Regulation
After an eventful 2025 that saw the US off-patent industry chalk up wins on tariffs and biosimilar streamlining, AAM president and CEO John Murphy III talks to Generics Bulletin about how the association will be stepping up its lobbying efforts in a US election year.
The first multinational clinical trial approval under the EU’s 70‑day fast-track pilot pathway is expected by the end of April 2026.
In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.
Speaking to Generics Bulletin on the sidelines of the AAM’s Access! 2026 conference, IGBA chair for 2026 Jim Keon – also president of the CGPA and Biosimilars Canada – discussed IP abuses, supply challenges, biosimilar streamlining and the importance of giving the off-patent industry a global voice.
A Senate report finds GSK’s withdrawal of Flovent and shift to an authorized generic increased costs, restricted access and disrupted asthma care, while helping the company avoid Medicaid rebates, raising broader concerns over pricing loopholes.
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?
Asieris Pharmaceuticals' hexaminolevulinate, for treating high-grade squamous intraepithelial lesions, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
NRx says the FDA has identified no bioequivalence deficiencies in its Ketafree ANDA, clearing a key hurdle ahead of a potential mid-2026 decision as the firm pursues parallel generic and innovative ketamine strategies.
FY 2026 OMUFA facility fees are $19,188 for OTC monograph drug manufacturers and $12,792 for contract manufacturing organizations also making the products. FY 2025 fees were $37,556 and $25,037.
The final week of February saw the AAM hold its Access! 2026 annual conference in Miami and Medicines for Europe hold its annual regulatory and scientific affairs conference in Amsterdam. Generics Bulletin was there at both events and our reporters discuss the key takeaways in our latest podcast.
Zydus’s investment in a differentiated drug-device combination for semaglutide has led to a win-win GLP-1 co-marketing deal with Lupin even as the Indian drug regulator keeps a watch on advertising activities
India issues firm advisory on promos for obesity and metabolic disorders therapies ahead of loss of exclusivity for semaglutide later this week, with 50-plus generic brands seen in the wings for a share of the pie. Will Eli Lilly and Novo Nordisk have to tweak their multimedia campaigns?