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Latest News & Analysis
The US FDA will seek industry feedback on the Commissioner’s National Priority Voucher pilot during a June public meeting as the ultra-fast drug review program marks its first year amid growing scrutiny of its scope, timelines, and sponsor obligations.
Scrip spoke with Debiopharm’s Luke Piggott about the Swiss biotech’s interest in synthetic lethality and strategy around development and partnering.
In a signal that prescription drug and generic drug user fee talks are nearing completion, the FDA and industry are preparing to start biosimilar user fee reauthorization talks with America First and other issues potentially looming.
New ACC/AHA dyslipidemia treatment guidelines say prescribers should consider LDL cholesterol-lowering drugs’ costs, but Amgen and Esperion note the work they’ve done to ensure access to their products.
Spotlight on China
Kintor's topical androgen receptor inhibitor KX-826 posts win in China Phase III trial in male androgenetic alopecia, following a Phase III setback in 2023.
Multinationals showed up with open arms for partnering with Chinese developers at the recent BIOCHINA meeting, but there were signs approaches are changing and firms are now looking beyond straight licensing.
Spanish firm's CSO Karl Ziegelbauer shares with Scrip his views on potential alliances with Chinese and other companies and what Almirall can bring to the table.
The Spanish company has set up shop in Shanghai to be closer to current and future dermatology partners.
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