State lawmakers Feb. 22 introduced A.B. 150 to limit the diversion of pseudoephedrine-containing OTC medicines to methamphetamine production by requiring prescriptions for the products, along with those made with ephedrine and phenylpropanolamine. The Consumer Healthcare Products Association strongly opposes the bill and will express its concerns in Nevada the week of Feb. 26. The bill is modeled after a 2005 Oregon law (1"The Tan Sheet" Aug. 22, 2005, p. 5). The Bush administration has said it will monitor the effectiveness of behind-the counter provisions of the federal Combat Meth Act as well as stricter state strategies (2"The Tan Sheet" June 12, 2006, p. 6)...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.
The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.