Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating. Now, though, that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cup of stimulation. Our choice today is maple bourbon — a shot of salvation, so to speak. Feel free to join us. Remember, no prescription is required. Meanwhile, here are a few items of interest. Best of luck accomplishing your goals, and we hope you conquer the world. And, of course, do keep in touch. …
The U.S. Food and Drug Administration Center for Drug Evaluation and Research has formed a board to oversee and advise on exclusivity decisions, aiming to improve clarity and consistency of those decisions, Reuters notes. The board will focus on five-year new chemical entity exclusivity that is granted to a drug whose active ingredient has never before been approved by the FDA. It will also oversee three-year new clinical trial exclusivity grants that are meant for drugs that use a previously approved active ingredient, but whose approval relies on new clinical studies conducted or funded by a drugmaker.
Belgian Prime Minister Bart De Wever called for stronger protection of the country’s pharmaceutical sector, arguing that pressure from the U.S. and China is threatening European industries despite their competitiveness, Anadolu Agency says. Speaking on the sidelines of the European Union summit in Brussels on Thursday, De Wever said the planned restructuring at GSK, which could result in more than 1,200 job losses in Belgium, was linked to the company’s need to increase investments in the U.S. He also criticized China’s practices in clinical trials, describing them as unfair competition backed by substantial state subsidies.