Archive for May 2018

Patients with tears in their digestive tracts should generally be excluded from clinical trials of drugs designed to treat complicated intra-abdominal infections, the FDA says. Source: Drug Industry Daily

Despite opposition from some stakeholders, the European Commission proposes to grant waivers to Europe’s drugmakers to produce generic drugs for export to countries outside the EU. Source: Drug Industry Daily

Chinese regulators will crack down on corruption and unfair competition in the pharmaceutical sector, its government has announced. Source: Drug Industry Daily

The FDA slammed Cerno Pharmaceuticals for producing adulterated drugs at its Miami, Florida facility. Source: Drug Industry Daily

The creation of nonprofit drugmakers could help remove the perverse incentives that keep generic drug prices high, three public health experts contend in a New England Journal of Medicine commentary. Source: Drug Industry Daily

An administrative law judge tossed out the Federal Trade Commission’s complaint challenging an agreement between Impax Laboratories and Endo Pharmaceuticals that the FTC claims illegally kept a generic version of the opioid pain medication Opana ER off the market. Source: Drug Industry Daily

Spending on U.S. cancer medicines nearly doubled over the last five years—and may well double again in the next five years, a new report from IQVIA claims. Source: Drug Industry Daily

The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may require such labels. Source: Drug Industry Daily

Pfizer agreed to pay $23.85 million and enter into a five-year corporate integrity agreement to settle U.S. government claims that the company engaged in illegal kickbacks to Medicare patients that were masked by an independent charity. Source: Drug Industry Daily

Seniors covered by Medicare Part D are paying more for generic drugs even though the market prices remain stable, according to new research by Avalere, a healthcare consulting firm. Source: Drug Industry Daily