authority (Medsafe) have posted for comment a consultation paper on proposed medicines scheduling provisions, as the two regulatory agencies gear up for the establishment of a joint authority.
On the same day that the FDA held a public hearing on clinical research conducted under an emergency exception rule, Sen. Chuck Grassley (R-Iowa) sent a letter to HHS Secretary Mike Leavitt requesting that he convene a meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) to address a controversial study of a blood substitute that is being done under that rule.