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The Pharmaceutical Research and Manufacturers of America (PhRMA) is incensed about the reconciliation bill the Senate passed on Sunday night, which would permit the government to negotiate with drugmakers on some prescription drug prices for the Medicare program. Read More
The FDA issued a warning letter to over-the-counter (OTC) drug manufacturer DSP Skin Care for quality lapses at its facility in Los Angeles, Calif., noting that the company had failed to remediate issues documented during agency inspections in 2018 and 2021. Read More
After more than a year of missed opportunities, Senate Democrats yesterday passed a landmark, $740 billion reconciliation bill that would grant Medicare the authority to negotiate the price of prescription drugs. Read More
In a continuing saga of disapprovals, the FDA issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals on its supplemental New Drug Application (sNDA) to expand the use of its Parkinson’s psychosis drug Nuplazid (pimavanserin) for treatment of Alzheimer’s disease psychosis (ADP). Read More
A federal court in Kentucky has dismissed a multidistrict lawsuit against AstraZeneca, Bristol Myers Squibb and McKesson that alleges they sold two diabetes drugs that caused heart failure in some patients. Read More
The company’s “failure to maintain effective controls against abuse and diversion has directly contributed to the ongoing opioid crisis,” the AG said. Read More
Lilly said the drug will be available in the week of Aug.15, before the anticipated depletion of the U.S. government’s currently available supply. Read More
Janet Woodcock, principal deputy FDA commissioner, made clear the dire situation her agency will be in if user fees aren’t rapidly reauthorized and the FDA doesn’t receive new money from Congress to update its flagging IT infrastructure. Read More