Rise and shine, everyone, another busy day is on the way. We can tell because the official mascots are especially enjoying the Pharmalot grounds now that spring is springing and various work crews are dotting the nearby environs. This is an especially busy day for us, in fact, since we are hosting a session later on biosimilars — mark your calendar for 1 p.m. ET. To prepare, we are, of course, brewing cups of stimulation. So far, our choice today is peppermint mocha. Please do join us. Meanwhile, here are few items of interest for you to peruse. We hope you have a smashing day and conquer the world. And as always, we hope you keep in touch. …
The Biotechnology Innovation Organization, the industry trade group, is cutting ties with China’s WuXi in response to increasing U.S. government scrutiny of the biotech and other Chinese companies, STAT tells us. The move is an about-face for a lobbying organization that recently was willing to defend WuXi against attacks, and a sign that the U.S. biotechnology industry will have to make do without a company that it has come to heavily rely on for developing and making drugs. WuXi is the only BIO member among the four Chinese companies that would be blacklisted from doing business in the U.S. by the Biosecure Act, a bipartisan bill that was introduced in both the House and Senate.
European Union lawmakers proposed a compromise on exclusivity periods for new drugs in the biggest overhaul of pharmaceutical rules in 20 years, Reuters reports. The legislation, proposed by the European Commission last April, would slash approval time for new drugs, incentivize antibiotic production, and improve patient access. Industry argues innovation will be harmed. The draft compromise would raise baseline data protection to 7.5 years with one extra year of incentives if a drug meets “unmet medical needs” and if studies are held in the EU. A company would also get three years of market protection from generics, raising exclusivity to 11.5 years, up from 10 years as proposed.
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