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First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its Fluflix campaign) asking people to submit videos about what it's like to have the flu. Earlier this year, Insmed upped the ante by posting a video lobbying for new legislation for the approval of follow-on biologics in the US. However, these pharma assaults on YouTube pale in comparison to the launch of Johnson & Johnson’s health channel on YouTube earlier this week.

The channel currently showcases a small selection of health information videos created by NBC News chief medical editor Nancy Snyderman while she worked J&J. Video sites, like YouTube and Vimeo, offer pharma companies a place to feature expensive off media advertising assets (that are currently collecting dust) and to post ads for new drugs and products that are ready for launch.  J &J is the first pharma company to recognize that it can leverage the current social media craze to increase its visibility, sell more drugs and bolster its stock price!

While companies could host videos on their own websites,YouTube’s massive traffic of more than 80 million users offers companies a much larger and diverse audience. And unlike blogs or forums, pharma companies have complete control over the content of the videos that they post on video websites. Moreover, they don't have to worry about negative comments being left after a post (YouTube comments can be turned off), and they can brand and edit video content to target a particular demographic or audience. Finally, videos can be changed or removed by companies as needed.

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In case you didn’t know, chocolate is big business. Do you know of anybody who doesn’t like to snack on a piece of chocolate from time to time? Because of the growing incidence of tropical diseases, pests and global climate change, Mars, the giant candy maker (M&Ms, Snickers), announced that it will sequence and analyze the cocoa genome (cocoa is the key ingredient in chocolate) to “to discover genetic building blocks of traits like disease and pest resistance, drought tolerance and perhaps flavor.” The likely long term goals of the project are to identify ways reduce cultivation costs and increase crop yields.

Another reason why Mars is keen on the project (at least according to the corporate press release) is to protect the livelihood of more than 6.5 million cocoa growers, mostly family-run farms,70% of which are in Africa. 

Mars is working with the US Department of Agriculture (USDA, sequencing) and IBM (data analysis) on the project. The results of the research will be free through the Public Intellectual Property Resource for Agriculture.

I hope that the cocoa genome project is successful. What would the world be like without a copious supply of chocolate?????

Until next time…

Good Luck and Good Job Hunting!!!!!!

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Have you ever felt like mixing up a few batches of DNA in your  spare time? Well, for those of you who sometimes get the urge I found an easy-to-use recipe to make your own custom designed DNA sequences. Of course I was joking about doing it at home but if you happen to be at the University of Wisconsin-Madison Biotechnology Center you can give it a whirl.

Of course, the ability to build DNA sequences nucleotide-by-nucleotide has been available for over a decade or more.  That said, the relatively simple system devised by scientists at the UW Biotechnology Center allows even the neophyte molecular biologist to do it successfully.

Until next time…

Good Luck and Good Genetic Engineering!!!!!!

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Having been called a “smartass” most of my life, I found a recent post entitled the “Science of Sarcasm” by Karen Ventii (who runs the Science to Life Blog) fascinating. After reading it, I have yet to figure out why I am a smartass, but at least I know what part of the brain may be responsible! This is what Karen wrote:

A new study aimed at confirming the region of the brain that is important in detecting sarcasm may open the door for new diagnostic tools in detecting mental illness, according to an article in The New York Times.

Study leader Katherine P. Rankin, a neuropsychologist and assistant professor in the Memory and Aging Center at the University of California, San Francisco, used MRI (magnetic resonance imaging) technology and a language test to highlight the region of the brain where the ability to detect sarcasm resides.

The findings, which were presented at the American Academy of Neurology's annual meeting, showed that the 'sarcasm center' is located in the right parahippocampal gyrus.

So, why is this research important?

The ability to perceive sarcasm is linked to one of the most important aspects of human social relations: the ability to figure out what others are thinking. This ability to detect sarcasm is characteristically lost very early during the course of frontotemporal dementia. To date, early detection of this type of dementia has been difficult because afflicted individuals can still perform perfectly well on traditional neuropsychological tests early on in their disease. Therefore, studies like this could help neurologists develop new tools to diagnose and track the early stages of this illness.

During the study, researchers used linguistic cues to localize the sarcasm detection region to the right hemisphere. This is interesting because the brain's language and social interaction centers were previously thought to be located on the left side while the right was known to specialize in a visual context.

This led researchers to propose new functions for the right side of the brain. "It's now thought that the appreciation of humor and language that is not literal, puns and jokes, requires the right hemisphere," said Dr. Anjan Chatterjee, an associate professor in the Center for Cognitive Neuroscience at the University of Pennsylvania.

This current study corroborates previous findings suggesting that the front and right regions of the brain work together to comprehend sarcasm.

Until next time…

Good Luck and Good Job Hunting (remember to keep the sarcasm at a minimum during job interviews!)!!!!!!!!!

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I want to thank Emily who sent me the following comment about red yeast rice.

"Red yeast rice is rice that has been fermented by the red yeast, Monascus purpureus. It has been used by the Chinese for many centuries as a food preservative, food colorant (it is responsible for the red color of Peking duck), spice, and ingredient in rice wine." Based on this information, I clearly had eaten some red yeast rice during my recent trip to China.

My friends and I ate Peking Duck in a restaurant in Beijing (recommended by a Chines chef ) that is  famous for it--I even have a certificate that indicates the number of the duck that we ate--the restaurant keeps track of every duck that it has served for the past 50 years or so!  That said, I doubt that the amount of red yeast rice used to prepare Peking Duck is not enough to counteract the negative effects of duck fat on cardiovascular health.  Nevertheless, my knowledge of its positive effects on the cardiovascular system will help to assuage some of the health concerns that I may have the next time I order Peking Duck in my favorite Chinese restaurant.

Until next time...

Good Luck and Good Eating (try Chinese--it's good for you)!!!!!!!!!!

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You may recall that last August, Johnson & Johnson sued the Red Cross for inappropriate use of its symbol —the red cross—that has universally become associated with the non-profit relief agency. that they reached a settlement in the dispute over the mark. Not surprisingly, a settlement was reached shortly after a judge threw out much of J &J’s trademark claim against the Red Cross. Of course, as it typically in these cases, the terms of the settlement were not disclosed.

J & J brought the suit against the Red Cross, because, starting in 2004, the Red Cross started licensing the symbol to other companies for use on commercial items sold in stores as part of the organization’s fund-raising program. J& J argued that the organization had promised not to engage in certain commercial activity—a part of the original trademark agreement that was struck between the drugmaker and relief agency almost 100 years ago. However, the judge presiding over the case ruled that Congressional charter gave the Red Cross the right to use the symbol even for business purposes.

Although J & J looked incredibly avaricious and took a PR hit by suing the Red Cross for trademark infringement, the company claimed that it had the right to vigorously protect its trademarks—after all, business is business. However, as several patent and trademark attorneys have repeatedly told me, it is advisable to settle or reach an agreement before any case goes to trial—you just never know what a judge is going to rule even if you think that you have a rock-solid claim! I guess J & J needs to hire some new attorneys!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

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This may be one of the more notable years for Salmonella food poisoning. First, there was a modest outbreak in the eating clubs at Princeton University and now a larger outbreak in Texas and New Mexico. This is the first time that I can recall in my almost 30 years as a card-carrying food microbiologist that there has been this many highly-publicized cases of Salmonella food poisoning in one year. Although I don’t wish Salmonella gastroenteritis on anybody, it is kind of rewarding that an organism that led to my PhD is making headlines once again. Typically, Salmonella outbreaks are not noteworthy and rarely receive much notice— usually taking a backseat to potentially life-threatening outbreaks of enteropathogenic Escherichia coli.

Like the Princeton outbreak, the exact source of the Salmonella infection is unclear. That said, public health and CDC officials are leaning towards large, raw tomatoes. In 2006, the Food and Drug Administration discovered that consumption of tomatoes in restaurants had caused a salmonella outbreak that affected 21 states. , “until the source of the outbreak is identified federal and local health officials in both states have recommended that infants, the elderly and anyone with an impaired immune system avoid eating Roma and red round tomatoes that are not grown at home or sold attached to the vine.” So far, 40 confirmed cases, with patients ranging in age from 3 to 82, have been reported in New Mexico and Texas since April. To date, 17 people have been hospitalized, but no deaths have been reported.

Molecular analyses indicated that all of the cases in New Mexico and Texas were caused by the same strain, a relatively rare serovar called Saint Paul (6^th most common serovar infecting humans). Federal health officials at the Centers for Disease Control in Atlanta, GA fear that this may be the beginning of a large national outbreak of Salmonella gastroenteritis. This is because about 30 cases caused by the Saint Paul strain, have also been reported this year in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas and Utah. Like the New Jersey, Texas and New Mexico outbreaks, the cause of those other outbreaks is under investigation.

Salmonella gastroenteritis generally last between four and seven days, and most people are able to recover without medical (antibiotic) treatment. But, it can sometimes lead to death in immunocompromised adults or young children. Symptoms include headache, nausea, abdominal pain, diarrhea and sometimes vomiting.  Although textbook descriptions of the pathogenesis of Salmonella gastroenteritis generally portray it as a mild illness, I can tell you that people I know (lab mates of mine) who came down with the disease (gee, how did that happen?) suggest otherwise!

I suspect that fecally-contaminated water may be source of the infection. But, then again, it has been almost 30 years since I thought about Salmonella gastroenteritis. That said, I don’t think that you ever forget the essence or minutiae of your thesis work!

For those of you who are interested, the electron micrograph of Salmonella typhimurium shown with this post is from my PhD dissertation. As I recall, the electron micrograph was taken in 1980 and the bacterium shown in the micrograph was grown for 48 hours on nutrient agar . Althought I would like to take credit for the shot (nice pose eh?),  it was taken by Phil Hegge in the Department of Bacteriology at the University of Wisconsin-Madison, my alma mater. if you look closely you may be able to see fimbriae along with the flagella.

Until next time

Good Luck and Good Job Hunting (and remember to wash your tomatoes)!!!!!

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Karen Ventii is a science/ medical writer and blogger—Science to Life blog—based in Atlanta GA. She is currently working on her Ph.D. in the field of cancer biochemistry at Emory University. Karen has posted some really cool stuff on her blog. I thought it would be fun to bring a younger perspective to my blog (especially on topics that I know very little about). So, let me know what you think about the following post!

Google Health, the latest service from Google, was launched about three weeks ago as a beta version. Online personal health services have been around for a while (including Revolution Health and Microsoft's HealthVault) but here's what Google says is different about theirs:

1. Portability: Through Google Health, you will be able to have access and control over your health data from anywhere. People who travel will be able to move health data between their various health providers seamlessly and with total control.

2. Ease of use: Clean, easy-to-use user experience that makes managing your health information straightforward and easy.

3. Partnerships: Due to the integration of third-party services you'll be able to automatically import information such as your doctors' records, your prescription history, and your test results into Google Health in order to easily access and control your data. In the future you will be able to do things like schedule appointments and refill prescriptions.

4. Security: Google Health will protect the privacy of your health information by giving you complete control over your data.

I was particularly curious about the security issue. Google Health is not regulated by HIPAA (Health Insurance Portability and Accountability Act)-the national policy on health information privacy-because Google does not provide health care services.

In an Associated Press article, Pam Dixon, executive director of the World Privacy Forum, said that by transferring records to an external service, patients could unwittingly make it easier for the government, a legal adversary or a marketing concern to obtain private information.

Google has provided a chart describing how their data confidentiality practices compare to those mandated by HIPAA. I am no expert on health information security but based on this chart, Google's policies appear fairly similar to HIPAA's.

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I apparently made a few errors in the post about the recent Salmonella food poisoning outbreak at PU (pun intended). I want to thank the anonymous member of the Princeton Graduating Class of ’09 for pointing out the inconsistencies and errors in the post.  First, the so-called “dining clubs” are actually called eating clubs. Second, fraternities and sororities are allowed at PU and I hear that they are alive and well. Finally, I inadvertently noted that the University has severed contracts with several of its produce suppliers which may have been the putative source(s) of the outbreak. In fact, the University didn’t cancel contracts but only temporarily closed a few of the eating stations at the Frist Campus Center. My local newspaper reported that contracts where severed–I guess you truly can’t believe everything that you read!

I was duly chastised for not adequately verifying my information before I hastily crafted the post. I stand corrected and will attempt to be more vigilant in the future. That said, I think that my lack of understanding of the practices and customs at Princeton University is directly related to the fact that I attended Cornell as an undergraduate. Mea Culpa!

Until next time…

Good Luck and Good Job Hunting!!!!!

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It looks as though Enzon Pharmaceuticals, the first company to successfully commercialize protein PEGylation, finally buckled under the pressure exerted by Carl Icahn, one of its major shareholders.  As I mentioned in a previous post, Carl recently started buying large blocks of Enzon stock to gain a controlling interest in the company to maximize shareholder value. To accommodate Icahn’s "vision" and demands, Jeff Buchalter, Enzon’s Chairman and CEO has decided to spin out a new biotechnology company.  According to an Enzon press release, the new company (to be named later) will get Enzon’s core technology (PEGylation) and its entire preclinical pipeline (i.e.; their RNA antagonist oncology portfolio). Enzon will also invest $150m in the new venture.

So, what does Enzon get out of the deal? It retains ownership of a small, aging manufacturing facility and a portfolio of nominally-performing specialty pharma drugs. I think comments made by Eben Tessari, a financial analyst who follows Enzon, sums up of the essence of the proposed spin out.  He writes: “Maybe I’m way off here but it seems to me in analyzing this deal that the new company gets all the goodies while Enzon is left with a manufacturing plant and a stable of marginal drugs (zero out of four therapies have over $50m a year in revenue). Now, I don’t mean to imply that I think Enzon is a bad company - hell, they’ve managed to make more profit this quarter than any pharma company I’ve ever worked for - I’m just saying they are selling their future based on the advice of a man notorious for breaking up companies and wringing every last dime out of a shakeup.”

Not surprisingly, Jeff Buchalter, the brains behind the deal, thinks it will provide Enzon shareholders with the value that they demand. “By separating these unique businesses into two focused companies, the opportunities for both the specialty pharmaceutical business and the biotechnology business could be substantially enhanced and greater value could be created than under the current structure. Operating separately will allow each company to benefit from greater strategic and managerial focus and appeal to their own unique shareholders. The separation will enable the two businesses to compete more effectively in their respective markets and optimize their business goals, research initiatives and capital requirements. We look forward to creating this opportunity for the shareholders,” said Buchalter.

Jeff, who learned how to turn around failing companies from his former boss Fred Hassan (turn around specialist and current CEO of Schering Plough) ought to know a little something about value. According to SEC filings, last year Jeff made $773,558 (base salary) with $1,162,500 in bonuses for a total cash compensation of about $2 million. In addition, Jeff received just over $3.1 million in equity bringing his total 2007 compensation package to approximately $5.2 million —almost 3 times the amount received by any other Enzon executive.  Not that there is anything wrong with that!!!!!!!!!!!!

Until next time….

Good Luck and Good Job Hunting (try Enzon’s spin out, they are flush with cash)!!!!!!

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The first biosimilar version of granulocyte colony stimulating factor (G-CSF) received a positive opinion from EMEA last month.  The European commission is expected to grant marketing approval for the product in the EU. The product, developed by Israel-based Teva, a global generics manufacturer, will be sold under the brand name TevaGrastim. The company is seeking EU approval for TevaGrastim a as treatment of chemotherapy-induced neutropenia.  

Amgen’s Neupogen, the innovator product, yields annual revenues of approximately $300 million in the EU. Teva hopes to cash in on a piece of that action. It appears that biosimilars are alive, well and making money in Europe!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Yes, even the Ivy League isn’t immune to food poisoning outbreaks from time-to-time. There are currently 10 confirmed cases of Salmonella food poisoning at Princeton U. Another 50 people or so have also fallen ill with gastrointestinal symptoms consistent with Salmonella food poisoning.  As a precaution, university officials have temporarily discontinued doing business with their produce suppliers. For those of you who don’t know, Princeton is famous (infamous?) for its so-called dining clubs. These clubs take the place of sororities and fraternities which are not allowed at this august institution of higher education. Obviously, there is more than eating that goes on at these “dining clubs.”

The reason I am blogging about the outbreak is two-fold. First, I live about seven miles from Princeton and it has been all over the local news. Second, I did my PhD work on the pathogenesis of Salmonella gastroenteritis. So, Salmonella food poisoning is dear to my heart (thankfully, not my gastrointestinal tract). Many infectious disease experts tend to dismiss the seriousness of Salmonella gastroenteritis. This is likely because it is usually not as devastating as shigellosis or infections caused by enteroinvasive strains of Escherichia coli (which is actually Shigella masquerading as E. coli). As my major professor once put it “You know when you have Salmonella gastroenteritis—if you can’t decide than it is not salmonellosis.”

I am happy to report that I never came down with gastroenteritis while working for over three years with enteroinvasive Salmonella strains (even though I was routinely mouth pipetting and eating lunch in the lab; practices which aren’t acceptable by today’s standards). I like to think that “the bugs” were afraid of me. Alternatively I had either a great immune system or extremely good aseptic techniques. Whatever the reason, it is always embarrassing when card-carrying microbiologists come down with the disease(s) that they are studying. Luckily, I never came down with the disease caused by the bacterium that I was studying during my first postdoctoral fellowship—Neisseria gonorrhoeae. That would have been extremely difficult to explain!

Until next time…

Good Luck and Good Job Hunting (remember to wash your hands)!!!!!!!!

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Brand name pharmaceutical and biotechnology companies have been quietly spending millions to lobby Congress for changes in US patent law. Specifically, these companies want to overhaul the intellectual property rules dealing with the doctrine of “inequitable conduct”. When a company or individual engages in inequitable conduct, it means that the company or individual has misrepresented or concealed information with the intent to deceive the US Patent and Trademark Office (USPTO). In such cases, a federal judge has the legal authority to void the patent and declare that it is unenforceable. Not surprisingly, brand-name drug companies are lobbying Congress to eliminate or curtail inequitable conduct penalties. 

According to the New York Times, in the last 15 years the US Court of Appeals for the Federal Circuit (which handles appellate patent litigation) have ruled in the affirmative on 40 cases of inequitable conduct–14 of which involved pharmaceutical or healthcare companies. Similar rulings have been issued by federal district judges in an indeterminate number of cases that were not appealed (and never reached the Federal Circuit court). The article contends that some drug makers knowingly submitted false statements to the USPTO, inaccurately described experiments in patent applications or concealed information (usually prior art) that contradicted their claims. In one high profile case, the appeals court ruled that the Danish drug maker Novo Nordisk failed to disclose that it had not performed an experiment described in a patent application for human growth hormone. In another notable case, the court contends that Pharmacia (now Pfizer) used an “inaccurate and misleading” affidavit to win a patent for a new glaucoma drug.  Personally, I am aware of several instances in which companies willfully and knowingly failed to disclose prior art in patent applications that were ultimately approved.

Those of us in the biz know that patents are valuable commodities and that the financial stakes surrounding patent estates and intellectual properly are extremely high. A robust patent estate can either make or break a company. Nevertheless, in my opinion, if a company (or individual) cheats by falsifying, concealing or omitting pertinent information in a patent application, they ought to be penalized for it.  As one former USPTO commissioner, who served under George HW Bush puts it: “Patents can be very valuable. There are strong incentives to want to get them. Cheating occurs from time to time. The inequitable conduct doctrine says that if you cheated to get a patent, you should not be able to enforce it.”

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About five years ago, a friend of mine and I had an idea to form a non-profit dedicated to providing consumers with information regarding the safety of marketed pharmaceutical and biotechnology medicines.  At the time, we observed that consumers were repeatedly being misinformed about the safety and efficacy of many products, most notably follow-on biologics aka biogenerics. Unfortunately, we could not garner enough interest or financial support to get the organization off the ground. I guess that  we had a good idea, but, as usual, were a little ahead of our time. A new organization called The Coalition for a Competitive Pharmaceutical Market has recently set up shop with the same concept in mind.

Members of the coalition include insurance companies (Aetna, Humana, United Health Care and Blue Cross Blue Shield), pharmacies and drug distributors (CVS, Medco, Express Scripts, Rite Aid and Wallgreens), generic manufacturers (Barr Laboratories, Hospira, Teva, Mylan Laboratories and Watson Pharmaceuticals) and a large roster of Fortune 500 companies including General Motors, Ford, Caterpillar, Chrysler, Dow and Eastman Kodak. Think of the lobbying power–how cool is that?

I guess the time has come for rational drug pricing for the US. Big pharma and biotech beware–a nationalized healthcare system may not be far behind!

Until next time….

Good Luck and Good Job Hunting!!!!

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Has it really been 10 years since the launch of Viagra, the first drug that was approved to treat erectile dysfunction (ED)?  Why it seems like just yesterday. For those of you who don’t know, Pfizer was originally developing Viagra as a treatment for cardiovascular disease (it increases blood flow). However, members of the Viagra clinical development teams quickly observed Viagra’s unmistakable erectogenic potential and understood the impact that it would have on male sexual function for years to come.

Before Viagra’s launch in 1998, impotence, (the term previously used to describe what is now known as ED) was rarely discussed or mentioned by anyone, including many physicians. Now, with the advent of Viagra, Levitra and Cialis ED has become a part of the American lexicon.  So-called tough guys like Bob Dole to NFL players are no longer ashamed to mention that they suffer from ED now that they can take a pill to overcome the condition. All kidding aside, Viagra has helped many men with conditions ranging from diabetes, atherosclerosis to prostrate cancer. But, there is one question that I have. “Are there really that many men who suffer with ED to account for the roughly $6.0 billion per year that is spent on Viagra and related medications? 

Anyway, Happy Birthday Viagra! Maybe the little blue guy’s birthday can get a “rise” out of Pfizer’s stock today–sssshhhhhhh, let’s not put too much pressure on Viagra, it may interfere with its performance!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!!!

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Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the FDA to the punch and issued draft guidance for follow-on biologics known in Canada as subsequent entry biologics. The Canadian regulatory agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway.

If approved, a subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly- available safety and efficacy data. Product interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A meeting to review the draft document is scheduled for May. The proposed Canadian legislation is very similar to that adopted by the European Union for biosimilar products (what they are called in Europe). Not surprisingly the recently proposed US legislation is markedly different than the Canadian and European legislation. Go figure!

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Until recently, Amgen dominated the biotechnology industry and was anointed the world's largest biotechnology company.  However, Amgen recently lost its number 1 ranking to Genentech.  Over the past year or so, Amgen, which is now ranked number 2,  has been acting a lot  like Avis,  the car rental company , which in the 1970s adopted the slogan  “Avis: We Try Harder” when it was number 2 to Hertz in the car rental rankings.  Like Avis, which never overtook Hertz to claim the number 1 spot,  Amgen’s efforts to regain its number 1 ranking are failing.

Today, market analysts noted that, for the first time, Gilead Sciences had overtaken Amgen as the world's second most highly-valued biotech company. Genentech still maintains its comfortable number 1 ranking with an extraordinary market capitalization of more than $83 billion. That said, it is still somewhat of a horse race between Gilead and Amgen for the number 2 spot– as of this morning, Amgen's market cap was approximately $43.5 billion whereas Gilead's was $45.5 billion. Amgen is still ranked highest when it comes to annual revenues: $14.8 billion in 2007 versus Genentech's $11.7 billion and Gilead's $4.2 billion.

Are rankings really that important? Maybe we should ask the Georgetown and Duke men’s basketball teams after this weekend’s NCAA second round tournament games! They might have some interesting insights to share.

Until Next Time….

Good Luck and Good Job Hunting (Stay out of A Thousand Oaks)

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Basilea Pharmaceutica Ltd announced yesterday that the U.S. Food and Drug Administration issued an Approvable Letter for ceftobiprole, a first-in-class anti-MRSA broad-spectrum cephalosporin, for the treatment of complicated skin and skin structure infections including diabetic foot infections. Results from two Phase III studies involving 1600 patients with complicated skin and skin structure and diabetic foot infections showed that ceftobriprole was as effective and safe as other cephalosporin antibiotics.

The Approvable Letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections; assessment of clinical and microbiological data provided but not yet reviewed; and further characterization of patients with diabetic foot infections. Ceftobiprole is currently being reviewed by regulatory authorities in Canada, the European Union and in Switzerland. The antibiotic is being co-developed and marketed with Johnson and Johnson.

Until next time…

Good Luck and Good Job Hunting!!!!!!

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As you all know, the brackets for this year’s NCAA Men’s Basketball Tournament were revealed Sunday evening. As I have done for the past 20 years, I waited until this morning to find a detailed, printed version of the brackets to use for my office pool. That said, I was pleasantly surprised this morning to see that the sports editor of the NY Times decided to arrange the teams that did (and didn’t) make the tournament in a “basketball version” of the periodic table of the elements!

I want it on record that I am not a big fan of inorganic chemistry. However, I must admit that the New York Times rendering of team participation in this year’s tournament was innovative, creative and refreshing. Why, I bet that even Mendeleev – the guy who is credited with creating the first periodic table in 1869– would have been very pleased and proud of the NY Times’ effort! Does anybody know whether basketball was invented by 1869?

I say BRAVO to the NY Times for divining a creative way to make a connection between sports and science. I think that similar efforts ought to be attempted to convince American children (and possibly “grown ups”) that science can be “cool” and as much fun as sports! American science literacy is trending to an all time low. This trend must be reversed so that America can regain a  global competitive edge in science and engineering.

Again, kudos to the NY Times!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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According to a press release by IMS, a company that tracks pharmaceutical sales, growth of the US pharmaceutical market shrank from 8% in 2006 to a meager 3.8% in 2007–the slowest growth rate since 1961. Total U.S. prescription sales in 2007 only reached $286.5 billion. The 2007 slowdown in sales was attributed to:

• Loss of patent exclusivity for branded products
• Fewer new drug approvals
• Effect of Medicare Part D on annual growth
• Renewed focus on safety issues by US Food and Drug Administration

Industry officials place the blame for the slow down on FDA because fewer newer drugs were approved in 2007 as compared with years past. However, I believe that the slow down has more to do with:

• Higher prices of branded medications as compared with generic drugs
• Lack of public confidence in the pharmaceutical industry
• Increased scrutiny by regulators on direct to consumer advertising and continuing medical education (CME)
• Fewer and less innovative drugs in company pipelines

Bashing FDA is easy. The willingness of the pharmaceutical industry to assume ownership of some of its own shortcomings and missteps is substantially more difficult to do!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

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Who can resist those adorable black and white Giant Pandas? Late last week, the International Giant Panda Genome Project was launched by Beijing Genomic Institute-Shenzhen, China. The goal of this project is to finish the sequencing and assembling of the draft sequence within six months. 

According to the news release:” The giant panda is a much loved animal all over the world and is considered a symbol of China, as illustrated by its being one of the mascots for the upcoming Olympics in Beijing. The excitement surrounding the launch of this ambitious project, however, has been built around how this new genomic information will have extensive impact in numerous scientific areas -- from ecology to evolution to sequencing technology. Such data will aid in understanding the genetic and biological underpinnings of this unique species, especially with regard to its very specific niche in the environment and the molecular mechanisms of its evolution.”

“Of special interest is that these data will be extremely useful for protecting and monitoring this endangered species and will provide information on the impact of captive breeding. In addition, it will have considerable use in controlling diseases that could devastate these fragile populations.” For those of you who don’t know, breeding pandas is not an easy thing. In fact, according to a guy I used to work with, who is a panda breeding expert, it is more art than science. However, it may not be as arcane as he makes it out to be considering that he had a sweet consulting gig for panda breeding with the Chinese government.

The giant panda project (GPP) will be conducted by Chinese scientists as well as scientist from other countries including, Canada, Wales, Denmark and the United States! It is truly an international collaboration!

Long live the pandas!

Until next time…

Good Luck and Good Job Hunting (try GPP- China)!!!!!!

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Where have the folks at FDA been hiding for the past decade?  I thought that by now everybody had heard about multi-drug resistant bacteria and the need for new antibiotics. Why, I bet that even President Bush knows this –hmmmm– well, okay– but you get my point!

FDA announced today that it needs more data and time to evaluate Johnson and Johnson’s “new indication” NDA for its antibiotic Doribax (doripenem). The antibiotic is already approved to treat urinary tract and intra-abdominal infections. The company is seeking approval to expand treatment to cover nosocomial or ‘hospital-acquired’ pneumonia as well as ventilator-associated pneumonia.

The new application was submitted in June 2007 but the FDA’s request for new data means that the review period has been extended by at least three months. Doribax is licensed from Japanese drug maker Shionogi and is currently undergoing regulatory review in Europe, Canada and in other countries.

This delay comes less than a month after the agency cancelled a meeting of its anti-infective drugs advisory committee which was scheduled for February 28. At that meeting, the agency was scheduled to review another J&J antibiotic ceftobiprole, which is being co-developed with Switzerland’s Basilea Pharmaceutica. No reason was given by the agency for cancellation of the ceftobiprole meeting which is being evaluated as a treatment of complicated skin and skin structure infections, including diabetic foot infections.

I am not sure why FDA can’t make up its mind about the approvability of new antibiotics. They certainly had little difficulty approving Vioxx, Zyprexa and Avandia.  Maybe FDA ought to hire some more microbiologists? 

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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Maybe Pfizer executives ought to ask their doctors for Zoloft prescriptions to deal with the compulsive buying spree that they have been on for past 6 months or so. After acquiring after Encysive Pharmaceuticals just two weeks ago,  Pfizer announced plans to acquire Serenex, a privately-held biotechnology company that specializes in oncology.  Pfizer also acquired Copely Pharmaceuticals last November.

 No financial details of the deal were disclosed but Pfizer is acquiring the rights to SNX-5422, an oral heat shock protein 90 inhibitor which is currently in Phase I trials for the potential treatment of solid tumors and hematological cancers. The company is also acquiring Serenex’ proprietary drug discovery technology and “extensive small molecule Hsp90 inhibitor compound library”, which has potential uses to treat cancer, inflammatory and neurodegenerative diseases.

Surprisingly absent from the deal are the rights to SNX-1012, Serenex’ lead compound, which is for treatment of oral mucositis in cancer patients. It is scheduled to complete Phase II trials in mid-2008 and researchers working on the drug will form part of a new company that is to be spun off and owned by the current shareholders of Serenex.

I guess the adage “You can’t teach old dogs new tricks” is apt for Pfizer. I guess they still haven’t learned that bigger is always better!!! Go figure.

Until next time

Good Luck and Good Job Hunting!!!!!!!!

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The US Food and Drug Administration said Monday it still had several "outstanding issues" with televancin an antibiotic being developed by Theravance Inc and Astellas Pharma of Tokyo. to treat skin infections.

The agency had canceled an advisory committee meeting scheduled for Wednesday that was set to evaluate the drug, televancin.

In a statement, the agency said that the meeting was being canceled to "allow time for the FDA to review and resolve several outstanding issues." The FDA said it would schedule an advisory committee meeting in the future, if needed.

Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review.

Earlier this month the FDA canceled a Feb. 28 meeting for another antibiotic, ceftobiprole that would also be used to treat skin infections. That drug is being developed by a unit of Johnson and Johnson Co. and Switzerland-based Basilea Pharmaceutica Ltd. The FDA is expected to make a decision on whether to approve ceftobriprole sometime next month.

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Due to some technical problems, articles posted after February 4th, 2008 are currently unavailable. So, if you were looking for them, I apologize.  But, the good news is that the IT guys over at Lexblog, the company that built and hosts biojobblog, told me they all should be back by tomorrow AM.

Until next time (that time?).....

Good Luck and Good Job Hunting

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The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for follow-on biologics.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said "BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood added that "The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session." This is quite a policy turnaround for BIO which over the past 8 years has spent tens of millions or more lobbying against allowing follow-on biologics in the US.

Continue Reading...

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Over the past few years, I have heard rumors that artificial sweeteners like saccharine, aspartame and sucralose actually cause people to gain rather than lose weight. I summarily dismissed these stories because they did not make sense to me nor did I think that they had any scientific merit–until today!

Purdue University psychologists Drs. Susan Swithers and Terry Davidson fed rats yoghurt sweetened with glucose (15 calories per teaspoon) or yoghurt containing the artificial sweetener saccharin (0 calories per teaspoon). Rats that were fed the saccharin-sweeten yoghurt subsequently consumed more calories, gained more weight, put on more body fat and were unable to regulate dietary intake of calories as compared with rats that were fed glucose-sweetened yoghurt. The authors surmised that breaking the connection between a sweet sensation and high-calorie food, changes the body’s ability to regulate caloric intake. This could partly explain why obesity has risen with the increasing use of artificial sweeteners in drinks. The study’s findings are consistent with emerging evidence that people who drink more diet drinks are at higher risk for obesity and development of the metabolic syndrome that increases the risk for heart disease and diabetes.

So, how do the authors explain their seemingly paradoxical findings? Swithers and Davidson postulate that ingestion of sugar-rich (sweet) foods provides a ‘salient orosensory stimulus” that signals that the body is about ingest a lot of calories. This, in turn, induces the body to physiologically-prepare itself for ingestion of a high calorie meal. However, when the false sense of sweetness (provided by the artificial sweetener) is not followed by consumption of large amounts of calories, the system gets “confused”– causing people to eat more or expend less energy to account for the calorie imbalance. Nevertheless, the good news is that people who use artificial sweeteners can still count calories to regulate caloric intake and body weight. Unfortunately, as the authors suggest, counting calories requires a more conscious effort and a lot more work than routinely consuming low-calorie foods.

Although this study was conducted in rats, its findings are consistent with the observations that increased use of artificial sweeteners can contribute to human weight gain. Despite the study’s findings, similar experiments must be conducted in people to substantiate or refute the authors’ hypothesis.

Until next time…

Good Luck and Good Job Hunting (lay off the aspartame and splenda)!!!!!!

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For the past 30 years or so, the Unites States government has been looking for any reason what so ever to argue against the legalization of marijuana. This is despite a growing body of evidence that marijuana use provides documented, palliative and therapeutic benefits to people who suffer from serious illness like glaucoma, chronic pain and the side effects of cancer chemotherapy. Although marijuana use for medicinal purposes is illegal at the federal level, some Western States, most notably California, have legalized its use —it can now be purchased by people who have valid prescriptions from specially-designed .

From time to time, papers have appeared in the literatures which suggest that marijuana use has deleterious effects on mental acuity, emotional stability, breathing and sperm production. A  recent report  from New Zealand (which was published in the Journal of the American Medical Association) suggests that chronic marijuana use can increase the likelihood of periodontal disease in young adults.

C’mon, gum disease….are you kidding me? Don’t get me wrong, untreated periodontal disease is a serous medical issue. That said,  I suspect that more people are likely to develop periodontal disease from poor dental hygiene and a lack of dental insurance than from smoking a joint from time to time. The fact that the American Medical Association is subliminally try to turn marijuana-induced periodontal disease into an American public health crisis signals to me that government officials are running out of credible arguments to prevent the legalization of marijuana in this country.

Growing up in the 60s, I am very familiar with the consequences and negative outcomes of drug misuse and abuse. While I don’t advocate the use of marijuana and other psychotropic drugs for recreational use, I do believe that patients with serious medical illnesses ought to have legal access to drugs that are safe and offer therapeutic benefits. Further, I think that many drugs that are currently illegal in America ought to be legalized. In my opinion, the legalization of drugs in America will help to reduce crime, allow monies currently allocated to combat illegal drug trafficking to be used for struggling social programs and to demystify the use of illegal drugs American children and young adults. Ironically, illegal drug use by  American children and young adults has been declining over the last few years whereas abuse of  legal, prescription drugs has been skyrocketing out of control. Maybe it is time for America to re-think its drug polices and craft new ones that do a better job of safeguarding America’s youth.

Until next time….happy trails to you! And as always…..

Good Luck and Good Job Hunting!!!!!!!!

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Last December, the US Food and Drug Administration (FDA) asked GlaxoSmithKline for additional information related to its cervical cancer vaccine Cervarix. The company has yet to reply to unspecified queries in the FDA's "complete response letter" that it received last December.

Many analysts believe Cervarix is now unlikely to be launched until 2009 at the earliest. GSK won European regulatory approval last July for the vaccine and had originally anticipated a US launch by the start of this year. However, FDA requested clarification after GSK's submission last April based on interim clinical data that the submitted from its most comprehensive five-year clinical trial for the vaccine. Financial analysts believe that FDA concerns may center on GSK's proprietary AS04 adjuvant that is used  in Cervarix to improve the effectiveness of the vaccine.

The delay has been a serious blow to GSK’s efforts to generate fresh product sales and catch up with Gardasil, the rival HPV vaccine developed by Merck & Co, which is available in the US and Europe.

I wonder whether the delay at FDA is really based on legitimate regulatory and scientific concerns. As you may recall, Merck launched a flat-out, take-no-prisoners lobbying campaign to get State and Federal legislators to mandate that all girls 10-21 years old be vaccinated with Gardasil. While Merck abruptly abandoned its lobbying efforts last fall after it came under fire from various legislative and regulatory sources, I can’t help but wonder whether Merck achieved its intended objectives anyway—to keep Cervarix out of the US market as long as possible so that Merck can capture a majority share of the lucrative American cervical cancer market.

Until next time….

Good Luck and Good Job Hunting (try Rahway)!!!!!!!!!