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Teva Pharmaceuticals is facing Department of Justice (DOJ) allegations — and potential penalties of $12 billion — that the Israeli drugmaker defrauded Medicare by paying kickbacks to charitable foundations that subsidized patients’ out-of-pocket payments for its multiple sclerosis blockbuster Copaxone (glatiramer). Read More
CMS has proposed removing the national coverage determination for the positron emission tomography (PET) beta amyloid imaging needed to diagnose the onset of Alzheimer’s disease and prescribe the newly approved antiamyloid antibody drug Lequembi (lecanemab). Read More
Illumina and Pfizer are each heading up collaborations starring pharmaceutical heavy hitters who will work together to accelerate drug development, although in different ways. Read More
Regenerative medicine development faces challenges in standardization, regulation and manufacturing the Government Accountability Office (GAO) determined in a recently released report. Read More
The FTC has lobbed its latest volley at pharmaceutical mergers with a request for a preliminary injunction to temporarily halt the pending $28 billion merger of Amgen and Horizon to allow time for the FTC’s June 22 administrative complaint to be adjudicated prior to potential consummation of the deal. Read More
The FTC is withdrawing two antitrust policy statements related to enforcement in healthcare markets that it says no longer reflect market realities at the same time it demonstrates its intentions by pursuing administrative actions against two pending mergers. Read More
Researchers from the Brookings Institution are calling for fresh incentives to improve manufacturing infrastructure and drug quality to reduce ongoing, persistent shortages of generic sterile injectables (GSIs). Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
Following a fiery social media post, Johnson & Johnson has agreed to grant licenses to Stop TB Partnership’s global drug facilities to middle and low income countries to produce generic versions of its Sirturo (bedaquiline), the first new drug to treat multi-drug resistant tuberculosis (MDR-TB) in 50 years. Read More
A revised report from the Institute for Clinical Evaluation and Research (ICER) has reiterated that two experimental gene therapies for sickle cell disease (SCD) would likely be cost-effective if priced at $2 million. Read More