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Republican members of the House Energy and Commerce (E&C) Committee are pressing FDA Commissioner Robert Califf on the effectiveness of the agency’s foreign drug inspection program given that numerous Indian and Chinese firms have repeatedly flouted FDA regulations. Read More
Two more drugmakers — Johnson & Johnson’s Janssen Pharmaceuticals and Astellas Pharma — filed lawsuits this week against CMS seeking relief from the Drug Price Negotiation Program established by the Inflation Reduction Act (IRA), claiming the program is unconstitutional and bringing the number of lawsuits filed to six. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the GMP Quality Management vSummit, and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
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
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