Wyeth Regulatory Woes Continue
The regulatory problems at Wyeth continue. The US Food and Drug Agency announced that it issued an approvable letter for Tygacil (Wyeth’s tetracycline-like antibiotic) to treat community acquired pneumonia (CAP). Apparently, FDA regulators want more data on the effectiveness and safety of Tygacil in severe cases of CAP and additional information on possible liver toxicity.
Tygacil, an intravenously administered antibiotic, won FDA approval in 2005 to treat adults with complicated intra-abdominal infections and complicated skin and skin-structure infections. Tygacil had about $138 million in sales last year; falling far short of the projected $500-$800 million in annual sales that it was expected to yield when it was first brought to market. If Wyeth gains approval for CAP, expect Tygacil sales to soar.
In other regulatory news, FDA granted Wyeth “fast-track approval” for a new version of its market-leading pediatric pneumococcal vaccine called Prevnar. The new 13-valent formulation will provide protection against 13 different pneumococcal serotypes. The older version only provided protection against 7 serotypes. Wyeth hopes to complete its filing for pediatric use of the new Prevnar vaccine in early 2009. Prevnar is Wyeth’s second-leading product with sales of about $2.5 billion in 2007.
The new Prevnar vaccine will likely go head-to-head with GlaxoSmithKline’s new 10-valent pneumococcal vaccine called SynflorixTm which is in late stage clinical development and is currently being reviewed for marketing approval in the EU. Unlike Wyeth’s vaccine, SynflorixTm was found to be effective in protecting against otitis media (ear infections) caused by Haemophilus influenzae.
Until next time,
Good Luck and Good Job Hunting (avoid Collegeville, PA)!!!!!!!!
I returned from my trip to China on Monday evening and I think that I am finally functioning on US time again (actually it took me less time to adjust than I expected). 
Bristol-Myers Squibb announced today that it will purchase California-based Kosan Biosciences for approximately $190 million. Kosan has been developing two classes of oncology drugs known as heat shock protein 90 (Hsp90) and epothilones. One of Kosan's Hsp90 compounds is currently in Phase III clinical testing for the treatment of multiple myeloma. 
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!
When I was working as a recruiter, I always called my candidates a day before a scheduled face-to-face job interview. I did this to reassure them, build confidence and provide them with any insights that I may have had regarding the hiring manager or the job. But, more importantly, I called to insure that they were adequately prepared to go on the interview. I typically talked with them about dress, interview etiquette, cell phone usage, body language etc. Sometimes, when I was concerned about particular candidates, I even sent (via fax or e-mail) an interview preparation checklist. 
Much has been said (and written) about the impact and power of a firm handshake in business settings. Are the urban legends and "old wives tales" really true? Peggy McKee 
I came across this excellent article written by 
Who hasn’t heard the old adages “Beauty is only skin deep” or “It’s not what’s on the outside but what’s on the inside that counts?” While these sayings may be apt when looking for a soul mate, they are absolutely not true when it comes to networking or job interviews. I know this may seem shallow and superficial, but the stark reality is that appearance does count when making a first impression or finding a job. There is nothing wrong in adopting a “superficial” persona when it comes to job interviews or networking. I know; we scientists work hard to avoid being superficial and shallow, but let’s face it, sometime you just gotta do what you gotta do to get or job or advance your career!
As a self-anointed career development professional, I frequently read blogs and online articles dealing with jobs and career development advice. That said, I happened upon a piece in Yahoo Education entitled “
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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a 
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 .jpg)
I came across an interesting article in Forbes Magazine that 
In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). 
Merck announced last week that it will cut 1,200 sales jobs in the U.S. by the end of July. The company also confirmed a plan to eliminate a small natural products group in Spain and Rahway, NJ. Whereas the salespeople who lost their jobs were given notice by the company, the natural products researchers in Spain (and Rahway) learned of their imminent demise via a power point presentation given by a Merck executive (whose name has not been disclosed)..jpg)
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. 
t layoff at the medical devices manufacturer in over 5 years. According to a press release, slightly over a third of the layoffs will come from the company’s local operations, which has about 8,000 employees. The overall effect of the reorganization will be relatively small—affecting roughly 3% of the company’s worldwide workforce of 39, 500..gif)
When the job market gets tough, it is the “little things” that can make the difference between a job offer and a rejection letter. As you all know by now, face-to-face interviews are the “make or break” event in any job search. To that end, any edge that you can get may make the difference between being employed or receiving unemployment benefits in today’s job market. Although I am not a big fan of quizzes or surveys, it may be worth the time to take an 
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As I mentioned in previous posts, things are simply not going Merck’s way. Merck has been .jpg)
Yes, even the Ivy League isn’t immune to food poisoning outbreaks from time-to-time. There are currently 10 confirmed cases of .jpg)
I often wonder what makes companies/organizations tick! Based on my personal experiences, I am amazed that anything gets done in highly structure corporate/ organizational setting. My observations have caused me to think about the different personality types of the people who make up the corporate/organizational workforce. While reading .gif){kind=small}
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