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In a 269-page report released Friday, the House Committee on Oversight and Reform challenges claims that high prescription drug prices are necessary to support innovation and details a slew of anticompetitive practices drugmakers have allegedly used in recent years. Read More
The individualized products should be from “a well-characterized chemical class for which there is substantial clinical and nonclinical experience,” the agency said. Read More
The settlement marks Allergan’s withdrawal from the ongoing trial in the Suffolk County State Supreme Court, leaving Teva Pharmaceuticals as the sole defendant. Read More
Minor changes to a drugmaker’s chemistry, manufacturing and controls (CMC) production processes for approved biologics must be documented in a yearly report, the FDA said in a final guidance released yesterday. Read More
In a draft guidance released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) offer advice for sponsors on the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Read More
Allergan has agreed to pay $200 million to resolve New York-based claims that it helped facilitate the state’s opioid crisis through deceptive marketing. Read More
The FDA has granted AstraZeneca’s long-acting antibody combination Evusheld an Emergency Use Authorization (EUA) for preventing COVID-19 in adults and children 12 years of age and older with weak immune systems. Read More
The FDA offered guidance for sponsors of individualized drugs developed for use against life-threatening genetic diseases in two draft guidances released yesterday. Read More
Cutting prices for costly therapies approved under an accelerated pathway may not significantly reduce total prescription drug spending by Medicare, says a new study by researchers at Brigham and Women’s Hospital in Boston, Mass. Read More
Janus kinase (JAK) inhibitor anti-inflammatories made by Pfizer, AbbVie and Eli Lilly for inflammatory diseases, such as rheumatoid arthritis and ulcerative colitis, have all received the strictest warnings added to their labels by the FDA, which cited risk of serious health issues and the possibility of death in patients age 50 and over. Read More