Rise and shine, everyone, another busy day is on the way. And this will be a particularly busy one for us, since we are visiting the home office for a round of meetings. This may sound familiar to many of you, yes? To cope, we are chugging a few extra cups of stimulation this morning. Feel free to join us. We understand that you have your own challenges. Meanwhile, here are some tidbits. Hope you have a productive day and, as always, do keep in touch …

The American Action Network is launching a $4.8 million ad campaign to defeat a plan by the Obama administration to overhaul the way Medicare Part B pays for medicines, The Hill reports. The campaign is targeting 61 congressional districts and focuses on Republican lawmakers. The overhaul is designed to discourage use of higher-cost medicines and would change reimbursement for doctors, but drug makers worry the plan will harm revenue.

More than 10,000 pregnant women in France took Sanofi’s Depakine epilepsy drug between 2007 and 2014, even though a risk of birth defects was known, according to a study quoted by Le Canard Enchaine, Reuters reports. The weekly wrote that the French health ministry delayed publishing the study, although the ministry denied this. In October, the Paris prosecutor launched a preliminary investigation into the authorization and marketing of the drug.

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Takeda Pharmaceuticals is upset that the UK’s National Institute for Health and Care Excellence failed to recommend its Adcetris treatment for Hodgkin’s lymphoma for Cancer Drugs Fund, Pharmaphorum says. The agency decided the drug’s clinical effectiveness is “immature and limited” and could not be considered a cost effective use of National Health Services resources. “This poses a challenge to the NICE methodology,” a Takeda exec complains.

Eli Lilly says an interim analysis of a late-stage study testing its abemaciclib breast cancer drug showed the treatment was not effective, according to Reuters.

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Teva Pharmaceuticals recalled an injectable antibiotic that is one of only two products made at a plant in Hungary where production was suspended following a crackdown by the US Food and Drug Administration.

After Biogen spins off its hemophilia drug unit into a separate company early next year, the business will be called Bioverativ, the Boston Globe writes.

The US Substance Abuse and Mental Health Services Administration is revamping management to focus on medicine and medications, Alcoholism & Drug Abuse Weekly reports.

India’s Central Drugs Standard Control Organisation and Pharmacovigilance Programme of India are jointly forming guidelines for good pharmacovigilance practices for drug safety, PharmaBiz says.

Bayer recalled its Kogenate injectable hemophilia treatment in Spain after regulators found problems with product stability, according to InPharma Technologist.

  • A refreshing change is afoot if our scribe summarizes The Hill piece correctly. None of the usual blather about physician independence or patient care, ” drug makers worry the plan will harm revenue.” That’s putting it honestly! …. Did they really say that?

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