Samsung Bioepis Sharpens Differentiation Strategy As Global ADC Market Matures
In an interview with Scrip, Samsung Bioepis’ VP and Innovation Project Lead talks about the newly launched innovation project as well as the firm's strategies and goals in ADCs and other novel therapeutics.
Scrip - March 12, 2026

FDA Weighs Second Citizen Petition On Bamboo Health’s NarxCare
The FDA’s device center has received a second citizen petition relating to the NarxCare algorithm by Bamboo Health. Both petitions argue that NarxCare qualifies as a regulated clinical decision support product, but it is not clear whether the second petition will succeed where the first failed.
Medtech Insight - March 11, 2026

FDA Announces May Rollout For MAUDE Replacement
The US FDA is replacing its individual product type adverse event reporting portals with a unified database, known as AEMS. While adverse event reports for some sectors such as drugs and vaccines joined the new portal on March 11, devices, human foods and tobacco products will be added in May.
Medtech Insight - March 11, 2026

Agilent Pays $950M for Biocare Medical To Expand Pathology Reach
The acquisition adds an immunohistochemistry antibody, reagent and instrument portfolio to Agilent's pathology offering, expanding its clinical and research lab client groups.
Medtech Insight - March 11, 2026

EU Notified Bodies Warn MDR/IVDR Amendments Will Deliver Lower Levels Of Patient Safety
The public consultation on the European Commission’s proposed revision of the MDR and IVDR has been extended to accommodate late delivery of translated texts. EU notified bodies’ group TEAM-NB says the proposals need more balance to ensure the resulting regulations do not do more harm than good.
Medtech Insight - March 11, 2026

Estée Lauder Suit Against Walmart Renews Scrutiny Of Counterfeits Sold Online
Retailers selling third-party counterfeits online could be doing more to prevent the sale of the products, says an attorney.
HBW Insight - March 12, 2026

OTCs, Cosmetics In FDA’s Unified Adverse Event Monitoring Launch, Supplements Added In May
FDA launches first phase of unified platform for adverse event reports, replacing separate databases for different product types. Cosmetics, OTC drugs in initial launch; supplements start in May.
HBW Insight - March 12, 2026

Industry Hails ‘Common Sense’ FDA Rethink On Non-US Comparators For Biosimilars
The latest biosimilars guidance from the FDA – which promises to further streamline applications by making it easier for developers to rely on non-US comparator products – has been warmly received by the off-patent industry.
Generics Bulletin - March 11, 2026

Genentech Targets Biocon In USITC Case Over Perjeta Biosimilar Imports
Genentech has asked the US International Trade Commission to investigate Biocon and related entities over alleged infringement tied to pertuzumab biosimilars, seeking remedies that could block imports into the US.
Generics Bulletin - March 11, 2026

The Game Of Balancing Green Regulations While Keeping Off-Patent Drug Investment In Europe
In the second part of our exclusive interview with Medicines for Europe leaders, Generics Bulletin delves into medicinal product regulation by environmental and chemical agencies, and the need to maintain the historical off-patent drug heritage in Europe.
Generics Bulletin - March 11, 2026

Biocon And Cipla Build On Teva’s First Generic Saxenda Launch
Biocon’s FDA approval and Cipla’s US launch – via partner Orbicular – add momentum to the early generic market for Novo Nordisk’s Saxenda.
Generics Bulletin - March 11, 2026

At The Immune Frontier, The Hardest Questions Are Commercial
As immune-system science attracts record capital and scientific talent, five companies at the vanguard of the field reveal a shared conviction: the immunome is the organizing principle of human health. The harder question is how to build a business around it.
In Vivo - March 11, 2026

Excited About AI, Skeptical Of The Price Tag: Seed Investors Sound Off
Seed investors are enthusiastic about AI in drug discovery but skeptical of the valuations it is used to justify. At a recent panel, they drew a sharp line between real capability and an “AI veneer.”
In Vivo - March 11, 2026