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Archive for June, 2009

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 Remicademore

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 industrymore

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 drugsmore

AND – the doctor will text you now.

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I think it’s going to be more than 3 today…!

Does Lantus (Sanofi drug for diabetes) increase cancer risk?

Takeda‘s alogliptin (new diabetes treatment) – FDA says, more info please.

European Medicines Agency approves a variety pack of new drugs and expanded indications. Here’s the rundown.

Drug companies increasingly using Medical Science liaisons. In my industry crystal ball, I think MSL-type folks will increasingly replace pharma sales reps. More from the original WSJ article here.

Newest version of Elan rumors – Novartis perhaps buying the MS part of the portfolio? Could make sense, given Novartis’ recent entry into that therapeutic area.

Roche: bye-bye Accutane – Roche is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease. Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement...more

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A 9th PML case with Tysabri since reintroduction - Biotechnology company Biogen Idec Inc. said late Friday a ninth Tysabri patient developed a potentially deadly brain infection since the drug was reintroduced to the market in 2006. The drug, which treats multiple sclerosis, was pulled from the market in 2005 following occurrences of a rare, but deadly, brain infection called progressive multifocal leukoencephalopathy. The drug was reintroduced in July of 2006, with restrictions and a monitoring programmore

Merck and Schering-Ploughmore merger info, please (FTC).

Some interesting oncology/HIV links, with hat tip to Sally Church:

:: Glaxo drug delays kidney cancer progression – it will be interesting to see how it compares to, say, Sutent.

:: Perfusion treatment for liver cancer shows some promising results.

:: How does adrenal cancer form?

:: Combined retroviral and targeted chemotherapy treatment may flush out hide-and-seek virus remaining in immune cells.

PLUS – are too many patients self-diagnosing?

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THE BIG DEAL – Pharma and the U.S. government come up with drug discount agreement. More detail here.

New Forest Labs pneumonia drug reaches goals – Forest Laboratories Inc said on Friday its experimental antibiotic proved to be at least as effective as an older medicine in pneumonia patients, reaching its main goal in two late-stage trials. Forest said its drug, ceftaroline, was well tolerated and met its primary goal of similar effectiveness and high clinical cure rates compared with ceftriaxone in patients with moderate to severe community-acquired, bacterial pneumonia requiring hospitalizationmore

Pfizer manager sentenced for off-label Bextra promotions.

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I’m prepping to meet tomorrow with a biotech client about potential usage of social media. But in looking over the client’s website, and thinking about pharma SM issues, and reviewing my “Ten Consulting Questions”, I had to chuckle.

We’ll really be brainstorming a communications strategy.

Not a single one of the 10 main issues necessitates social media. It just happens to be a possible tool and approach. As neatly summarized by Geoff Livingston. And encapsulated in this quote from a rather provocative Ad Age article: “What if we stopped getting all hot and heavy over the latest new media success stories du jour, and starting realizing that the real triumph of…a campaign was the product and the story, not the channel used for storytelling?”

I don’t think I ever want to be a “social media guru.” I’d rather become an increasingly effective communications strategist. Who participates in and understands social networking.

We’re better off focusing on terms like community-building, connecting, and communicating. That’s the point. SM tactics are…well, tactics.

UPDATE: The meeting was fantastic…!

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Medtronic, a doctor, transparency, and 800K – Remember that former Army doctor accused of faking data in a published study that found positive results for a Medtronic product? Turns out, Medtronic paid him nearly $800,000 over the past three years. Here’s the report from this morning’s WSJmore

RA drug Mabthera: use early, use often – Trials show rituximab, marketed as MabThera, almost completely halts the deterioration of the joints in people showing the first signs of the disease…The latest study on 755 patients shows the drug, when used with the gold standard treatment for early RA methotrexate for a year, not only reduces symptoms but slows joint damage to almost a complete stop if used early enoughmore

Novartis gets approval for…well, you’ll have to read it for yourself. Swiss drugmaker Novartis said Thursday that the U.S. Food and Drug Administration has approved its Ilaris medicine for the treatment of children and adults with cryopyrin-associated periodic syndrome…more

PLUS – Sanofi to donate 100m swine flu vaccines. Nice.

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Are you trying to find an ideal vendor partner for your sales training or eMarketing endeavors? Contact Impactiviti for expert recommendations…free client consultations!

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Why are Doctors so down on Pharma?

Only a tenth of prescriptions are truly “up for grabs”? Interesting analysis – Traditional promotion efforts, including details and sampling, can only affect about 10% of prescriptions, an IMS study found, suggesting that the bulk of promotion dollars is misplacedmore

Another gout drug (this one from Savient Pharmaceuticals) approved by FDA – The 14-to-1 vote for approval reflected a general consensus that the effectiveness of the drug in relieving severe pain and disability outweighed the risk of allergic reactions and suggestions that it could cause cardiovascular problemsmore

PLUS – UCB Pharma comes up with a plan to report Adverse Events via a community site. This is an important initiative – one of the big excuses pharma company regulators have used to shy away from social networking is the AE canard. This issue can be dealt with, and what UCB is doing will help light the way. Plus, here’s a Washington Post article on how drug companies are delving into the on-line space.

Breaking news: Watson acquiring generics maker Arrow.

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Over the span of days and weeks, an accumulation of various and sundry items piles up relating to pharma marketing. Sometimes, they just need a blog post mixed bag collection. Here it is.

Could iPhones transform pharma marketing? (from Fierce Pharma blog)

Why mobile marketing for pharma matters (from Pharma 2.0 blog).

Internet advertising has stopped dead in its tracks (from Pharma Marketing blog)

10 Digital Marketing ideas the Pharma Companies will never try (but should) (from Dose of Digital blog)

7 things that will definitely rule pharma marketing in 2010 (from S&R blog)

Google Trends – a great tool for Pharma competitive intelligence (from Pharma Strategy blog)

5 Ways Gaming may transform the Future of Health and Wellness (from Influential Marketing blog)

HCMA conference will be free for unemployed marketing/communications professionals (from Medical Marketing and Media)

ePromotion – equal or superior to face-to-face selling? (from World of DTC Marketing)

Drug prescription data-mining – the legal battle goes on (from Business Week)

PLUS: Upcoming pharma marketing conferences that I plan to attend in 2009.

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Cumberland Pharmaceuticals gets an injectable approved – Cumberland Pharmaceuticals (www.cumberlandpharma.com) today announced the U.S. Food and Drug Administration (FDA) has approved Caldolor(TM), an intravenous formulation of ibuprofen, through a priority review. Caldolor is the first and only injectable product approved for sale in the United States for the treatment of both pain and fevermore

Pfizer‘s experimental RA drug looking good – Pfizer Inc. said Thursday its experimental oral treatment for rheumatoid arthritis has met key goals in two midstage studies by improving tender and swollen joints. While the drug is still years away from market, it could eventually become a key competitor to several blockbuster treatments. A key advantage would be that it is taken orally, instead of injected like current treatmentsmore

Oscient cutting way back – As part of a restructuring to conserve financial resources, the company said it will eliminate approximately 180 positions, including its 150-person sales force and approximately 30 additional sales, marketing and corporate positions, in the next month..more

Merck/Schering Plough: 16,000 job losses.

Ghostwriting: another way pharma has managed to erode public trust – Eli Lilly & Co. officials wrote medical journal studies about the antipsychotic Zyprexa and then asked doctors to put their names on the articles, a practice called “ghostwriting,” according to unsealed company files. Lilly employees also compiled a guide to hiring scientists to write favorable articles, complained to journal editors when publication was delayed and submitted rejected articles to other outlets, according to documents filed in drug-overpricing suits against the Indianapolis-based company, the largest manufacturer of psychiatric medicines. Drugmakers’ use of ghostwriters has created “a huge body of medical literature that society can’t trust,” said Carl Elliott, a University of Minnesota bioethicist who has written about the practicemore Withholding of clinical information isn’t too trust-building either, by the way. Or off-label marketing, for that matter.

Novartis - radically re-making its drug business (BusinessWeek article). And, also producing the first batch of H1N1 flu vaccine.

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Pfizer‘s Chantix still getting the slow-burn investigation by the regulators - Federal regulators are still investigating the safety of Pfizer’s anti-smoking drug Chantix, a probe that began last year after thousands of patients reported blackouts and other problemsmore Also, Pfizer at the forefront of the newest “Who wants to buy Elan??” rumors.

Merck‘s experimental Phase III heart failure drug is a…failure – Merck & Co., Inc. today said that preliminary results for the pivotal Phase III study of rolofylline (MK-7418), the Company’s investigational medicine for the treatment of acute heart failure, show that rolofylline did not meet the primary or secondary efficacy endpointsmore

The sniping begins even before GSK takes the wraps off its Avandia safety study. Not that the lawyer quoted has any ve$ted interest…it’ll be interesting to see what the data are, AND what real medical professionals have to say about the methodology and conclusions.

J&J can hardly wait to go after the premature ejaculation market – Johnson & Johnson will pursue U.S. approval for the world’s first pill to treat premature ejaculation after tests on 6,000 men showed it more than tripled the time before they reached climax. J&J will discuss approval with the Food and Drug Administration later this year, Joanne Waldstreicher, chief medical officer at the New Brunswick, New Jersey-based company, told investors and analysts today. The FDA rejected the drug in 2005. Since then, J&J has conducted three additional human trials, doubling the number of patients tested for safety and effectivenessmore

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