Dear Readers,
Many of you have shown interest in a post about Primatene Mist that I published some time ago.I wanted to update you on the situation so that you can take the necessary measures to safeguard your health.Primatene Mist is the only asthma inhaler presently available over the counter.
Unfortunately,in accordance with FDA rules,Primatene Mist,as currently formulated with a CFC that damages the earth's protective ozone layer,must be removed from U.S. shelves by December 31,2011.The product's maker,Armstrong Pharmaceuticals,is arranging to produce a non-CFC form of the asthma inhaler,but will have to submit it for FDA approval.That means there will probably be a doughnut hole period when you will not be able to purchase this popular asthma medication in the U.S.How long this will last is anyone's guess.
In the meantime,patients will have to obtain a prescription for another inhaler.Yes,a prescription will perhaps be more expensive-especially unwelcome in these troubled economic times.At this point,the medication is still being advertised for online purchase.
Sincerely,
Andrew Taylor
Showing posts with label Baltimore medical research Food and Drug Administration. Show all posts
Showing posts with label Baltimore medical research Food and Drug Administration. Show all posts
Thursday, October 6, 2011
Thursday, November 18, 2010
Key Committee Recommends Lupus Drug Approval
On November 16,a key Food and Drug Administration committee recommended approval of Benlysta,the Human Genome Sciences/GlaxoSmithKline drug for the treatment of systemic lupus erythematosus.
The Arthritis Advisory Committee,which made the recommendation,provides the FDA with independent expert advice on rheumatology drug products such as Benlysta.Its nonbinding recommendation normally carries a great deal of weight in the FDA's deliberations.
Benlysta is the first new treatment expressly for lupus in 50 years.The vote to recommend approval was hailed by patient advocates as a sign of hope.Benlysta is also the first in a new class of drugs,the BLys-specific inhibitors.
Since 2006,Human Genome and Glaxo have been developing Benlysta together,with Human Genome having lead responsibility for conducting Phase 3 trials.The companies will share equally in development costs,sales,marketing expenses and any profits pending final FDA approval.Analysts consider Benlysta a prospective blockbuster,worth billions of dollars.
Lupus is a chronic inflammatory disorder most common in black,Hispanic and Asian women.It causes the immune system to attack the body's own organs and tissues,resulting in effects ranging from joint pain to kidney damage.The disease is potentially life-threatening.Like another autoimmune disorder,multiple sclerosis,lupus is hard to diagnose and varies from patient to patient.
Human Genome is located in Rockville,Maryland,and Glaxo is based in London,England.
Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)
The Arthritis Advisory Committee,which made the recommendation,provides the FDA with independent expert advice on rheumatology drug products such as Benlysta.Its nonbinding recommendation normally carries a great deal of weight in the FDA's deliberations.
Benlysta is the first new treatment expressly for lupus in 50 years.The vote to recommend approval was hailed by patient advocates as a sign of hope.Benlysta is also the first in a new class of drugs,the BLys-specific inhibitors.
Since 2006,Human Genome and Glaxo have been developing Benlysta together,with Human Genome having lead responsibility for conducting Phase 3 trials.The companies will share equally in development costs,sales,marketing expenses and any profits pending final FDA approval.Analysts consider Benlysta a prospective blockbuster,worth billions of dollars.
Lupus is a chronic inflammatory disorder most common in black,Hispanic and Asian women.It causes the immune system to attack the body's own organs and tissues,resulting in effects ranging from joint pain to kidney damage.The disease is potentially life-threatening.Like another autoimmune disorder,multiple sclerosis,lupus is hard to diagnose and varies from patient to patient.
Human Genome is located in Rockville,Maryland,and Glaxo is based in London,England.
Human Genome Sciences(HGSI),GlaxoSmithKline(GSK)
Thursday, October 21, 2010
Frontiers In Medicine:Genentech's Cancer Treatment Approved
The FDA has approved Genentech's biotech medicine Herceptin,in combination with chemotherapy,as a treatment for certain stomach cancers-metastatic ones with the protein HER2 on tumor cells.
Early studies suggest Herceptin may block signals that cause tumor cells to grow and divide,and also signals the immune system to destroy the cancer cells.
About 21,000 Americans will be diagnosed with stomach cancer in 2010,and more than 10,500 will die of it.Often,symptoms of the disease do not appear until the late stages,when it has become metastatic,or spreading,or cannot be surgically removed.
The latest analysis shows that median overall survival with the Herceptin/chemotherapy regimen was 13.1 months,versus 11.7 months with chemotherapy alone.Herceptin is also used to treat HER2+ metastatic breast cancer.
Hal Barron,M.D.,executive vice president of Product Development and chief medical officer,said the FDA approval provides an important new personalized medicine for people with the life-threatening disease who have few treatment options.
Formerly an independent firm,Genentech became a member of Switzerland's Roche Group in March 2009.Considered the original biotech company,Genentech uses human genetic information to discover,develop,manufacture and commercialize medicines for gravely ill patients.
The Roche Group is traded on the over the counter pink sheets in the U.S.,under the ticker symbol RHHBY.
Early studies suggest Herceptin may block signals that cause tumor cells to grow and divide,and also signals the immune system to destroy the cancer cells.
About 21,000 Americans will be diagnosed with stomach cancer in 2010,and more than 10,500 will die of it.Often,symptoms of the disease do not appear until the late stages,when it has become metastatic,or spreading,or cannot be surgically removed.
The latest analysis shows that median overall survival with the Herceptin/chemotherapy regimen was 13.1 months,versus 11.7 months with chemotherapy alone.Herceptin is also used to treat HER2+ metastatic breast cancer.
Hal Barron,M.D.,executive vice president of Product Development and chief medical officer,said the FDA approval provides an important new personalized medicine for people with the life-threatening disease who have few treatment options.
Formerly an independent firm,Genentech became a member of Switzerland's Roche Group in March 2009.Considered the original biotech company,Genentech uses human genetic information to discover,develop,manufacture and commercialize medicines for gravely ill patients.
The Roche Group is traded on the over the counter pink sheets in the U.S.,under the ticker symbol RHHBY.
Friday, October 16, 2009
Medical Research Means Business
A professor at University of Maryland, Baltimore's School of Medicine is showing that he is a businessman as well as a scholar.Dr.J. Marc Simard,M.D.,PhD.,receieved the Research Lecturer of the Year Award from the university in 2007 for discovering a new use of the diabetes drug glyburide.An intravenous form of the drug may be used for treating strokes,head or spinal cord injuries.The drug can reduce brain cell death,swelling and hemorrhaging.In 2008,Dr.Simard received the university's Entrepreneur of the Year Award for his effort to market his discovery.This involved setting up a company,Remedy Pharmaceuticals,which aims to raise enough capital for extensive clinical trials on the way to Food and Drug Administration approval of the new use for glyburide.The company raised its initial goal of 22 million dollars,but more needs to be done.
Dr.Simard has spent many hours pitching his discovery to investors,explaining the complex science and outlining the business implications as well.He has known success as an inventor in the past,with 30 patents issued or pending to his name.Dr.Simard said he's happy to do the legwork for the benefit of patients with untreatable diseases.
University of Maryland, Baltimore has six professional schools,plus a graduate school.It is a world-class research institute and seed-bed for business.
Dr.Simard has spent many hours pitching his discovery to investors,explaining the complex science and outlining the business implications as well.He has known success as an inventor in the past,with 30 patents issued or pending to his name.Dr.Simard said he's happy to do the legwork for the benefit of patients with untreatable diseases.
University of Maryland, Baltimore has six professional schools,plus a graduate school.It is a world-class research institute and seed-bed for business.
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