Brazil

Brazil’s drug regulator ANVISA has also published its first post-marketing authorization monitoring reports on advanced therapies Yescarta, Zolgenma, Kymriah, Carvykti and Luxturna.

India’s Torrent managed to register growth in its financial third quarter – despite being hit by severe currency headwinds in Brazil and suffering a decline in the US – as growth in Germany and its domestic market more than offset the damage.

As Torrent joins Indian majors with plans to launch semaglutide in India and Brazil post patent expiry, market access topics like price and demand come up for discussion. Meanwhile, the supply chain is seen overcoming shortages

Only days after its initial announcement, Hypera Pharma has refused EMS’ proposed merger on grounds of undervaluation and different strategic priorities.

Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.

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

Regulators in Europe and the US have demonstrated a commitment to providing guidance that will make decentralized and point-of-care manufacturing a reality, the CSO of GermFree, a company that provides mobile and modular cleanrooms for manufacturing advanced therapies, tells the Pink Sheet.

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

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.