An 1advertisement in the Oct. 23 issue of All You magazine says Novartis' Prevacid 24HR could be "available as early as November 12th." The Web site for the proton pump inhibitor, 2www.prevacid24hr.com, has been updated with additional information about the product, including packaging and drug facts. Novartis, which licenses Prevacid 24HR (lansoprazole 15 mg) from Takeda Pharmaceuticals, appears to position the drug as an alternative to prescription heartburn remedies, rather than attempting to draw away users of Procter & Gamble's Prilosec OTC (omeprazole 20 mg) - as the company said upon FDA approval of the switch in May (3"The Tan Sheet" May 18, 2009). The OTC PPI market may grow more crowded after December, when FDA's decision on Santarus/Schering-Plough's Zegerid (omeprazole 20 mg/sodium bicarbonate) is due (4"The Tan Sheet" June 29, 2009, In Brief)
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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.’
President Trump’s new Executive Order on drug pricing reprises several policy themes from his first administration, including giving the FDA many tasks intended to increase competition in the marketplace.
FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
