FDA Eases Rules on Drug Manufacturing
“Drug makers will not need regulatory approval for every change in their manufacturing processes under new guidelines designed to prevent supply disruptions, U.S. health officials said on Wednesday.
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The modification is part of a just-completed, two-year effort to overhaul regulation of pharmaceutical manufacturing, a major issue for drug makers. “
Archive for September, 2004
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September 30, 2004
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September 28, 2004Online Extra: “It’s a Perfect Storm” for Drugmakers: “Glaxo CEO Jean-Pierre Garnier on the industry’s hardships and how his company is improving its search for new drugs “
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September 28, 2004“It’s a Perfect Storm” for Drugmakers
“Glaxo CEO Jean-Pierre Garnier on the industry’s hardships and how his company is improving its search for new drugs “
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September 27, 2004Long Trip for Psychedelic Drugs
“Psychedelic drugs are inching their way slowly but surely toward prescription status in the United States, thanks to a group of persistent scientists who believe drugs like ecstasy and psilocybin can help people with terminal cancer, obsessive-compulsive disorder and post-traumatic stress disorder, to name just a few. “
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September 21, 2004Genetically altered grass spreads like wildfire
“A new study shows that genes from genetically engineered grass can spread much farther than previously known, a finding that raises questions about the straying of other plants altered through biotechnology. That could hurt the efforts of two companies to win approval for the first bioengineered grass”
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September 19, 2004How Dublin Keeps Big Pharma Happy
“It’s moving from basic manufacturing to sophisticated R&D to fend off rivals”
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September 8, 2004The Trials of ImClone
“A founder in handcuffs, financials in disarray, and a vital product in doubt-for CEO Daniel Lynch, it was the turnaround from hell.”
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September 1, 2004The Time Is Right for These Seven Biotechs
“In most years, biotechs decline in the spring as investors anticipate a summer hiatus in the conferences where new clinical results are announced. They rally in the fall as the conference schedule and the volume of news increases … Buy when the playing field is biased in my favor, and avoid it when it isn’t. “
