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A television advertisement for the Orexigen Therapeutics weight loss drug Contrave (naltrexone HCl and bupropion HCl) drew a warning from the FDA’s Office of Prescription Drug Promotion (OPDP), the office’s first of 2017. Read More
FDA Commissioner Scott Gottlieb pitches the agency’s proposed fiscal 2018 budget to House appropriators on Capitol Hill today, as industry and other stakeholders voice their concerns over the impact of the administration’s proposal. Read More
The FDA warned Chinese API manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Materials for inadequate quality management and record-keeping. Read More
The FDA has warned that water systems used by manufacturers of non-sterile, water-based drugs are at risk of contamination from Burkholderia cepacia, a pathogen resistant to a wide range of antimicrobials. Read More
The U.S. Supreme Court ruled that patent infringement lawsuits may only be filed where defendant companies are incorporated, and not simply in any location where their products are sold — a decision with serious implications for drugmakers. Read More