Pharma Industry Archive

The New York Times reported that the FDA is investigating one of its past approval decisions, publicly questioning for the first time whether or not political pressure unduly influenced an outcome. Wait, what? This is the first time the agency has publicly questioned if politics played a role in its decision-making? I’m not surprised it happened; I’m surprised this is the first time...

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AstraZeneca’s stock is up on the news speculation that it might be a takeover target for Novartis. It’s not going to happen. Here’s why. AZ and Novartis share only one thing in common: They have similar operating leverage, in that both get about $3 in revenues for every $1 they spend on reps and marketing. But the similarities end there. AZ is facing a massive patent cliff as...

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AstraZeneca appears to be on a suicide mission in its average wholesale price litigation. Yesterday we saw how it lost a $13 million appeal of a Massachusetts federal court ruling that found AZ illegally marketed the spread between the actual price of Zoladex and its Medicare reimbursed rate, thus bribing doctors, ripping off taxpayers and generating increased sales of the cancer drug. That...

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Plaintiffs in the Neurontin litigation have accused Pfizer of “blatant hypocrisy” for insisting that witnesses should not contact each other in the case because Pfizer once sent an ex-CIA agent to the home of a witness in a separate Neurontin case. Download the motion here. The duelling claims come in a case regarding the death of Hartley Shearer, a Massachusetts man whose family...

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Johnson & Johnson must be loving their new deal with Elan. Remember, this was the deal in which they paid $1.4 billion for a stake in the company, including $500 million for its Alzheimer’s drugs, such as bapineuzumab, and still didn’t come away with Tysabri, the MS wonder drug. Having lost Tysabri, J&J now finds that its new partner is under investigation by the SEC regarding...

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Former InterMune CEO W. Scott Harkonen faces 20 years in prison and a $250,000 fine for writing and distributing a press release that falsely portrayed clinical trial results on Actimmune, a lung drug. Download the indictment of Harkonen here. The verdict, from a California federal court, will doubtless be appealed. In the meantime, it will send shivers down the spines of anyone involved in...

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AstraZeneca lost a federal appeals court ruling and must pay $13 million in damages for manipulating the price of prostate cancer drug Zoladex. The case involved an AZ campaign to persuade doctors to over-bill the government for Zoladex. It urged, “DO THE MATH!” in letters that explained how using Zoladex was more profitable for docs than other cancer drugs. Download the Zoladex...

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What can you say about Sequenom, where the board just fired its CEO and six other executives after it emerged that data it used to back its Trisomy 21 test for Down Syndrome contained “inadequately substantiated claims, inconsistencies and errors”? We all know that drug companies spin data and stretch claims. But trying to get a product approved based on flawed data crosses a line...

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Chantix made someone shoot me! Drugs that look like candy! GSK’s CASSPER ghostwriting program was “a horrible idea”! It all happened in September, 2009. Enjoy: Pfizer sued by family of drunk man shot while on Chantix Dallas musician Carter Albrecht got wasted while on the anti-smoking drug, went berserk, and ended up being shot dead by a neighbor. His family believes Pfizer...

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Despite both Teva and Sandoz dipping their generic toes into the Solodyn acne franchise, sales of Medicis‘ pimple-popper are still going up, reports Jefferies & Co. analysts David Windley and Andrew Hilgenbrink. Limited generic at-risk launches captured 18 percent of the market, J&C says, but Medicis’ sales are still growing. The rate of annual sales growth has declined,...

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