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…

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…

After more than a year of missed opportunities, Senate Democrats are finally slated to pass a landmark, $740 billion reconciliation bill as soon as today that would grant Medicare the…

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…

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…

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…

Pfizer is scrapping its phase 3 trial of rare-disease cardiology candidate PF-07265803 and development of the drug, which the company inherited from Array Biopharma in its $11.4 billion acquisition of…

A U.S. District Court in Illinois has found that Eli Lilly shortchanged Medicaid’s drug rebate program in 26 states and must pay a $61 million penalty for violating federal and…

Amgen announced that it is acquiring ChemoCentryx, a developer of oral therapies to treat autoimmune diseases, inflammatory disorders and cancer, for approximately $3.7 billion. Source: Drug Industry Daily

Alnylam Pharmaceuticals announced that a year-long phase 3 trial of its drug patisiran showed that the therapy met both its major objectives in patients with transthyretin-mediated amyloidosis (ATTR) with cardiomyopathy,…