Histosonics Inc. signed an exclusive distribution agreement with Gunze Medical Ltd. to bring its novel histotripsy-based therapeutic model, the Edison System, to Japan. The strategic alliance with Gunze Medical, a wholly owned subsidiary of Osaka, Japan-based Gunze Ltd., paves a figurative runway for Histosonics to introduce its Edison platform in Japan — one of Asia’s largest medical device markets.

In a deal that could top $2 billion, China-based Innocare Pharma Ltd. licensed the exclusive worldwide development and commercialization rights to the BTK inhibitor orelabrutinib to Zenas Biopharma Inc. for multiple sclerosis and other indications aside from oncology.

Two biopharma companies launched within the past year raised top amounts in series B financings for 2025, seeking to advance their therapeutic candidates for cardiovascular diseases and obesity.

Biocryst Pharmaceuticals Inc.’s near-term dilution should “pave the way for entrenchment” in the hereditary angioedema (HAE) space, thanks to the buyout of Astria Therapeutics Inc., RBC analyst Brian Abrahams said.

Abbott Laboratories made plans to enter the cancer screening market with its reported acquisition of Exact Sciences Corp. The deal will pay Exact Sciences shareholders $105 per share in cash, a nearly 50% premium to Exact’s unaffected share price on Nov. 19. That represents a total equity value of approximately $21 billion and an estimated enterprise value of $23 billion.

The budget impasse between Democrats and Republicans on Capitol Hill has implications for a wide range of federal government operations, including at the U.S. FDA, which is absorbing another round of layoffs and cannot accept new premarket filings that require user fee submissions.

John Squires, the recently anointed director of the U.S. Patent and Trademark Office, has determined that a machine learning (ML) patent application met the standard for patent subject matter eligibility, an outcome that seems to bode well for ML-based patent applications going forward.

One in six common bacterial infections diagnosed worldwide in 2023 were resistant to treatment with antibiotics, according to the latest surveillance data gathered by the World Health Organization (WHO). Drug-resistant gram-negative bacteria that cause bloodstream infections that can lead to sepsis, organ failure and death are an increasing threat globally.

Although U.S. President Donald Trump’s Oct. 1 start date for a hefty biopharma sector tariff has come and gone, the threat remains, serving as both a stick and a carrot to get drug companies to come to the table with their best deals.

Pulse Biosciences Inc. presented late-breaking results from its successful first-in-human study of its nanosecond pulsed field ablation technology in treating atrial fibrillation at the 39th European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark. The Hayward, Calif.-based company’s Npulse cardiac surgical system takes PFA technology into the cardiac surgery setting.