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

The combination of Merck’s blockbuster anti-PD-1 therapy Keytruda and Eisai’s Lenvima failed to show superiority to the standard of care of Lenvima alone as a first-line treatment for patients with…

A U.S. appeals court panel has said no to resurrecting a 2019 lawsuit alleging that AbbVie broke antitrust laws by using a “patent thicket” to cover its blockbuster monoclonal antibody Humira…

The FDA has approved Coherus BioSciences’ Cimerli (ranibizumab-eqrn) as the first interchangeable biosimilar for Roche’s retinal disease blockbuster Lucentis across all five of its indications. Source: Drug Industry Daily