Pharma Industry Archive

The Indian government is proposing new regulations to control drug trials in its country. India seeks to create a Central Drug Authority to monitor the ativities of U.S. and European drug giants who have outsourced much of their clinical testing to India, China and Africa. There are currently no rules governing drug trials in India, according to the Times of India. The news comes after 49...

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UPDATE: Dr. Sanjay Kaul was bounced from the FDA’s prasugrel panel after Eli Lilly called the FDA to question his inclusion on the panel, according to HeartWire. The FDA has admitted it made a “mistake” by axing Kaul. “At every step of the way there were errors by multiple parties,” said Janet Woodcock, director of drugs at FDA. When is a unanimous vote for...

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You probably noticed the item in the WSJ Health blog noting that Pfizer’s top executives gave themselves one year’s pay if they are laid off, even though regular employees get only 16 weeks of base pay (more if they meet certain conditions). That’s a significant double standard. But did you know that CEO Jeff Kindler (who gets $10 million if he’s fired) et al actually...

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MannKind Corp., which burns cash at a rate of $83 million and $75 million per quarter, has only $46.5 billion in current assets left. So it will have to borrow $350 million from Al Mann, the company chairman, to see itself through, according to Zack’s. If you check out its balance sheet, only $28 million of those current assets are cash. Mannkind expects to submit a 450,000 page new drug...

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At Stryker, the maker of bone replacement devices and drugs, there appears to be a policy of rewarding management for the moral failings of their company. Over the last two years, Stryker has been the subject of investigations by the SEC, FDA and Department of Justice into corrupt practices and the manufacturing quality of their products. You can read the NY Times story on the most recent...

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Merck CEO Richard Clark made a few headlines when he said in his Q4 conference call that “I wouldn’t rule anything out” when it came to large-scale M&A transactions. CEOs always say this sort of vague, noncommittal thing, but in Merck’s case it is looking as if the company may be increasingly desperate to acquire its way out of the problems it has. Or be acquired....

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Roche has raised $16 billion from the bond market to fund its takeover of Genentech. It will probably need to pay $40-45 billion to get the company. Roche has about $4.9 billion in cash on its balance sheet, so … still about $20 billion to go, guys! Roche may have been smirking slightly at the news that the FDA put out a public health advisory for Genentech’s plaque psoriasis drug...

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Shire revealed its Q4 2008 results today in a press release that uses a cunning new transparency trick: It gives so much information, in so many different forms, that it’s difficult to figure out quickly what exactly is going on at this company. Here’s Shire’s official take on its own results: New product sales were up 34% to $270 million including strong growth for VYVANSE...

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The increasing use of foreign drug trials may hurt U.S. patients because of genetic and environmental differences in overseas study subjects, a new study in the New England Journal of Medicine suggests. “Are trial results accurate and valid, and can they be extrapolated to other settings?” asks a team from Duke University. “A major concern is the ethical oversight of research...

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AstraZeneca, Novartis, Vertex Pharmaceuticals and Boehringer Ingelheim have started experimenting with Twitter with varying degrees of enthusiasm, reports Pharmaceutical Executive. Drug companies have so far looked at social media with a mixture of fear and loathing. They believe (perhaps wrongly) that giving consumers more opportunities to talk to drug companies will lead to an increase in...

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