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Should FDA Penalize Drug Makers Over Diabetes Drug Ads?

A consumer watchdog has asked the FDA to stop several drug makers from promoting their diabetes medicines for losing weight, because the drugs were not approved for this purpose.

Sarepta Therapeutics CEO Resigns Amid Tumult With the FDA

The Sarepta Therapeutics ceo abruptly resigned not long before the biotech is expected to seek FDA approval for its Duchenne muscular dystrophy drug and just a few months after the company appeared to get into a tiff with agency officials.

Trouble with Sovaldi, Or Not?

I wish that this were some sort of April Fool's entry, but it isn't. There appears to be an outside chance that Gilead's huge-selling Sovaldi (sofosbuvir) for hepatitis C has some cardiovascular problems. There have been a few reports from the field, and the FDA has asked for a label change when the drug is used in patients who have taken amiodarone. Show More Summary

Rotten Rottlerin

Here's one of the problems with the various schemes to do "deep learning" using the published scientific literature: a fair proportion of that literature is junk. This is not news, of course, and to some extent I feel that that's always been the case. Show More Summary

Pharmalot.. Pharmalittle.. Good Morning: We’re Catching up on Takeda, PD-1 Drugs and More!!

Top of the morning to you. The middle of the week is upon us and, since you made it this far, why not forge ahead? After all, there is always light at the end of the proverbial tunnel. You never know you may accomplish. So please join us as we celebrate this notion with a cup or three of delicious stimulation. Show More Summary

23andMe Appoints “e-Patient Davide” to the Newly Created Position of Chief Patient Officer

I just received the following press release via email. 23andMe Appoints "e-Patient Davide" to the Newly Created Position of Chief Patient Officer Appointment is a First for the Silicon Valley Pharmaceutical Company MOUNTAIN VIEW, Calif.,...Show More Summary

BREAKING NEWS: Rite Aid Acquires Candy Maker, Launches New Rewards Program

Wow, the hits keep coming. This morning, Rite Aid announced its acquisition of Just Born, the privately-held Bethlehem, PA, company best known for making delicious Marshmallow Peeps. Read the press release. To coincide with the deal, Rite Aid also announced a new Peepness+ rewards program. Show More Summary

FDA Gets Poor Grades When it Comes to Allowing Scientists to Speak Freely

The FDA did not fare well in a new report looking at how policies effect the ability of its scientitsts to speak their minds and review reports on which they have worked.

Another Argument For Tau

Just to give most everyone in the Alzheimer's field a little more reason to doubt themselves, the Mayo Clinic has published a study suggesting that the pathology associated with tau protein (neurofibrillary tangles, NFT) is (as someShow More Summary

Switch Flasks, Switch Products

A reader sent along a note about this paper in the Journal of Organic Chemistry. At first, it looks like another study of what happens when you do copper-catalyzed coupling reactions on heterocycles. C2-unsubstituted benzoxazoles couple...Show More Summary

Pharmalot.. Pharmalittle.. Good Morning: We’re Catching up on Glaxo, Pfizer and Lots More!!

Hello, everyone, and how are you today? A warm and shiny sun is enveloping the Pharmalot campus this morning, where things have quieted down now that the shortest of short people has left for the schoolhouse and the official mascots are happily snoozing in their recliners. Show More Summary

OptumRx Sails Away with Catamaran: Deal Analysis and Industry Implications

Yesterday, UnitedHealthcare, which operates the OptumRx pharmacy benefit manager (PBM), announced its acquisition of PBM Catamaran. Read the press release. Catamaran has long been considered a likely acquisition target in the consolidating PBM business. Show More Summary

Pharmacists Group Tells Member Not to Participate in Executions

The American Pharmacists Association, the leading organization representing pharmacists in the U.S., has voted to discourage its approximately 62,000 members from providing medications for executions.

Amgen Loses Another Round in its Battle to Fend Off a Biosimilar Rival

The FDA denied a citizen's petition filed by Amgen seeking to thwart a biosimilar version of its best-selling Neupogen drug.

Pfizer Continues to Dominate DTC Ad Spending

If Pfizer chose not to do direct-to-consumer (DTC) advertising, we'd have less bad ads to criticize (as, for example, this ad for Viagra) and the total spending on DTC advertising would be 30% less than it is today. In 2014, Nielsen estimates that the U.S. Show More Summary

Pfizer Thwarts UK Docs From Prescribing a Drug Over Patent Dispute

In a victory for Pfizer, a U.K. court recently ruled that physicians should prescribe generic versions of its Lyrica medicine – but only for treating pain – as the result of an ongoing patent dispute.

As Pharmacy Benefits Managers Merge, Will Drug Prices Really Drop?

UnitedHealth is buying the Catamaran benefits manager to gain negotiating power with drug makers, but to what extent consumers recognize savings remains to be seen.

Herbal Disclosure

Rather quickly, we have some results from that conflict between the New York State Attorney General and the herbal supplements retailers. GNC has reached a deal with the office, and will (1) use DNA barcoding assays to verify that their...Show More Summary

Transferring Compounds From Pharma to Academia

Here's a look from Bayer at their experiences providing vitamin D receptor ligands to the academic community over the last twenty years (which takes the compounds back into their Schering AG origins). Overall, they've found that theShow More Summary

Pharmalot.. Pharmalittle.. Good Morning: We’re Catching up on Teva, Sanofi and Lots More!!

Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and restful because, once again, that demanding routine of meetings and deadlines and what-not has returned. You knew this was coming,...Show More Summary

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