The U.S. Justice Department sought court permission to participate in settlement negotiations aimed at resolving lawsuits by state and local governments against opioid manufacturers and distributors.
U.S. Food and Drug Administration chief Scott Gottlieb criticized pharmacy benefit managers, health insurers and drugmakers for “Kabuki drug-pricing constructs” that profit the industry at the expense of consumers.
Heart devices that use software or wireless communications may be vulnerable to hacker attacks that could cause life-threatening malfunctions, U.S. cardiologists say.
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the EU.
The U.S. Food and Drug Administration announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies.
Supplies of thousands of medicines are at risk of disruption if Britain leaves the European Union without a trade deal, forcing manufacturers to prepare for duplicate product testing to ensure their drugs stay on the market.
U.S. shareholder activists are addressing a soaring death toll from opioid drug abuse, asking companies that make and distribute the painkillers to review the risks their businesses could face from their role in the sector.
New Mexico sued eight opioid manufacturers and wholesale distributors, becoming the latest state or local government to file a lawsuit seeking to hold corporations accountable for a national drug addiction epidemic.
A very high percentage of Prior Authorization (PA) requests are approved…but about 40% of these prescriptions are abandoned during the PA process, around 74.4 million prescriptions a year.
The good news … is that innovation is addressing diseases with high-unmet need such as oncology, autoimmune diseases, and central nervous system (CNS) disorders. But, there is a complicating factor in the economic story: the patient population benefiting from launch brands is becoming smaller.