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Good morning, everyone, and how are you today? We are just fine, thank you. A shiny, warm sun is hovering over the Pharmalot campus, where the shortest person has left for the local schoolhouse and the official mascots are contentedly snoozing away. As for us, there is much to be done. So please join us as we reach for another cup of stimulation — Cinnamon Dolce is our choice today. We hope you survive the middle of the week and great things happen for you …

Both the Department of Justice and the Centers for Medicare and Medicaid Services declined to testify voluntarily at a Nov. 30 Senate Judiciary Committee hearing on Medicaid rebates paid on by Mylan Pharmaceuticals, according to Senator Chuck Grassley (R-Iowa). A $465 million settlement with the drug maker has been criticized, although the Justice Department says the agreement has not been executed.

Starting in 2000, the Food and Drug Administration approved four drugs to treat premenstrual dysphoric disorder, a form of PMS said to be so severe that it qualifies as a psychiatric condition. But PMDD wasn’t recognized as a disorder until 13 years after the first drugs were available, MedPage Today and the Milwaukee Journal-Sentinel write. The approvals began less than two years after an unusual private meeting involving six FDA officials and four executives from Eli Lilly, which sought to develop a new market for Prozac after its patent expired. And this new market was built on a disputed condition, inflated estimates of how many women had PMDD, and drugs that carry severe risks and side effects, such as suicidal thinking.


France is creating a fund to meet compensation claims from people affected by Sanofi’s Depakine epilepsy treatment, which is believed to cause birth defects, Reuters reports. The French parliament voted to create a nationwide compensation fund of about $10.7 million. Parents claim the government and the drug maker were too slow to warn of side effects after the risks to fetuses became clear by the early 1980s.

A mid-stage trial of a cholesterol-lowering drug being developed by the Medicines Co. significantly lowered “bad” LDL cholesterol in high-risk patients with no major safety issues, Reuters writes. Although the drug, called inclisiran, belongs to the new class of PCSK9 inhibitors, its works differently than the two already on the market and is given far less frequently, an important potential commercial difference if it eventually wins approval.


Novo Nordisk chief executive Lars Sorensen may have been named as the world’s best performing CEO by the Harvard Business Review for the second consecutive year, but 2016 is turning “annus horribilis,” the Financial Times notes. After a decade of uninterrupted growth, the drug maker is experiencing a sudden in decline in fortunes as pressure mounts on its diabetes business in the US.

How much? In the first half of 2016, the federal 340B Drug Pricing Program accounted for 18 percent of Genentech sales, suggesting hospitals and other entities in the program claimed discounts on about $3.4 billion in purchases annually from the company, writes Adam Fein on the Drug Channels blog. And with profit margins averaging 58 percent, that translates into about $2 billion in financial benefits. But, he asks, where did the money go?

A study involving reduced doses of Johnson & Johnson’s Xarelto blood thinner suggests patients with two types of heart disease may not need three different drugs to prevent stroke and heart attack, the Wall Street Journal says.

The European Medicines Agency proposed revisions to its guidelines on first-in-human clinical trials as part of an effort to improve the safety of participants.

The UK’s National Institute for Health and Care Excellence rejected Shire’s Onivyde pancreatic cancer treatment because the survival gain did not justify the price, Pharmaphorum explains.

  • Ed, correction on the PMDD. The diagnosis was officially first recognized in DSM IV, which was published in 1994, seven years after Prozac was launched. The patent expired in 2001 so that Lilly had a seven year window between 1994 and 2001 to get the additional indication. Thus, according to my timeline, PMDD was not a “lifestyle disease” that Lilly conjured in order to jack Prozac sales but was merely a next step in the life cycle management of a very popular drug.

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