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Cancer Genomics: Data, Data and more Data

PLOS Medicine’s Senior Research Editor, Clare Garvey, recently caught up with Francis Ouellette, the Associate Director of Informatics and Biocomputing at the Ontario Institute for Cancer Research (OICR) to find out about progress in...Show More Summary

Weekly Roundup 4.17.15

A few weeks ago it snowed, this week the lawn mowers were revved up. The car is covered in pollen. The cherry trees in DC have peaked. The ranks of tourists have swollen. Taxes have all been done and filed … Continue reading ?

Stopped For Efficacy - Again

Well, just weeks after Merck halted a trial of their anti PD-1 antibody Keytruda (pembrolizumab) due to efficacy, Bristol-Myers Squibb has announced that a trial of their own PD-1 antibody, Opdivo (nivolumab) against non-squamous non-small-cell lung cancer has been halted for the same reason: it's working so well that it's unethical to continue. Show More Summary

Otsuka Struggles to Prevent the FDA From Approving Generic Abilify

Otsuka is hoping to prevent the FDA from authorizing generic versions of its best-selling Abilify pill as early as this coming Monday.

You Have One Minute

The European Federation for Medicinal Chemistry has a competition open, for the best one-minute video explaining what medicinal chemistry is and why it's important. Here's the link - the prize is 500 euros, and fame/fortune/etc. "Why...Show More Summary

Pharmalot.. Pharmalittle.. As the Weekend Nears: We’re Catching up on Amgen, Glaxo and Lots More!!

Once again, another working week will soon draw to a close. And you may say to yourself 'This comes not a moment too soon,' yes? In any event, this is our treasured signal to daydream about weekend plans and our agenda is rather modest. Show More Summary

Addressing the Challenges of Non-Adherence

Today’s guest post comes from Magnar Kvilhaug, RPh, MBA and Kathleen Kvilhaug RPh, of Odin Pharmacy Innovations. They describe AppaGrapha, a new free mobile app for improving patient adherence to drug therapy. This intriguing app allows...Show More Summary

That Can't Be Right

Crazy structure alert! See Arr Oh has pointed out a paper that appeared a few months ago in PLoS ONE, describing a new antibiotic. Yep, that's it at left. Note that it's a symmetric sulfoxide, with those...unusual groups on each side. Show More Summary

Warning and NOV Letter Summary – 1st Quarter 2015

In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. … Continue reading ?

FDA Approves Generic Copaxone, but When Will it Become Available?

The FDA has approved a generic version of Copaxone, a widely used multiple sclerosis drug sold by Teva Pharmaceuticals, but patent litigation may delay when the generic becomes available.

Once Known as Star Scientific, Rock Creek Labors to Develop a Drug

The dietary supplements company that figured in the scandal involving former Virginia Gov. Bob McDonnell is trying to transform itself into a drug developer, but ran into a glitch when a board member resigned after a dispute over a clinical trial.

The Patients Included Movement: My Comments on the Global Charter, re "Key Patient Advocates" & Transparency

"Patient centricity" is all the rage these days among pharmaceutical industry conference attendees and speakers. It is even becoming more common for actual patients to be part of the faculty/speakers and/or attendees of these conferences. This...Show More Summary

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

Good morning, everyone, and how are you today? A bright, shiny sun is hovering over the Pharmalot campus, where the shortest of short people has departed for the local schoolhouse and our mascots are happily snoozing yet again. As for...Show More Summary

How Many Chemists Have You Seen on a Team?

I'm traveling today to give a talk (at this regional meeting of the AAPS), so I don't have my usual train commute wherein to do the morning blog post. So I wanted to set off a bit of discussion instead. I had an email from someone whose...Show More Summary

Determining How Much Pharma Spends on Internet vs. TV DTC Advertising is a Daunting Task!

I prepared the chart on the left for the Pharma Marketing News article "DTC Ad Spending Rises from the Grave," which was published this Monday. You should compare this version of the chart to the one I published here on Pharma Marketing...Show More Summary

Using the Same FEP Ruler

With free energy perturbation having its time in the calculational spotlight, thanks to Schrödinger and others, it seems worthwhile to link to this new paper. It's a proposal for a common framework to analyze the results of such work. Show More Summary

Will a New Vertex Drug for Cystic Fibrosis Become a Budget Buster?

Prime Therapeutics, a pharmacy benefits manager, is warning that a forthcoming combination treatment for cystic fibrosis from Vertex Pharmaceuticals may become the latest example of a budget-busting drug.

WHO Joins the Push for Greater Disclosure of Clinical Trial Data

The World Health Organization has released a new position statement calling for companies to publish all research studies.

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