Lilly faces Zyprexa Lawsuit
June 28, 2007
Eli Lilly Co. could face its first trial this fall in personal injury lawsuits over it’s schizophrenia drug Zyprexa.
Judge Jack Weinstein in Brooklyn said he will try about 30 Zyprexa lawsuits at one time and set a tentative trial date of Oct. 15.
At least eight lawsuits have been filed by several states that claim Lilly failed to disclose that Zyprexa causes high blood-sugar levels, weight gain, diabetes complications and other health problems.
Some of the suits claim the company marketed Zyprexa for off-label uses, including treatment of Alzheimer’s disease, Tourette’s syndrome and autism, without warning about its risks.
Lyrica approved for treatment of Fibromyalgia
June 22, 2007
On Thursday, The U.S. Food and Drug Administration approved Pfizer’s Lyrica to treat fibromyalgia, a pain disorder.
The approval marks the first time a drug has been approved for this condition, which is believed to affect three to six million Americans.
Lyrica is already on the market to treat nerve pain associated with diabetes and shingles. The drug had $1.2 billion in sales last year, and has is used by five million people world-wide.
The FDA granted Lyrica priority review status, which cuts four months off the standard 10-month drug review time. Priority Review status is assigned to drug products that, if approved, would be a significant improvement compared to marketed products in the treatment, diagnosis or prevention of a disease.
UK backs HPV vaccination plan
June 21, 2007
The UK has provisionally agreed to begin a program of HPV vaccination to prevent cervical cancer for girls starting secondary school.
The Department of Health says it has agreed, in principle, to accept advice from the UK Joint Committee on Vaccination and Immunisation that HPV vaccinations should be given for girls around 12 to 13 years old. Read more
US Court Upholds Patent for Heart Drug Plavix
June 20, 2007
A US judge on Tuesday upheld the patent for Plavix by French group Sanofi-Aventis and its US partner Bristol-Myers Squibb, blocking a generic version of the multibillion-dollar-selling heart drug. A Sanofi-Aventis spokesman in Paris said the company was “satisfied” with the decision. Apotex said it would immediately file an appeal.
Click here for more.
Free PowerPak C.E.
June 20, 2007
When I look for Free C.E.’s I try and find something relevant (or at least interesting) for a Tech. And here is one that you may like:
Precise Dosing of Levothyroxine
This accredited program is targeted to pharmacists, pharmacy technicians, physician assistants, and nurse practitioners.
The goal is to understand the use of levothyroxine, with emphasis on the importance of the precise dosing of this hormone.
Conn. Gov. Vetoes Medical Marijuana Bill
June 20, 2007
Conneticut Governor Jodie Rell, a breast cancer survivor, vetoed a bill that would have allowed people with serious illnesses such as AIDS and Cancer to use grow and use marijuana. Rell said it was fraught with problems and sent a mixed message to children.
Governor Rell Said:
“I am not unfamiliar with the incredible pain and heartbreak associated with battling cancer”
The issue pits the patients’ rights against concerns of legalized access to an illicit drug. Today, twelve states let some patients use marijuana despite the federal laws against it.
Republican state Rep. Penny Bacchiochi, who risked arrest more than 20 years ago to obtain marijuana for her husband afflicted with bone cancer, called it “A Big step backwards.”
The 12 states that currently allow medical marijuana under certian conditions, can be seen here.
Pharmacists improve asthma care
June 15, 2007
Some advice and help from a pharmacist may help asthma sufferers get their condition under better control, according to an Australian study.
Researchers found that a pharmacy-based asthma care program helped patients adhere to their medication regimen and prevent attacks of breathlessness and wheezing. Among 191 patients who had a couple meetings with their pharmacist over 6 months, the percentage with severe asthma — more than one attack per week — fell from 87.9 percent to 52.7 percent, a statistically significant difference.
That compared with virtually no change among patients at pharmacies that did not institute the program.
(Full Story VIA Reuters/Yahoo)
Tentative Approval for Generic of Risperdal Tablets.
June 13, 2007
Barr Announces Tentative Approval for a Generic Version of Risperdal(R) Tablets.
Click here for company website and details.
FDA To Review Sanofi Weight Loss Pill
June 13, 2007
Experts from the FDA are scheduled to review the safety and efficacy of a weight loss pill named “Accomplia” that is approved for use in Eurpoe. The drug is made by Sanofi-Aventis, and if approved in the states, will be named Zimulti (Rimonabant).
The drug is a cannabinoid receptor antagonist and blocks the CB1 receptors in the brain that control hunger. Taking the drug reduces hunger and suppresses appetite. There is also promise that the drug may reduce the urge to smoke.
The pannel will weigh the drugs benifits versues it’s risks.
Benefits include that a dose of 20MG/day helped people to lose weight and reduce levels blood sugar, cholesterol, and fats.
However, in clinical trials there was an increased risk of suicide or suicidal thoughts in those who took the drug compared to patients who took the placebo.
The Manufacturer has emphasized that the drug is not for cosmetic purposes and is intented for those who are overweight or obese as part of a diet and exercise program.
For more detailed information on the drug’s assessment in Europe, see the European Public Assessment Report (PDF).
Buse claims GSK made threats over Avandia
June 6, 2007
The recent controversy over Avandia deepened today when Dr. John Buse [pictured at left from a press photo], a medical expert in diabetes, came forward with clams that GlaxoSmithKline tried to silence him when he questioned the drug’s safety.
Buse claims that he received telephone calls from GSK executives when drug went on sale in 1999. he said [Glaxo] were claiming that his “actions were scurrilous enough to attempt to hold me liable for a loss in market capitalization”.
Dr. Buse brought the threats of legal action public in a written statement that was then submitted to a congressional hearing on Avandia’s safety. After the GSK made the alleged threats, He signed a statement drafted by Glaxo to appease Shareholders who were concerned about his warnings.
Read the full story here
