Lipitor in perspective: With $6.45 bil. in annual sales in 2001, Pfizer's Lipitor generates more revenues than the annual Gross Domestic Product of 78 countries, based on calculations of purchasing power parity by the Central Intelligence Agency. If Lipitor meets growth expectations in 2002, it should surpass the GDP of Tajikistan ($7.3 bil.)....Zocor heart protection study: Merck will present data on the effect of Zocor (simvastatin) in the 20,000-patient Heart Protection Study at the American College of Cardiology meeting in March. Preliminary results show that Zocor "reduced the risk of heart attacks and stroke by at least one-third," company says. A filing based on the data is planned for this year...
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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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European regulators must work hard to maintain and build vital but fragile trust in science and processes, said speakers at an event celebrating the European Medicines 30th anniversary.
Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.