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Pharmalot.. Pharmalittle.. Good Morning.. We’re catching up on Valeant, Walgreen and..

pic thx to mick kelly on flickr creative commons [1]

pic thx to mick kelly on flickr creative commons

Good morning, folks. A happy, shiny sun is hovering over the Pharmalot campus where, after a brief road trip, we have resumed our usual ritual of brewing needed cups of stimulation and foraging for interesting items. However, we are also kvelling since our shortest of short people celebrates a special day. We will tend to that later, though, since a long to-do list awaits. As always, we hope you have a smashing day and, of course, do keep in touch…

The New England Journal of Medicine has endorsed Robert Califf as the next FDA commissioner amid chatter that he has a pro-industry tilt. NEJM editor Jeff Drazen writes [2] that “actions should be driven by data, not innuendo.” And he points to seven clinical trials Califf reported, noting that four had negative outcomes. “Given this performance, it is impossible to argue that Califf has a pro-industry bias,” he writes in an editorial. This posture follows a series [3] of controversial essays earlier this year in which a NEJM argued that concerns over conflicts of interest are increasingly overblown.

The widely used class of cholesterol-lowering drugs known as statins may undermine the effectiveness of flu shots, new studies suggest, a finding that could complicate care for older adults, Stat [4] writes.  The effect is particularly marked among people taking synthetic statins — Lescol and Baycol are examples — rather than naturally produced varieties of the drugs.

Valeant Pharmaceutical relies on some pushy, “back door” tactics to get prescriptions filled, including the use of identification numbers of pharmacies to secure payment, The Wall Street Journal [5] tells us. The practice, which is overseen by Philidor Rx Services and which runs a pharmacy network for Valeant, is unusual and could backfire by angering payers.

Two US senators urged the US Federal Trade Commission to scrutinize the Walgreens Boots Alliance $9.4 billion bid for Rite Aid, a deal that would unite two of the three biggest U.S. drugstore chains, Reuters [6]reports. And for those tracking the bid, Drug Channels [7] offers a tip sheet on a few things you ought to know about a deal, such as a prediction that the FTC will approve the deal anyway, a sentiment seemingly shared by many Wall Street analysts.

Sanofi cut its sales forecast for diabetes therapies in the next three years after demand for its best-selling Lantus insulin slumped, according to Bloomberg News [8].

Theranos authorized new shares that would value the laboratory startup at over $10 billion, a filing shows, three days before reports detailed its struggles with its blood-testing technology, The Wall Street Journal [9] reports.

Nephron Pharmaceuticals may lay off up to 180 workers from its Florida facility as it shifts work to a new facility in South Carolina, The Orlando Sentinel [10] reports.

The Comparative Effectiveness Public Advisory Council concluded that PCSK9 inhibitors, a new class of  cholesterol-lowering drugs, did not offer reasonable value to most patients given their cost, The Boston Globe [11] says.

Sanofi issued a voluntary recall of Auvi-Q epinephrine auto-injectors, which are used to treat life-threatening allergic reactions, after receiving reports of malfunctions, MarketWatch [12]writes.

A sharp rise in fees associated with a popular type of drug plan is chipping away at pharmacies’ profits across the US, according to The Wall Street Journal [13].