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BioWorld - Wednesday, June 11, 2025
Home » Topics » Regulatory » FTC

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Digital brain and silhouette

Authorities in EU, UK and US eye competition in AI marketplace

July 25, 2024
By Mark McCarty
Regulation of artificial intelligence for medical devices is still a developing space, but market competition authorities in the European Union, the U.K. and the U.S. are already examining the potential for anticompetitive behavior in this rapidly growing technological arena.
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Magnifying glass on wooden table

Loper Bright bringing more scrutiny, uncertainty to US agencies

July 19, 2024
By Mari Serebrov
As the U.S. Congress continues to pass laws that require federal agencies to issue rules to implement new statutory provisions, a group of lawmakers is reminding the agencies that it will be looking over their shoulders to ensure they don’t stray beyond the scope of the law or overstep their authority.
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Is enforcement enough to address PBM issues?

July 11, 2024
By Mari Serebrov
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.
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Gavel and FTC logo

US FTC’s Noncompete Rule on shaky ground

July 10, 2024
By Mari Serebrov
In the recently cast shadow of the U.S. Supreme Court’s Loper Bright decision that unraveled Chevron deference for federal agencies, the FTC’s broad rule banning noncompete employment clauses is on shaky ground. The first tremor hit July 3 when the U.S. District Court for the Northern District of Texas temporarily enjoined the FTC Noncompete Rule that is scheduled to go into effect Sept. 4 on the grounds that the agency overstepped its authority.
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Few surprises in FTC’s interim report on PBM practices

July 9, 2024
By Mari Serebrov
The redacted interim report released July 9 of an ongoing FTC investigation into pharmacy benefit managers (PBMs) shed little, if any, new insight into PBM practices and how they impact availability and pricing of prescription drugs in the U.S.
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Hand pointing at digital M&A screen

Lilly acquires IBD developer Morphic for $3.2B

July 8, 2024
By Lee Landenberger
In the third-largest acquisition announced this year, pharma giant Eli Lilly and Co. is buying oral integrin therapies developer Morphic Holding Inc. for $3.2 billion. Morphic stock (NASDAQ:MORF) got a tremendous boost from the acquisition, with shares closing 75% upward at $55.74 each on July 8, the day the deal was announced.
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Device patents still listed, FTC embraces chance to expand review

June 24, 2024
By Mari Serebrov
Even though the U.S. FTC recently claimed a court victory in its campaign to shut down the listing of device patents for drugs in the FDA’s Orange Book, 80% of the listings targeted in the commission’s first round of warning letters remain in place more than seven months later.
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FDA Orange Book

US court adopts FTC stance in Orange Book listing challenge

June 12, 2024
By Mari Serebrov
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.
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Coins, cash, calculator, pills

Illumina’s spinoff of Grail not necessarily the final chapter

June 5, 2024
By Mark McCarty
The saga of Illumina Inc.’s attempt to reacquire Grail Inc., seems to have come to an end with a capitulation to market regulatory authorities, but Illumina has chosen to spin off Menlo Park, Calif,-based Grail rather than sell the company outright.
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U.S. flag and money

US FTC meets reality on budget request amid overreach concerns

May 16, 2024
By Mari Serebrov
The FTC’s request for a nearly 25% increase in funding for fiscal 2025 was splashed with cold water May 15 in a U.S. House Appropriations subcommittee hearing. That’s “a dramatic increase in funding for an agency whose work continues to raise concerns among many members of Congress and the public,” Rep. David Joyce (R-Ohio), chair of the Subcommittee on Financial Services and General Government, said as he opened the hearing.
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