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Archive for February, 2009

Prasugrel – the saga continues. Gets approval to launch in the EU; positive study results versus Plavix for a certain group of patients; but controversy swirls around FDA approval process.

Synta‘s Phase III trial for melanoma drug fails badly. In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a study a trial for metastatic prostate cancer and a monotherapy dose escalation study.

Wearisome to report – more scandals. AstraZeneca buried some Seroquel data? Ranbaxy falsified records and gets major smackdown. Forest accused of off-label marketing practices (anti-depressants for children). And, from Peter Rost’s blog, here’s an interesting chart showing who paid the most/least in government fines and settlements since 2000 (the winner on the “least” scale: Novartis!)

Sanofi gets US clearance to market Apidra pen. Sanofi-Aventis  has won U.S. approval to market its Apidra Solostar injection pen which contains insulin to treat diabetes, the world’s third-biggest drugmaker said on Thursday. The disposable pen is prefilled with Apidra, which is indicated to improve glycemic control in adults and children of at least four years with type 1 diabetes or adults with type 2 diabetes, the most common form of the disease.

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Sales force efficiency (revenue generated per sales rep) measured and reported among 20 pharma companies – who do you think is on top? Plus, PWC issues a report with a keen grasp of the obvious about targeted (vs. mass) sales forces in the future.

Onyx: Good news! Another reported loss! (OK, sales of Nexavar are strong…)

Baldness drug reducing the onset of prostate cancer? Who’d a thought it?

PLUS – just do the right thing. What a concept. So many problems would be prevented, issues avoided, scandals circumvented, if leaders in companies would follow an informed conscience instead of pursuing short-term gain at all costs…

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Merck has laid off 750 sales reps so far this year. Ouch.

Genentech to Roche: No. Again (translation: move us from “no” with “dough”…)

Endo brings Indevus into the fold.

PLUS – who is actively involved in social media in pharma? I’m assembling a growing list…here’s what we have so far on this expanding community.

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The Skinny on Diabetes Drugs – a helpful little summary on current treatments from the Motley Fool.

Beaker’s Blog tells us that only 4 life sciences companies really matter. Who are they, and why?

Astellas continues to pursue CV Therapeutics after takeover bid rejected.

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John Mack at Pharma Marketing blog discusses the downturn in marketing spend.

Newly discovered (by me, anyway!) blog on pharma eMarketing: Dose of Digital. Some interesting recent posts – FDA Uses Social Media, but You Can’t | Gaming to Save Healthcare Marketing | The Myth of Adverse Event Reporting

And, here’s my take on the dance of pharma and social media: Social Media Salsa meets Pharma Waltz.

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Genentech‘s Raptiva: TroubleThe FDA said today that patients taking the Genentech drug Raptiva are at risk of developing a potentially fatal condition known as PML, or progressive multifocal leukoencephalopathy. The drug’s label already carried a warning about this possibility. But last week, Genentech sent a letter to alert doctors that a third case of PML had been confirmed in a Raptiva patient, following two other cases reported last fall. Meanwhile, Roche still raising cash to try to take over Genentech.

U.S. government joins in on whistleblower suit against J&J biz unit SciosThe U.S. government is joining two lawsuits against Johnson & Johnson and its Scios unit, accusing the companies of promoting heart failure drug Natrecor for unapproved uses, the Department of Justice said on Thursday. The drug is approved to treat patients with acutely decompensated congestive heart failure who experience shortness of breath. But DOJ officials said in a statement their investigation found Scios aggressively began marketing the drug to patients with less severe heart failure soon after its approval in 2001.

Crestor cuts stroke risk in half (Jupiter study) – A new analysis from the JUPITER study presented today at the International Stroke Conference (ISC) in San Diego, California describes details of the stroke data according to gender, ethnicity and baseline risk factors. This data adds to the primary analysis of the JUPITER study which demonstrated that CRESTOR® (rosuvastatin calcium) 20mg significantly reduced the risk of stroke by nearly half (48%; p=0.002), compared to placebo among men and women with elevated high-sensitivity C-reactive protein (hsCRP) but low to normal cholesterol levels.

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After Hours 022009

Endless Interestingness – an endless collage of images pulled from Flickr. Cool idea. Hat tip: Guy Kawasaki.

The Crisis of Credit visualized. What happened to our financial markets? This simple, entertaining, and informative animation explains the blow up. Well worth a few minutes of your time. Hat tip: David Armano.

The “blog” of “unnecessary” quotation marks. Fun pictures of a “real annoyance”.

The Top 25 things you didn’t know about Facebook’s Terms of Service (will only be understood by Facebook users!)

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The training event has happened. And now you’re left wondering – will they remember it? Will the learning be applied? How can this be reinforced over time?

We can help.

Impactiviti’s Preferred Partner network includes a company with a uniquely useful offering – a template-driven tool that allows you to create mini-scenarios (1-3 minutes), which can be e-mailed. These quick hit reinforcement and application exercises are perfect for follow-up to training, and the back-end analytics allow you to see where the gaps and successes are. These simple and compelling mini-bytes can be deployed at any time (pre-event also)!

If this type of offering is what you’re looking for, contact Steve Woodruff at Impactiviti. We’ll introduce you to an optimal vendor/partner with a proven track record of success.

(And, if you’re in need of a robust and engaging on-line testing and assessment service, we know where you need to turn for that also!)

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Impactiviti is a consultancy focused on helping companies identify optimal partners for training/marketing needs. This vendor/client “matchmaking” service is provided free of charge to client companies (preferred partners pay a referral fee when a new business relationship is established).

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(Image credit)

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I was recently asked, by a pharmaceutical client, what was “new” and leading-edge in training.

trends1I haven’t seen a lot of specific programs or approaches that struck me as the latest-and-greatest must-haves, but there are certain social and technology trends that will profoundly impact training in the years to come. Here are a handful that I think are important:

1. Who – specifically, from whom will we get our knowledge, coaching, and support? I believe that the formal, centralized model of training will increasingly be displaced by social, peer-to-peer networking and resourcing on the job. New platforms are now emerging, combining elements of learning management, knowledge management, content management, and social networking, including such features as wikis, blogs, and micro-sharing (peer-to-peer messaging). People are now getting used to learning from one another via networking, and this will (should!) shape training approaches in the years to come.

Example: Pfizer’s Pfizerpedia project. Pfizer researchers creating a living wiki that is peer-to-peer driven. See Karl Kapp’s overview (with more helpful links); a .pdf case study; article from Information Week.

2. When – these days, with the one-click-away Google, presence apps like Twitter, and cell-phone connectivity, it’s all about the NOW. We’re getting used to finding what we need when we need it, and training will need to migrate increasingly to a Continuous Training Development / Continuous Learning Access / Constant Update / Immediate Equipping model. While there will always be some training content on the long development cycle slow train, we’re now entering a technology era where fingertip performance support is potentially ubiquitous.

Example: On-line coaching tools. For software apps and other needs, context-sensitive help & coaching, now including audio/video/screencasts, is being rolled out. This is far superior to sitting in a classroom for 5 days with fire-hose training, and a hope and a prayer that students will retain the material.

3. Where and How – With smart phones, notebook computers, Kindles, and who-knows-what-will-be-launched-next-month, information and communication are finally untethered. We can take pictures, chat, videoconference, blog, search, and listen anywhere and everywhere. Training will gladly hop aboard this fast-moving express. Multi-channel communications (podcasts, e-mail simulations, webcasts, videos) are being woven into daily life, and will increasingly shape training, as will the use of gaming environments and virtual worlds.

Example: One of my pharma clients recently rolled out laptops that included integrated webcams. This capability soon led to a new layer of productivity – pre-event training practice on selling skills that could be conducted “live” and at a distance, making the on-site training more efficient.

4. What – The era of personalized information experience is here, and is increasingly moving into training platforms. Anyone can set up an iGoogle or My Yahoo page and add information and application boxes, or customize widgets on Facebook pages, or set up RSS feeds around their own interests. As these technologies are embraced in training, whole new layers of efficient and customized training delivery become possible.

Example: Some Learning Management Systems are rolling out portal-like front-ends, which allow people to see customized training, resources, and information according to login. This trend will accelerate as personalized information delivery becomes the norm across all web technologies.

And now, one final trend that SHOULD be embraced – Strategic Design and development of training with a focus on operational efficiency. But that’s a whole separate topic…

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Teva aggressively seeking to “genericize” Merck‘s Singulair, Amgen‘s Neupogen.

Warren Buffet pulling back from pharma investments that contain 2 letters (P&G, J&J).

GSK‘s nausea drug Zofran may help with drug withdrawal symptomsGlaxoSmithKline Plc’s Zofran, approved to treat nausea and vomiting, appears to reduce symptoms of withdrawal from morphine, codeine, heroin, OxyContin and similar pain medicines, a study shows. The drug, which is now available as a generic called ondansetron, was used to treat eight men for morphine withdrawal, according to a study in the Journal of Pharmacogenetics and Genomics. Compared with placebo, the patients receiving ondansetron were less likely to experience anxiety, hot flashes, aches, restlessness, nausea and vomiting.

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