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Posts Tagged ‘Amylin’

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TODAY’S NEWS

New experimental RA/Lupus drug suspended after patient deaths – Swiss drugmaker Roche Holding AG and U.S. biotechnology company Biogen Idec are suspending rheumatoid arthritis and lupus treatment ocrelizumab after it caused deaths, casting doubt over the drug’s futuremore

So, what about Amylin‘s Byetta? The pundits are dueling as potential once-a-week version approval draws near…

An interesting background story on Pfizer‘s expensive oncology “miracle” drug Sutent.

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A “trifecta” social media approach – Novartis sponsors a community, Twitter account, and Facebook Fan Page for Cystic Fibrosis patients. How are they doing? An Impactiviti review.

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Top 10 Most Stupid Inventions. No disagreement here!

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TODAY’S NEWS

Big change – Dan Vasella to step aside as Novartis CEO. This article also details the other internal leadership changes – very interesting.

Novo Nordisk gets approval for new diabetes drug Victoza – Federal health officials on Monday approved Danish drugmaker Novo Nordisk’s once-daily injection for treating type 2 diabetes but said more safety studies are needed before it can be cleared as a first-line treatment for the disease. The Food and Drug Administration said it approved the drug, Victoza, to help lower blood sugar levels when coupled with diet, exercise and other diabetes medicines. It was not recommended as an initial therapy for patients who have not been able to control their diabetes with diet and exercise alonemore Meanwhile, Amylin waiting for once-weekly treatment to be approved.

Will 2010 be a big year for big pharma?

No matter what, I’ll still enjoy red wine – GlaxoSmithKline shocked the pharmaceutical industry in 2008 when it dropped $720 million to buy Sirtris Pharmaceuticals, a biotechnology company working on drugs based on resveratrol, a chemical in red wine thought to combat the effects of aging. But now researchers at rival companies are openly questioning whether the compounds will work. They say they are unable to replicate key laboratory experiments backing the drugs’ promisemore

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The post I keep wanting to write…but haven’t yet. Well, I finally partially wrote it….

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Dilbert on Doing What Matters. :>}

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TODAY’S NEWS

FDA warning letters to Lilly, Bayer, Amylin, Cephalon.

Wow: ARBs for hypertension reducing Alzheimer’s symptoms? – Drugs commonly used to lower blood pressure, sold by AstraZeneca Plc, Sanofi-Aventis SA and Merck & Co., may also reduce the risk of developing Alzheimer’s disease. Researchers from Boston University analyzed the medical records of more than 800,000 U.S. veterans and found those taking angiotensin receptor blockers were up to 24 percent less likely to develop dementia than patients on other medications. Patients already diagnosed with Alzheimer’s disease were half as likely to be admitted to a nursing home and had a 17 percent reduced risk of dying if they were taking the medicationsmore

FTC wants to put a stop to the “pay-to-delay” deals – Jon Leibowitz will hold a press conference today to ask Congress to include a provision in the health care reform bill to end deals in which brand-name drugmakers offer payments or other inducments to generic rivals to delay copycat versions of best-selling medsmore

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Social Media, Opportunity, and Serendipity – my guest post on the Hive Awards blog.

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Visual awesomeness. Photo of Martian dune field. Quite spectacular!

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TODAY’S NEWS

Amylin to be led by former Novartis exec – Amylin Pharmaceuticals has taken another step forward in its long & storied history. The company has announced that former Novartis executive Paulo Costa will become its new chairmanmore

An interesting lawsuit: individual suing Celgene for blockbuster drug idea – In 1996, Beth Jacobson was watching her husband, a 35-year-old cardiologist, die from the blood cancer multiple myelomamore

Gene variation impacts 1/3 of Plavix patients? – A common gene variation explains why many people are not helped by the widely prescribed blood thinner Plavix, U.S. researchers said on Tuesday in a study confirming earlier research and paving the way for tests to screen patients before they get the drugmore

From the rumor mill – Glaxo eyeing Human Genome Sciences? And, is B-I cutting a major percentage of its sales force in the U.S.? (can anyone confirm or deny with facts?)

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Are placebos getting more effective? What’s going on here? – From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebomore

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Who’s got the better colors? An eye-popping series of 3 photos you’ll enjoy!

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Abbott and J&J to duke it out in court over a patent dispute on new rheumatoid arthritis drug.

Amylin eliminating 200 sales positionsDrugmaker Amylin Pharmaceuticals Inc. said Monday it will eliminate about 200 jobs, or more than a third of its sales force, as it combines its primary care and specialty drug sales units.Amylin partners with Eli Lilly & Co. to sell the diabetes drug Byetta, and is also developing a once-per-week version through that alliance. Amylin said the reorganization of its sales force will strengthen the partnership.

Gelnique works for OAB Applying a gel containing the anti-spasmodic agent oxybutynin to the skin is safe and effective for women with overactive bladder, according to a study reported here at the annual meeting of the American Urological Association.

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Avastin + Tarceva = better results in lung cancerGenentech said the trial was stopped early after an interim analysis found that combining Avastin, known generically as bevacizumab, and Tarceva, or erlotinib, significantly extended the time patients with non-small cell lung cancer lived without their disease advancing.

Amylin‘s leadership under fire from Carl Icahn and others – “While we have not lost faith in the potential of Amylin’s products and pipeline, we have lost confidence in Amylin’s leadership to take this rich product portfolio and execute an operational strategy that is in the best interest of the shareholders…”

Does insulin help protect brains from the development of Alzheimer’s? – Insulin appears to shield the brain from toxic proteins associated with Alzheimer’s disease, U.S. researchers said on Monday, supporting a theory that Alzheimer’s may be a third form of diabetes.

PLUS – the usual rumor mill: blah, blah, blah…Sanofi-Aventis…blah, blah, blah…Bristol Myers-Squibb. You know the drill. And, business advice from the NY Times for navigating through a downturn.

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Astellas makes a big to acquire CV Therapeutics. Japan’s Astellas Pharma is offering a billion dollars in cash for CV Therapeutics. The bid comes in at $16 a share, a whopping 41 percent premium over yesterday’s close.

Abilify as an add-on therapy for depression – not everyone is convinced.

Watson‘s topical Overactive Bladder gel (Gelnique) gets FDA approval.

PLUS – Amylin hurting. Abbott‘s Vicodin CR delay means 200 layoffs. And Feds say, “Enough with the off-label promotion already!

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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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Barren pipelines abound – the drug drought of pharma.

Schering‘s promising clot drug continues to do well in trials.

Amgen and Roche go another round in court over anemia drugs – this round to Amgen.

Sleep drugs – wildly popular, but how effective? Related news: Sepracor‘s earnings (and a 16% cut in the sales force).

The 2007 drug company layoff tally – sobering.

Takeda‘s experimental cholesterol drug (lapaquistat) takes a hit.

Gila monster saliva diabetes drug looking good in longer-lasting version (Amylin‘s Byetta)

OK, it’s not pharma, but it’s a very cool idea for treating skin cancer – portable, inexpensive light therapy. Fascinating.

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