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Posts Tagged ‘prasugrel’

Prasugrel – the saga continues. Gets approval to launch in the EU; positive study results versus Plavix for a certain group of patients; but controversy swirls around FDA approval process.

Synta‘s Phase III trial for melanoma drug fails badly. In a devastating blow to the company, Synta Pharmaceuticals has halted a Phase III melanoma drug trial after a greater number of people taking elesclomol died than those receiving standard care. The findings were so bad that the company also suspended other ongoing studies of the drug, including a study a trial for metastatic prostate cancer and a monotherapy dose escalation study.

Wearisome to report – more scandals. AstraZeneca buried some Seroquel data? Ranbaxy falsified records and gets major smackdown. Forest accused of off-label marketing practices (anti-depressants for children). And, from Peter Rost’s blog, here’s an interesting chart showing who paid the most/least in government fines and settlements since 2000 (the winner on the “least” scale: Novartis!)

Sanofi gets US clearance to market Apidra pen. Sanofi-Aventis  has won U.S. approval to market its Apidra Solostar injection pen which contains insulin to treat diabetes, the world’s third-biggest drugmaker said on Thursday. The disposable pen is prefilled with Apidra, which is indicated to improve glycemic control in adults and children of at least four years with type 1 diabetes or adults with type 2 diabetes, the most common form of the disease.

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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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Finally! New anti-clotting drug prasugrel (Effient) is given a thumbs up by advisory committee! Great news for Daiichi Sankyo and Eli Lilly.

King Pharmaceuticals the latest to announce major layoffs (22% of workforce). Ouch.

Intermune gets hopeful results in late-stage trials of experiment lung disease drug.

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The FDA gives a hint of hope for the long-delayed Eli Lilly/Daiichi Sankyo drug prasugrel. Burrow deep inside this 357-page FDA document just posted online, and you’ll find this jargony but significant sentence: The Division recommends approval of prasugrel for reduction of myocardial infarction in patients with ACS who are managed with PCI.

Glaxo the latest Big Pharma to announce major upcoming cutsBritish drugs company GlaxoSmithKline Plc.  is set to announce about 6,000 job losses when it posts results on Thursday, the Sunday Telegraph newspaper said. The cuts by Glaxo, the world’s second largest drugs company after U.S. group Pfizer, are part of Chief Executive Andrew Witty’s strategy to meet the challenges facing the industry, including increased competition from generic drug makers, the British newspaper said.

Teva gets FDA OK for generic version of J&J‘s Risperdal. And, Takeda gets approval for new GERD drug Kapidex.

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Novartis to cut a bunch more (sales) jobs; does another management shuffle – As reorganizations go, this one reaches most parts of the company. First, the drugmaker is cutting 550 sales reps, although half of the jobs are said to vacant, as part of a new business model with five new regional units for reaching doctors and insurers called “Customer Centric Initiative” (back story). The move should save $80 million annually as of 2010…more

But, at least Novartis is making some profitIn good times and in bad times, people will get sick. That reality has helped Swiss drug maker Novartis post strong earnings for the third quarter on Monday, in spite of the banking crisis and global economic slowdown. Yet even as the pharmaceutical sector sticks to the pattern of being insulated from greater financial troubles, growth at Novartis will not be as robust as last year…more

Is specialty pharma the place to be? – Here are some interesting numbers to chew on…

B-I has some interesting stuff in the pipeline – Boehringer Ingelheim announced that patients and physicians may have several innovative Type 2 Diabetes treatment alternatives available in the coming years. At its Second International Research & Development Press Conference, Boehringer Ingelheim unveiled a pipeline of unique oral anti-diabetic compounds in phase II and III, establishing the company in the Type 2 Diabetes arena…more

Genentech sales soaring – It seems Genentech made the right choice in turning down a takeover bid from its majority holder, the Swiss pharmaceuticals company Roche Holding: its sales are soaring and investors apparently don’t mind that its latest earnings missed Wall Street’s estimates, possibly because of costs associated with defending itself against the bid…more

New study: Vioxx does cause heart risks – An analysis of an infamous Vioxx study found the notorious painkiller does, indeed, double the risk of heart attacks and strokes, although the likelihood of a serious cardiovascular event lessened one year after people no longer took the pill…more

Pfizer’s desperate times/desparate measures – As the big drugmaker grapples with its big slowdown, the board and top management are exploring a number of interesting ways to jumpstart business, according to sources. The moves may involve laying off still more employees – a large number of reps, for instance; plans to sell off some of the R&D units that are being eliminated and possibly purchasing a brand-name biotech, our sources tell us…more

Effient: wait ’til Feb – Members of the FDA’s Cardiovascular and Renal Drugs Advisory Committee have been contacted about their availability for a February panel meeting specifically on prasugrel, sources tell The Pink Sheet. And the agency’s Drug Safety and Risk Management Advisory Committee may also be convened…more

Fred Baron to receive Tysabri after all (this human/medical interest story is a bit involved, but brings up important issues about experimental/compassionate use).

High-dose Zevalin with stem-cell infusion leads to strong survival results for NHL.

Abbott’s experimental bioabsorable stent looking very interesting – Abbott today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries…more

FDA becomes FDelAy – Takeda drug, others stalled at agency. Who needs those stinkin’ deadlines?? But, next-generation Astelin (from Meda) does get an approval.

Wisconsin Medical Society bans pharma gifts – The doctors’ group, which boasts 12,000 members, has joined a growing number of academic medical centers, professional societies and legislators that have decided gifts from the pharmaceutical industry are questionable, if not unacceptable forms of influence…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 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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