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Posts Tagged ‘Nexavar’

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TODAY’S NEWS

Busy days at Novartis: Licensing deal with Array for oncology drugs; major quarterly profit rise; buying up more generics with Oriel purchase; oral MS drug Gilenia draws closer to review; however, bad timing on Tekturna.

Nexavar and tailored treatments for lung cancer – The study found that Nexavar prevented lung-cancer from progressing in 61 percent of patients with KRAS mutations. The research, presented yesterday at the meeting of the American Association for Cancer Research in Washington, was designed to show how gene testing of tumors can improve treatment when drugs are matched with biomarkers that predict their successmore

Evista and tamoxifen guarding against breast cancer, but with some differences –  The latest results from a landmark, long-running study find that both tamoxifen and raloxifene help prevent breast cancer in postmenopausal women, although some differences are starting to emerge between the two drugs. Raloxifene (Evista), originally an osteoporosis drug, was less effective at preventing invasive breast cancer and more effective against noninvasive breast cancer than tamoxifen. But raloxifene compensated by having fewer side effects and a lower likelihood of causing uterine cancer than its older cousin. Both drugs work by interfering with the ability of estrogen to fuel tumor growthmore

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Feeling blue? Good – here’s 10 Amazing Blue Animals for you…

JUST FOR FUN

Bring TIM to shorten those drawn-out meetings!

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TODAY’S NEWS

It’s going to be a big week for Social Media in Pharma. Here’s the scoop.

Cancer drug Nexavar shows efficacy in breast cancer – Bayer and Onyx Pharmaceuticals‘  cancer pill Nexavar has demonstrated impressive results in treating breast tumours, brokerage Baird said on Monday, citing an abstract from a medical congress…Patients given Nexavar plus Xeloda had a 74 percent improvement in the time they lived without their disease progressing….more

AstraZeneca and Nektar Therapeutics in big licensing deal – Under the agreement, AstraZeneca will develop Nektar’s late-stage drug to treat opioid-induced constipation, NKTR-118, and NKTR-119, which is in its early-stage studies to treat pain without the side effects of constipationmore

Avastin for melanoma? That could be exciting. Melanoma has been notoriously resistant to everything thrown at it.

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Everything you always wanted to know about Instructional Design Models. It’s actually a lot more than I want to know! Hat tip: Ellen Wagner

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100% accuracy for the weather? Announcing…The Weather Channel Classic! (spoof)

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Sales force efficiency (revenue generated per sales rep) measured and reported among 20 pharma companies – who do you think is on top? Plus, PWC issues a report with a keen grasp of the obvious about targeted (vs. mass) sales forces in the future.

Onyx: Good news! Another reported loss! (OK, sales of Nexavar are strong…)

Baldness drug reducing the onset of prostate cancer? Who’d a thought it?

PLUS – just do the right thing. What a concept. So many problems would be prevented, issues avoided, scandals circumvented, if leaders in companies would follow an informed conscience instead of pursuing short-term gain at all costs…

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The Xa factor: not looking so promising for Pfizer and Bristol – Bristol-Myers Squibb and Pfizer’s apixaban blood clot preventer raised rates of bleeding in a 6-month study but showed some encouraging signs of protecting at-risk heart patients, researchers said on Tuesday. Apixaban, which works through a new mechanism of action by blocking a protein called Factor Xa, suffered a setback last week when it failed its primary goal in a late-stage trial for preventing clots after orthopaedic surgery…more A little more promising for Daiichi Sankyo, however. 9/2

This potential advance on a drug to treat Hepatitis-C is quite interesting…especially if you really like medical-technical terms! 9/1

Sciele bought by Japanese pharma company: Shionogi & Co plans to buy U.S.-based Sciele Pharma Inc for $1.1 billion, the fourth big overseas deals in nine months by Japanese drug makers eager to expand overseas…more 9/1

Prasugrel (investigational anti-clotting drug) shows strong results in diabetic patients – Patients who were diabetic and diagnosed with acute coronary syndromes (ACS) were 40 percent less likely to suffer a heart attack if they were treated with prasugrel vs. clopidogrel…more 8/31

Crestor a no-go on heart failure – AstraZeneca Plc’s cholesterol drug Crestor has failed in a second clinical trial for heart failure, suggesting such statin medicines don’t improve survival in patients with the chronic condition…more 8/31

Glaxo does not score with preemption ruling in suicide case. I’m sure the lawyers are loving this. 8/30

A little fun – The Top 10 Weirdest Pharma Stories of the Month. 8/30

Anti-psychotics may double stroke risk – People taking antipsychotic drugs are nearly twice as likely to have a stroke compared to those not on the treatment, British researchers reported on Friday…more 8/29

A swipe at glitazones for diabetes treatment (from PharmaGossip) 8/29

Good news from Teva on Parkinson’s treatment: Teva Pharmaceutical Industries Ltd. said its Azilect pill is the first to slow the progression of Parkinson’s disease in new findings that may increase sales of the medicine to more than $1 billion…more 8/28

A few baby steps into social media by pharma companies. 8/28

Stroke prevention with drug combos: maybe not so much – Two studies released on Wednesday call into question the advantage of using a blood pressure medicine and a well-known blood thinner for preventing the recurrence of a stroke…more 8/28

UCB brings out a heavy axe – The Belgian drugmaker that bought Schwarz Pharma is cutting 2,000 jobs, or 17 percent of its staff, to spur profits and lower administrative costs. The move is part of an effort to redirect $444 million into research on meds for immunology and the central nervous system…more 8/28

Amgen getting rid of “bundling sales” practice (it’s about time) – the company is getting rid of “bundling” — giving docs discounts on other Amgen drugs based on how much of their anemia-drug business consisted of Amgen’s Aranesp…more 8/28

Cell Genesys plunges after troubling trial results…butRecent news of high fatalies during one its drug trials has weighed on Cell Genesys‘ stock price, but the company may be able to overcome the blow

if data from a different study helps it gain FDA approval…more 8/28

Replidyne plunging downhill fast – Drug developer Replidyne Inc said it will restructure its operations, reduce its headcount by about 80 percent to 5 employees and take a charge of $3.1 million…more 8/28

From Forbes: Vytorin efficacy questions still nipping at the heels. And, the cancer scare. 8/28

More bad pancreatitis news with Byetta. 8/27

An interesting analysis of Abbott’s strengths and weaknesses moving forward. 8/27

Lilly’s Cymbalta: a Swiss army knife drug with too many indications? 8/27

BMS/Pfizer new blood clotting drug not flowing smoothly – Bristol-Myers Squibb Co and Pfizer Inc said on Tuesday their apixaban blood clot preventer failed its primary goal in a late-stage trial, and that they no longer plan to seek marketing approval next year for the pill…more 8/27

Scrips and tripspharmas paying out big for “medical education” junkets 8/25

So now we have the Ambien rooster?? 8/25

Amgen gets drug approval from FDAAmgen Inc drug Nplate is safe and effective for treating a rare clotting disorder that can cause dangerous bleeding, the Food and Drug Administration said on Friday in approving the product for U.S. sales…more 8/25

King making bid for Alpharma – The unsolicited cash bid is a move to create a bigger specialty drugmaker and expand a nascent effor to develop meds for treating pain. The offer is $33 per share amounts to a 37 percent premium over the $24.04 closing price of Alpharma’s common stock yesterday. King actually first made the offer to Alpharma in a letter on Aug. 4 and said the offering represents a 49 percent premium, based on the share price that day…more 8/22

After all that battering in the press, a positive spin on HRT – Hormone replacement therapy can improve the quality of a woman’s life, easing the distress of hot flashes, sleep disturbances and restoring lost sexual functioning, researchers reported on Thursday…more 8/22

A promising experimental cystic fibrosis drug (PTC Therapeutics) 8/22

Abbott Diagnostics planning big cuts – Abbott Laboratories Inc  said on Thursday it would eliminate about 1,000 jobs over the next four years as part of a plan to streamline operations and cut costs in its medical diagnostics business…more 8/22

Genentech employees getting restless about potential Roche takeover: recruiters circling, retention bonuses adding up -Aside from announcing that Genentech is not settling for Roche’s $44 billion offer because it “substantially undervalues the company,” the San Francisco-based biotech made it known that if would be implementing an employee-retention program to help its people make sense of the Roche deal… more 8/22

Gilead Sciences – growing! 8/22

J&J’s Doribax for pneumonia: more info, please. 8/21

Buying out biotechs – A buyout bull’s-eye will likely remain on biotechnology companies over the next few years as major pharmaceutical companies continue taking advantage of a weak dollar and a surplus of cash to buy pipeline additions….more 8/21

Wyeth, Elan, and Alzheimer’s: is this experimental drug worth the pursuit? – In what is becoming a sadly common ritual, Wyeth and Elan are pressing forward with an expensive, large-scale “phase III” trial of a risky drug based on wishful thinking and shoddy statistical analysis…more 8/21

Expensive cost cutting at Sepracor. 8/21

Gardasil – not worth the cost? – That’s the conclusion of a new study that is going to make life much harder for Merck to wring needed sales out of its controversial HPV vaccine. The study, which appears in the New England Journal of Medicine, comes as the drugmaker is already struggling to convince college-age and older women to get the vaccine, which costs about $360 for a three-dose regimen….more 8/21

Might daily Cialis help with symptoms of enlarged prostate? 8/20

Just came across this BNET Industries site which consolidates Pharma news. Looks pretty good! 8/20

Feel like debating a single-payer (government-run) healthcare system? Here’s a lively debate, from the WSJ Health blog (see the comments). 8/20

Roche, Accutane, and IBD – is there any link? 8/20

Clinical trials: cancer gets the lion’s share – Most registered trials were in oncology, followed by central nervous system disorders, cardiology, infectious diseases, endocrinology, and respiratory diseases. These six therapeutic areas accounted for 68 percent of 3,515l protocols…more 8/20

BMS and PDL go after MMLBristol-Myers Squibb Company and PDL BioPharma, Inc.  today announced an agreement for the global development and commercialization of PDL BioPharmas anti-CS1 antibody, elotuzumab, previously known as HuLuc63, currently in Phase I development for multiple myeloma…more 8/19

Vytorin prescriptions: hitting bottom? 8/19

My pipeline’s bigger than your pipeline – who’s got the goods to be able to claim it? You might be surprised… 8/18

Warning on deaths associated with Byetta – The FDA is working on a stronger label for the widely used diabetes drug, which is marketed by Lilly and Amylin Pharmaceuticals after deaths continue to be reported despite earlier government warnings. Six new new reports were received of patients developing a dangerous form of pancreatitis while taking Byetta… more 8/18 But, fair balance 8/20

Jersey jobs walking out – Layoffs and restructurings are taking a toll on drug and device makers in New Jersey, which for decades has prided itself on being home to many of the world’s biggest such companies…more 8/18

Was a key Vioxx study less than scientifically stellar? – A 1999 Merck study of Vioxx, which was touted to participating doctors and patients as easier to stomach than another drug, was primarily a stealth marketing strategy, according to a report to be published this week in The Annals of Internal Medicine…more 8/18

Do “charming” sales reps earn more? (from John Mack’s Pharma Marketing blog). And, in a similar vein: D’uh! 8/18

What’s Next? Ban Free Drug Samples? (from John Mack’s Pharma Marketing blog). 8/18

Which presidential candidate has received more donations from pharma execs? By a factor of three? 8/18

Abbott to co-promote Crestor – Seeking to increase its share of voice without beefing up its sales force, AstraZeneca is partnering with Abbott on a co-promotion of Crestor in the US…more 8/14

New antibody drug helps nail blood cancer – A new kind of antibody drug that makes the body’s own “killer” cells fight tumors has produced promising early-stage results in patients with a deadly form of blood cancer, researchers said on Thursday…more 8/14

Genentech to Roche: No thanks, but maybe. 8/13

MS drug may work against viral infection – A drug that Novartis AG is testing in people with multiple sclerosis also has the potential to treat certain viral infections, perhaps including the AIDS virus, U.S. researchers said on Wednesday….more 8/13

FDA extends review of Centocor drug – Centocor, Inc., today announced that the U.S. Food and Drug Administration (FDA) hasextended the review timeline for the Biologic License Application for ustekinumab, a subcutaneous biologic therapy, by three months to December 2008. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate to severe plaque psoriasis…more 8/8

It’s a slow year so far for FDA drug approvals 8/8

Go ahead, Massachusetts…make my day – This morning, five trade groups representing drugmakers and biotechs took out a full-page ad in The Boston Globe arguing the bill will “significantly curtail, if not end altogether, the availability of these last hope clinical trials in Massachusetts….more 8/7

Kidney cancer drugs too costly? Yes, says UK – Is extending life by a few months worth $50,000? No, says the UK’s National Institute for Health and Clinical Excellence. In a report out today, the group concluded that several new drugs for advanced kidney cancer aren’t cost-effective…more 8/7

King Pharma income takes a plunge. And some other question marks about an upcoming pain treatment here. 8/7

Rituxan may help a kidney disease – The cancer drug rituximab can help heal the kidneys of patients with a common condition known as membranous nephropathy, Italian researchers reported on Wednesday…more 8/6

Eat your broccoli! 8/6

Artificial blood producing genuine problems. A recent meta-analysis of trials on several substitutes — including Hemopure — contains some gory results. Turns out, the fake bloods scavenge nitric oxide, causing vasoconstriction; patients who get them are 2.7 times more likely to have a heart attack and 30 percent more likely to die… 8/6

Abbott dips into podcasting (for Chrohn’s patients). 8/6

Live long and prosper, with Byetta? – Can Byetta, an injectable drug that lowers blood sugar, really help people with diabetes to live longer? Possibly, according to the results of a major clinical trial presented at the American Diabetes Association annual conference…more 8/6

Which pharma company will be biggest in 2014? The projections might surprise you… 8/6

FDA to advertise fake blood pressure pill – OK, that’s weird… 8/5

Maybe sleep meds not so great – In its latest bid to track prescription drug use, Consumer Reports conducted a survey last spring of 1,466 Americans who took sleeping pills and found that nearly half have difficulties. Consquently, many are turning to prescription meds with what CR calls “frightening results.” Here they are…more 8/5

Rutgers unveils mini-MBA program for pharma professionals. 8/5

Feel-good story about Sinemet helping a young boy who has Parkinson’s. 8/5

SGP entangled with a whistleblower mess (inherited from Organon) – Last month, Schering-Plough’s lawyers filed a motion in federal court in New Jersey arguing that a former medical director at Organon, which the drugmaker recently paid $14.3 billion to acquire, wasn’t qualified to bring a whistleblower lawsuit alleging Organon covered-up serious side effects prior to launching two drugs several years ago…more 8/5

The Medicines Company gets approval for cleviprex – The Medicines Company announced today that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy CleviprexTM (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable…more 8/4

Careful about giving cold meds to babies – Yet another study raises questions about the dangers of giving cough and cold meds to babies. A “surprising” number of small children taken to emergency rooms after they stop breathing or lose consciousness have OTC meds in their systems, USA Today writes, citing the study in Pediatricsmore 8/4

Beware of Mass. reps bearing gifts – When Massachusetts’ House of Representatives approved a big healthcare bill last month, drug and device makers and data firms thought they’d ducked several bullets, but the final bill, passed by both houses last night, includes a few nasty surprises for industry – including a code of conduct for drug marketers, an academic detailing program and stringent reporting requirements for payments to physicians…more 8/4

GSK cutting down oncology personnel – The ax is falling again at GlaxoSmithKline (GSK). This time it’s the oncology group… more 8/4

Who might be next in the pharma takeover phrenzy? 8/4

A doctor’s balanced perspective on the recent Vytorin kerfuffle. 8/4

Schering announces encouraging results for experimental Hep-C drug – Schering-Plough Corp  said on Monday that interim results from a mid-stage study of its experimental hepatitis C drug showed promising results, sending shares of rival Vertex Pharmaceuticals Inc down more than 10 percent in early trading…more 8/4

Novartis get two big approvals for HPB combo pills – The US Food and Drug Administration (FDA) has approved two single-pill combination medications, Diovan HCT® (valsartan and hydrochlorothiazide) and Exforge® (amlodipine and valsartan), as initial or ‘first-line’ therapies in patients likely to need multiple drugs to achieve their blood pressure goals…more 8/4

Good news on statins and memory loss – People at high risk for dementia who took cholesterol-lowering statins are half as likely to develop dementia as those who do not take statins, a new study shows…more 8/4

New/old cancer treatment: methadone effective against leukemia! – “Methadone kills sensitive leukemia cells and also breaks treatment resistance, but without any toxic effects on non-leukemic blood cells…”more 8/4

Backing away from CME – Trying to steer clear of potential conflicts of interest, two medical industry giants are distancing themselves from a little-known breed of marketing specialists. The recent steps by the drugmaker Pfizer (PFE) and Zimmer Holdings (ZMH), a medical device manufacturer, illuminate subtle promotional tactics other companies continue to aim at doctors, despite mounting concern on the part of some physicians and ethicists…more 8/4

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Who needs exercise? Maybe we can get the benefits in a pill! – That dream, cherished by millions of sedentary couch potatoes, just got a little bit closer. Today, researchers are reporting that an experimental drug can mimic the results of an exercise regimen — with no exercise required. After four weeks of taking the pill, mice who hadn’t worked out displayed a 44 percent increase in their running endurance…more

Schering gets a surprise FDA thumbs down.

BMS looking to buy up the rest of ImClone.

BMS: more jobs on the chopping block. Will BMS be an acquisition target?

OK, you don’t hear about this every day – A contractor for Novartis was charged with running a prostitution ring from his desk at the drugmaker in suburban New Jersey…more

Sales rep access limits identified – Pharma sales reps that want to see a doctor might want to take a less-is-more approach—and by less, we mean fewer doctors. It turns out that the more physicians a practice has on staff, the more likely a rep will get denied access…more (from Pharma Exec)

Viagra for tumors, depressed women? – Viagra, a popular anti-impotence pill, may help some women on antidepressants have better sex, U.S. researchers said on Tuesday…more Impotence drugs may help carry cancer-fighting drugs through the brain to treat malignant tumors, U.S. researchers reported on Monday…more

Encouraging liver cancer results for Nexavar – Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. today announced that The New England Journal of Medicine published landmark results of a Nexavar study in liver cancer. The data of the Phase III trial showed that Nexavar® (sorafenib) tablets decreased the absolute risk of death by 31 percent in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, versus patients who received placebo. This represents a 44 percent improvement in median overall survival for patients treated with Nexavar…more

Zyprexa and freedom of non-speech.

Elan, Wyeth, and others – not the greatest progress on Alzheimer’s treatments.

Tysabri: the return of brain infections. More here.

Congress wants Vytorin/cancer data – The House Energy and Commerce Committee wants the FDA to turn over the results of an analysis looking into the potential links between Vytorin and cancer…more

Tax money for counter-detailing? – In an effort to dilute the impact of sales reps, several Senators and Congressmen today are introducing a bill that would create funding for a program to send trained pharmacists, nurses, and other health care professionals into a doctor’s office with independent data about benefits, risks, costs, and comparative effectiveness of prescription drugs, including generics…more

Big Pharma stocks – safe haven no more.

The price of malpractice. This is kinda scary.

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After all that effort with alpha-blockers, beta-blockers, ACE inhibitors, etc….are we just going to circle back to diuretics??

Will Eli Lilly fork over $1,000,000,000 to make Zyprexa marketing headaches go away?

More on the statin question – do statins really prolong life? And more on whether cholesterol matters.

Bayer‘s Nexavar – looking promising for leukemia (AML).

NovartisGalvus gets approval in EU. This diabetes treatment (similar to Merck‘s Januvia) has had problems getting marketing clearance in the U.S. – it’ll be interesting to track its safety record in Europe in coming years.

Pfizer‘s anti-smoking drug Chantix gets a stronger warning for psychiatric side effects.

BREAKING NEWS: Amgen and Takeda announce major deal to collaborate on pipeline biotech drugs.

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Looks, on the surface, like a good match of products and market presence – Celgene buys Pharmion. And, in other important oncology news, Nexavar (from Bayer) gets expedited approval for liver cancer.

Also, Schering cleared to take over Organon – by divesting bird vaccines to Wyeth.

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