Value-Added Medicines
Samsung Bioepis’ explorations for an alternate semaglutide formulation will be powered by G2GBIO’s microsphere technology.
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.
Outlook Therapeutics gave little detail about its next steps following a meeting with the US FDA, but said it was evaluating regulatory options toward approval. Meanwhile, expansion in Europe continues with a fresh Swiss commercial distribution deal.
Teva’s R&D chief Eric Hughes discusses the company’s long-acting injectable olanzapine program, how it could address adherence challenges in schizophrenia, and why the therapy forms a key pillar of the firm’s growing injectables franchise.
In the second part of our exclusive interview with Medicines for Europe leaders, Generics Bulletin delves into medicinal product regulation by environmental and chemical agencies, and the need to maintain the historical off-patent drug heritage in Europe.
Europe is facing one of the biggest pharmaceutical reforms in two decades. Medicines for Europe’s Beata Stepniewska and Adrian van den Hoven outlined how the regulatory trinity – EU pharmaceutical legislation, Critical Medicines Act, and Biotech Act – will reshape the industry.
Generics Bulletin previews the most noteworthy and anticipated events for March 2026.
After multiple knockbacks from the US FDA over its Lytenava ophthalmic formulation of bevacizumab, Outlook Therapeutics is hoping to resolve issues with the agency. It said the latest complete response letter was “inconsistent” with the BLA's evidence and “unexpected” after earlier FDA advice.
After taking the reins as president of Medicines for Europe at the start of 2026, Zentiva CEO Steffen Saltofte sets out priorities for the group that include ensuring access to medicines, industry resilience and competitiveness, harmonized regulation, and sustainability for the off-patent sector.
Generics Bulletin previews the most noteworthy and anticipated events for February 2026.
Hyloris and Orion continue to build on their partnership with another value-added medicine collaboration in Europe.
European CNS specialist rolls out a value-added methylphenidate and a first-to-market guanfacine generic as it sharpens its European ADHD strategy.