Gifrer Acquisition To Boost Celltrion’s French Reach, Portfolio
Celltrion acquiring Gifrer to strengthen its commercial footprint in France, better respond to the French government's biosimilar substitution policy and diversify its product portfolio beyond prescription biologics.
Scrip - May 12, 2026

Roche’s Alzheimer’s Blood Test Achieves CE Marking, One Day After Fujirebio
Roche’s Elecsys pTau217, co-developed with Eli Lilly, uses a dual-cutoff approach and — unlike Fujirebio’s rival test — is cleared for primary care.
Medtech Insight - May 12, 2026

OMUFA II Sets Oct. 1 Due Date For Facility Fees, Allows Split Payments In FY 2027 ‘Transition Year’
Recent ONPD webinar provided explanations on how firms can request refunds of OMUFA facility fees; determine whether they are subject to those fees; and when to register to avoid being subject to fees before starting production of monograph drugs.
HBW Insight - May 11, 2026

How People Talk To AI About Health Revealed By Microsoft Study
Research from Microsoft analyzes Copilot conversations to understand what kinds of health questions users ask AI and how this could affect response design.
HBW Insight - May 11, 2026

Digestive Category Is ‘Strong Anchor’ For Opella In First Year Of Independence
Exclusive: Opella speaks to HBW Insight about its financial performance in 2025 and gives an insight into some of its priorities for this year.
HBW Insight - May 11, 2026

Over The Counter: How Agentic AI Could Reshape Consumer Health, With IQVIA’s Volker Spitzer
In the latest Over the Counter podcast, IQVIA’s Volker Spitzer discusses how emerging “agentic AI” could reshape consumer health by acting as a persistent, autonomous advisor, raising questions around trust, regulation, and the future role of pharmacists.
HBW Insight - May 11, 2026

US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency
One-day inspections could help broaden the FDA's domestic and foreign surveillance reach and would employ artificial intelligence to identify low-risk facilities.
HBW Insight - May 11, 2026

Growing GRAS Change From Idea To Proposed Rule Takes Time – FDA Foods Program Chief
“Any reports that the administration doesn't support” HHS Secretary Kennedy’s proposal to cut the GRAS self-affirmation option, “I would say are not accurate,” says FDA Human Foods Program director Kyle Diamantas.
HBW Insight - May 11, 2026

‘Dietary Substance For Use To Supplement The Diet’? US FDA Plans To Answer With Guidance
“Getting some clarity so we all know what we're looking at when we think about a dietary substance for use by man to supplement the diet by increasing the total dietary intake. It's clear as mud,” says FDA supplement programs director Cara Welch.
HBW Insight - May 11, 2026

Alvotech Assured After FDA Facility Feedback
Alvotech has sounded a note of optimism over its pending US biosimilar filings, after an FDA inspection of its Reykjavik facility did not raise “substantial issues”. Meanwhile, the firm has just announced a US manufacturing deal with Fujifilm that delivers on its dual-source manufacturing plans.
Generics Bulletin - May 11, 2026

Biosimilar Streamlining Means All Should ‘Reach The Fruits’
Regulators say comparative efficacy studies will no longer be routine for many biosimilars, but the next phase will test how far the tailored approach can go, and whether markets can keep pace, as discussed at Medicines for Europe’s recent Biosimilar Medicines Conference.
Generics Bulletin - May 11, 2026

Towa Writes Down Sunsho With $94m Impairment
Ahead of reporting full-year results later this week, Japan’s Towa has announced a significant write-down of almost $100m in the value of its Sunsho business.
Generics Bulletin - May 11, 2026

AI Becomes ‘The Equalizer’ In Healthcare Delivery
Healthcare is beginning to benefit from the impact of AI, “but it’s just a small percentage of what we expect to see long term,” Avner Halperin, CEO of Sheba Medical Center’s commercialization arm, told In Vivo on the eve of Biomed Israel 2026.
In Vivo - May 11, 2026

Innovative Trial Designs And RMAT Pathways: Accelerating Rare Disease Approvals In 2026
Rare disease drug development is accelerating via RMAT pathways, adaptive trials, and RWE – but faster approvals must translate into sustained patient access.
In Vivo - May 11, 2026

Paul Stoffels’s Playbook For Impactful Innovation, How India Can Step Up
Industry doyen and J&J research veteran Paul Stoffels talks about the core principles behind getting innovation right and developing the best science with highest impact on disease, sharing experiences from his storied career along the way.
In Vivo - May 11, 2026