South America

Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.

Brazil looks to EU, UK and others for inspiration on introducing a regulatory sandbox.

OTC private label/store brand product giant’s Q2 net sales down 10.7% to $1.1bn, but women’s health product sales jump 31.4% largely on Opill launched late in Q1. Biggest hit to results from infant formula business, down a reported 82% due to ongoing manufacturing quality-control remediation.

Following its recently announced leadership changes, Hyloris has made two announcements linked to the marketing of its combined pain therapy Maxigesic IV in Brazil and the US.

Generics Bulletin recaps the most recent regulatory news and updates from across the world.

A new pilot aims to take Brazil closer to ‘digital transformation.’

A new federal law aims to promote the conduct of trials and speed up access to innovative drugs in Brazil.

The deal comes at a time when Latin American countries are increasingly looking to improve the regulatory environment for pharmaceuticals and move towards greater convergence.

The 25th IMDRF meeting in March 2024 agreed that regulatory reliance models save resources, encourage innovation, bring devices to the market faster and boost patient access. Singapore and Thailand have operated a model of mutual regulatory reliance for three years. Thailand also recently broached deeper collaboration with Brazil’s Anvisa.

Adult immunization programs can save “billions” for society, but their value is underestimated because of challenges around measuring broader value evidence and a lack of incentives for companies to collect this data, says the Office of Health Economics.

Brazil has listed 42 international regulatory bodies as equivalent authorities, including US FDA and the EU’s EMA.

Perrigo spares little about Opill’s launch, advertising and outlook in Q1 earnings briefing, but management also makes clear it’s a large firm and some other segments of its global consumer health products business are holding back overall results.

Direct seller reports Q1 sales up 1% to $1.3bn but net sales off 17.1% from year-ago period to $24.3m. Its distributor ranks jumped so far in 2024, particularly in China, where changes were made in the past year including new company leadership.

India’s Biocon Limited has struck an exclusive deal for a generic version of semaglutide in Brazil with local player Biomm. And a recent court ruling means that launch could come sooner rather than later for the Ozempic rival.

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

This week, Paragonix announced that its BAROguard lung preservation system is now available throughout the US; Brazil planned to leverage some foreign device approvals; Medical Microinstruments’ Symani Surgical System won de novo clearance; and the FDA updated its safety warnings for Essure and certain plastic syringes.

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.