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Archive for the ‘Avandia’ Category

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Had a great time last week at the SPBT conference. Planning to get out a summary post later this week…

TODAY’S NEWS:

Big news for Novartis: FDA panel unanimously recommends approval for oral MS drug – A Food and Drug Administration panel has unanimously backed the safety and effectiveness of Novartis’  multiple sclerosis treatment fingolimod. The panel voted 25-0 in support of fingolimod’s “substantial evidence of effectiveness” in treating patients with relapsing remitting multiple sclerosis. That makes it likely the drug will be the first oral MS treatment to gain FDA approval, beating Merck, Sanofi  and Teva – all of which are developing their own oral MS drugs – to the punchmore

Glaxo cuts 700 more sales/marketing positions – A Glaxo spokeswoman said 700 sales and marketing staffers (and related support staff) have taken buyout offers in recent months, while others’ jobs are being cut. She declined to give a total figure, but said the cuts are affecting “a variety of different positions in the U.S. pharma commercial staff.”more

Uncomfortable links being investigated – ARB high blood pressure drugs/cancer; Daiichi‘s Benicar and heart disease; troubling new data on GSK‘s Avandia and heart disease.

A “pill mill” in Kansas and multiple fatalities from the “lollipop of death.”

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Fresh from the tube this weekend: the first ever DTC commercial for medical devices?

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This may just be the most hideous website “designed” by man. Do not click with any consumables in your mouth…

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TODAY’S NEWS:

Could low-dose Avandia be useful in preventing diabetes onset? This would be good news for GSK GlaxoSmithKline Plc’s Avandia helped prevent the onset of diabetes when taken at a low dose with another drug, according to a company-sponsored study that suggests the regimen may help patients without raising heart attack risk. Half doses of Avandia and the therapy metformin, when combined, cut the risk of developing diabetes by two-thirds compared with placebo, Canadian researchers said..more

We’re in the gusher phase of the pre-ASCO press release flood. This sneak peek on BMS products is intriguing. More here – Four Scenarios for BMS.

Lying about data – people just don’t seem to learn. Sigh. And that goes for financial folks, politicians, climate scientists – it ain’t just pharma, folks!

Cephalon, Provigil and Nuvigil.

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New iPhone app released by Novartis subsidiary CibaVision. My “live” review while playing with it – mixed feelings. And, while we’re doing reviews – a north Jersey restaurant (Tabor Road Tavern) that blew me away.

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Who needs PSA tests for prostate cancer when you have Fido? What’s interesting is that this is – amusingly – serious!

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TODAY’S NEWS

Big news for Novartis on two fronts – Novartis has received a couple of pieces of good news from regulators in the USA this morning who have approved its meningococcal vaccine Menveo and granted a priority review for the Swiss major’s investigational oral treatment for multiple sclerosis fingolimod…more

Avandia – the bad news just won’t quit. The heart attack factor, and the when-did-they-not-share-what-info questions. And a call to just pull it from the market. A rough patch for GSK.

BI gets FDA approval for new Extended Release version of Mirapex (for Parkinson’s)

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From Wendy Blackburn: 7 things I Learned at the ePharma Summit. And, from Betsy Raymond StevensonCuring Pharma. Restoring the industry’s reputation will mean a lot of hard work, not just a PR campaign.

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NEWS

One of Eli Lilly‘s patents on Gemzar invalidated; may shave off 3 years of exclusivity – the method of use patent for its cancer drug Gemzar was invalidated by a federal court in Michigan, the drugmaker said today…more

Merck‘s Gardasil vaccine safe overall, though some questions about promotional practices – two researchers at Columbia College of Physicians and Surgeons reported that Merck wrongly got professional medical groups to help promote its vaccine through speakers who didn’t provide balanced recommendations concerning Gardasil’s risks and benefits…more

Canadian study: GSK‘s Avandia does have more heart risks than Takeda‘s Actos – Researchers analyzed prescription data for 39,736 patients ages 66 and older who were enrolled in the Ontario Public Drug Benefit Program and began taking Avandia or Actos from April 2002 to March 2008. During the six-year study, 6.9 percent of patients on Avandia died or were hospitalized for a heart attack or heart failure, compared with 5.3 percent of those on Actos…more

So – what about Key Account Management? Some thoughts from Pharmaceutical Executive.

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ePharma Review: My take on Novartis Oncology’s CML Earth. A very good start here for a social media platform; still room for improvement.

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Thought-provoking: People don’t Leave Organizations – They Leave Managers. AND – from my StickyFigure blog – Ask the Right Questions. Where you start determines where you end up…

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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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General news:

Approvals: Genzyme’s stem cell transplant drug Mozobil; Abbott‘s triglyceride drug TriLipix; Eisai‘s Lusedra for anesthesia.

Novartis‘ experimental MS drug (oral) looking really good compared to competition.

Wyeth and ghostwritten articles. This is going to be ugly – Wyeth paid a company to ghostwrite medical journal articles about its hormone therapy products and seek academic scientists to sign them as authors, a U.S. senator said. Documents from lawsuits suggest the drugmaker hired DesignWrite Inc. of Princeton, New Jersey, to draft manuscripts related to the Wyeth products and breast cancer risks, according to letters released today from Senator Charles Grassley of Iowa to the companies. Wyeth makes the hormone replacement drugs Prempro and Premarin…more

Roche CEO to other pharma/biotech companies: Let’s get gloomy.

More trouble for Elan/Biogen’s Tysabri – Yet again, the multiple-sclerosis medication has caused a serious brain infection, the same malady that prompted the drug to be withdrawn in 2005 for about a year. A German MS patient contracted PML, or progressive multifocal leukoencephalopthy, and remains hospitalized…more When you look at the numbers, however, it’s still a pretty small incidence. My question – if it weren’t an exotic brain infection, would this get so much press attention??

Would you like some Ritalin with that syllabus? – “We should welcome new methods of improving our brain function,” they write. “In a world in which human workspans and lifespans are increasing, cognitive enhancement tools – including the pharmacological – will be increasingly useful for improved quality of life and extended work productivity, as well as to stave off normal and pathological age-related cognitive declines. Safe and effective cognitive enhancers will benefit both the individual and society.” more

Newer antipsychotics: much ado about nothing? – The common distinction between first- and second-generation antipsychotics has no scientific basis and should be dropped, according to a paper in The Lancet. A meta-analysis of 150 double-blind studies found little evidence that newer, so-called atypical antipsychotics are more effective than older drugs for symptoms of schizophrenia, MedPage Today writes…more

Choose your friends wisely-and happily – Researchers looked at the social networks of more than 4,700 people whose happiness, along with other factors, had been tracked for 20 years. Those surrounded by cheery souls were more likely to have sunny dispositions, even if they didn’t known them…more

KV Pharma CEO: walked out or booted out? – This is one for the gossips. Marc Hermelin, the KV Pharmaceuticals ceo, is leaving under what could be politely called disputed circumstances. The drugmaker says he was fired, but Hermelin issued his own statement that he informed the board earlier this week that he is simply retiring, according to reports…more

J&J loses another Duragesic patch verdict, to the tune of $16.5M

Malaria vaccine one step closer – Two papers published in The New England Journal of Medicine are reporting the success of a pair of new vaccines tested in children in Africa. And experts say the results may open the door to sweeping trials of the vaccines in seven African nations by early 2009 and a completed formulation ready for approval by 2011. “We are,” Christian Loucq, director of the PATH Malaria Vaccine Initiative, tells Time, “one step closer to the day when malaria will join diseases like smallpox and polio.”  more

ImClone to cut field sales force by almost half, following acquisition by Eli Lilly.

Two blows to Avandia, one to Actos. Increased death risk: Avandia. Increased fracture risk among women: Both.

Using nicotine as a cure? Nope.

A summary of “where we’re at” with MS drugs, from PharmExec.com.

Fewer sales reps? Docs are OK with that. And here’s a 33-company list of where the jobs ain’t (recent layoffs). Ouch.

PhRMA’s beefed up drug advertising guidelines. As the pirate says, “these are more like guidelines…”

AstraZeneca‘s Symbicort cleared by FDA panel for asthma.

Top 50 Health 2.0 blogs.

Last week was ASH (American Society of Hematology) week, so we’ll feature a number of news items about blood diseases and treatments…

Encouraging blood platelet boost seen with Glaxo’s oral drug Promacta – Patients treated with GlaxoSmithKline PLC’s Promacta rather than a placebo were eight times more likely to have sustained increases in platelet counts, according to pivotal trial results announced by the company on Saturday…more

Zevalin – effective. You’ll have to flounder through all the technical terms to grasp the details!

Encouraging CLL treatment results with Celgene’s Revlimid in older patients.

Treanda may get to first-line treatment – Cephalon Inc’s Treanda was as effective in treating non-Hodgkin’s lymphoma as the standard chemotherapy regimen with far less toxicity, according to interim analysis of a late-stage study that could pave the way for the drug’s use as an initial treatment for the disease…more

Allos experimental drug for lymphoma shows strong results – Allos Therapeutics Inc said on Saturday a small, but potentially pivotal, trial of its experimental drug pralatrexate found it helped curb cancer in 27 percent of patients with an aggressive type of lymphoma…more

Efficacy of long-term treatment with Novartis’ Glivec/Gleevecawesome. And good stuff with Tasigna in CML patients also. Staying with Novartis, results reported for its oral iron-reducing drug Exjade.

Rituxan + chemo for leukemia: yep. – A combination of Genentech Inc’s cancer drug Rituxan and chemotherapy reduces by 41 percent the risk of death or cancer progression, compared with chemotherapy alone, for patients with a common form of leukemia, the company said on Saturday…more

The coming clot-busters.

On the breast cancer front:

Zometa: tumor shrinker – the osteoporosis drug zoledronic acid (Zometa) appears to shrink breast tumors in patients who undergo chemotherapy. The drug is already approved to treat breast cancer that has spread to the bone and, earlier this year, was reported to lower the risk of breast cancer recurrence in pre-menopausal women with early estrogen- or progesterone-positive tumors…more

Tykerb + Femara = survival benefit.

Hormone replacement pills: not good news – Taking the hormones for five years doubles the risk for breast cancer, according to a new analysis of the Women’s Health Initiative, a large federal study, revealing the most dramatic evidence yet of the dangers of the popular pills..more

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The connection between high cholesterol and risk of stroke is questioned.

Is Avandia contributing to bone breakage? And more bad news for the GSK diabetes treatment…two healthcare providers drop the medication from their formularies. For switcheroos, it appears that most doctors are leaning toward Januvia or Byetta.

Long-ish article from Business Week on Genentech‘s current and future status. And, here is one doctor’s summary about why he voted “nay” on the FDA panel considering Avastin for breast cancer.

Novartis has plans for 4 more cancer drugs.

Certain lymphoma drugs may be derailed based on this Medicare decision.

Teva‘s Copaxone may actually cut the risk of developing MS.

An interesting perspective from Derek Lowe on why it’s not all bad that companies developing competing drugs in the same class.

An update on the status of eDetailing.

Here’s a fascinating finding – does body temperature (specifically, a fever) unlock the effects of autism??

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