The FTC’s request for a nearly 35% increase in funding for fiscal 2025 was splashed with cold water today 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. Noting that the commission has “prioritized the issuance of many polarizing regulations that push the legal boundaries” of its authority, Joyce specifically called out the FTC’s recently released rule banning noncompete agreements and proposed changes to premerger filing forms and notifications that would nearly quadruple the average time involved in preparing a premerger filing.

Biopharma industry faces next wave of layoffs: Bolt, Tenaya, Trevena, Takeda among firms making cuts

Biopharma companies have announced additional layoffs and restructurings in the past few weeks, after more than 7,800 job cuts were reported this year through late April. Bolt Biotherapeutics Inc. is slashing its workforce by 50% while also cutting development programs, and Tenaya Therapeutics Inc. is following suit with a workforce reduction of 22%. Takeda Pharmaceutical Co. Ltd. announced the closure of its research site in San Diego, a move that could affect up to 340 positions. Additionally, Trevena Inc. disclosed a 35% reduction in its workforce since the end of last year.

New PTSD fix in the offing? Lykos PDUFA nears, Alto forging ahead

As Lykos Therapeutics Inc.’s Aug. 11 PDUFA date approaches for midomafetamine (MDMA) capsules used in combination with psychological intervention for post-traumatic stress disorder (PTSD), hope grows for a new therapy in the condition. On May 6, the U.S. FDA slated a meeting of the Psychopharmacologic Drugs Advisory Committee for June 4 to discuss the MDMA prospect. Also busy in the PTSD space is Alto Neuroscience Inc.

US legislation for AI described as ‘long-term process’

Artificial intelligence (AI) has roiled the global regulatory world of late, but the U.S. Congress has yet to dive into the task of legislating on the concept. Barrett Tenbarge, general counsel for Sen. Bill Cassidy (R-La.) told an audience here in the nation’s capital that while the Senate is considering several legislative proposals, the desire to avoid legislation that will create as many problems as it solves suggests that the legislative development process for AI “is a long-term process.”

BioWorld Insider Podcast: Fibrobiologics walks the unconventional financing path

A non-traditional route for financing has been the path to success for Fibrobiologics Inc. In the newest BioWorld Insider podcast, CEO Pete O’Heeron offers insight into the company’s unusual path to a Nasdaq listing in January. SPACs, reverse mergers and traditional IPOs weren’t attractive enough for Fibrobiologics’ management or board, so they decided to go public through a direct listing with no banks as underwriters. It took about seven months to get the company ready for its listing, an around-the-clock effort that O’Heeron said was worth the effort. “We couldn’t be more happy with the outcome,” he said.

BioWorld reader feedback needed: Cyberattack impact survey

The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Are there downstream impacts that are being overlooked in the biopharmaceutical and/or medical technology sectors? Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here.

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