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Posts Tagged ‘Gleevec’

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Impactiviti Daily will not be published next week, as I will be attending the annual Society of Pharmaceutical and Biotech Trainers conference (SPBT) in Orlando.

TODAY’S NEWS:

As the pre-ASCO news heats up, the big headline will be leukemia treatments – specifically, BMS‘ Sprycel and Novartis‘ Gleevec and Tasigna (just inTasigna shown superior to Gleevec in slowing CML: 18-month results). Treatments in this class, by the way, are something near miracle drugs. They’ve totally revolutionized blood cancer treatments. In related news, Novartis’ Afinitor (approved for kidney cancer) meets goals in a trial for pancreatic cancer.

Why should you be interested in a “nanosponge”? Well, there’s this – Scientists have found that a delivery system based on a technique called nanosponge is three to five times more effective at reducing tumor growth than direct injectionmore

Will Amgen‘s new osteoporosis drug Prolia find its true home in oncology treatment? - The company has also applied for FDA approval to market the drug to breast cancer and prostate cancer patients who are undergoing a hormone treatment that weakens their bones. What’s more, the company is conducting tests designed to show that Prolia prevents cancer from spreading to the bones — an indication that could push sales of the drug to as much as $6 billion annually, some analysts predictmore Also – huge sales force push for Prolia.

20% of high school students abuse prescription drugs. Wow – sobering.

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How to reduce e-mail ping-pong. You know all that back-and-forth? Here’s a way to undercut it at the start!

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See-through animals. Ten of them. Amazing.

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TODAY’S NEWS

A rough patch for J&Joff-label Topomax promotion; Corporate Integrity Agreement (CIA) means “ride-alongs”; OTC product recalls. Ouch.

Glaxo and Novartis dinged by FDA for potentially misleading promotions. More here on the Novartis situation, which involves Gleevec websites.

Intermune gets major setback for lung treatment – InterMune took its best case for pirfenidone to the FDA, and lost. The agency ruled Tuesday afternoon that the developer would need to mount a new clinical trial for the drug before it could provide a green light for marketingmore

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Moving Beyond Blue – my review of a book by an individual struggling with depression, OCD, anxiety, and more.

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Gorgeous pictures of railway bridges. Lots of ‘em!

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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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Cymbalta approved for Fibromyalgia – The U.S. Food and Drug Administration (FDA) has approved Cymbalta® (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company announced today…more

Takeda’s Actos may help prevent diabetes – Actos, a pill to treat diabetes, can prevent development of the disease in people with early symptoms, U.S. researchers reported…more

Amylin’s once-weekly Byetta looks promising for lowering blood sugar – Amylin Pharmaceuticals Inc said on Monday that a once-weekly version of its Byetta type 2 diabetes medicine led to additional improvements in blood sugar levels over the currently available drug that must be injected twice a day…more However, their stock was pounded after many positive news reports of competitive drugs.

Ranbaxy up for grabsDaiichi makes bid. Also, strikes deal with Pfizer over generic Lipitor.

Elan/Wyeth experimental Alzheimer’s drug continues to progress in clinical trials – A closely watched Phase II study of an experimental Alzheimier’s drug being developed by Elan and Wyeth shows the med appears to be effective in some patients. Known as bapineuzumab, the drug failed to achieve statistically significant results in the primary outcomes, but managed to do so in subgroups lacking a higher genetic risk to develop the disease…more

J&J, Red Cross, call it quits on legal fight – The lawsuits had an absurdist, has-it-really-come-to-this quality about them. Johnson & Johnson and the Red Cross — Band-Aids and baby powder, blood drives and disaster relief — were suing each other over the rights to the red cross emblem that both had long shared. Now, after getting most of its suit against the Red Cross tossed out by a judge, Johnson & Johnson has picked up its legal toys and gone home. The company said today that it is dismissing its remaining claims against the august nonprofit. And the Red Cross, for its part, threw out its counterclaims against J&J. The companies’ statement is online here more

FDA and Genentech in a staredown – Last year, Genentech caused a ruckus by restricting distribution of its Avastin med to compounding pharmacies, which were repackaging and selling the drug to opthalmologists for treating wet macular degeneration. Unlike Avastin, Genentech’s similar, but newer Lucentis was approved to treat the malady, but at $2,000 a dose will cost about 40 times as much…more

Cancer drug Gleevec may help with strokes? Very cool – A highly effective leukemia pill may reduce complications and boost the effectiveness of a treatment for the most common type of stroke, an international team of researchers said on Sunday. Studies in mice showed giving Gleevec or imatinib, a drug made by Novartis AG, significantly reduced bleeding in the brain associated with the clot-busting drug known as tissue plasminogen activator or tPA…more

Millennium/Takeda’s Velcade gets expanded approval – Takeda Pharmaceutical Co, Japan’s largest drugmaker, won U.S. approval to promote its cancer drug Velcade for earlier treatment of multiple myeloma, the company said on Friday…more

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Some interesting oncology results:

Millennium‘s Velcade used in combo therapy for multiple myeloma shows impressive results.

Cephalon‘s Treanda shows impressive remission numbers for CLL, and effectiveness in non-Hodgins lymphoma (NHL).

Celgene‘s Revlimid continues to produce good results at a low-dose regimen.

Novartis‘ Gleevec: effective at halting leukemia progression up to 6 years.

Eisai decides to grab MGI Pharma, and its stable of oncology drugs.

Biogen-Idec‘s Zevalin, a radioimmunotherapy agent, halted NHL progression in 76% of patients (single treatment!).

AZ’s Arimidex shown superior to tamoxifen for breast cancer, even 4 years after treatment.

GSK‘s Tykerb helps fight brain tumors in combo with Xeloda.

And, on the bleeding edge:

Prasugrel (new blood thinning treatment from Daiichi-Sankyo and Lilly) continues to show promise – and some mixed results in certain populations.

Glaxo‘s experimental platelet booster shows efficacy in long-term treatment (Glaxo also announced new deals with 2 biotechs). However, GSK is now hit with a delay on its Cervarix vaccine.

Bayer and J&J’s experimental blood thinner takes on market-leader Lovenox in blood clot prevention study.

WSJ has summary article on the blood thinner race to market.

And, in other news:

Novartis the latest to announce major job cuts.

Merck still developing obesity and cholesterol drugs.

FDA approves new blood pressure drug from Mylan/Forest.

Lilly CEO to retire.

Changing endpoints…a clinical study no-no. WSJ has the story, on a long-delayed Vytorin study.

Is Alzheimer’s a form of diabetes? Very intriguing line of research…

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