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Archive for the ‘Medical Devices’ Category

TODAY’S NEWS

Celgene to buy Gloucester Pharmaceuticals, another company with a focus on developing drugs for blood cancer. I really like Celgene’s laser-like focus in its product portfolio – very smart.

Keep those new blood thinners coming.

AstraZeneca‘s Seroquel gets an expanded label for Major Depressive Disorder (add-on treatment).

Folotyn: 30K/month cancer treatment?? Wow (from NY Times).

The race for the new oral MS drug approval – did Novartis just take the lead?

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PLUS

Pharma: Socializing in a Straitjacket? A somewhat shallow brushstroke in AdWeek about pharma and social media. AND – only TWO FDA inspectors in all of China (where much drug manufacturing is moving)? I bet that gets changed fast!

JUST FOR FUN

Will a young dog remember a family member who has been gone for 3 months? Watch and see!

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I was in downtown Philadelphia earlier this week for the inaugural ePatient Connection 2009 conference, a first-time event by the relatively new Kru Research (headed up by Kevin Kruse). I’ve known Kevin for years through our mutual work in pharma training/eLearning, but this was his first venture into organizing a conference.

KruseKimballCount me impressed.

Unlike last week’s Digital Pharma conference, which took encouraging steps in the direction of a more “unconference” format (review here), ePatient Connection had a more traditional, structured format. But unlike others – and I’ve been to MANY over the years – it was fresh, interesting, and basically…it rocked. The two days each flew by quickly.

I’m not going to attempt a content overview – that has actually been nicely done by Eric Brody here. And PharmaExec on-line gives a nice quick scan here, including some of the juicier quotes. Suffice it to say that the speakers were diverse, knowledgeable, and well-chosen. I’m saving my two thumbs up for the following:

thumbsupThis event was tight. By that, I mean it was run incredibly efficiently and smoothly. Sessions started on time, ended on time, did not drag, and the speakers were clearly prepped with directions to keep it focused and well-structured. The audio/visual setup was one of the best I’ve seen, even to the point of having a photographer going about the entire time taking a tremendous variety of pictures (immediately uploaded to Flickr). The Wi-Fi was strong. There were outlets/extension cords along one entire side. There was a Twitterscreen. Sessions were captured on video. The attendee goodie bag was one of the best ever, including several books, and even an iPod Touch! There were standard presentations, panels, interviews, open forums, 1-on-1 sessions, and even a Pecha Kucha (20 slides, each for 20 seconds) slot. Vendors had a chance to briefly show their wares up front, which is a great way to give them exposure without turning sessions into sales pitches. All in all, other conference organizers could learn a lot from this freshman endeavor. Kudos to Kru & crew for pulling this off.

thumbsupThis event was well-targeted. It’s way past time to start bringing together people from the pharma/device industry, the ePatient community, and other stakeholders in healthcare. Hearing from bloggers with medical conditions, and getting their perspectives (not only on stage, but actively throughout the conference on Twitter), was both inspiring and enlightening. Folks on the business side and on the consumer/patient/people side need to better understand one another, and this was a very helpful format to move the dialogue forward. The fact that we had a late entrant show up from FDA/DDMAC (Paul Loebach, a really nice guy) was a huge bonus.

I had the privilege of co-facilitating, with Jack Bilson and John Mack, two lunchtime discussions on Developing Guidelines for Social Media. Those sessions could have gone on for hours – very rich interaction and a high level of interest among the participants. But, of course, everything was running on time (I told you it was tight!), so we had to move along by 1:45 pm!

It does seem to me, after the last few weeks, that we really have turned the corner when it comes to use of Twitter in pharma/healthcare industry conferences, as there was an incredibly active and informative Tweetstream (hashtag: #ePatCon). Many, many people were “tuned in” to parts of this conference from around the globe, and participating virtually. And, of course, we enjoyed social occasions and a tweetup, where many of the pharma “early adopters” renewed friendships or met each other for the first time – always very rewarding.

This event was an exhausting and exciting pleasure to be a part of. Looking forward to the sophomore edition!

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Pharma Social Media resources: SocialRx

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Tune in TODAY – I’ll be doing a live on-line interview on Social Media in Pharma with Paul Chaney – starts at 1 pm EST (just use the call-in number – see the link). Also, here’s a page on my site with all sorts of social media resources for pharma professionals: http://bit.ly/socialrx

TODAY’S NEWS

AstraZeneca’s new Plavix-competitor Brilinta expected to go big – It is the first antiplatelet drug to demonstrate it can reduce cardiovascular (CV) deaths compared to the current gold standard treatment, Plavix (clopidogrel) in patients with acute coronary syndromes (ACS). Results of the 18600 patient Phase III PLATO trial comparing the two drugs, were revealed at the recent European Society of Cardiology (ESC) Congress in Barcelona…Platelet expert Dr Victor Serebruany agreed the mortality data is ”marvelous,” with 107 extra lives saved compared to Plavix. “It has never been seen before and no one expected it,” he saidmore

Big oncology news (approval for new lymphoma drug) today – Allos Therapeutics Inc. said Friday that regulators approved its injectable drug Folotyn as a treatment for peripheral T-cell lymphoma, a group of rare, agressive blood cancers, sending its shares soaring. Allos said the Food and Drug Administration granted accelerated approval, allowing the company to market Folotyn for use in patients whose cancer has returned or not responded to previous treatment. Allos expects to begin selling the drug in October. There are no drugs on the market that treat peripheral T-cell lymphoma, Allos saidmore Plus, some future hope from Roche on melanoma?

So the FDA is finally going to start wresting with social media in pharma! Here’s what companies need to do to prepare for the hearing this fall. And here also.

This bothers me.

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Compliance training. When y0u need compliance training development partners for your employees, we’ve got g. Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for information and recommendations!

PLUS

An interview with the President and CEO of Sanofi-Aventis US (Gregory Irace), on the big changes they are undergoing to re-structure the company, and the way they deliver information.

Coming up next month:

DigitalPharma

Oct. 19-21 – eXL’s Digital Pharma conference, Bridgewater, NJ. This event will be quite progressive, with more of an informal “unconference” format to maximize interaction. I’ll be co-leading a pre-conference workshop on the 19th on social media, and live-blogging/Twittering. Here’s a discount code for 15% your registration: P615WOO

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Where I’ll be next week: Sept. 23-24 – MedAdNews PharmaMed Marketing and Media conference, Princeton, NJ. I’ll be speaking on social media opportunities in pharma, and live-blogging.

TODAY’S NEWS

Novartis sees positive results with experimental COPD drug – Swiss drugmaker Novartis said a respiratory medicine improved lung function and significantly reduced breathlessness in a late stage trial. The outcome added to data suggesting QAB149 will challenge blockbusters like Pfizer’s Spiriva and GlaxoSmithKline‘s Advair, giving Novartis an edge in one of the industry’s most lucrative therapeutic areasmore

J&J/Elan deal getting the once-over to try to appease Biogen Elan, the Irish domiciled biotech company, will receive $115m less than previously agreed from Johnson & Johnson as part of a revised investment deal designed to salvage a pivotal partnership with Biogen Idecmore

Eli Lilly to do massive re-org – Eli Lilly announced that it would eliminate approximately 5,500 positions as part of a massive reorganization strategy that’s expected to net the firm reduce $1 billion in costs by 2011. This move will drop the company’s headcount from approximately 40,500 to 35,000. The company hasn’t revealed where the cuts will come from or how many will be real layoffs and how many will simply be reduced positionsmore More from the Lilly CEO here.

New MRSA drug approved – Theravance Inc. and partner Astellas Pharma won FDA approval for their superbug-fighting drug telavancin, which will bring the South San Francisco company a $20 million milestone paymentmore

GSK will have to share Paxil e-mails in birth defect lawsuit.

An interesting analysis of Qnexa (the next weight-loss drug?) by Jim Edwards. Is it too good??

Metformin as a treatment for cancer??

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Change. Innovation. Do you need to provide training to your team on change management? Or bringing about effective innovation? The Impactiviti Partner network has great vendor/partners who can help you with these offerings. Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for information and recommendations!

PLUS

A new site for accessing medical device/pharmaceutical sales positions listed by recruiters: MedPharmReps.

JUST FOR FUN

Do you know anyone with their internal organs reversed? Turns out that there are such folks…maybe even you!

We had a wonderful and restful vacation last week, touring through Massachusetts, Maine, New Hampshire, and Vermont. I uploaded some pictures along the way on my “twitpic” account – here’s one sample:

VermontWine

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FDA to Zeltia: NO – An FDA advisory committee has handed Spain’s Zeltia a crushing blow, deciding against a combination therapy that includes its lead cancer drug Yondelis (trabectedin) by a vote of 14 to 1. The news cost Zeltia 35 percent of its share price…more

FDA to Shire: Fast-track – Shire plc, the global specialty biopharmaceutical company, announces it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type I Gaucher disease…more

Pfizer: We want to be #3! – Pfizer Inc. plans for its worldwide sales of medicines for treating cancer to increase 10-fold by 2018, said Andreas Penk, regional president of the company’s cancer business in Europe. Pfizer, the world’s biggest drugmaker, had about $2.5 billion in cancer-medicine sales in 2008, according to the company. Pfizer plans to become the third-largest maker of cancer treatments, up from about seventh now…more

Daiichi chief talks about Effient.

Med Device firms and Kickbacks – Several large medical device companies have been accused of marketing their products for unapproved uses while charging the federal government, according to documents unsealed in Houston federal court…more

PLUS – What if I was to go back into Pharma Sales?

AND – some recent stats on physicians on-line (globally). Pretty big. And while we’re at pretty big, here is the horrendous tangle that could be the future of healthcare here in the U.S.

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AstraZeneca‘s Crestor reduces risk of blood clots in the veinsA new analysis from the JUPITER study shows that CRESTOR® (rosuvastatin calcium) 20mg significantly cut the risk of venous thromboembolism (VTE) by 43% (p =0.007) compared to placebo among men and women with low to normal cholesterol levels and elevated high-sensitivity C-reactive protein (hsCRP).

Abbott gets a boost with stent results – Abbott Laboratories‘ drug-coated stent, Xience V, is significantly more effective than Boston Scientific Corp.’s Taxus three years after implantation in an artery, according to new long-term data. The data, presented Sunday at the American College of Cardiology meeting in Orlando, Fla., come from a 300-patient, Abbott-sponsored international trial known as SPIRIT II. The data are the longest to date for Abbott’s market-leading stent. Boston Scientific also markets Xience, which was approved last year, under the name Promus.

TriLipix for cholesterol: looking goodA combination of Abbott Laboratories’  new TriLipix triglycerides medicine and a low dose of AstraZeneca Plc’s Crestor cholesterol drug proved better than the individual pills in helping improve heart risk factors, researchers said. The combination did significantly better at lowering bad LDL cholesterol and other blood fats called triglycerides, as well as raising levels of good HDL cholesterol in patients with complex lipid disorders.

PLUS – Eli Lilly on mega-mergers: No“I think we are seeing deals that are really driven more by weakness than what I would describe as strong strategic combinations … That will improve short-term problems but fail to answer the long-term question of research productivity.”

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You have a need to pull together a bunch of scattered training materials/workshops into a comprehensive curriculum. Maybe you also need a vendor/partner who can not only head up design and development, but can also take the lead on organization and faciltation (locally or globally).

We can help.

Impactiviti’s Preferred Partner network includes some top-notch companies and consultants who take on these complex challenges. If this type of expertise and service is what you’re looking for, contact Steve Woodruff at Impactiviti. We’ll introduce you to optimal partners who have a proven track record of success.

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Impactiviti is a pharma consultancy focused on helping pharma/biotech/medical devices companies identify optimal partners for training/marketing needs. This vendor/client “matchmaking” service is provided free of charge to pharma, biotech, and medical device companies.

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