The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial…
Ongoing quality issues at an Oklahoma outsourcing facility drew the ire of the FDA and a Form 483 for Qualgen—not a first for the company. Source: Drug Industry Daily
Janssen Biotech is suing Celltrion and Hospira in the latest of a series of lawsuits related to its blockbuster Remicade (infliximab) therapy. Source: Drug Industry Daily
GlaxoSmithKline and ViiV Healthcare redeemed a priority review voucher for their application for a single-tablet antiretroviral regimen of Tivicay (dolutegravir) and Edurant (rilpivirine) for maintenance treatment of HIV-1 infections. The…
Lawmakers in Nevada and California continue to target drugmakers in health care proposals. Source: Drug Industry Daily
Belcher Pharmaceuticals petitioned the FDA to amend its warning requirements for epinephrine injectables containing sulfites. Source: Drug Industry Daily
The nation’s largest pharmacy benefits manager, Express Scripts, has sued Kaleo — maker of Evzio, an injectable emergency treatment for heroin and painkiller overdoses — claiming it owes nearly $15…
Following two other firms, Pfizer filed its own petitions with the PTO over a Herceptin patent owned by Genentech, as it continues to develop its biosimilar. Source: Drug Industry Daily
The Department of Justice announced plans to review the Drug Enforcement Administration’s efforts to combat the spread of illegal opioid use through the agency’s enforcement actions against industry companies. Source:…
FDA inspectors found extensive cleanliness and sterility issues during visits to California Pharmacy and Compounding Center in Newport Beach, Calif., in March and April. Source: Drug Industry Daily