Sen. Jeff Merkley (D-Ore.) introduced the Low Prices Drug Act (S.3680) — a bill that would tie drug prices to drugmakers’ access to Medicare and Medicaid patients and align U.S.…

The FDA announced plans Friday to collaborate with the World Health Organization (WHO) under a pilot program aimed at speeding up reviews of HIV drug applications. Source: Drug Industry Daily

In a wide-ranging analysis of ways to improve access to cancer drugs, the World Health Organization found the drugs remain costly even in countries with strict drug pricing regulations, price…

The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement…

Virginia Attorney General Mark Herring led 22 state attorneys general in filing an amicus brief urging the Supreme Court to uphold states’ right to hold drugmakers liable for misleading claims.…

The FDA issued a warning to CustomRX of Wichita, Kansas, for serious deficiencies identified during an inspection of its compounding facility, including inadequate cleanroom conditions and product testing. Source: Drug…

In a rare warning letter from the FDA’s Office of Prescription Drug Promotion (OPDP), Vanda Pharmaceuticals was cited for failing to include any risk information on the product page of…

Three former Genentech employees were indicted by a federal grand jury for allegedly stealing trade secrets from the San Francisco-based Roche subsidiary, which is pursuing litigation of its own against…

A federal appeals court has backed up the FDA’s decision to block prescription generics of Bayer’s MiraLax after the branded version switched to over-the-counter status. Source: Drug Industry Daily

The FDA hit drug manufacturer Oakmont Products of Lincoln, Nebraska, with a Form 483 for lacking a quality control unit, among other serious deficiencies. Source: Drug Industry Daily