Final Chance To Challenge UK MHRA’s 70% Post-Market Surveillance Fee Hike
UK device registration including post-market surveillance fees are due to rise 70% in April 2027 under the MHRA’s biennial all-fees uplift program. Residual government subsidies prevented a higher device registration fee rise.
Medtech Insight - September 22, 2026

Stock Watch: A Quantum Of Biosimilar Solace
Sandoz hailed the coming biologics patent cliff as a golden age of biosimilars. However, product-level detail on biosimilar erosion remains largely unobserved and is only detected as revenue falls at innovator companies.
Scrip - September 22, 2026

EU Pharma Reform: Member States May Have Final Say On OTC Antimicrobials
The proposed final text of the revised EU pharma directive makes all antimicrobials prescription-only by default, but leaves member states free to waive the requirement for topical products rather than exempting them across the EU.
HBW Insight - September 22, 2026

Edge Medical Ventures – The Transatlantic ‘C-Suite Plug-In’ for Medtech Start-Ups
Edge Medical Ventures is an Israel-US innovative medtech venture fund and incubator with an Israel venture studio and US go-to-market branch, and enjoys support from the Israel Innovation Authority. Cofounder and managing partner Gal Atarot explained Edge’s needs-driven business ethos.
In Vivo - September 22, 2026

Prestige’s Caribbean Biosimilar Approval Paves Way For International Expansion
Singapore-based Prestige Biopharma has received a first Caribbean approval for its Tuznue trastuzumab biosimilar, an equivalent to Roche’s Herceptin for the treatment of HER2-positive breast and gastric cancers, which the firm says will help open up other global markets.
Generics Bulletin - September 22, 2026

Amneal Takes Advantage Of Cipla’s Absence With US Lanreotide Launch
Amneal looks set to capitalize on Cipla’s absence from the US lanreotide arena after the firm’s own Somatuline generic was approved by the FDA with a CGT designation, paving the way for an immediate launch into the near-$1bn market.
Generics Bulletin - September 22, 2026

How Elucid Plans To Outperform HeartFlow Without Computational Fluid Dynamics
Elucid's CEO Kelly Huang says the company's AI-based FFR-CT approach outperforms computational fluid dynamics by incorporating plaque composition into the blood flow calculation — a distinction he argues matters clinically, regulatorily and competitively.
Medtech Insight - September 22, 2026

FDA Looks To Cut Interchangeability Burdens As Biosimilar Science Evolves
The FDA is signaling a lighter-touch approach to interchangeability as analytical science advances, while device-design, human-factors and product-specific uncertainties remain key development challenges.
Generics Bulletin - September 22, 2026

Study Says GLP-1 Apps Can Improve Adherence, As UK Addresses ‘Evidence Gaps’
Reset Health shared data showing its Roczen platform could improve GLP-1 adherence as NICE asks the company and its competitors to prove their value to the NHS.
Medtech Insight - September 22, 2026

Quality Assets Don’t Wait: How to Win A Consumer Health Deal Before It Goes to Market
Buyers that win the best consumer health deals, according to the leading advisors in the field, build category conviction before assets come to market, offer certainty of close, and offer assurances they will protect what made the business a success. Part 2 of the Inside Consumer Health M&A series.
HBW Insight - September 22, 2026

Unnatural Products’ Long Bet On Oral Macrocycles Is Paying Off
Unnatural Products is betting that macrocyclic peptides can become a mainstream drug-discovery modality. After a decade that began in a spider-filled garage and has evolved into a string of high-profile partnerships, it may be right.
In Vivo - September 22, 2026

Dialybrid Closes €15m Series A As Silkothane Graft Enters Vascular Access Race
Italian start-up has raised €15m and implanted the first patient with Silkothane, a hybrid silk-fibroin/polyurethane graft designed to cannulate early like a synthetic AVG and integrate like a native fistula. It enters a field where Xeltis and Humacyte are further along.
Medtech Insight - September 22, 2026

NIH Hub Developing Organoids For Research Among HHS Steps Away From Animal Testing
HHS announcements of “agency-wide actions” on reducing animal testing includes closing NIH’s last beagle laboratory and more than $88m for NIH biomedical infrastructure projects nationwide.
HBW Insight - September 22, 2026

US FDA Expects To Spur Options To Animal Testing By Inserting ‘Nonclinical’ In Regulatory Language
FDA says it’s “optimistic fostering the use of scientifically valid NAMs will lead to a reduced need for animal testing and to the use of fewer animals and of animals lower on the phylogenetic scale,” but “there remain areas where animal testing is important necessary.”
HBW Insight - September 22, 2026

Bioengineered Cosmetics Have Direct Line To UK Regulators Under New OPSS Sandbox; UK Reg Roundup
Cosmetics will be a test case as the UK’s Office for Product Safety and Standards kicks off an initiative to foster innovation while ensuring product safety. Separately, the UK diverges from the European Commission on silver, hexyl salicylate concentration levels.
HBW Insight - September 22, 2026

Withings Adds AI Heart And Lung Analysis To FDA-Cleared BeamO Home Health Device
Withings is launching StethO Sense, a third-party service that analyzes cardiac and respiratory sounds in children and adults starting Oct. 1. The product uses Withings’ FDA-cleared BeamO handheld device as part of a wider effort to bring clinical-grade health checks to families.
Medtech Insight - September 22, 2026

Strategic Intent: Rubedo’s ‘Seno-Adaptive’ Bet On Longevity Medicine
In this episode of Strategic Intent, Rubedo Life Sciences CEO Frederick Beddingfield discusses turning aging biology into drugs, Rubedo’s “seno-adaptive” approach, its AI-enabled platform and pipeline strategy.
In Vivo - September 22, 2026