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Posts Tagged ‘Celgene’

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TODAY’S NEWS

Hugely encouraging results for Novartis‘ new experimental (oral) MS treatment – Novartis’ Gilena has delivered an impressive performance in a Phase III trial in patients multiple sclerosis, cutting relapse rates by 62% in treatment-naïve patients and sustaining its effects for more than two years. Importantly, data from the two-year FREEDOMS study, presented at the American Academy of Neurology annual meeting, also showed that relapse rates were reduced by a significant 44% in patients who had previously been treated with other drugs for MS, highlighting the potential benefit of switching therapiesmore

Gilead starts late stage testing of “4-in-1″ HIV pill.

An interesting account of regulatory “unintended consequences.” How to make a cheap drug very expensive.

Cephalon hopes to gain more cheddar by adding some Swiss. Sorry – couldn’t resist…

Celgene: the new “big kid” on the block.

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Coaching Skills – The Impactiviti Partner Network is your resource if you’re looking to improve the coaching skills of your employees.  Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

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An amusing patient health video made by J&J. Well worth 4 minutes of your time. The Appointment.

JUST FOR FUN

Oldie but goodie from The Onion – American to start charging fees to Non-passengers.

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Coming up on May 11th: BDI’s Social Communications & Healthcare event – half day session in NYC with Case Studies and Roundtables (I’ll be leading one of the roundtables). Top speakers from J&J, Pfizer, and more! These are always great networking and learning events. Hope to see you there!

For more information, including registration, please click here to visit the event website. Use promo code IMPACT for a discounted rate of $155.

TODAY’S NEWS

In Celgene‘s pipeline – a promising oral RA (Rheumatoid Arthritis) treatment – Celgene Corp. believes sales of lead development candidate Apremilast will be $2 billion to $3 billion a year in psoriasis and psoriatic arthritis. The drug, which would compete with some of the world’s biggest selling therapies, is expected to enter late-stage trials this year and could be launched in 2014 or 2015, the company said. The projection came during the Summit, N.J., drug maker’s research and development presentation in New York Thursdaymore But, not such good news about low-dose aspirin as a RA preventative.

Oh, by the way – there were a few suicides, too. How not to get approval for Daxas (Forest Labs).

The arguments begin the Novartis discrimination lawsuit. How many isolated incidents indicate a systemic problem? This one’s going to get sticky…

Letting Go. A challenge to think differently.

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Diversity/Ethics training– We can recommend best-in-class partners and programs for your needs.  Contact us (stevew at impactiviti dot com, or phone at 973-947-7429) for recommendations.

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“Compulsive Generosity” due to Parkinson’s Rx – an embezzler gets off with an imaginative “the drug made me do it” plea. Ludicrous.

JUST FOR FUN

The Enlightened Stupid Marketer. 3 1/2 minutes of fun with Kevin Nalts.

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Sign up for the Impactiviti Connection twice-monthly e-newsletter (see sample)

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Ahhh, the politics of drug approval processes. Some sniping going on about who was and wasn’t included in the FDA review panel for prasugrel. No matter what choices you make, somebody’s going to paint a bulls-eye on your back. Just sayin’…

Promising new treatment for MDS (Celgene‘s Vidaza) – A new drug sharply improves the survival rate of patients with a bone-marrow disorder that often develops into acute myeloid leukaemia (AML), according to a study released Wednesday. Up until now, there has been no known treatment for the disorder — called myelodysplastic syndrome (MDS) — besides bone-marrow transplant, which is suitable for only a small percentage of patients.

Merck and Novartis vie worldwide for top sales force honorsNew TNS Healthcare research shows that physicians in four out of the five major European countries — the UK, Germany, Spain and Italy — give Novartis top marks for effectively delivering key sales and service activities. Merck takes the top spot in the US and ties with Novartis in the UK and Germany. In 2008, Merck and Novartis tied for the top spot in the US, with the highest ratings across all service activities. This year, Merck pulls ahead in the US, with stronger ratings for both its Web-based physician services and its patient information programs.

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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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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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