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Posts Tagged ‘FDA’

Pharma and biotech sales (and training) leaders, take note: the FDA is actively training doctors to sniff out your transgressions and turn you in.

The FDA has recently launched an e-learning course in order to educate the medical community on misleading drug promotions.

From the FDA’s press release: The FDA’s Office of Prescription Drug Promotion announced Monday the launch, with MedScape, of the e-learning course, which offers continuing education credits for healthcare professionals. The course is part of Bad Ad, a program designed in 2010 to raise awareness about misleading and untruthful drug ads. It’s aimed at healthcare professionals, but anyone can take it, the agency said. The office has developed several case studies based on warning letters the FDA has sent to drug companies, representing common problems.

You can launch the course here (anyone, in fact, can go through it). The screen shot below shows the structure of the course:

FDA course menu

Of particular interest is Module 5, where actors representing sales reps engage in questionable promotional practices to demonstrate violative sales tactics. This should be examined carefully by every commercial biopharma organization.

FDA Rep ecourse

Hat tip to Corey Nahman for the heads-up.

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TODAY’S NEWS

Why one hospital is restricting drug sales reps (news clip). Interesting perspectives on sampling.

Possible heart problem with HIV drug combo – The U.S. Food and Drug Administration said on Tuesday that HIV drugs Invirase and Norvir might lead to an abnormal heart rhythm when used in combination, according to preliminary data the agency is reviewingmore

Salix‘ antibiotic gets thumbs up from FDA panel – Salix Pharmaceuticals’ diarrhea drug Xifaxan should be cleared to treat patients with a debilitating liver disorder, but more study would still be needed after approval, a U.S. Food and Drug Administration advisory panel said on Tuesday. FDA’s outside advisers, in a 14-4 vote, said the antibiotic appeared to help patients with the liver condition, but that the company’s single clinical trial did not look at the sickest patients or follow subjects long enough given that the drug would be used until patients get a liver transplant or diemore

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From EyeonFDA blog – Is Congress the new FDA?

JUST FOR FUN

More Olympics goodies – the 20 Funniest Figure Skating Faces.

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TODAY’S NEWS

FDA warning letters to Lilly, Bayer, Amylin, Cephalon.

Wow: ARBs for hypertension reducing Alzheimer’s symptoms? – Drugs commonly used to lower blood pressure, sold by AstraZeneca Plc, Sanofi-Aventis SA and Merck & Co., may also reduce the risk of developing Alzheimer’s disease. Researchers from Boston University analyzed the medical records of more than 800,000 U.S. veterans and found those taking angiotensin receptor blockers were up to 24 percent less likely to develop dementia than patients on other medications. Patients already diagnosed with Alzheimer’s disease were half as likely to be admitted to a nursing home and had a 17 percent reduced risk of dying if they were taking the medicationsmore

FTC wants to put a stop to the “pay-to-delay” deals – Jon Leibowitz will hold a press conference today to ask Congress to include a provision in the health care reform bill to end deals in which brand-name drugmakers offer payments or other inducments to generic rivals to delay copycat versions of best-selling medsmore

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Social Media, Opportunity, and Serendipity – my guest post on the Hive Awards blog.

JUST FOR FUN

Visual awesomeness. Photo of Martian dune field. Quite spectacular!

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TODAY’S NEWS

FDA panel to Forest on new use for heart drug: thumbs down – Federal health advisers on Monday unanimously rejected a new use of Forest Laboratories’ hypertension drug for patients at risk of heart failure. The Food and Drug Administration’s outside panel of heart specialists voted 8-0 against approving Bystolic to prevent death or hospitalization caused by heart failure, according to an agency spokeswoman….more

Withdrawal rates, Oxycontin, and selective publication of details. Sigh, Purdue.

Vivus’ new erectile dysfunction drug: fast results – Vivus Inc. on Monday reported positive test results for its erectile dysfunctional drug candidate avanafil, saying most men who took the drug were able to have sex within 15 minutesmore

Vertex lost less than $650 million in 2009. Well, that’s a relief!

The Medicines Company cutting 10% of workforce. Ouch.

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$3M CME grant with NO strings attached? Wow (Pfizer-Stanford)!

JUST FOR FUN

Obnoxious guitar design. Really. Obnoxious.

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Pharma “e-stuff” has been on my mind lately, having recently attending the ePharma Summit in Philadelphia. Here are some random links that have surfaced which might be of interest to you:

Pfizer doing some interesting web 2.0 applications with “Pfizerpedia” – Karl Kapp‘s overview (with more helpful links); a .pdf case study; article from Information Week.

Manhattan Research on the use of Search all along the Treatment continuum. Linked from Fabio Gratton‘s blog.

On PharmaExec.com: The Future of Media and Social Influence Marketing.

Learn the Art of Communicating with People using social networks for Health and Wellness. From Fard Johnmar‘s blog (free report link). Also, from the same blog, Questions about the Effect of Physician Social Networks on prescribing patterns.

Activated Patients, and Why Pharma Should Care. From Pharma 2.0 blog.

From the Eye on FDA blog: Two More Pharmas jump into YouTube, and the federal government going big also into Web 2.0.

And, two items from Medical Marketing and Media:

Social media renders commercial model obsolete? Ummm, a little overstated there…!

Marketers should offer holistic solutions, not just drugs.

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The FDA gives a hint of hope for the long-delayed Eli Lilly/Daiichi Sankyo drug prasugrel. Burrow deep inside this 357-page FDA document just posted online, and you’ll find this jargony but significant sentence: The Division recommends approval of prasugrel for reduction of myocardial infarction in patients with ACS who are managed with PCI.

Glaxo the latest Big Pharma to announce major upcoming cutsBritish drugs company GlaxoSmithKline Plc.  is set to announce about 6,000 job losses when it posts results on Thursday, the Sunday Telegraph newspaper said. The cuts by Glaxo, the world’s second largest drugs company after U.S. group Pfizer, are part of Chief Executive Andrew Witty’s strategy to meet the challenges facing the industry, including increased competition from generic drug makers, the British newspaper said.

Teva gets FDA OK for generic version of J&J‘s Risperdal. And, Takeda gets approval for new GERD drug Kapidex.

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Will pharma sales forces drop (overall) by another 20% in the coming years? ZS Associates thinks yes. Interesting perspectives in this article.

FDA missing yet another drug review deadline (Takeda’s experimental gout drug). Question: if these pharma companies are paying additional fees to ensure that the FDA gives prompt reviews, why is there no accountability when FDA is chronically late?? Perhaps the FDA should undergo the sanctions that pharma companies receive for false claims…

DTC spending. Heading down.

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Roche‘s MabThera can help extend CLL patients’ lives. Meanwhile, surprisingly good results for AZ‘s lung cancer drug Iressa. But, disappointment for an experimental lung cancer drug being developed by Amgen and Takeda. And, Novartis‘ promising kidney cancer drug Afinitor gets the FDA delay treatment (fuller Novartis pipeline update here).

Glaxo gets U.S. approval for platelet drug Promacta.

Biotech bankruptcies looming?

AstraZenecacutting, selling, stopping.

More positive info for Takeda‘s experimental gout drug.

Can Pharma learn from the Detroit automaker situation? Some good thoughts here.

Generic coming? Let’s hike the price! – Cephalon has already taken heat for off-label promotion of its narcolepsy drug Provigil. Now, facing the prospect of generic competition to Provigil in 2012, the company is dramatically hiking Provigil’s price…more

Javelin tosses 15% – Javelin Pharmaceuticals, Inc., a leading developer of novel products for pain management, today announced that it will reduce its workforce by approximately 15 percent. The reduction is intended to reduce Javelins cost structure…more

Cancer drugs for diabetes? The mice say maybe… – Two popular leukemia drugs, Gleevec and Sutent, kept lab mice from developing type 1 diabetes and put 80 percent of diabetic mice in remission, an international team said on Monday…more

J&J patch leads to costly settlement.

Merck’s Gardasil promising in boys – Scientists are reporting at a scientific meeting in Nice, France, today that 90% fewer men ages 16 to 26 years developed genital warts and other lesions after receiving Gardasil…more

Pfizer: big bucks toward stem cells – Over the next five years, the drugmaker will create dual facilities in the UK and Massachusetts to use stem cells to treat heart disease, diabetes, cancer and vision loss common among the elderly. In doing so, Pfizer is touting that it becomes the first big pharma to have such a dedicated effort, which will include hiring 70 scientists to staff the labs…more

Beauty fillers, ugly side effects? – An ugly side of the beauty business emerged today, as an FDA briefing listed 930 reports of side effects for injectable wrinkle fillers such as Restylane and Juvederm…more

King’s new pain pill might make the grade – An FDA advisory committee determined that Remoxy is less susceptible to abuse than the notorious OxyContin, suggesting the pill will win FDA approval, Bloomberg News reports, although the committee did not take a formal vote…more

FDA to require meta-analyses of diabetes drugs.

More questions about Effient? – Researchers have overestimated the ability to the experimental drug without causing dangerous bleeding, according to a prominent cardiologist, Reuters writes. Prasugrel, you may recall, has twice been delayed by the FDA, which is reportedly set to hold an advisory meeting early next year…more

Major Amylin layoffs – The 25 percent staff reduction, which follows sluggish sales of its flagship Byetta diabetes med, is designed to save more than $100 million next year. After the dust clears, Amylin will have 1,800 employees…more

All right, what’s the big deal with the Crestor/Jupiter/cholesterol study? Some questions answered.

Did you know that the FDA gives drug review vouchers? Neither did I – Two months ago, a new program got under way in the US to promote the development of drugs for so-called neglected diseases that continue to plague the poorest nations. Here is the outline: a drugmaker that seeks approval of a drug to treat one of these infectious diseases gets a voucher, which awards an expedited FDA review of a new drug application for any other med…more

Amgen doing an “Obama” to market new drug? – Taking a leaf out of the marketing playbook of President-elect Barack Obama, biotechnology company Amgen Inc plans to make use of the Internet and social networking sites to market its drugs to consumers…more, plus another take here.

Merck: we still have heart – Merck wants the world to know that when it comes to developing new drugs for cardiovascular disease, the company is in the fight for the long haul…more

The cost of rep sales calls. Have a calculator handy. From John Mack’s Pharma Marketing blog.

I have some real problems with this. Brand-name drug manufacturers liable for generic injuries – A ruling on Friday by a California appeals court is likely to spark a good many lawsuits against big pharma. The upshot – brand-name drugmakers were put on notice that they can be held liable not only for harm caused by their own meds, but also for injuries caused by a generic drugmaker selling a copycat version…more

More doctors quitting.

This is really funny. From the Colbert Report, via PharmaGossip.

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Glaxo: more big cuts, and the U.S. HQ needle pointing south – GlaxoSmithKline (GSK) announced that it will reduce its sales personnel by 12% to 7,500 down from 8,500. The company will slash 1,800 jobs resulting in a total of 1,000 layoffs. Some positions have already been eliminated while other personnel will be reassigned to new areas. The company is also consolidating operations and moving personnel from its Philadelphia facility to Research Triangle Park in North Carolina, where it employs about 5,000 people…more

Gilead gets a boost from new HIV treatment guidelines – The DHHS named Gilead’s Truvada, a combination of the company’s HIV treatments Emtriva and Viread, the lone preferred regimen for previously untreated HIV patients. Gilead’s shares added 3.2% to $47.31 in regular trading…more

Genzyme pours serious cash into Osiris – Genzyme Corp. will pay Osiris Therapeutics Inc. as much as $1.38 billion to develop therapies that use stem cells to treat blood cancers, inflammation and joint damage. ..more

Amylin’s Byetta LAR gets extended delay for extended release – Shares of Amylin Pharmaceuticals have collapsed after it emerged that US regulators have rejected data for a once-weekly version of its diabetes drug Byetta…more

UCB gets OAB drug approval – UCB announced today that the U.S. Food and Drug Administration (FDA) has approved the anti-muscarinic agent Toviaz® (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency…more

What does Jupiter have to do with cholesterol treatments? A lot!

But will Winnie be used to sell obesity treatments? Pooh characters as Seroquel sales aids? Hmmm…

Cephalon’s Treanda gets another indication – on Friday received a second approval from the Food and Drug Administration for its cancer drug Treanda, this time as a treatment for patients with non-Hodgkins lymphoma (NHL)…more

CV Therapeutics’ Ranexa gets a first-line approval – CV Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved a new, first line indication for Ranexa® (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias including ventricular arrhythmias, new onset atrial fibrillation and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. In addition, the new labeling states that Ranexa reduces hemoglobin A1c (HbA1c) in patients with diabetes…more

Promising experimental Hep-C treatment in the Schering pipeline – results being reported.

Obesity drugs: everybody bails out – For those of you hoping that America’s obesity crisis could be solved with a pill, think again. Pfizer announced late Wednesday that it is scrapping its anti-fat drug, the as-yet unnamed “CP-945,598,” for essentially political reasons. Sanofi-Aventis today also announced that it was ending its trials on Acomplia/Zimulti, an obesity pill that was approved and then yanked in Europe. And Merck a couple of weeks ago pulled its fat pill taranabant, from its pipeline…more

Why did J&J consolidate its drug advertising biz between 2 big agency holding companies?

Big Pharma’s loss may be Little Pharma’s gain – as big drugmakers continue to trim jobs, smaller biopharmaceutical makers and specialty pharma are benefiting from the downsizing, according to David Poling, director of state business operations at Aerotek, a staffing firm…more

The 10 weirdest drug stories of the month.

First glimpse of the secrets of the cancer genome. Fascinating.

If you’re not up on the latest pharma/legal issue called pre-emption, you need to be. Go here for the latest.

Want even more news? Chris Truelove over at Pharmalive has a big roundup this week – lots of interesting tidbits and links..

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