Eisai Picks Up Henlius’s Serplulimab For Japan In $400m Deal
Henlius planning Japanese NDA by end of March 2027 for ES-SCLC and development in several other indications.
Scrip - February 6, 2026

J&J Unit Cerenovus Recalls Aneurysm Treatment Systems Following Patient Death
Cerenovus is recalling multiple products from its Cerepak Uniform, Cerepak Heliform and Cerepak Freeform product lines due to a higher-than-expected failure to detach rate. While customers were sent a safety alert in October, the US FDA announced the recall on Feb. 5.
Medtech Insight - February 5, 2026

Roche Diagnostics Sees China Pricing Headwinds Easing In 2026 As Margins Recover From 2025 Lows
Besides China pricing reforms, Roche continued to face cost pressures linked to investments in new technologies such as CGM and LumiraDx. Tariffs also weighed on performance.
Medtech Insight - February 5, 2026

CDRH Highlights Harmonization Progress In International Assessment Report
The US FDA has published its annual international harmonization assessment for fiscal 2025, which reports on the device center’s progress in aligning medical device regulations with global standards to improve patient access to safe, innovative technologies.
Medtech Insight - February 5, 2026

Execs On The Move: January 26–30, 2026
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
Medtech Insight - February 5, 2026

Midi Health Gains Unicorn Status With $100M Funding Round; Adds Serena Ventures, Foresite Capital
Women’s health start-up Midi Health has raised $100m in a Series D financing, led by Goodwater Capital with new investors Foresite Capital and Serena Ventures. Midi, which focuses on women in midlife, said the money will support the next phase of growth.
Medtech Insight - February 5, 2026

US FDA Explains: ‘Artificial’ Color Added To Food Doesn’t Equal Not Native To The Product
Agency exercises enforcement discretion on requirement for products to be labeled as containing artificial colors or dyes when those aren’t native to foods or ingredients, including added colors made from natural sources.
HBW Insight - February 6, 2026

Strides Pharma: US-Led Global Fund Cut Hurts; Greater Focus On Ex-US Markets
Strides Pharma aims for higher revenues from Canada and other ex-US markets while waiting for controlled substances to ramp up gradually under the leadership of ex-Apotex CEO Peter Hardwick. However, a cut in US funding for the Global Fund is hurting the company and its competitors.
Generics Bulletin - February 5, 2026

Kashiv Biosciences Expands Latin American Footprint Through Saya Biologics Partnership
A biosimilar collaboration between Kashiv and Saya aims to expand access to affordable supportive oncology therapies in Mexico and 10 additional Central America and Caribbean markets.
Generics Bulletin - February 5, 2026

Krka Doubles Down On Vertical Integration With €140m Investment Push
Slovenia’s Krka is ramping up capital spending to expand global manufacturing capacity, betting that industrial scale and supply resilience will drive its next phase of growth.
Generics Bulletin - February 5, 2026

Amgen Benefits From US Biosimilar Monopoly With $700m Sales For Pavblu
Amgen has revealed just how significant its first-mover advantage on biosimilar aflibercept has been in the US, with the firm’s Eylea rival bringing in sales of $700m in 2025 and helping to push Amgen’s annual biosimilars turnover up by more than a third to $3bn.
Generics Bulletin - February 5, 2026

Update On ADCs: Sales, Deals, Targets And Approvals
The antibody-drug conjugate pipeline has more than doubled to 895 candidates since 2023, with DNA topoisomerase I overtaking HER2 as the dominant target.  
In Vivo - February 5, 2026