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Acknowledging that collecting diverse patient data prior to drug approval is not always feasible, the FDA has published draft guidance that gives direction on gathering underrepresented population data in the postmarket setting. Read More
Texas has settled with Takeda Pharmaceuticals and Baxter International for $42 million over allegations the companies provided kickbacks to Medicaid providers to recommend prescription medications including the attention deficit hyperactivity drug (ADHD) Vyvanse (lisdexamfetamine dimesylate). Read More
The big three drug associations, representing brand pharmaceuticals, generics and biotechnology, have all expressed strong objections to the CMS proposed rule for the Medicaid Drug Rebate program “stacking” requirement that revises the definition of “best price.” Read More
Nektar Pharmaceuticals has launched a two-pronged attack on Eli Lilly: A legal filing charging that Lilly intentionally sabotaged its development of Rezpeg, an investigational biologic the companies were co-developing for systemic lupus erythematosus (SLE) and dermatologic conditions, and a public relations campaign designed to alert the public to the allegedly shady dealings. Read More
Pharmaceutical and medical device companies should not be held liable for terrorist actions after providing medical products to the Iraqi government, says an amicus brief from the U.S. Chamber of Commerce and PhRMA filed to the U.S. Supreme Court. Read More
More than two dozen lawmakers signed onto a letter pressing the FDA on what steps it is taking to “minimize the potential for disruptions to supply and patient care” as deadline for implementation of the DSCSA nears. Read More
The FDA and the European Medicines Agency (EMA) have both issued guidances on various aspects of detecting, measuring, limiting and avoiding the presence of nitrosamine impurities in pharmaceuticals. Read More
LXR Biotech received a warning letter from the FDA for having methods, facilities, controls for manufacturing, processing or holding its drug product that do not conform to GMPs, after the company’s response to a Form 483 included a statement that it no longer manufactures drugs. Read More
The FDA has released a final guidance spelling out when and how drugmakers may seek a waiver, exception or exemption from its regulations as permitted by the Drug Supply Chain Security Act (DSCSA) while a bipartisan group of House lawmakers is pressing the FDA on whether the industry is prepared for the final stage of the act’s implementation. Read More