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The Department of Justice (DOJ) and the FTC have issued draft guidelines the government will use to determine whether a merger may violate anti-trust laws by risking lessened competition now and in the future. Read More
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
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
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
Eli Lilly’s generic insulin Lispro can cost nearly four times as much as the company’s promised price of $25 per vial, according to a new report from Democratic Senators Elizabeth Warren (Mass.), Raphael Warnock (Ga.) and Richard Blumenthal (Conn). Read More
With COVID-19 vaccines moving to the open market postpandemic, their manufacturers should remember the support they received from the federal government when setting prices, said HHS Secretary Xavier Becerra in an open letter to COVID-19 vaccine manufacturers. Read More
The FTC will continue its ongoing examination of the pharmacy benefit management (PBM) industry at an open meeting July 20 when it decides whether to issue a warning to PBMs to stop relying on older FTC advocacy materials that opposed mandatory PBM transparency and disclosure requirements. Read More
It is not clear yet whether the reported cases are linked to the drugs, to the patients’ underlying conditions or other factors, the EMA stated. Read More