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Posts Tagged ‘Genzyme’

Pay-for-Fail

Finally, after a long (and at times contentious) set of turns around the dance floor, Sanofi and Genzyme have agreed to merge.

The big winner? Henri Termeer, who presided over the decline and now sale of Genzyme. A nice $160 million reward for…..what? Certainly not success.

I’m an unabashed capitalist. But this is yet another in a long string of Board-of-Director-abdications-of-responsibility that give pharmaceutical companies (and plenty of companies in other industries) a bad name.

Nobody should get a package anything like this. And, if a top leader does earn (note the word: EARN) a rich payout at the end of his/her tenure, it should be tied to metrics of growth that have clearly rewarded the shareholders, employees, and patients first. If you run a company into the ground, you should be run out on a rail, not driven out in a stretch limo with a bursting bank account.

It’s enough to make you need an anti-emetic.

Yes, the pharmaceutical industry has a P.R. problem. But this type of fiscal irresponsibility is a self-inflicted wound. I can hardly blame a CEO for taking the money and running. But shareholders need to revolt against directors who approve packages like this, and put them out to pasture ASAP. It’s an embarrassment and a travesty.

Pay-for-Performance – let’s start right at the top and then work our way down, shall we??

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TODAY’S NEWS:

Very big news for Vertex75% of hepatitis C patients never treated before achieved a viral cure after receiving a 12-week course of the company’s experimental drug telaprevir plus the current standard of care, according to results from a phase III studymore

Genzyme’s Pompe remedy approved by FDA; meanwhile, more detail on their consent decree.

More on alleged Wyeth tactics to promote Rapamune off-label. If true, yuck! Gold-in Rule at work.

Connecticut passes new pharma ethics code.

Part 2 of my interview over at MessagingLab blog (by Karl Schmieder): Pharma, Social Media, and the FDA.

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Social Media in Pharma stuff today: An “Ultimate Guide to Facebook“, from our friends over at Pixels and Pills. And, reporting adverse events on social media. More? Sure – comparing how pharma companies are using social media currently (from @healthcarengage). Even more? OK, you asked for it – Social Media and Celebrities in pharma (from John Mack’s blog)

JUST FOR FUN

Examples of Lightning Photography. Stunningly beautiful.

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TODAY’S NEWS:

Watson gets FDA approval to start shipping generic Valtrex.

Novartis oral MS drug – FDA extends review another 3 months – Novartis will have to wait a bit longer in its bid to get the first oral treatment for multiple sclerosis on the market after regulators in the USA put back a review of Gilenia. The US Food and Drug Administration has extended by three months, to September, its review period for Gilenia (fingolimod), previously known as FTY720more

Genzyme: Big fine, big changes to get manufacturing back under control.

Another day, another whistleblower suit comes to light. This time, Wyeth and Rapamune promotion for unapproved uses.

Layoffs at Quintiles.

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The Three “I’s” of Tomorrow’s Successful Company. An important perspective from Dennis Urbaniak (VP U.S. Diabetes, Sanofi-Aventis). Titles, Budgets, and Staff are out – Ideas, Initiative, and Inspiration are in.

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50 Beautiful Examples of Architecture Photography.———-

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TODAY’S NEWS

Novartis announces a major US reorganization, including re-aligned business units, and cuts. Ouch.

Crystal ball – what will be the biggest drug(s) in 2014? Here are some educated guesses.

Use Remicade early in Crohn’s, the results say – “The results are pretty definitive,” Sandborn told MedPage Today. “Most patients should receive infliximab combination therapy as the most effective strategy.“…more

Genzyme‘s Campath for MS:  preliminary data look quite promising – Data presented on Wednesday at the annual meeting of the American Academy of Neurology showed that after four years, 71 percent of patients had no relapse or worsening of disability. That compares with 35 percent for patients taking Rebif, a rival drug made by EMD Serono, an affiliate of Germany’s Merck KGaA and Pfizer Incmore

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I’m Restless – how about you?

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Come out of your shell. Cool photos – just trust me and look.

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TODAY’S NEWS

What about those bone fracture risks with biophosphonate drugs? The jury is still out – A new study gives reassuring news about the safety of Fosamax and Reclast, bone-building drugs taken by millions of American women. It found that long-term use does not significantly raise the risk of a rare type of fracture near the hipmore

Monthly hepatitis C treatment looking promising – Human Genome Sciences Inc. said Wednesday a midstage study of the potential hepatitis C treatment Zalbin showed a monthly dose of the drug candidate could be as effective as a weekly dose of the standard treatment. The Rockville, Md., company said interim results from the study support evaluation of the monthly dose in a bigger, late-stage trial. The midstage study was conducted by Novartis, which is developing the drug with Human Genome Sciences. It combined the drug with ribavirin in 391 patients with forms of chronic hepatitis Cmore

Massive Multaq Mess Might Mean Major Meltdown – The scale of Sanofi-Aventis (SNY)’s Multaq mess is starting to become apparent: The heart drug, hailed by the company as a €1 billion-plus blockbuster prior to its launch, may miss Wall Street sales estimates by as much as €1.3 billion, according to analysts at Jefferies International. When investors wake up and downgrade their expectations for the atrial fibrillation drug, Sanofi’s stock may suffer, they say…more

Genzyme - feeling fines.

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Another reason to like Gilead Sciences (besides the fact that they have the best logo in the industry) – they actually have a rational pay plan for their top executive. What would it look like if pharma upper executive pay were based on annual performance for these measures: Profitability ratio (earnings vs. # of employees – something Gilead excels at, by the way); company share increase over a 3-year running average; and regulatory compliance? We might then see real pay-for-performance!

JUST FOR FUN

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TODAY’S NEWS

So, have we been pursuing the wrong course for GERD all this time? Is it actually caused by immune system cells, not stomach acid?

Maybe cheap/old/tried-and-true really is better. Diuretics for HPB, for instance. Or just plain generic simvastatin for cholesterol.

Pfizer gets good news on Revatio (which is the same as Viagra, by the way) for the treatment of PAH; Spiriva for COPD; and the Prevnar 13 vaccine.

Genzyme: Train wreck?. But wait – there’s more.

Getting excited about sex: not so easy to be excited about B-I‘s experimental treatment for female desire; Vivus‘ competitor to current ED drugs still on track, however.

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Blind Spots and Broken Limbs. I’ve got them, too…

JUST FOR FUN

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Solvay shopping its drug business. Belgian conglomerate Solvay is eying an exit of the drug business with a sale of its pharmaceutical division that could be worth upwards of €5 billion, or $6.6 billion. Solvay didn’t go into details about why it might give up its fastest-growing and most profitable division. But after talk of a deal involving Solvay, the company issued a statement Wednesday saying it was exploring “various options for its pharmaceutical activities,” and that this review involves “discussions with third parties.”

Watson wins an important round with J&J on Concerta going generic.

Genzyme takes over rights to MS and Oncology drugs from Bayer HealthCare - Genzyme has scooped up key worldwide rights to the leukemia drug Campath–which is being studied as a treatment for MS–and two cancer therapies from its development partner Bayer HealthCare in a deal with a potential $2.8 billion payout.

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The pre-emption ruling (Wyeth vs Levine) just handed down by the Supreme Court is huge for the pharma industry. And for lawyers. Get some background here and here.

Genzyme gets bad news about drug delay; then gets pounded for withholding the bad news.

Pfizer‘s anti-smoking drug Chantix may also reduce the desire for alcohol.

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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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Sanofi-Aventis suspends sale of Acomplia in Europe. Acomplia, an obesity drug that once looked like it would be a blockbuster for Sanofi-Aventis, is being pulled off the market in Europe. The EMEA, the European version of the FDA, said today that a key committee “concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union.”…more

Jim Edwards summarizes what he calls Pfizer‘s Race to the Bottom. With some similar commentary on Novartis‘ growth/shrinkage.

Merck announces more big cuts – As part of its earnings announcement, the drugmaker says it expects to eliminate approximately 7,200 positions – 6,800 active employees and 400 vacancies – across all areas of the company worldwide by the end of 2011, with about 40 percent of the total reductions coming in the US (see statement). This amounts to 12 percent of the workforce…more

Pfizer’s Chantix: going down…or up, depending on which continent you’re on…US researchers say even more warnings needed.

FDA: Another day, another stall – U.S. regulators have extended by three months their review of a proposed osteoporosis drug from Pfizer Inc to study the pill in more depth, a company spokeswoman said on Tuesday…more And, while we’re at it, a thumbs down (for now) for Abbott‘s new version of Vicodin. Oh, and hey, let’s delay Abbott’s new cholesterol drug while we’re in foot-dragging mode!

Novartis buys up Nektar’s pulmonary business – Nektar Therapeutics  today announced that Novartis AG has agreed to acquire from Nektar specific pulmonary delivery assets, technology, and intellectual property for $115 million in cash…more

Will BMS lead the charge in buying up undervalued biotechs?

Earnings roundup for Schering, Pfizer, Roche - here’s the scoop.

What about Amgen’s growth? An interesting analysis here. Plus – how 6 pharma companies have dodged (or not) the current financial crisis (extracts from earnings announcements from Pfizer, Bayer, Abbott Labs, Gilead, Wyeth and Genentech, all on the topic of how each company has fared in the crisis.)

Celgene seems to be doing quite OK.

J&J’s HIV drug gets expanded approval – U.S. health regulators have expanded approval for Johnson & Johnson’s Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday…more

Avastin: what doesn’t this drug do? - After tagging the antibody drug with a radioactive tracer and injecting it into mice, researchers found it successfully targeted cancer cells and this enabled them to produce well-defined images of tumours during scanning…more

Speaking of which, does leukemia drug Campath help stop early stage MS? Fascinating possibility – A drug developed to fight leukemia appears to stop multiple sclerosis in its early stages and restore lost function to patients, British researchers said on Wednesday…more

Forest Labs growing green – Forest Laboratories Inc posted higher-than-expected quarterly profit on Tuesday, fueled by stronger sales of its drugs for Alzheimer’s disease and depression and lower research spending…more

Biologics and safety concerns: really not a big surprise here – Approximately one in four biologics approved since 1995 in the US and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a Black Box warning, according to a study in the Journal of the American Medical Association…more

Take a Chill, Pill: are oral cancer drugs all they’re cracked up to be?

B-I has some encouraging potential early results for novel cancer drugs.

The WSJ talks about healthcare, IT, and the future. Interesting stuff.

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