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“While we understand that this Draft Guidance is specific to severely debilitating or life-threatening hematologic disorders, BIO believes it could be used as a model for other disease areas,” the industry group said in a written statement. Read More
Australia’s Therapeutic Goods Administration has updated its plan for mandatory drug shortage reporting based on public comments in response to an April request. Read More
Novartis and BIO sent feedback to the FDA about its draft guidance on developing treatments for severely debilitating or life-threatening (SDLT) hematologic disorders, urging the agency to broaden its guidance. Read More
Democrats in Michigan’s state legislature have introduced a bill to repeal the Michigan Product Liability Act, a 1995 law that gives pharmaceutical companies immunity from legal action relating to sale or misleading advertising of dangerous products if the drugs in question are FDA-approved. Read More
Greater Manchester will receive a large investment from NHS England to connect health and social care IT systems across its ten boroughs to more efficiently share information. Read More
FDA Commissioner Scott Gottlieb said the approval “serves as a reminder that advancing sound development programs that properly evaluate active ingredients… Read More
The Federal Trade Commission should examine the impact of “pay-for-delay” deals on the availability of cheaper biosimilars, two U.S. senators said in a letter Friday. Read More
Two pharmacy benefit managers took in more than $223 million last year through their work with Ohio Medicaid plans, according to a new report commissioned by the state. Read More