FDA to Watson on 24-week Trelstar: Ummm, not yet. Oh, and to Bayer and J&J for Xarelto: Ummmm, not yet.

Bayer’s Yaz and blood clots – the legal wrangling continues.

Solvay selling out on pharma, narrows it down to 2 bidders – Solvay has whittled down the list of bidders for its pharmaceuticals business to Nycomed, the privately held Swiss company, and Abbott Laboratories of the US…more

Transplant drugs have to alter labels to include increased risks – The U.S. Food and Drug Administration today said that it will require manufacturers of some immunosuppressant drugs used in kidney (renal) transplantation to update their labeling to reflect an increased risk of infections…more

More bad news on hormone therapy – Women who took hormone replacement therapy after menopause had a sharply increased risk of ovarian cancer, researchers in Denmark are reporting…more

It’s very early, but this Roche potential cancer drug shows some interesting promise. Glioblastoma is a real problem, in need of some new therapies. And, speaking of early, here’s a very counter-intuitive positive result for an Alzheimer’s treatment. Like, 180-degrees counter-intuitive!

PLUS: From Forrester Research – How to Create a Social Application for Life Sciences without Getting Fired ($$ report).

AND: What are the pharma company early adopters doing on Twitter? Here’s the overview, with stats.

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Finally – FDA approves DSI/Lilly blood thinner Effient. Narrow indication with warnings, however – The approval makes Lilly’s Effient the first real competition to the blood thinner Plavix, the world’s second-best selling medication made by Sanofi-Aventis and Bristol-Myers Squibb…more

Debate ignited over newer vs. older schizophrenia drugs – Schizophrenia patients given a cheap older drug are less likely to die prematurely than people on newer treatments, despite the older product’s well-known adverse side effects, Finnish researchers said on Monday…more

Sermo and AMA get into a public spat. Who represents doctors, really?

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Roche-Genentech – the cuts begin – Anxiety rippled through Genentech this week as the Swiss drug firm Roche began to cut rank-and-file jobs as it folds the South San Francisco biotech firm into its global operations…more

Sciele-Victory link-up: Nah, guess not.

J&J, Vertex, and biodollars.

Merck gets expanded approval for HIV drug – The Food and Drug Administration said Thursday it has approved expanded use of a Merck & Co. HIV drug, Isentress. Known chemically as raltegravir, it is now approved for treating new and existing patients with the virus that causes AIDS, in combination with other types of HIV drugs…more

Wyeth has the anti-aging market to itself, and didn’t know it!

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Physican on-line network Sermo about the AMA: Wow – Sermo polled the 100,000 US physicians in our community as to what they thought of the AMA.  Within five days, over 4,100 US physicians voted on the poll and discussed it in over 700 comments.  The results were nothing short of  stunning – 89% of those physicians say, “the AMA does not speak for me”. Check out this visual also.

Did you know about UpToDate.com, an on-line clinical resource for healthcare? I didn’t either until this week.

Adverse Event Reporting and Dialogue in Pharma Social Media. This is an important point to think through – often made out to be a much bigger problem than it really is.

The Pharma and Healthcare Social Media Wiki. It just keeps getting better. Want to find out what’s happening in social networking? – here’s your starting point.

Deloitte takes a fresh look at the Pharma Sales and Marketing model (Asia).

White Paper – Patients Rising: How to Reach Empowered Digital Health Consumers (from Kru Research)

Pharma Search Engine rankings – in need of a fix. Interesting analysis from Dose of Digital blog.

FDA – Waking up with more warnings?

Measuring Return on Involvement.

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Study ended early – who’s the winner? Zetia or Niaspan?

Could New Jersey lose its pharma edge?

BiogenIdec gets a fast track – Biogen Idec Inc., a Cambridge company known for its multiple sclerosis drugs, said that US Food and Drug Administration has granted it Fast Track designation for a potential treatment of relapsing multiple sclerosis…more

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Amgen’s big win – Amgen’s experimental denosumab is more effective than Novartis’ blockbuster Zometa in preventing advanced breast cancer from damaging bone, Amgen said in a press release Tuesday…more

Wyeth’s Prevnar: how about 25% off? – What’s the right amount of the childhood vaccine Prevnar? A study published in JAMA today suggests that three doses may be as effective as the four doses that are standard in the U.S. and many other countries…more

OSI on the move – The company expects to consolidate about 350 of its U.S. employees to the new facility at Ardsley, in Westchester County, New York, in the second half of this year, it said in a statement…more

Good results for GSK’s cervical cancer vaccine.

Plus – Immuneering? Sounds like an interesting approach…

—— Are you formulating Social Media strategies? Impactiviti provides consulting and expertise for pharma companies seeking to employ the newest e-tools for networked communications…

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Last week, I had the pleasure of attending a conference on Emerging Media in Pharma, sponsored by the good folks at CBI. It was held in a Doubletree Hotel in Philly – the majority of pharma-themed conferences are now held in Philly, it seems (with a few scattering into Princeton NJ, or other nearby locales).

My immediate impression was on the downcast side – the number of attendees was clearly going to be small, which can bring a deadening feel to any event. However, on a positive note, a number of my active fellow pharma networkers were there, including Jon Richman, Phil Baumann, and John Mack, and together, we kept up a very lively interaction with the “outside” world that was tuned into to the Twitter #pharmedia hashtag.

This conference had an interesting mix of speakers – the first day was a bit more on the classic principles, case studies, and discussions, but the second day shifted gears into some broader areas, like what the VA is doing to reach suicidal vets, and perspectives from patient advocates (diabetes, in this case). This was helpful because it got us out of the pharma bubble, and into thinking of some other effective networking angles.

Here are some snippets and sound bytes from the tweetstream over the 2 days:

Years to reach 50 million users: Radio 38 yrs, TV 13 yrs, Facebook 2 yrs

The “authority shift” on health content – doctor as primary source decreasing, communities/on-line/consumer opinion leaders increasing

Mobile platforms for patient drug adherence – huge potential. 25% of epharma consumers demand mobile health tracking (among those with mobile)

Twazzup – very cool context-tracking interface (try it!)

Strategic changes: 1) push strategies are failing 2) pull strategies are working

Do pharma marketers really want to start a conversation? Or just talk? And, do consumers want to converse with pharma? It’s not just about pharma talking to consumers and consumers replying. It’s about consumers talking to consumers.

People here at #pharmedia really want to know HOW to do it. Others are doing it. Here’s all the social media in pharma. http://bit.ly/11dBiH

AEs (Adverse Events – the reporting of which on-line scares a lot of pharma regulators -SW) are easy to hide behind and help the risk averse. A set process like AE reporting should be easy to overcome.

Even at this marketing conf. a pharma speaker has to give fair balance and give out the PI. Seriously.

(Bayer) Connecting patient taking Betaseron with MS-trained nurse and a mentor. Nice. Like the idea of connecting patients with a mentor. If they meet offline, then no off-label or adverse events online.

Some of ppts are available from #pharmedia as peeps tweet presentations. Wonderful idea! http://tinyurl.com/lnelda @ideahaus My keynote to UCP: Using Social to Grow Social Capital: http://bit.ly/12F0IL

“If you build it, they will come.” Not. @jonmrich is giving a refresh on web presence, away from static shop front. http://bit.ly/cbidod

74% of Rx drug WOM takes place in person (less than 10% on-line). Interesting stat from @healthtalker

“SM is Pharma’s last best hope to improve its image.” Not if it follows this model: http://bit.ly/gwQgO

Just don’t get the Adverse Event Reporting fear for pharma soc med. Content mgmt, moderation, hand-off to pharmacovigilance. So? The Myth of Adverse Event Reporting. http://bit.ly/JJSl3

“Twitter is to brains what Google is to servers”

Personally, if I only hear “rainbows and unicorns” messages about a drug, it definitely raises my eyebrows.

Victor Wahby, MD going to give an overview of a communications campaign launched by VA (suicide prevention). 3,600 veteran lives (documented) saved from suicide via this campaign?? Wow. The hotline is 800-273-TALK. Here’s a link to a news article about the VA suicide prevention campaign: http://bit.ly/prI2D So often we talk about campaigns and ideas that are abstractions or trivial pursuits. What the VA is doing is life-saving.

Twegulate! The world’s first FDA-compliance Twitter regulator application for Pharma. (yes, this was a joke mock-up, dreamed up during the prior evening’s tweetup at a local Irish pub) http://bit.ly/CIJUO

Now, from the patient side: @sixuntilme and @askmanny, two Type 1 diabetics, start with a crucial point. WE ARE PEOPLE. I do wish pharmas would START here when considering Networked Communications: How can we ADD VALUE to our audience?

askmanny: See the presentation @sixuntilme and I did today: “Become A Partner With The Patient Blogger” http://bit.ly/qJouL

The “Loads Of Hope” initiative started by P&G teaches a big lesson that all other companies can learn from http://bit.ly/453lq

Participatory Medicine is being talked about http://e-patients.net being touted. @ePatientDave would be proud.

Having practiced in US and Asia, I can say participatory medicine is over-rated. Despite my overly participatory style, many patients do best w classic paternalism.

The Conclusion: If your company can’t be remarkable online, don’t even try. If it’s gonna be overly complicated, forget about it. 

#Pharmedia was fun, with very active twittering (far more back-channel discussion than in-room, actually!) Thanks to all who took part!

That should give you a pretty good taste of the themes, and the flavor, of the two days.

The organization of the conference was excellent, the food was quite good, and some of us had a very pleasant tweetup with other Philly folks on the Monday evening – which, coincidentally, was being held just a few blocks away. Some speakers bailed at the last minute – that was disruptive – and the use of mics could have been better coordinated. Otherwise, it was a fine time.

Hopefully, I’ll see you at some other upcoming pharma conferences this year – here’s where I’ll be!

JUST IN: Sanofi gets FDA clearance for heart treatment Multaq – The Food and Drug Administration cleared (FDA) Multaq twice-daily 400 mg tablets to reduce the risk of cardiovascular hospitalisation in patients with atrial fibrillation or atrial flutter, Sanofi said on Thursday…more

More JUST IN: Elan and J&J in a joint venture for Alzheimer’s.

Stiffer warnings (black box) for Chantix and Zyban.

Can I sign up for this trip-to-France-clinical-trial? How about a westbound follow-up to Fiji?

More on the Lantus blow-up this week – reporting rushed because of Sanofi stock drop? FDA raising questions about the scary “conclusions.” And what connections to a competitor does a doctor have who rang the alarm bell?

PLUS: Testing drugs for one thing, finding they work for another.

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Strangest Indication of the Year Award: first drug I’ve seen with a directional indication – Cephalon, Inc. today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL® (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel…more

Sutent for colon cancer – no dice.

New anemia drug approved – AMAG Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Feraheme™ (ferumoxytol) Injection for intravenous (IV) use as an iron replacement therapy for the treatment of iron deficiency anemia in adult patients with chronic kidney disease...more

Cost/benefit ratio of cancer drugs – this is going to be a hot topic in coming years.

Pain drugs under scrutiny.

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Ouch. Jury returns $ 1.67 billion verdict against Abbott (patent infringement vs J&J) – A U.S. federal jury returned a $1.67 billion verdict against Abbott Laboratories in a patent suit brought by Johnson & Johnson related to arthritis treatments, the drug companies said on Monday. An Abbott spokesman said the company would appeal the verdict delivered in Marshall, Texas. The case involves Humira, Abbott’s newer blockbuster drug that blocks tumor necrosis factor, or TNF, and which competes with Johnson & Johnson’s older blockbuster medication Remicade…more

Sanofi hits back on “poor quality” Lantus studies.

Roche leaving PhRMA – Hoffman La Roche is severing its ties to Big Pharma. The venerable drug maker this week plans to drop its membership in the Pharmaceutical Research and Manufacturers Association. PhRMA, as it is known informally, is the leading trade group for the U.S. pharmaceutical industry…more

PLUS – on the far reaches of the cancer treatment galaxy – Australian scientists have developed a “trojan horse” therapy to combat cancer, using a bacterially-derived nano cell to penetrate and disarm the cancer cell before a second nano cell kills it with chemotherapy drugs…more

AND – the doctor will text you now.

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