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BioWorld - Monday, May 18, 2026
Home » Topics » North America » U.S.

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Moderna signage

Moderna’s cytomegalovirus vaccine fails a phase III

Oct. 23, 2025
By Lee Landenberger
No Comments
Moderna Inc. stopped its efforts to develop mRNA-1647 as a vaccine for preventing congenital cytomegalovirus infection, the most common infectious cause of birth defects in the U.S. The pivotal and placebo-controlled phase III CMVictory study of mRNA-1647 missed the primary efficacy endpoint, which was preventing the infection in seronegative females ages 16 to 40.
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PRIMA implant

Science Corp.'s Prima implant enables blind patients to read

Oct. 22, 2025
By Annette Boyle
Interim results from the PRIMAVERA study published in the New England Journal of Medicine demonstrated that Science Corp.'s Prima retinal implant restored vision, enabling 80% of patients to read at 12 months. Participants had age-related macular degeneration-related geographic atrophy resulting in total loss of central vision.
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Antibodies attacking cancer cell

Innovent rings up $11.4B deal with Takeda for three I-O/ADC assets

Oct. 22, 2025
By Marian (YoonJee) Chu
No Comments
Takeda Pharmaceutical Co. Ltd. agreed to codevelop and commercialize up to three of Innovent Biologics Co. Ltd.’s immuno-oncology (I-O) and antibody-drug conjugate (ADC) candidates with the signing of a $11.4 billion deal, including $1.2 billion paid up front.
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Red arrow pointing downward on a stock market ticker

Alector stock and staff halved after phase III fail in dementia

Oct. 22, 2025
By Lee Landenberger
No Comments
The failure of Alector Inc.’s phase III study of latozinemab in treating dementia halved the company’s stock on Oct. 22. That is also about the same percentage of staff that Alector is letting go after the clinical trial stumble.
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AI-generated digital horse illustration
Artificial intelligence

PTO director strikes a blow for ML patent subject matter eligibility

Oct. 22, 2025
By Mark McCarty
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.
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Illustration of liver with DNA double helixes
ESMO 2025

Delcath’s Chemosat plus ICIs triples PFS in uveal melanoma

Oct. 21, 2025
By Annette Boyle
While positive results from the investigator-led phase II CHOPIN trial at ESMO 2025 failed to get investors dancing, they were no doubt music to management’s ears, particularly with Delcath Systems Inc.’s third quarter earnings report missing a beat.
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Glass globe with documents and pen

Hologic to go private in $18.3B deal

Oct. 21, 2025
By Annette Boyle
In the largest med-tech M&A deal in nearly three years, Hologic Inc. agreed to be acquired by funds led by Blackstone and TPG in a transaction valued at $18.3 billion. After five months of rumored negotiations, the outlined deal provides Hologic shareholders with $76 per share in cash plus up to $3 per share in contingent value rights (CVR) to be paid on achievement of revenue goals for the breast health business over the next two years.
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US flag, gavel, book

Dexcom faces class action lawsuit following FDA warning

Oct. 21, 2025
By Mark McCarty
San Diego-based Dexcom Inc., is the target of a class action lawsuit in U.S. district court over the company’s G7 continuous glucose monitors, an action which follows a U.S. FDA warning letter by a mere seven months and a recall announced in July, suggesting that litigation often follows other sources of bad news for firms in the med-tech business.
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Wooden blocks spelling TARIFFS with a U.S. flag on top, placed on a map of Europe

Trade associations push back on Trump Section 232 review

Oct. 21, 2025
By Mark McCarty
The Trump administration’s consideration of a new round of tariffs has prompted two major med-tech trade association to advise the White House to leave medical consumables and medical devices out of any new tariffs, citing concerns about the impact on patient care.
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World with digital overlay

BIX 2025: What ‘radical’ changes in US, China mean for bio sector

Oct. 21, 2025
By Marian (YoonJee) Chu
No Comments
Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.
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