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 U.S. Patent Trial and Appeal Board (PTAB) rejected a petition from generic drugmaker Alvogen seeking to invalidate Celgene’s Revlimid patent. Read More
Merck may not have broken any antitrust laws with a discount scheme for its rheumatoid arthritis drug Remicade—but not for lack of trying, British regulators concluded. Read More
In a victory for Merck, the U.S. Patent Trial and Appeal Board (PTAB) invalidated one of Pfizer’s patents for the company’s best-selling drug, the pneumonia vaccine Prevnar 13. Read More
The agency released a separate guidance listing approved countries for importing and batch testing medicines and manufacturing active substances. Read More
Twenty-eight percent of insulin manufacturers told Nevada’s state Department of Health and Human Services that they made no profit on insulin sales in 2017, according to the state’s first insulin price transparency report. Read More
The FDA issued final guidance for developers of drugs to treat severely debilitating or life-threatening hematologic disorders (SDLTHDs), such as hemophilia and sickle cell disease. Read More
The FDA released two clinical-related guidances on Thursday for sponsors of drugs and biologics, on enrichment of clinical trials and on risk-based monitoring. Read More