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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We hope to catch up on reading, manicure the Pharmalot grounds, and spend time with our shortest person. And what about you? This may be a good time to book that trip to London, which has just become more affordable, since the pound is in free fall thanks to the Brexit vote. You could enjoy the great outdoors or simply plan the rest of your life, such as it is. Well, whatever you  do, have a lovely time. But be safe. See y’all soon …

The VFA, which is the pharmaceutical industry association in Germany, says the European Medicines Agency will have to relocate from London now that the United Kingdom voted to leave the European Union, according to Reuters. “The administrative hurdles that we are now facing as a result of Great Britain’s exit from the Union will require great efforts on the part of our member companies,” the group said in a statement.

The US Food and Drug Administration defended its decision to accept more than 1,000 patient injury reports from Medtronic regarding the Infuse bone graft in summary form years after filings were due, the Minneapolis Star-Tribune writes. Medtronic closed a study in 2008 without reporting injuries, but did not give data to the FDA until 2013, even though federal law requires companies to report injuries within 30 days of discovering them.

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Santa Barbara County, Calif., became the ninth county government in the nation to adopt an ordinance that requires the pharmaceutical industry to pay for a drug take-back program. Massachusetts has a similar requirement, and Cook County, Ill., meanwhile, is expected to vote on such an ordinance shortly, although a date has not been scheduled.

The pending merger between Cigna and Anthem could lead to higher costs for large companies offering employee medical benefits, says Reuters. Most large employers buy worker health benefits from just one or two insurers, and among 75 companies representing a cross-section of industries, 54 percent used one insurer and 26 percent used two. UnitedHealth, Anthem, Aetna, and Cigna are the only national players in the employer health insurance market.

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A doctor who was once the top prescriber of antipsychotics in Florida’s Medicaid program is in federal custody awaiting sentencing on fraud charges, ProPublica reports. The development comes seven years after he was cited by US Senator Chuck Grassley, an Iowa Republican, who pressed Medicaid directors in all 50 states to explain how they were monitoring top prescribers of antipsychotics, narcotics, and other risky drugs.

Sanofi may add a “contingent value rights” to its $9.3 billion takeover offer for Medivation, but it may not convince enough investors, according to TheStreet.

Pfizer is closing a facility in Boulder, Colo., that was part of its purchase of Hospira and employs about 100 people, the Denver Post reports.

Gilead Sciences won European Commission approval to market a once-daily, single HIV tablet that combines three medicines, including tenofovir, PMLive reports.

The UK’s National Institute for Health and Care Excellence is sticking with its decision to bar some patients with acute myeloid leukemia from routine access to Celgene’s Vidaza, PharmaTimes says.

Biogen will shutter a production facility in Massachusetts by the end of the year if it fails to find a buyer, according to InPharma Technologist.

President Barack Obama says he will veto a bill allowing purchases of over-the-counter medications from health savings accounts, Modern Healthcare tells us.

  • eehm, why should a MRP be faster than a national procedure? Are you really sure you know what you are talking about? Regarding this Europe thing as well as drug marketing authorization? Just asking…

    • But if there is only national left, no MRP, they will have time for your national applications. Same authorities involved… Really strange what is going on there on your side of the pond. All going Tronald Dump? Take your British poodle and have a nice summer 🙂

    • It won’t matter how a product made in the UK gets approved. With the devaluation of the currency setting in companies like AZ and GSK will find that their already expensive drugs will be even more expensive in the US. Looks like Brexit buyer’s remorse is already setting in.

  • Regulatory drug approvals will grind to a halt as more and more countries decide to exit the EU. When the EU disappears three of the cogs of the European regulatory process will also disappear: the centralized procedure, the decentralized procedure and the mutual recognition procedure. That will leave only the nationalized procedure, which as we all recall is painfully slow. Once the EU disintegrates the EMA will go away with it.

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