The US Federal Trade Commission’s focus on potential anti-competitive behavior by pharmacy benefit managers picks up steam as Chair Lina Khan approaches the end of her term.

IGBA's secretary general, in an interview with Scrip, bolsters the case for enabling single global development of off-patent medicines and the acceptance of foreign comparators in bioequivalence studies as complex and niche therapeutics increasingly dot pharma’s pipeline. The global off-patent industry association, she maintained, is also “paying attention” to patent quality in various regions.

As India seeks to build on early gains in CAR-T cell therapy, experts call for ecosystem reform and also the need to demonstrate value to payer models of large economies to potentially back international reimbursements.

SK pharmteco CEO Joerg Ahlgrimm talks to Scrip about the "excitement" at BIO, potential CDMO shifts amid the US BIOSECURE Act, and the Korean CDMO's focus on business as usual as it seeks to diversify and grow.

US-based Citeline writer Sarah Karlin-Smith joins Brian Yang and Dexter Yan in China to discuss the US BIOSECURE Act and the recent BIO meeting in San Diego, while Dexter Yan discusses China-related ASCO highlights, in this mixed Chinese- and English-language episode.

Insights from Day Four of the BIO International Convention include FDA commissioner Califf on the state of real-world evidence and how it impacts IRA negotiations, Roche's interest in cardiovascular/metabolic assets, Merck's plans in immunology, and industry's rising interest in neuropsychiatry. 

IGBA's secretary general, in an interview with Scrip, bolsters the case for enabling single global development of off-patent medicines and the acceptance of foreign comparators in bioequivalence studies as complex and niche therapeutics increasingly dot pharma’s pipeline. The global off-patent industry association, she maintained, is also “paying attention” to patent quality in various regions.

Speaking of an impending launch of new biosimilars, including pembrolizumab, panelists at a recent event in India asked for regulatory easing from a waiver of Phase III trials for biosimilars to a single body for pre-clinical and trial approvals. The chicken and egg question of VC funding also came up.

The UK giant’s COVID-19 prophylactic sipavibart could soon reach Europe and competition is sparse.

A research fellow at South Korea's Science and Technology Policy Institute talked at a recent seminar about the key funding, management and other challenges faced by the domestic biotech sector to sustain growth, and how these contrast with the situation in the US.

Parexel’s chief strategy officer Kushal Gohil, Clinical EVP Stephen Pyke and India head Sanjay Vyas share thoughts on possible hurdles to, and the cascading impact of obesity treatments, GenAI progress and the opportunities and challenges of real-world data in India, in the second of this two-part interview with Scrip.

SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency.