A jury in a U.S. District Court unanimously found that Medtronic plc violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.
Pfizer Inc. upped its original $7.3 billion September offer to buy Metsera Inc., but the obesity specialist maintained that a now-improved unsolicited bid by semaglutide developer Novo Nordisk A/S is superior.
The U.S. Federal Trade Commission announced a $14.6 million grant it received for an upgrade of its IT infrastructure. The same grant mechanism is leveraged by the Department of Justice, which is a clear sign that U.S. enforcement will be more vigorously enabled by sophisticated analytics going forward.
U.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice.
Tired of waiting for the U.S. Congress to get around to making meaningful reforms to pharmacy benefit manager (PBM) practices, states are beginning to take the matter into their own hands. Arkansas recently became the first state to pass a law stopping PBMs, their affiliates or their parent companies from acting as a "fox guarding the henhouse" by being both a price setter and price taker, as the legislation puts it.
The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s supposed to be a five-member bipartisan panel with just two members, both of whom are Republicans. The commission already was down one member, as former Chair Lina Khan’s term expired last year and Trump’s appointee, Mark Meador, is awaiting Senate confirmation with a vote expected yet this month.
The fact that both the U.S. Federal Trade Commission and the Department of Justice have oversight of mergers and acquisitions is something of a regulatory oddity. But David Balto, an attorney specializing on antitrust matters, told BioWorld that this may change in 2025 thanks to support for such a move from both Congress and the White House.
A growing foray of pharmacy benefit managers’ (PBMs) private labels into the U.S. biosimilar space is intensifying concerns about the antitrust aspects of PBMs’ vertical integration that has them serving as price negotiator, formulary setter, payer, group purchasing organization, pharmacy, provider and now drug "manufacturer."
It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct. 1 letter that took FDA Commissioner Robert Califf to task for letting the FTC do the FDA’s job.
Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
