Archive for October, 2008

Some surprises in the new diabetes guidelines issue by the American Diabetes Association and European Association for the Study of Diabetes…more

Speaking of diabetes – we’re paying a lot more over the last few years!

And, a triple dose of diabetes news, including bad news for Avandia.

Medtronic exec says devices are finished?????? Now that’s an interesting PR move!

FDA accepts priority review of expanded Erbitux label.

My favorite headline of the week. Type-1 Diabetes Not So Much Bad Genes as Good Genes Behaving Badly, Stanford Research Shows.

Novo: we have cash and we know how to use it – Novo Nordisk A/S is earmarking as much as $2 billion for takeovers in the next 12 months as the financial crisis forces cash-strapped biotechnology companies onto the market, Chief Financial Officer Jesper Brandgaard said.“We are more or less able to finance in cash acquisitions within the $1 billion to $2 billion range,” Brandgaard said in a phone interview from Copenhagen. “We think there will be opportunities in biotech which we haven’t seen before.”…more

Meet the new team at Pfizer.

Ortho Clinical Diagnostics gets a biological tester approved.

Big Crestor study results could be “game changer” – A forthcoming AstraZeneca study could dramatically increase the market for cholesterol-lowering drugs, otherwise known as statins, which are already pharma’s biggest success story, Forbes writes…more

New “Superbug” antibiotics on the way? – Two experimental antibiotics appear to work safely against an increasingly common and dangerous form of infection called methicillin-resistant Staphylococcus aureus or MRSA, researchers said on Sunday…more

Schering’s new anesthesia-recovery drug looking good – An experimental drug worked many times faster than a standard treatment in helping surgery patients recover from anesthesia, according to a just-published study funded by its developer, Schering-Plough Corp…more

Lashes. Lovely lashes. And an eye-color change, too. Welcome to Lumigan.

$1.4 Billion – “not meaningful” to Eli Lilly. Huh?

Some promising Phase III clinical trial results – Novartis biologic shows great efficacy on a rare autoinflammatory disease. And, Merck‘s Isentress looks good on treatment-naive HIV patients.

Apidra approved for pediatric diabetes – Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra® (insulin glulisine [rDNA origin] injection) to improve glycemic control in children (4 years and older) with diabetes mellitus…more

U.S. drug sales growing much more slowly than forecast – The number crunchers at IMS Health just cut their estimate for growth of U.S. drug sales to 1% to 2% this year– way down from the 4% to 5% they’d previously forecasted, the WSJ reportsmore

BusinessWeek chats with a few pharma CEOs – As part of a package of stories about big pharma, BusinessWeek grabbed the ceo at four drugmakers – Pfizer’s Jeff Kindler; Bristol-Myers Squibb’s Jim Cornelius; Lilly’s John Lechleiter and Roche’s Severin Schwan – to discuss the varied and vexing problems the industry faces. Here are a few of their comments…more

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After Hours

If only all disputes were settled this way!

Would you donate if you got this letter?

Normal pets, OK. This bird – no!

This will be the funniest 5 minutes you spend today. The “Me Monster”!

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Blogging – according to Fard Johnmar, no longer niche.

The 2008 Patient Adherence Update – chock full of stats, charts, and other good stuff on a very important topic. From MedAd News.

Are free drug samples the last best hope for sales reps? An interesting take from a recent conference (though I have questions about the relative authority of the speakers). From John Mack’s Pharma Marketing blog.

Also from John Mack, Prescriptions and Recession.

Allergan: great marketing, less PhRMA code? What about that Botox marketing…?

On-line video growing in popularity among physicians. From Shwen Gwee.

Marc Monseau (from the J&J blog JNJ BTW) with some thoughts on pharma and social media. From Shwen Gwee.

Various Web 2.0/pharma thoughts and resources from Shwen Gwee.

An interview with Mark Senak, the EyeonFDA blogger.

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Sanofi-Aventis suspends sale of Acomplia in Europe. Acomplia, an obesity drug that once looked like it would be a blockbuster for Sanofi-Aventis, is being pulled off the market in Europe. The EMEA, the European version of the FDA, said today that a key committee “concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union.”…more

Jim Edwards summarizes what he calls Pfizer‘s Race to the Bottom. With some similar commentary on Novartis‘ growth/shrinkage.

Merck announces more big cuts – As part of its earnings announcement, the drugmaker says it expects to eliminate approximately 7,200 positions – 6,800 active employees and 400 vacancies – across all areas of the company worldwide by the end of 2011, with about 40 percent of the total reductions coming in the US (see statement). This amounts to 12 percent of the workforce…more

Pfizer’s Chantix: going down…or up, depending on which continent you’re on…US researchers say even more warnings needed.

FDA: Another day, another stall – U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc to study the pill in more depth, a company spokeswoman said on Tuesday…more And, while we’re at it, a thumbs down (for now) for Abbott‘s new version of Vicodin. Oh, and hey, let’s delay Abbott’s new cholesterol drug while we’re in foot-dragging mode!

Novartis buys up Nektar’s pulmonary business – Nektar Therapeutics  today announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash…more

Will BMS lead the charge in buying up undervalued biotechs?

Earnings roundup for Schering, Pfizer, Roche here’s the scoop.

What about Amgen’s growth? An interesting analysis here. Plus – how 6 pharma companies have dodged (or not) the current financial crisis (extracts from earnings announcements from Pfizer, Bayer, Abbott Labs, Gilead, Wyeth and Genentech, all on the topic of how each company has fared in the crisis.)

Celgene seems to be doing quite OK.

J&J’s HIV drug gets expanded approval – U.S. health regulators have expanded approval for Johnson & Johnson’s Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday…more

Avastin: what doesn’t this drug do? – After tagging the antibody drug with a radioactive tracer and injecting it into mice, researchers found it successfully targeted cancer cells and this enabled them to produce well-defined images of tumours during scanning…more

Speaking of which, does leukemia drug Campath help stop early stage MS? Fascinating possibility – A drug developed to fight leukemia appears to stop multiple sclerosis in its early stages and restore lost function to patients, British researchers said on Wednesday…more

Forest Labs growing green – Forest Laboratories Inc posted higher-than-expected quarterly profit on Tuesday, fueled by stronger sales of its drugs for Alzheimer’s disease and depression and lower research spending…more

Biologics and safety concerns: really not a big surprise here – Approximately one in four biologics approved since 1995 in the US and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a Black Box warning, according to a study in the Journal of the American Medical Association…more

Take a Chill, Pill: are oral cancer drugs all they’re cracked up to be?

B-I has some encouraging potential early results for novel cancer drugs.

The WSJ talks about healthcare, IT, and the future. Interesting stuff.

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I had the pleasure, this week, of attending the Digital Pharma conference (sponsored by eXL Pharma) in Princeton, NJ. I’ve been to a number of conferences over the past years that did not meet expectations. This one, however, EXCEEDED my expectations.

This conference was about the use of new media (esp. Web 2.0/Social Media) in pharma marketing, a topic near and dear to me.

The speakers, on balance, were solid and knowledgeable. As usual, in a setting like this, there were some who were just spewing platitudes and generalities, but some were quite engaging and well-informed.

I “live-blogged” the conference (first time I’ve done this) and the experiment was a great success – not the the least reason being that it forced me to stay engaged as I uploaded the messages in real-time to the Impactiviti blog. If you’d like a summary of the sessions, you can start with this link to the first one, and then scroll “up” to the various others.

I also was invited to speak on a panel, and showed the attendees how tools such as live-blogging and Twitter were being used (by me and handful of others attending) to interact and share with the “outside world” during the conference.

Some interesting statistics and resources were shared. Here is a list of related links that you might find interesting:

Internet Surpasses Doctors as the Top Source of Health Information (from Manhattan Research).

AstraZeneca digs into the Cause of Non-Adherence

Why Pharma fears Social Networking

Web portals open up pipelines of Information to Consumers

Marc Monseau (of J&J’s corporate blog JNJ BTW) on Healthcare Companies and the Social Web.

More resources–

FREE upcoming webinar: E-Detailing in a Web 2.0 world. Info here.

You may wish to purchase the “Social Media Pharma Marketing” Supplement to Pharma Marketing News. Click here for more details — including a table of contents and link for ordering the pdf file online. If you order it, use the discount code SMM444JM and get $17 knocked off the list price of $29.95!

You may wish to purchase the “ePharma Marketing Special Supplement, Vol. 2 Sec. 1 & 2” Supplement to Pharma Marketing News. Click here for more details — including a table of contents and link for ordering the pdf file online. If you order it, use the discount code sep268 and get $15 knocked off the list price of $29.95!

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Novartis to cut a bunch more (sales) jobs; does another management shuffle – As reorganizations go, this one reaches most parts of the company. First, the drugmaker is cutting 550 sales reps, although half of the jobs are said to vacant, as part of a new business model with five new regional units for reaching doctors and insurers called “Customer Centric Initiative” (back story). The move should save $80 million annually as of 2010…more

But, at least Novartis is making some profitIn good times and in bad times, people will get sick. That reality has helped Swiss drug maker Novartis post strong earnings for the third quarter on Monday, in spite of the banking crisis and global economic slowdown. Yet even as the pharmaceutical sector sticks to the pattern of being insulated from greater financial troubles, growth at Novartis will not be as robust as last year…more

Is specialty pharma the place to be? – Here are some interesting numbers to chew on…

B-I has some interesting stuff in the pipeline – Boehringer Ingelheim announced that patients and physicians may have several innovative Type 2 Diabetes treatment alternatives available in the coming years. At its Second International Research & Development Press Conference, Boehringer Ingelheim unveiled a pipeline of unique oral anti-diabetic compounds in phase II and III, establishing the company in the Type 2 Diabetes arena…more

Genentech sales soaring – It seems Genentech made the right choice in turning down a takeover bid from its majority holder, the Swiss pharmaceuticals company Roche Holding: its sales are soaring and investors apparently don’t mind that its latest earnings missed Wall Street’s estimates, possibly because of costs associated with defending itself against the bid…more

New study: Vioxx does cause heart risks – An analysis of an infamous Vioxx study found the notorious painkiller does, indeed, double the risk of heart attacks and strokes, although the likelihood of a serious cardiovascular event lessened one year after people no longer took the pill…more

Pfizer’s desperate times/desparate measures – As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees – a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us…more

Effient: wait ’til Feb – Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee have been contacted about their availability for a February panel meeting specifically on prasugrel, sources tell The Pink Sheet. And the agency’s Drug Safety and Risk Management Advisory Committee may also be convened…more

Fred Baron to receive Tysabri after all (this human/medical interest story is a bit involved, but brings up important issues about experimental/compassionate use).

High-dose Zevalin with stem-cell infusion leads to strong survival results for NHL.

Abbott’s experimental bioabsorable stent looking very interesting – Abbott today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries…more

FDA becomes FDelAy – Takeda drug, others stalled at agency. Who needs those stinkin’ deadlines?? But, next-generation Astelin (from Meda) does get an approval.

Wisconsin Medical Society bans pharma gifts – The doctors’ group, which boasts 12,000 members, has joined a growing number of academic medical centers, professional societies and legislators that have decided gifts from the pharmaceutical industry are questionable, if not unacceptable forms of influence…more

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After Hours 10_20

The most bizarre “We’re Open for Business” sign ever.

Ever wondered what the sun looked like – up close and personal? Wonder no more!

If your Sales Training dept. ran your Church – very funny!

Combine fall leaves with a slow shutter speed and a camera twist. Result: this! (from my iPhone).

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Live blogging the eXL Digital Pharma conference, from Princeton, NJ. This second day will focus on the Regulatory environment.

Shwen Gwee, Lead Business AnalystHealth Informatics New Media, Vertex Pharmaceuticals: Can Pharma make a business case for Social Media?

– Build audience and gain trust before there is a crisis!

– Hurdles we have here in pharma are not unique to us (but there are some legal/reg/fed aspects that are specific).

– Manhattan Research – Internet now first destination for health info, displacing doctors.

– Put someone influential and high-profile in charge of corporate social media strategy/implementation.

– Don’t just look inside the industry. Innovation from outside.

– Join the conversation at social media sites. Attend meetings. Get LinkedIn. Experiment and participate.

– Need an internal social media evangelist to seed multiple levels within company. Energize people!

– Ladder of participation – different levels of involvement and expertise (highest level: creators)

– Research data if you want to spend some $$

– Determine your objectives

::Don’t think traditionally. Like Google – launch quickly, iterate quickly.

::Define Policies and Processes. State rules of engagement explicitly. good ex: JNJBTW

– ROI: depends on your objectives.

– Lots of free tools to monitor traffic, etc.

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Live blogging the eXL Digital Pharma conference, from Princeton, NJ. This second day will focus on the Regulatory environment.

Mark Senak, Pharma Blogger EyeonFDA: Strategic Considerations in Crisis Response in an Era of Social Media.

– There have always been “new” and emerging media (TV, etc.)

– Today’s crises not like your father’s crises. Totally new communications and distribution methods.

– Bloggers beginning to take a far higher profile space in the information chain.

– Digital media getting integrated/inter-linked, with very rapid uptake.

Need for Speed. How to develop systems that will keep you in touch?

– Speaker/blogger talking about how a bad speaker caused the audience to Twitter about her talk – as I live-blog his talk. But he’s pretty good.

– Going from broadcasting to niche-casting. From talking to, to talking with people.

– Setting up an early-warning system via social media to catch news and respond. Tools like Facebook lexicon, and Tweetscan (tracks Twitter).

– You don’t have weeks to do damage control.

::Don’t cross the line. THERE ARE NO SECRETS!  And, do not fail to act…

(this was a very good session)

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Live blogging the eXL Digital Pharma conference, from Princeton, NJ. This second day will focus on the Regulatory environment.

Panel Discussion: Regulatory & Legal Concerns with Social Media.

This is a serial presentation by Legal/Reg types. Not much new to see here so far…

80% of pharma marketing violations reported by employees (whistleblowers) raising concerns. Wow.

Zzzzzzzzzzzz…oh, hello there! Just had a large dose of LawNada, new sleep drug that also creates Innovation Depression Disorder.

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