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In the latest chapter in the 340B Drug Discount Program saga, HHS has appealed decisions issued in three federal courts that called into question the agency’s authority to punish drug companies who refuse to participate in the controversial program for safety-net hospitals. Read More
A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a confirmation vote on Biden’s pick to lead the nation’s drug regulator. Read More
At present, it’s unclear when a trial will be held to determine Teva’s damages. But it’s not expected to occur for at least a couple of months. Read More
The Department of Justice alleged that the product was being marketed as a preventive or cure for coronavirus infection, making it an unapproved drug. Read More
A federal court has rejected Sanofi’s attempts to reinstate key patents covering a drug-device combination product dispensing its insulin blockbuster Lantus. Read More
A New York jury has found Teva Pharmaceuticals guilty of fueling the state’s opioid crisis through misleading marketing about the risks of its highly addictive painkillers. Read More
A federal court has ordered New Jersey-based Natural Solutions Foundation (NSF) to stop selling a “nano silver” solution marketed to prevent and treat coronavirus infections, and to recall and destroy all product distributed this year. Read More
Jeffrey Zients, White House COVID-19 response coordinator, acknowledged in a press briefing that deliveries will be slow to start, especially for Pfizer’s Paxlovid. Read More
Over the past year, President Biden touted that the nearly $2 trillion Build Back Better Act would bolster the nation’s social safety net, fight climate change and introduce drug pricing reform. Read More
Though the FDA last week authorized the first COVID-19 oral antivirals for at-home use — Pfizer’s Paxlovid and Merck’s and Ridgeback Biotherapeutics’ molnupiravir — access to the pills will be limited in the new year. Read More