Supplier manufacturing problems continue to postpone launch of Bristol-Myers Squibb's first "melt-in-your-mouth" pain reliever, firm says. Bristol is devising interim marketing plans for other Excedrin products, redesigning QuickTabs launch campaign. Current Excedrin ad agency Bozell Worldwide (New York) will handle QuickTabs market introduction. Product, which contains 500 mg acetaminophen, 65 mg caffeine, will be priced similarly with Excedrin Aspirin-Free and will come in 16- and 32-count sizes...
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
The European Medicines Agency’s ongoing pilot to streamline drug reviews by allowing companies to voluntarily pre-fill factual data in assessment report templates appears to add significant workload for industry, without delivering clear value to regulators.
Talks between the UK government and the pharmaceutical industry that were intended to resolve issues around high clawback rates under the voluntary pricing scheme for branded medicines have failed, meaning that the mechanism used to calculate rebates will remain in place.
After an Aug. 6 safety labeling change, the FDA became aware of “more compelling evidence” that the risk for serious chikungunya-like illness is not limited to older adults, CBER Director Prasad said.
