Ranbaxy may develop drugs for merck
discuss this article
India’s big generic drugmaker is expected to form an alliance with the beleaguered drug giant that could generate up to $100 million in revenue for Ranbaxy, according to LiveMint, which cites an unnamed senior exec.
The agreement would come nearly a month after Malvinder Singh, Ranbaxy’s managing director, indicated that such a deal was in the making, without naming the partner. Singh couldn’t be immediately reached for comment and a Ranbaxy spokesman declined to say anything to LiveMint. A Merck spokesman tells Pharmalot that the drugmaker won’t comment on “speculation.”
“The tie-up will ...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Merck Ranbaxy Laboratories Source Type: blogs
Abbott worried norvir pricing would attract feds
discuss this article
In December 2003, Abbott Labs raised the price of its Norvir AIDS drug, which is commonly used in HIV drug cocktails, by 400 percent, creating a firestorm in the AIDS community. The mark-up prompted the Service Employees International Union Health & Welfare Fund to file a class-action lawsuit the next year that alleges the price hike violated antitrust laws.
How so? Abbott sells a combo pill called Kaletra that includes Norvir and its own protease inhibitor. The lawsuit claims Abbott raised Norvir’s price - but not the Kaletra price - in order to boost Kaletra sales at the expense of other protease inhibitors that ...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbott Laboratories AIDS HIV Kaletra Norvir Prices Source Type: blogs
Uk drugmakers unveil a new code of conduct
discuss this article
Drugmakers must do more to encourage side-effect reporting under a new industry code of practice published by the Association of British Pharmaceutical Industry. As of November, new promotional info must explicitly and “prominently” state that “adverse events should be reported” and provide details of the website to contact with concerns.
What else? Drugmakers will have to make publicly available a short description of financial and significant indirect support of patient groups; and sponsorship declarations must accurately reflect the nature of the company’s involvement.
Pharma must have a contract for health pr...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Association Of British Pharmaceutical Industry Clinical Trials Side Effect Reporting Side Effects UK Source Type: blogs
Fda scraps helsinki rule on human subjects
discuss this article
Drugmakers will soon be able to use data from foreign clinical trials in new drug applications even if trials only compare new products to placebos instead of best available treatments. The change departs from the 1989 Declaration of Helsinki protecting human subjects in clinical research, the FDA’s previous standard, according to Integrity in Science Watch.
The new rule’s substitute standard says foreign trials should follow good clinical practices and include a review and approval by an independent ethics committee. A major difference between the Helsinki Declaration and GCP is the former’s insistence o...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Clinical Trials Helsinki Declaration Source Type: blogs
Thai official: compulsory licensing is working
discuss this article
Access to some HIV drugs is increasing in Thailand because of the country’s decision to issue compulsory licenses for certain meds, according to Winai Sawasdiworn, deputy secretary-general of the National Health Security Office, The Bangkok Post reports.
You may recall that, early last year, the Thai government issued a compulsory license to make a lower-cost version of Abbott’s Kaletra AIDS drug. The drugmaker later offered to sell an updated version called Aluvia at a reduced price, but only if Thailand agreed not to allow generics to be sold. But talks failed and Thailand last fall allowed India’s Matr...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbott Laboratories AIDS Aluvia Compulsory Licensing Efavirenz HIV Kaletra Merck Thailand Source Type: blogs
Sanofi faces a new generic plavix threat
discuss this article
This time, it’s in Europe. Switzerland’s Schweizerhall expects to market a lower-priced version of the widely used blood thinner within the month, and the news sent Sanofi-Aventis shares plummeting.
“The German authorities have basically finished the registration procedure and we’re now just waiting for the paperwork,” Luzi Andreas von Bidder, Schweizerhall’s chairman, tells Bloomberg News. The drugmaker is working with a “major generics company” and expects to start selling the product, called clopidogrel, this quarter. Sandoz and Ratiopharm will also market a generic Plavix...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Apotex Bristol Myers Squibb Plavix Sanofi Aventis Schweizerhall Source Type: blogs
As vytorin slumps, abbott’s new pill gains
discuss this article
Vytorin may be grabbing all the headlines, but the controversial cholesterol pill isn’t gaining as much attention among docs. Over the past several weeks, Abbott’s Simcor, a new drug that combines Niaspan and generic Zocor, has gained the highest share of detailing among primary care physicians and cardiologists, according to ImpactRx data cited by Wachovia Capital Markets analyst Larry Biegelsen in an investor note this morning.
Simcor was approved in mid-February, but wasn’t launched until the end of March, so the data reflects the first month in which Abbott began promoting its pill. As Biegelsen notes...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbott Laboratories ImpactRx Niaspan Simcor Vytorin Zocor Source Type: blogs
Legislation aimed at treating brain disorders
discuss this article
Lawmakers yesterday introduced legislation designed to speed the development of new, safer therapies for brain and nervous system disorders and injuries, which affect an estimated 100 million Americans and costs an estimated $1.3 trillion annually to treat, Scientific American reports.
The National Neurotechnology Initiative Act (NNTI), which has bipartisan support, calls for $200 million in federal funds to be set aside annually to research potential treatments and to establish an info clearinghouse from federal agencies to help coordinate efforts, the mag writes. The lawmakers charge a lack of coordination has impeded de...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized National Neurotechnology Initiative Act Patty Murray Pete Domenici Source Type: blogs
Fda developing rules for clinical trial oversight
discuss this article
The FDA and the HHS Office for Human Research Protections are working on a final rule for registering institutional review boards, marking the first FDA effort to issue regulations instead of guidances for clinical trials, FDANews reports.
Existing FDA regs don’t take into account all the different types of organizations - vendors, co-investigators, site management organizations and contract research organizations - involved in conducting clinical trials, David Lepay, the agency’s senior advisor for clinical science, told the Association of Clinical Research Professionals annual conference, FDANews writes.
What a...
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Clinical Trials Institutional Review Boards Source Type: blogs
Pharmalot… pharmalittle… good morning
discuss this article
Nice to see you again. We hope your week has gone well. As usual, we have been quite busy and look forward to a respite this weekend. Still, there is much to be done. So please join us as we grab our daily cup of stimulation and catch up with events. Hope your day goes well…
Bristol-Myers CEO Buys 100,000 Shares (Yahoo/Reuters)
Takeda Expects Profits To Fall On Takeover Costs (Bloomberg News)
German Drugmaker Hikes Thalidomide Compensation (Deutsche Welle)
Celgene Poised For International Growth (The Star-Ledger of New Jersey) (Source: Pharmalot)
Source: Pharmalot - May 9, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Bristol Myers Squibb Celegen Jim Cornelius Plavix Sanofi Aventis Takeda Pharmaceuticals Thalidomide Source Type: blogs
At merck, some layoffs are made by powerpoint
discuss this article
The news that Merck is cutting 1,200 sales reps made headlines, but researchers who work on natural products in Madrid weren’t too thrilled either. That’s because the drugmaker is closing down the 50-year-old research effort, although the disclosure was a mistake - a Merck executive inadvertently included the plan in a PowerPoint presentation to an audience that included Merck employees.
The decision to shutter in-house natural products research will affect about 50 researchers in Spain and “a significantly smaller number” in Rahway, New Jersey, according to a Merck spokesman. “There has been ...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized jobs Layoffs Merck Natural Products Source Type: blogs
Canada’s goodwill program riles generic makers
discuss this article
Now that Apotex has won a bid to produce and ship copycat AIDS meds to Rwanda, the generic drugmaker says it will never participate in the goodwill program again unless the federal government simplifies the process, The Toronto Globe & Mail reports.
Apotex became the first generic drugmaker in the world yesterday to be awarded a tender under a 2003 World Trade Organization deal to manufacture and supply copycats to AIDS-stricken nations. But Canadian legislation based on the agreement makes for such a cumbersome process that it took four years for Apotex to get this far, the paper writes.
“We’ve spent mill...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized AIDS Apotex Canada Rwanda World Trade Organization Source Type: blogs
Lowering the bar for barr as its stock plunges
discuss this article
The drugmaker reported disappointing first-quarter profit on weak US sales and slashed its 2008 forecast, pushing its stock down 23 percent to their lowest levels since 2004. Oral contraceptive sales fell short, and results were hurt by surprising competition and pricing pressure on a new generic of an osteoporosis drug. Sales of its Plan B emergency contraceptive were also lower than expected.
Barr reduced its 2008 outlook less than three months after issuing a forecast that also disappointed the market, Reuters notes. “It’s hard to imagine how they could get this so wrong in so many areas of their business in...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Barr Laboratories Seasonique Source Type: blogs
Congress criticizes fda over hrt ingredient
discuss this article
A bi-partisan group of Congressional reps have introduced a resolution* criticizing the FDA for its recent move to warn compounders about their use of estriol in their bioidentical versions of hormone replacement treatments.
Last January, the agency questioned the safety and effectiveness of BHRT products, citing unsupported medical evidence, and false and misleading claims. The agency accused seven compounders of claiming their products are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat such diseases as Alzheimer’s, stroke, and various forms of cancer, according to the FDA.
And last mo...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Compounders Prempro Tom Coburn Wyeth Source Type: blogs
Watch the congressional dtc hearing right here!!
discuss this article
Yes, we are trying something new today. With the enormous interest in DTC ads, in general, and the controversies surrounding the Lipitor and Vytorin advertising, in particular, we thought you would enjoy watching the hearing as it takes place.
Not only that - special just for you - we are including another feature that allows you to write some comments as the events unfold. For instance, if Deepak Khanna, senior vp of the Merck/Schering-Plough joint venture says something incredible, you can chime in. Sounds like fun, yes? Here’s the witness list. It’s over now - hope you enjoyed it. We’ll try it again s...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Bart Stupak Deepak Khanna DTC Ads DTC Advertising Jim Sage Kim Taylor Ruth Day Source Type: blogs
Pharma: oig compliance guide made an impact
discuss this article
Five years after the HHS Office of Inspector General issued its compliance guidance for pharma, 92 percent of drugmakers surveyed say the guidelines “significantly impacted” the structure of their medical affairs teams - for instance, have since shifted medical science liasons and thought-leader development teams away from commercial development.
Meanwhile, 8 percent indicate the guidelines had caused a complete overhaul, according to Cutting Edge Information. And none of the 14 drugmakers that responded - a group that included Bayer, Glaxo and Novartis - believes the guidelines failed to have a serious impact. (Source: Pharmalot)
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Compliance Guidance Compliance Guidelines HHS Office of Inspector General Source Type: blogs
Fda is urged to ban j&j’s ortho-evra patch
discuss this article
Citing studies indicating the birth control patch increased the risk of dangerous blood clots, Public Citizen has petitioned the agency to withdraw the Johnson & Johnson product over a six-month transition period in which the healthcare giant is urged to release a newer formulation. (Look here).
The consumer group argues that Ortho-Evra results in 60 percent more estrogen on average exposure; greater variability in estrogen levels; a possible two-fold increased risk of venous thrombosis; increased risk of side effects such as breast discomfort, severe menstrual pain, nausea, and vomiting; a 50 percent increased likeli...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Contraception Johnson & Johnson Ortho Evra Source Type: blogs
Fred hassan in graceland: lots of cheap options
discuss this article
When Schering-Plough shareholders show up in the oh-so convenient location of The University of Memphis next Friday for the annual meeting, their proxy statements won’t include one detail about Fred Hassan’s compensation. Although page 34 notes that the ceo received about $30 million in compensation last year, a more recent award of 836,000 options isn’t listed.
Now, the drugmaker may argue that an annual grant was also awarded last year after the proxy was filed and, unlike last year, there were no scandals causing shareholder and government scrutiny. So what’s the big deal? But consider that the l...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Featured Uncategorized CEO Pay Fred Hassan Schering Plough Vytorin Source Type: blogs
Amgen’s kevin sharer: ‘i felt real economic pain’
discuss this article
The Amgen ceo confronted an often testy group of shareholders Wednesday, his first annual meeting with investors since the biotech entered a prolonged crisis. “Last year was awful. I deeply, deeply regret that,” a calm and confident Sharer told the crowd of several hundred during an hourlong presentation at the Four Seasons Hotel in Westlake Village, California, The Los Angeles Times writes.
He also sought to reassure investors by maintaining Amgen was off to a good start this year and suggested many of Amgen’s woes should be viewed along with problems affecting all drugmakers. “I’m not making...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen CEO Pay Kevin Sharer Source Type: blogs
Glaxo accused of monopolizing wellbutrin market
discuss this article
A federal judge has certified a class action antitrust suit that accuses Glaxo of using monopolistic tactics to boost profits of its Wellbutrin antidepressant, by delaying a generic version from coming to market, The Legal Intelligencer reports.
The suit was brought by direct purchasers who claim Glaxo devised a scheme to keep Wellbutrin prices high by making fraudulent assertions to the US Patent and Trademark Office and by engaging in “sham” patent litigation against generic drugmakers, the paper writes.
According to the suit, the plan worked because the patent litigation delayed the market entry of generic v...
Source: Pharmalot - May 8, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Drug Wholesalers Generics GlaxoSmithKline Wellbutrin Source Type: blogs
Lsd and the corruption of medicine (part ii): the entanglement of academia
discuss this article
This study study suggested that this was ‘particularly effective for democratically-run membership organizations, which need to assure their own unwitting members and collaborators, as well as their hostile critics, that they have genuine, respectable, private sources of income.’ (US Senate 1976: 182-183)[5]In some cases funding was passed through ostensible research foundation auspices to conceal the source of funding from the researcher's institution[3,17] even if the researchers themselves were aware.It is undoubtedly the case that a few of these academics did not know the true source of funds. As pointed out in the...
Source: Scientific Misconduct Blog - May 7, 2008 Category: Pharma Commentators Tags: LSD and the corruption of academia Source Type: blogs
From the lab to the ice cream counter
discuss this article
What is former research scientist Gal Hever doing with those big spoons? The 35-year-old opened an ice cream parlor after being laid off by Amgen, which is in the process of shedding 2,600 jobs to cope with its crisis. His plight reflects the problems that will be picked over at Amgen’s annual meeting today. As CNBC’s Mike Huckman notes, some shareholders are unhappy and want to bounce Amgen ceo Kevin Sharer. You can watch here. (Source: Pharmalot)
Source: Pharmalot - May 7, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen Kevin Sharer Source Type: blogs
Glaxo tries to corner the market on weight loss
discuss this article
The drugmaker, which sells the Alli over-the-counter fat pill, has filed a citizen’s petition in hopes of convincing the FDA to change the rules governing health claims made by dietary supplement manufacturers. The gambit turns on the notion that weight-loss supplements should be vetted for claims that address a disease - and in this case, being overweight is a risk for various diseases.
In its petition (look here), Glaxo argues any claims that a supplement will reduce a risk factor for disease is, in fact, a disease claim and, as a result, weight-loss supplement manufacturers should be forced to substantiate their c...
Source: Pharmalot - May 7, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Alli Diet Pills dietary supplements Fat Pills GlaxoSmithKline Obesity Weight Loss Source Type: blogs
Glaxo threatens not to invest in massachusetts
discuss this article
Glaxo is playing hardball with Massachusetts. Chris Viehbacher, who heads the drugmaker’s North American pharma biz, sent what The Boston Herald calls “harshly worded letters” to three state politicans to accuse the state of a “strong anti-biopharmaceutical streak” and complains of attempts to “attack and demonize the industry.”
His ire was prompted by Senate President Therese Murray’s proposed ban on gifts to docs and, in his letters, Chris suggests Glaxo may not invest as much in the state if “political developments…devalue” assets there. His missives arri...
Source: Pharmalot - May 7, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Chris Viehbacher Freebies Gifts GlaxoSmithKline Massachusetts Sales Reps Sirtris Pharmaceuticals Source Type: blogs
How the fda will spend some pdufa fees
discuss this article
Where will the money go? Well, the agency says it will significantly expand its postmarketing safety activities, adopting new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act, FDA News reports.
The agency plans to spend fees to fund epidemiology “best practices” and data acquisition ($7 million in fiscal 2008, increasing to $9.5 million in fiscal 2012); new drug trade name review ($5.3 million in fiscal 2008, rising to $6.5 million in fiscal 2012); and risk management and communication ($4 million in fiscal 2008, rising to $5 million in fiscal 2012), accordi...
Source: Pharmalot - May 7, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Adverse Event Reporting Adverse Events Drug Safety PDUFA Source Type: blogs
Pharmalot… pharmalittle… catching up
discuss this article
Do you remember what the Morning Mayor used to say? Every brand new day should be unwrapped like a precious gift. So go ahead, open yours. And after you do so, grab a cup of something refreshing and take a peek at these…
Baxter Says Heparin Legal Costs Are Insignificant (The Chicago Tribune)
Roche Targets Diabetes To Replace Cancer Sales (Bloomberg News)
FDA Panel Rejects Wider Use of Cephalon Drug (Yahoo/Reuters)
Teva Seeks Judgment On Nexium Patents (Yahoo/Reuters) (Source: Pharmalot)
Source: Pharmalot - May 7, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized AstraZeneca Baxter International Cephalon Fentora Heparin Nexium Ranbaxy Laboratories Roche Teva Pharmaceuticals Source Type: blogs
Us attorneys probe schering-plough over vytorin
discuss this article
How many and from which offices? The filing with the Securities and Exchange Commission doesn’t specify. We asked a Schering-Plough spokeswoman for clarity, but until we receive a reply, we are left to wonder whether this involves a securities matter, healthcare reimbursement or, perhaps, both.
To an extent, this is not surprising. As Schering-Plough notes in the filing, “Schering-Plough, the joint venture and/or its joint venture partner, Merck, have received a number of governmental inquiries and have been the subject of a number of investigations” concerning Vytorin. And most, but not, all of this has ...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Featured Uncategorized Enhance Fred Hassan Merck Robert Kirsch Schering Plough Vytorin Source Type: blogs
Quiz question - who produced lsd for the cia and mk-ultra in 1954?
discuss this article
Before I post episide II of the MK-ULTRA story and its relevance for University contracting (See: LSD and the corruption of medicine -Part I), Matt Holford prompted me to find out who produced LSD for the MK-ULTRA sponsored torture studies. In my previous post I implied that Sandoz remained the source. In fact CIA documents show that a U.S. source for LSD supply was desired. In 1953 the CIA provided Eli Lilly with funding to attempt synthesis of LSD for CIA use without the need for the expensive and scarce reagents required by Sandoz. A year later, Lilly chemists succeeded in their quest, and subsequent supplies were from ...
Source: Scientific Misconduct Blog - May 6, 2008 Category: Pharma Commentators Tags: Eli Lilly LSD and the corruption of academia Source Type: blogs
Another axe falls: medtronic to cut 1,100 jobs
discuss this article
We mostly write about drugmakers throwing people overboard, but today it is a devicemaker. The move comes after a protracted slowdown in sales of implanted cardiac defibrillators, which has been shrinking ever since Medtronic and its rivals recalled product three years ago. And last year, Medtronic halted sales of the thin wires that connect the heart to defibrillators after links to five deaths.
Medtronic already began cutting back last year, a step that included trimming 900 jobs, The Minneapolis Star-Tribune reports. The latest job losses will hit R&D and manufacturing. For example, the company intends to move card...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized jobs Layoffs Medtronic Source Type: blogs
Npr: on the air, but not in the open
discuss this article
The latest saga of an undisclosed connection between experts and pharma comes to us courtesy of Slate. This is how a new piece begins: A few weeks ago, devoted listeners of National Public Radio were treated to an episode of the award-winning radio series The Infinite Mind called “Prozac Nation: Revisited.”
The segment featured four experts discussing the controversial link between antidepressants and suicide. In their considered opinions, all four said that worries about the drugs have been overblown, Slate writes. The radio show, which was broadcast nationwide and paid for in part by the John D. and Catherine...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized andrew leuchter center for medicine in the public interest fred goodwin manning selvage & lee nada stotland national public radio npr peter pitts the infinite mind Source Type: blogs
Canadian patent rule would delay generics
discuss this article
A new set of patent rules proposed by the federal government would delay generic versions of Lipitor, Viagra and several other blockbuster drugs by as much as two years, The National Post reports. And generic drugmakers, not surprisingly, are warning the effort will cost consumers and taxpayers tens of millions of dollars annually.
The government says the regulations would simply restore fairness and stability to the brand-name industry after two court rulings put unexpected new curbs on the practice of “evergreening,” which involves filing new patents on a drug in an attempt to stave off generic competition. G...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Canada Generics Source Type: blogs
Us kids use antipsychotics more than in the uk
discuss this article
American children take antipsychotics at about six times the rate of children in the UK, according to a comparison based on a study published in Pediatrics.
But does this mean kids in the US are being overtreated? Or are Uk children undertreated? Experts say that’s almost beside the point, because use is rising on both sides of the Atlantic, Reuters reports. And with little long-term safety data, the drugs may be overprescribed for children in both countries, research suggests.
In the study, there were 595 antipsychotic scrips for kids in 1992, or a rate of fewer than four children per 10,000 using the drugs. By 200...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Adolescents Antipsychotics Pediatrics Risperdal Thioridazine Source Type: blogs
China: baxter is obstructing heparin probe
discuss this article
This is the international version of the blame game. Last month, Chinese officials voiced doubt that a contaminant identified in Heparin caused 81 deaths and severe allergic reactions in hundreds of Americans, and suggested the problem could have occurred in the US. Now, they insist the Chinese-made blood thinner wasn’t to blame and accused Baxter International of obstructing an investigation.
“Apart from the US and Germany, more than 10 other countries using heparin products containing the ‘heparin-like substance’ have not reported adverse reactions,” China’s Food and Drug Administratio...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Baxter International China Heparin Source Type: blogs
How to bank $41 million: delay the vioxx deal
discuss this article
Last November, Merck reached a $4.85 billion settlement to cover most Vioxx lawsuits in the US. As with any such deal, of course, there are stipulations, including one that calls for Merck to deposit $4.1 billion in an escrow fund by a certain date. In this case, the money was to have been deposited by April 16, based on a clause citing to two items - an enrollment date and a walk-away right.
Here’s how it works: the settlement agreement gave Merck until February 29 to convince 85 percent of the eligible claimants to participate in the deal. However, the drugmaker can exercise its right to walk away from the settleme...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Featured Uncategorized Merck Vioxx Source Type: blogs
Fda won’t test all drugs for psychiatric problems
discuss this article
Despite recent reports that may have suggested the agency is eyeing suicidality studies for drugs across the board, one FDA official says that just isn’t happening.
“That’s simply not true,” John Jenkins, who heads the FDA’s Office of New Drugs, tells The In Vivo Blog. “It’s being done in a targeted manner, wherever it seems to be appropriate based on what we’ve seen from other products in the class, the pharmacology of the drug itself, or other studies of that same drug.”
Although the agency is investigating Merck’s Singulair, for instance, not every new asthma or allergy drug will be s...
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized John Jenkins Merck Psychiatric Side Effects Singulair Suicide Source Type: blogs
Pharmalot… pharmalittle… good morning
discuss this article
The sun is shining on the nation’s medicine chest this morning. And so as we reach for our first cup of stimulation, please join us in catching up on events. We hope your days goes well - meetings, deadlines and assorted pressures aside…
Pfizer Drops NicOx Glaucoma Drug (Yahoo/Reuters)
Long-Term Ibuprofen Use Cuts Alzheimer’s Risk (Reuters)
Glaxo Creates New Venture Fund (The In Vivo Report)
Lilly Discovery Could Help Control ‘Hunger Hormone’ (Indianapolis Star)
Teva Profit Weighed Down By CoGenesys Charge (Globes)
Roche Moves 300 US Jobs To Germany (Associated Press) (Source: Pharmalot)
Source: Pharmalot - May 6, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Alzheimers Eli Lilly GlaxoSmithKline NicOx Pfizer Roche Teva Pharmaceuticals Source Type: blogs
Merck is cutting 1,200 sales reps
discuss this article
Battered by the drop in Vytorin and Zetia prescriptions, as well as the unexpected rejection of its follow-up Cordaptive cholesterol pill, the drugmaker is cutting still more jobs. This comes on top of a companywide reorganization that was begun in 2005 that, at the time, involved eliminating approximately 7,000 positions.
“Merck is taking this step as part of our previously disclosed, continuing efforts to optimize our cost base and improve Merck’s effectiveness and efficiency across all aspects of our business as part of our Plan to Win strategy,” Ken Frazier, president of the global human health unit, ...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Source Type: blogs
Data retrieval a major challenge for pharma, survey finds
discuss this article
QC and drug safety demand quick information access, but the drug industy still has some issues in managing data, the precursor to managing knowledge.
A recent survey of 1000 professionals (228 of them working for the drug industry) by the software firm, QKnow Technologies, found that retrieving information was a major problem across all industries, but particularly [...] (Source: On Pharma)
Source: On Pharma - May 5, 2008 Category: Pharma Commentators Authors: pharmamanufacturing Tags: Miscellany The Pharma Industry Information Technology and Software Source Type: blogs
Pfizer: “our time to run new chantix ads”
discuss this article
The new campaign appears to replace the “My Time To Quit” ads that ran after links to suicide were reported earlier this year. A Pfizer spokesman tells us the drugmaker is “exploring” advertising Chantix again in various print and TV outlets after holding talks with the FDA, and claims the ads are being revived because smoking is a public health problem and the ads prompt smokers to talk to docs about quitting.
This comes just three months after the FDA issued a health advisory about abnormal behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior with Pfizer’s anti-smoking drug, new...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Chantix DTC Ads DTC Advertising Pfizer Source Type: blogs
Will outsourcing cool off? a recent poll finds…
discuss this article
Some may view this as a bit of surprise - 52 percent of companies plan to boost their outsourcing spend by 6 percent or more, compared with 62 percent last year, according to Contract Pharma, which surveyed more than 175 R&D, quality control, regulatory affairs and clinical research heads, among others.
Last year, 22 percent of total respondents believed that they’d spend the same or less on outsourcing in the coming year; this year, that number dropped to 16 percent. Last year, 30 percent of respondents reported they’d increase outsourcing spending by 10 percent or more in the coming year; that number d...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Source Type: blogs
Wal-mart: generics at $10 for a 90-day supply
discuss this article
The world’s biggest retailer will offer about 350 generic meds at the low price and, according to a statement, has also added $9 meds to treat breast cancer, menopause and hormone deficiency as part of a plan to save women more than $100 million annually. Here’s the list of drugs.
The retailer, which started its $4 generic program in 2006, faces growing competition from Kmart, Walgreen, and CVS/Caremark, which are targeting Americans who lack insurance to pay for their drugs, Bloomberg News notes, adding that nearly a third of Wal-Mart’s over-the-counter drugs now sell for $4 or less.
“We are tryin...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized CVS/Caremark Generics Kmart Wal Mart Walgreen Source Type: blogs
The new psychiatric bible and author conflicts
discuss this article
More than half the 28 new members of writers of the next edition of the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) have ties to the drug industry, according to the Center for Science in the Public Interest’s Integrity in Science Watch.
The conflicts of interests were posted online by the APA last week (look here). They ranged from small to extensive. Leading the pack was William Carpenter Jr., director of Maryland Psychiatric Research Center at the University of Maryland, who over the past last five years worked as a consultant for 13 drugmakers, includi...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders DSM V Source Type: blogs
J&j’s infantile plan: no babies at ‘camp baby’
discuss this article
When J&J recently decided to woo a group of influential women who blog about family life, it spared no expense. J&J zeroed in on more than 50 women who write widely read blogs about child-raising and related topics, and invited them to “Camp Baby,” a three-day retreat held last month near its New Brunswick, New Jersey, headquarters, The Star-Ledger of New Jersey writes.
To sweeten the deal, free plane tickets and lodging were offered at the upscale Heldrich Hotel, named for a former J&J exec. Scheduled events included a wine tasting with “Queer Eye for the Straight Guy” alum Ted Allen...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Camp Baby Johnson & Johnson Source Type: blogs
Whither cordaptive? merck may have a long wait
discuss this article
After the FDA rejected the drug, which was to have revived Merck’s cholesterol franchise, its shares plunged. The pill contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a common reaction to niacin. But the drugmaker offered no insights into the rejection, leaving Wall Street to speculate - and the speculation isn’t optimistic.
In an investor note this morning, Catherine Arnold of Credit Suisse writes that the “laropiprant component of Cordaptive presumably had cardiovascular signals. Even though this may have been in very small numbers, th...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Catherine Arnold Cordaptive Merck Zocor Source Type: blogs
To counter sales reps, insurers push step therapy
discuss this article
The battle to lower prescription drug costs is causing still more friction between doctors and insurers. Take the case of Lloyd Negoescu, who took Lopressor to stabilize his blood pressure, until his Medicare Part D plan changed, and his new insurer, RxAmerica, stopped paying for the brand-name med.
His doctor wrote letters to appeal, to no avail. “They wanted me to try generics first. My blood pressure went up astronomically on the new drugs,” the 57-year-old disabled man tells The Star-Ledger of New Jersey. Negoescu is an example of what’s known as step therapy - requiring patients to try and fail with...
Source: Pharmalot - May 5, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Aetna Generics New Jersey Step Therapy Switching Medicines Source Type: blogs
Unemployed in terms of science
discuss this article
A bit of cleaning, and I came across this minor bit amusement from a year ago. It is a postal invitation from Procter and Gamble to attend their sponsored satellite meeting at the 2007 International Bone and Mineral Society meeting in Montreal. This is the meeting at which data was presented showing very poor concordance between the "findings" reported by P&G in the third of their three "scientific" Sheffield publications, and the actual underlying data (when it was revealed to "authors"). In fact there was little meaningful concordance.I guess the meeting organizers had sold the list of registered attendees to P&G, and th...
Source: Scientific Misconduct Blog - May 4, 2008 Category: Pharma Commentators Tags: Amusement Source Type: blogs
Lsd and the corruption of medicine (part i): invention and the beginnings of mk-ultra
discuss this article
Albert Hofmann, the inventor of LSD died last week (on Apr 29 2008) at age 102 [1]. The invention of LSD is of considerable importance to any discussion about the corruption of science in medicine. The seeds for many of the current problems of medicine lie in the story of LSD and a mysterious organization called MK-ULTRA. Hofmann's invention was the stimulus underlying a program of research which involved murder and the torture of tens of thousands of unwitting human participants. MK-ULTRA set the standards for later industrial-university collaboration. It set the most important precedent for the collusion of academic lead...
Source: Scientific Misconduct Blog - May 4, 2008 Category: Pharma Commentators Tags: LSD and the corruption of academia Source Type: blogs
Drugmakers haggle with uk over pricing scheme
discuss this article
The pharmaceutical industry is taking a tough line in negotiations on drug pricing, offering to cut the $20 billion National Health Service bill for prescription medsl by roughly half the amount sought by the government, The Daily Telegraph writes.
In secret negotiations, industry leaders have offered to cut the price of patented drugs by under 5 per cent, significantly less than the 10 per cent to 12 per cent that the government is seeking. However, the Association of the British Pharmaceutical Industry sweetened the deal by cutting the price of drugs that come off patent but have no significant generic competition. And t...
Source: Pharmalot - May 4, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Association Of British Pharmaceutical Industry AstraZeneca Shire Pharmaceuticals Source Type: blogs
Fda collects singulair suicide stories
discuss this article
The agency interviewed a couple from upstate New York whose son committed suicide as part of its investigation into side effects associated with the Merck allergy drug, The Albany Times-Union reports. And as a result of the meeting, the couple has agreed to pass along to the FDA anecdotal info they’ve started to receive from parents whose children began acting strangely after taking the drug.
Kate and Dave Miller have been trying to raise awareness about potential side effects of the drug since their 15-year-old son, Cody, killed himself last August. The teen had taken the med for less than three weeks to treat seaso...
Source: Pharmalot - May 3, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Merck Singulair Source Type: blogs
Quote of the week: pharma has a black eye
discuss this article
At this point, former Merck ceo Roy Vagelos is arguably the elder statesman in the pharma biz, and he’s not shy about voicing some opinions. Sure enough, he shared a few while delivering a keynote speech this week at the annual meeting of the International Society for Medical Publication Professionals, which CNBC’s Mike Huckman dutifully noted in his blog.
“Most drugs are a terrific bargain,” says Vagelos, and he believes that high prices are justified if the drug offers high value. But he went on to say that he has a problem with the $50,000 price tag for a drug that adds four months of life. He di...
Source: Pharmalot - May 2, 2008 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Merck Prices Pricing Roy Vagelos Source Type: blogs
