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The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended fifteen drugs for approval at its first meeting of the year, including four generics and one biosimilar. Read More
Sponsors of biologics and biosimilars should carefully consider how they present safety and efficacy information in their promotional materials, the FDA said in a draft guidance released yesterday. Read More
A majority of consumers and physicians believe generic drugs are inferior in quality to branded products, FDA officials said at a National Press Club event in Washington, D.C., yesterday. Read More
More drugmakers have unveiled plans for countermeasures against the coronavirus as experts forecast that the outbreak is almost certain to become a pandemic. Read More
The Institute for Clinical and Economic Review (ICER) has updated its drug value assessment process for 2020 to include more real-world evidence, a one-year reevaluation and other new elements. Read More
The Trump administration last week unveiled a pilot Medicaid program that would allow participating states to negotiate drug prices by choosing the drugs covered for certain adults under age 65 — an approach that PhRMA strongly opposes. Read More
Priority review vouchers (PRVs) may have little to no effect on drug development, the Government Accountability Office (GAO) concluded in a report released on Friday — although some drugmakers surveyed said otherwise. Read More