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 FDA issued warnings to Indian API manufacturer Vikshara Trading and Investments over serious violations, including hindering the agency’s investigation, and to Huron Pharmaceuticals, citing quality documentation issues. Read More
Biosimilars consistently drive down average drug prices in markets where they are introduced, according to a report ordered by the European Commission. Read More
In a Tuesday meeting, the FDA’s Science Board reviewed and largely supported the agency’s proposed plan for implementing the 21st Century Cures Act over the next nine years. Read More
Merck Sharp & Dohme Corp. is settling its challenge over a Genentech patent on methods for artificially synthesizing antibodies, a process used for a variety of specialty medicines and cancer therapies. Read More
Ninety percent of counterfeit pharmaceuticals seized at the U.S. border in fiscal 2016 were shipped through China, Hong Kong, India, or Singapore. Read More
The EMA says it will continue to invite patients to in-person discussions between reviewers and product sponsors — following a successful two-year pilot project involving five medicines. Read More
An FDA workshop on opioids is going ahead today despite concerns from Sen. Ron Wyden (D-Ore.) that some panelists at the conference on pain management are too closely tied to the opioid industry. Read More