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…
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,…
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
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…
Generics makers will soon have the option to submit expedited safety reports electronically to the FDA Adverse Event Reporting System (FAERS), according to a new draft guidance that provides instructions…
Johnson & Johnson (J&J) disclosed that it has pursued arbitration against beleaguered vaccine manufacturer Emergent BioSolutions for alleged breach of contract. Source: Drug Industry Daily