Korea Govt Pharma Partnerships Provide Global Opportunities For Domestic Ventures
South Korea's government is expanding initiatives to attract clinical trials, foreign pharma investment and partnerships as it looks to support domestic firms' R&D and international expansion ambitions.
Scrip - March 5, 2026

‘The Place to Be’: How Real-World Evidence (And NEST) Are Reshaping Device Submissions
Real-world evidence (RWE) is increasingly significant in medical device submissions, with FDA guidance evolving to embrace RWE benchmarks. The National Evaluation System for Health Technology (NEST) partners with firms to streamline RWE use, enhancing regulatory processes.
Medtech Insight - March 4, 2026

Rethink Of UK’s Relationship With EU ‘Makes Sense For Patients And Medtech Innovators’
Regulatory uncertainty has affected business planning and funding opportunities for UK medtech businesses, says Gerard Hanratty, head of health and life sciences at UK and Ireland law firm Browne Jacobson. On the other hand, the UK industry should not squander the opportunities it uniquely faces.
Medtech Insight - March 4, 2026

‘We Can’t Wait Years’: European Medtechs Urge EU Co-Legislators To Move At Pace On MDR/IVDR
Petra Zoellner, regulatory affairs director at MedTech Europe, provides an update on the pace and direction of travel of recent European Commission proposals and actions for the EU medtech sector, while emphasizing the need for speed.
Medtech Insight - March 4, 2026

Sponsors Of OTC Switches, Other NDAs In US Provided Study Guide For Market Exclusivity Test
“New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers” draft guidance discusses statutory and regulatory criteria for three-year exclusivity eligibility and provides recommendations on content and format of requests.
HBW Insight - March 5, 2026

Three-Year Transition Allowed After 12-Digit NDCs Take Effect In Seven Years
FDA final rule effective date is March 7, 2033, when it will assign new 12-digit NDCs and convert all previously assigned 10-digit NDCs for OTC and Rx drugs to the 12-digit NDC format and start a three-year clock for compliance through March 6, 2036.
HBW Insight - March 5, 2026

Hikma Gets Backing Of US Solicitor General As Supreme Court Considers Skinny-Label Dispute
As the US Supreme Court prepares to review litigation over skinny-label generics with carved-out indications, Hikma has once again won the backing of the US solicitor general for its position.
Generics Bulletin - March 4, 2026

Cipla And Kemwell Shake Hands On Further ‘Biologics’ Development In India
Cipla will form a 60:40 joint venture with Kemwell Biopharma to develop, manufacture and commercialize biologics for global markets. The India-based venture will leverage Kemwell’s Bengaluru biologics facility and support development, licensing, and export of biologic products.
Generics Bulletin - March 4, 2026

First US Flovent Generic Offers Glenmark CGT Bonus
Glenmark says it plans to launch imminently the first US generic fluticasone propionate rival to Flovent, for which it has just received FDA approval – with an added bonus of 180 days of Competitive Generic Therapy exclusivity.
Generics Bulletin - March 4, 2026

The Autonomous Lab: Part 1
In this two-part series, In Vivo examines who is building the autonomous lab, what architectural and business model choices they are making, and what the implications are for drug discovery organizations, external R&D partnerships and the workforce that will be asked to operate these systems.
In Vivo - March 5, 2026