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Posts Tagged ‘Genentech’

Welcome back! First, a couple of links of interest to kick off the new year:

:: Are Walnuts now Drugs? Ask the FDA! (Nanny state alert)

:: Made-up Disease (YouTube)

UPDATE: Some more jobs that have been posted in the past week or so, in addition to the original list!

Director, Global Training and Development, Customer Management, J&J (NJ)

Sales Trainer, Stryker, NJ

Manager, Sales Training and Development, Eisai (NJ)

Manager, Sales Training, Aptalis (NJ)

Director/Sr Director, Commercial Training and Development, Regeneron (NY)

Dir, Global Sales Training and Development, Alexion (CT)

Sales Training and Program MgrBecton, Dickinson (Baltimore)

Assistant Skills Development, Sales and Marketing Director, Astellas (Chicago)

Dir, Sr Global Quality and Compliance Training, Allergan (CA)

It’s been a rough year for trainers, but it seems like the job opening spigot is beginning to open as we approach the end of 2011.

Here’s a list of some fresh opening for you to explore (Impactiviti has no further information or “inside track” on these listings – they’re posted here as a service to the Impactiviti network):

Training Manager, Specialty Products, Eisai (NJ)

Sales Training Specialist, Otsuka (NJ)

Associate Sales Training Director, Shire (PA)

Associate Director, Managed Markets Training, B-I (CT)

Assistant Director, Oncology Sales Training, Astellas (Chicago)

Corporate Medical Sales Trainer, Recruiter (Chicago)

National Sales Training Manager, Allergan (CA)

Director, Sales Training and Development, Somaxon (CA)

Brand Trainer, Genentech (CA)

Sales Training Consultant, Avanir (CA)

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TODAY’S NEWS

Delay on inhaled insulin – a case of FDA “ooops”??

Roches‘s Actemra (RA treatment) approved by FDA – The Food and Drug Administration cleared the medicine, Actemra, in adults with moderate to severe rheumatoid arthritis, the Swiss drugmaker said today in a statement released by its South San Francisco, California-based Genentech unit. The FDA delayed approval in 2008 after the drug was backed by the agency’s outside advisersmore

All that hubbub from the story about how well anti-depressants really work: this is a pretty telling paragraph from the NY Times – That story begins to take shape when you consider what the new study actually said: Antidepressants do work for very severely depressed people, as well as for those whose mild depression is chronic. However, the researchers found, the pills don’t work for people who aren’t really depressed — people with short-term, minor depression whose problems tend to get better on their own. For many of them, it’s often been observed, merely participating in a drug trial (with its accompanying conversation, education and emphasis on self-care) can be anti-depressant enoughmore

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JUST FOR FUN

A classic: The Saturday Night Live “Chicken of the Sea” skit.

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Merck has laid off 750 sales reps so far this year. Ouch.

Genentech to Roche: No. Again (translation: move us from “no” with “dough”…)

Endo brings Indevus into the fold.

PLUS – who is actively involved in social media in pharma? I’m assembling a growing list…here’s what we have so far on this expanding community.

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Genentech‘s Raptiva: TroubleThe FDA said today that patients taking the Genentech drug Raptiva are at risk of developing a potentially fatal condition known as PML, or progressive multifocal leukoencephalopathy. The drug’s label already carried a warning about this possibility. But last week, Genentech sent a letter to alert doctors that a third case of PML had been confirmed in a Raptiva patient, following two other cases reported last fall. Meanwhile, Roche still raising cash to try to take over Genentech.

U.S. government joins in on whistleblower suit against J&J biz unit SciosThe U.S. government is joining two lawsuits against Johnson & Johnson and its Scios unit, accusing the companies of promoting heart failure drug Natrecor for unapproved uses, the Department of Justice said on Thursday. The drug is approved to treat patients with acutely decompensated congestive heart failure who experience shortness of breath. But DOJ officials said in a statement their investigation found Scios aggressively began marketing the drug to patients with less severe heart failure soon after its approval in 2001.

Crestor cuts stroke risk in half (Jupiter study) – A new analysis from the JUPITER study presented today at the International Stroke Conference (ISC) in San Diego, California describes details of the stroke data according to gender, ethnicity and baseline risk factors. This data adds to the primary analysis of the JUPITER study which demonstrated that CRESTOR® (rosuvastatin calcium) 20mg significantly reduced the risk of stroke by nearly half (48%; p=0.002), compared to placebo among men and women with elevated high-sensitivity C-reactive protein (hsCRP) but low to normal cholesterol levels.

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The cuts continue – this time it’s AstraZeneca. U.K.-based drugmaker AstraZeneca PLC (AZN) Thursday forecast flat 2009 sales and unveiled plans to cut a further 7,400 jobs worldwide by 2013, while posting a 1.4% decline in fourth-quarter net profit.

Roche goes hostile in bid for Genentech. Roche cut the price of its bid for outstanding shares in Genentech, going hostile and dashing investor hopes of a sweetened offer for the 44 percent of the U.S. biotech group its does not already own. Roche Holding AG’s new and lower offer, pitched directly to shareholders, was a surprise and reflected tougher financing conditions and a drop in Genentech Inc shares, analysts said on Friday.

Glaxo pays out big over marketing probe. GlaxoSmithKline is the latest drugmaker to pay the price for a government investigation of off-label marketing. The company said it’s taking a $400 million hit over a Justice Department investigation of the way Glaxo marketed top drugs.

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FDA approves sharing unapproved drug uses with doctors. “The public health may be advanced by healthcare professionals’ receipt of medical journal articles … on unapproved new uses,” the agency states. Such uses may even “constitute a medically recognized standard of care,” according to the agency.

The Medicines Company to acquire TargantaTarganta’s lead product, oritavancin, is an innovative antibiotic with potent bactericidal (killing) activity against a broad range of gram-positive bacteria including staphylococcal strains with resistance to methicillin (MRSA) and vancomycin.

Roche to up the bid for GenentechGenentech stock rose from around $84 to around $86 on news that Roche is indeed going ahead with its bid to acquire the company. The FT reports Roche is look at $95 a share for the 44 percent of the company that it does not yet own. The timing of the bid will before early February…

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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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Is Eli Lilly the “mystery suitor” for ImClone? - Eli Lilly & Co. is in advanced talks to buy cancer-drug developer ImClone Systems for $70 a share, or $6.1 billion, The Wall Street Journal reported on Thursday, citing people familiar with the matter…more And why the big interest in ImClone? Business Week says “it’s the pipeline.”

Prasugrel delayed…again – Once again, the FDA has delayed its approval of prasugrel, a blood thinner that Lilly and its partner, Daiichi Sankyo, have been hoping will one day compete against Plavix, which is marketed by Bristol-Myers Squibb and Sanofi-Aventis…more

Judge: Amgen yes, Roche no – A federal judge in Boston ruled the drugmaker infringed on Amgen’s patents with its Mircera anemia med, essentially upholding a preliminary decision issued in February. The order by US District Court Judge William Young deals a big setback to Roche, which already cut costs after its plans to market Mircera flopped…more

Credit crunch? Roche says, nah…we still want Genentech – The market isn’t so sure Roche can raise the money to buy Genentech, but Roche seems pretty confident…more

Encouraging data for Pfizer’s HIV drug – The Pfizer Inc. AIDS drug maraviroc helps thwart the HIV virus in nearly half of people who have developed resistance to other treatments, according to two related studies published on Wednesday…more

Pfizer bailing out of some therapeutic areas for drug development – Pfizer Inc  will drop efforts to develop medicines for heart disease, as part of a reshuffling of its research activities that the pharmaceutical giant plans to announce on Tuesday, according to a Wall Street Journal report. Pfizer also is expected to announce it will abandon therapies for obesity and bone health to focus on more lucrative areas such as cancer and Alzheimer’s disease, WSJ said on its online site…more More here from Forbes

The Pfizer pipeline: current status - Even as Pfizer is bailing out of drug research for heart disease, the company’s late-stage pipeline has increased to 25 projects from 16 in the past six months…more

A potential Viagra competitor derived from a plant with…well, a pretty bizarre name!

Merck drops experimental weight-loss pill – The drugmaker made the decision after spending months reviewing trials showing the taranabant obesity pill caused psychiatric side effects. You may recall that a late-stage trial showed the drug didn’t yield the hoped-for weight loss of 5 percent at the 2 mg dose the drugmaker hoped to sell…more

Daiichi Sankyo cleared to buy Indian drugmaker Ranbaxy.

From PharmExecspecialty drug prices spiking.

Big settlement by Cephalon on out-of-bounds marketing practices. Whistleblower vindicated.

What’s $1.2 billion between competitors? Ask Boston Scientific

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The Sales Force Shuffle, from Pharmaceutical Executive – The last week the pharma atmosphere was abuzz with news about sales force cuts, outsourcing, and overhauls. First, Schering-Plough announced that it had eliminated the 1,000 sales positions it said it would trim in April. This is being done as part of a new sales model called—internally—a productivity transformation program (PTP). The new model, to go into effect next month, will streamline the sales force to take a more customer-centric approach, including targeted and relevant physician calls and a relationship management–oriented business model…more

Alpharma to King: No. – In a filing with the Securities and Exchange Commission, Alpharma calls the $37-a-share offer was inadequate and continues to explore all strategic alternatives, including a possible sale to King or another party for a higher price…more

Lilly CEO to Boston: you’re scaring us away – The ink is barely dry on a new law governing how drugmakers can market to docs, but Lilly’s John Lechleiter isn’t wasting time trying to make lawmakers regret their decision. In remarks to the Associated Industries of Massachusetts Executive Forum, he claims the law will hamper innovation and force companies to reconsider expanding in Massachusetts, The Boston Business Journal reports…more

B-I goes to the shrink – The drugmaker has ended a contract with InVentiv, one of the players in the Rent-A-Rep business, which was promoting its troubled Micardis, an angiotensin receptor blocker, otherwise known as a blood pressure med…more

The needle or the drug? – Acupuncture works as well as Wyeth’s antidepressant to fight hot flashes and other menopausal symptoms caused by breast cancer treatment, and its benefits last longer without causing unwanted side effects, according to new research…more

Pfizer’s Pfuture – The big drugmaker is dramatically stepping up sales efforts in emerging markets, overhauling US business operations and slashing more costs ahead of the 2011 patent loss for cholesterol blockbuster Lipitor, the Associated Press informs us…more Plus, going after emerging markets for growth

Paxil damages sperm? – A group of 35 healthy men who were given Paxil over a five-week period had higher levels of sperm with damaged DNA, according to a report..more

Medicis to re-state numbers; stock plunges.

Tarceva linked to liver damage - Genentech Inc and OSI Pharmaceuticals have alerted doctors about cases of liver damage among patients who took the cancer drug Tarceva in a post-approval study, U.S. regulators said on Tuesday…more

Takeda goes for diabetes combo – Takeda Pharmaceutical Co said on Wednesday it had applied for approval to market in the United States the SYR-322 and the Actos diabetes drugs in a single tablet for the treatment of type 2 diabetes…more

An interesting analysis on adverse event reporting, and social media.

Is the war on cancer really winnable? A realistic and pessimistic analysis from Newsweek.

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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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