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Noise and Nonsense Over Walgreens’ Inversion Plans

Since I published March’s Inversion Uncertainty: Is Alliance Boots Really Acquiring Walgreens?, Walgreens has become embroiled in a giant PR nightmare over its plans. Major politicians are attacking the company. Editorials are calling the company “unpatriotic.” A potent anti-Walgreens consumer movement is starting to spread online. Show More Summary

Targacept Comes Up Empty, Yet Again

Targacept's attempt to salvage something by testing TC-5214 for overactive bladder has failed. John Carroll at FierceBiotech counts eight straight failed clinical trials from this company: a record? I don't see anyone beating that very easily, that's for sure. Show More Summary

Upcoming AdComms By Subject Matter

In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often.  Today is every so … Continue reading ?

Summer Blogging

I wanted to let everyone know that blogging will be irregular around here for the next week or so. I'll be taking some time off here and there, and while I'll surely get a few blog posts in, they won't show up at the usual times. (IShow More Summary

Industry Keynote Speakers McClellan and Turner Announced for IIR’s MDRP 2014

IIR’s Medicaid Drug Rebate Program (MDRP) 2014  is back in Chicago September 15-17, 2014, just in time to provide you with essential regulatory updates surrounding the impact of the ACA, Medicare Part D, AMP Final Rule, and the 340BShow More Summary

Broken

http://www.bmj.com/content/bmj/347/bmj.f6980.full.pdf

Weekly Roundup 7.25.14

We sit on the cusp of August – the month when America goes on vacation.  Everything will slow down, rush hour will be less rushed, lawns will need less cutting and in our sights is Labor Day which brings the … Continue reading ?

The Antibiotic Gap: It's All of the Above

Here's a business-section column at the New York Times on the problem of antibiotic drug discovery. To those of us following the industry, the problems of antibiotic drug discovery are big pieces of furniture that we've lived with all our lives; we hardly even notice if we bump into them again. Show More Summary

MAC Transparency Legislation Gains Momentum

Today’s guest post comes from Todd Grover, President & CEO of ChainDrugStore.net and Co-Founder of Glass Box Analytics. Todd reviews the new Center for Medicare & Medicaid Services (CMS) final rule regarding the disclosure and updating of Maximum Allowable Cost (MAC) reimbursement limits. Show More Summary

Dr. Frances Oldham Kelsey is 100

Happy 100th birthday to Dr. Frances Oldham Kelsey, the pharmacologist whose bold stance against inadequate drug testing saved countless newborns from the perils of thalidomide, a drug which caused severe birth defects in over 10,000 infants. Show More Summary

Phenotypic Assays in Cancer Drug Discovery

The topic of phenotypic screening has come up around here many times, as indeed it comes up very often in drug discovery. Give your compounds to cells or to animals and look for the effect you want: what could be simpler? Well, a lot...Show More Summary

The "Risk-Only" Landing Page Requirement: Can We Get FDA to Adopt FTC's Thinking and Drop This Rule?

One of FDA's Ten Commandments -- the FIRST one, in fact -- states: You shall have no other regulatory agencies before Me. Several people have asked me, "John, what other agency could pharma worship before FDA?" Glad you asked. The Federal Trade Commission (FTC) also regulates product advertising. Show More Summary

How Many Biopharma Employees Would Rather Be Working Somewhere Else?

How many people working in the biopharma industry would jump to another company if they could? According to this survey, it's just over half: well above the average set by other industry sectors. The usual reasons are cited, in part (pay, opportunity for advancement). Show More Summary

Neratinib Comes Through For Puma

Yet another entry in the "Why do people keep investing in biopharma?" files. Take a look at the case of Puma Biotechnology. Their stock was as high as $140/share earlier in the year, and it gradually deflated to the high 50s/low 60s as time went on. Show More Summary

Even Though There Are Fewer Sales Reps, More Physicians Deny Rep Access

According to the spring 2014 AccessMonitor™ report from global sales and marketing consulting firm ZS Associates, pharmaceutical access to physicians continues to decline. Only 51% of physicians/prescribers now allow access to salesShow More Summary

The Broad Gets $650 Million For Psychiatric Research

The Broad Institute seems to have gone through a bit of rough funding patch some months ago, but things are looking up: they've received a gift of $650 million to do basic research in psychiatric disorders. Believe it, that'll keep everyone...Show More Summary

Put Them in Cells and Find Out

So, when you put some diverse small molecules into cellular assays, how many proteins are they really hitting? You may know a primary target or two that they're likely to interact with, or (if you're doing phenotypic screening), you may not have any idea at all. Show More Summary

Developing a Policy for Correcting Third Party Misinformation

Last week I held my Webinar on FDA’s Regulation of Social Media called “In More than 140 Characters…”  During the 1 hour presentation, I attempted to cover a lot of ground, wanting not only to focus on the latest two … Continue reading ?

Who Pays Less for Drugs: Medicaid, DOD, or Medicare Part D? The Answer May Surprise You

Hey there, pharmacy reimbursement nerds! The Government Accountability Office (GAO) has a fun new report for you: Comparison of DOD, Medicaid, and Medicare Part D Retail Reimbursement Prices. The report documents the interplay between...Show More Summary

Why is PhRMA Defending Gilead's Sovaldi Pricing?

In an article published in The Hill, Lori Reilly, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America (PhRMA), whose job is to develop federal legislative, regulatory and political strategies,...Show More Summary

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