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. Source: Drug…

Biosimilars consistently drive down average drug prices in markets where they are introduced, according to a report ordered by the European Commission. Source: Drug Industry Daily

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. Source: Drug…

The Senate confirmed Scott Gottlieb as the next commissioner of the FDA with a 57-42 vote on May 9, largely along party lines. Source: Drug Industry Daily

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…

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. Source: Drug Industry…

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…

Six generics manufacturers asked a federal judge to dismiss a price-fixing lawsuit brought by the attorneys general of 40 states. Source: Drug Industry Daily

The FDA hit API manufacturer Intas Pharmaceuticals over inadequate test records, water quality and other violations. Source: Drug Industry Daily

The FDA received 75 ANDAs in April, a steep drop from the 197 received in the previous month. Source: Drug Industry Daily