Vaccines to Prevent Cervical Cancer

Preventing Cervical Cancer: Tens of millions of girls and young women have been vaccinated against the disease in the United States and Europe in the two years since two vaccines were given government approval in many countries.In the United States, Merck markets its HPV vaccine as Gardasil.

Gardasil has been made available to the poorest girls in the country, up to age 18, at a potential cost to the United States government of more than $1 billion There are proposals to mandate the vaccine for girls in middle schools in 24 states, and in Virginia it will be mandatory this fall. Even the British National Health Service will start giving the other vaccine -- Cervarix, from GlaxoSmithKline -- to all 12-year-old girls at school this September.

The vaccines, which also offer some protection against infection from sexually transmitted viruses cost about $360 for the three-dose series.
Dr. Jon Abramson is professor of pediatrics at Wake Forest University and chairman of the committee of the Centers for Disease Control and Prevention that recommended the vaccine for all girls once they reached 11 or 12.

Of course, there are possible risks associated with any therapy, including vaccines. There is also some question as to whether a booster shot may be needed at some point in the future, but as a pharmacist and as a mother of 3 daughters, Gardasil was the right choice for my family.

New warning added to fluroquinolone class of antibiotics

The FDA is notifying the makers of fluoroquinolone antimicrobial drugs for systemic use of the need to add a boxed warning to the prescribing information about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones and to develop a Medication Guide for patients. This class of antibiotics include Cipro, Floxin, Levaquin and others.
Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.
This class of antibiotics are often used to treat respiratory and urinary tract infections and are quite effective and usually well tolerated. However, in the above groups of patients, extra care is warranted and healthcare practicioners should make sure that patients are counselled appropriately.

Generic Avalide receives Approval

Mylan Inc. today announced that the company has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Irbesartan and Hydrochlorothiazide Tablets, 150 mg/12.5 mg and 300 mg/12.5 mg. This is the generic version of Avalide which is manufactured by Sanofi, and is a medication used to treat hypertension and congestive heart failure.

Avalide had U.S. sales of approximately $288 million for the last year, according to IMS Health.

Currently, Mylan has 92 ANDAs pending FDA approval, 20 of which are potential first-to-file opportunities.

Glaxo receives Approval for Bird Flu Vaccine

The LONDON press reports that GlaxoSmithKline has received permission to market a human bird flu vaccine. This is significant because it is the first pharmaceutical to receive a license for pre-pandemic use in all 27-member European Union states. Noteworthy to those of us living in the USA, the U.S. Department of Health and Human Services has ordered for 27.5 million doses.

Glaxo has spent at least $2 billion developing the vaccine that targets the H5N1 virus. They have already received orders for 8 million doses from Switzerland, enough to cover that country's entire population,in addition to the 27.5 million doses ordered by the U.S., and orders from Finland and other European countries. Glaxo has agreed to donate 50 million doses of the vaccine to the World Health Organization in an attempt to create a pandemic vaccine stockpile for poor countries.

Experts believe H5N1, an influenza virus subtype which has killed at least 241 people worldwide, is the most likely candidate to mutate into a pandemic virus,said
Emmanuel Hanon, vice president of the Influenza Vaccine Franchise at Glaxo.
"This vaccine marks a significant step in the world's ability to cope with an influenza pandemic," said Glaxo Chief Executive Officer Jean-Pierre Garnier. Glaxo has said that its vaccine is effective against these other versions of the virus as well, announcing study results last year showing that that it even reacts against the Indonesian type of H5N1, a genetically different virus. It would not, however be effective against strains such as H5N5 or H5N7

"What we don't know is when the pandemic will come, but we do know that it will come," stated Emmanuel Hanon.

How should a business plan for a disaster such as pandemic flu?

How should a business plan for a disaster such as pandemic flu? An article published in the Washington Post last week pointed out that less than one-third of businesses have any type of plan. Former US Secretary of Health, Tommy Thompson points out why companies can't ignore this vital issue. I'm convinced, but as a small business owner, what resources are available to help start the planning process.? An informal poll: How many business owners out there would say they have a diasater plan ready and accessible??
http://www.washingtonpost.com/wp-dyn/content/article/2006/05/01/AR2006050101608.html

Anthrax Vaccine: New Developments

Anthrax... So you haven't heard about the vaccine for a while; is the threat of bioterrorism still real?
VaxGen, Inc. a biopharmaceutical company, announced today it has completed the sale of all assets and rights related to its recombinant protective antigen (rPA) anthrax vaccine product candidate and related technology to Emergent BioSolutions, Inc. Emergent BioSolutions paid VaxGen $2 million initially and may be obligated to pay up to an additional $8 million in milestone payments.
VaxGen is a biopharmaceutical company based in South San Francisco, California. The company owns a state-of-the-art biopharmaceutical manufacturing facility with a 1,000-liter bioreactor that can be used to make cell culture or microbial biologic products. For more information, please visit the company's web site at http://www.vaxgen.com/.
While the subject of anthrax may not make daily headline anymore,the companies involved in developing the vaccine are forging ahead. For Officials at CDC, Homeland Security, etc the concern of bioterrorism and the threat of these biological weapons have never wavered.

More Dismal News as Merck Announces 1200 jobs cut

Pharmaceutical manufacturer giant Merck & Company Inc. announces more bad news with the elimination of 1,200 sales jobs in its US salesforce. This news comes after a decision last week from the FDA that issued a non-approvable letter for Cordaptive which was supposed to be Merck's newest cholesterol lowering drug. Also, Merck had been notified that immediate improvements must be made at one of their vaccine maufacturing plants. How much bad news can one company withstand in one month?

Amy Rose, a Merck spokeswoman, said the lay-offs represent about 15 percent of Merck's salesforce. The job cuts are part of a global restructuring plan announced in late 2005, meant to generate a up to $5 billion in savings through 2010.

Merck's earnings have been hurt by disappointing sales of its Vytorin cholesterol fighter since studies were released showing some diappointing results.
So far, the news has had almost no impact on Merck shares.