Drug News
Hungary says it could make 50 million bird flu vaccine doses
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Hungary could make 50 million doses of vaccine for bird flu, mostly for export, the health authority chief said after he and the health minister became the first participants in the country’s human trials of the vaccine.
“We are not feeling as though our ears were growing and our nails are fine,” Health Minister Jeno Racz joked after he got the jab for the H5N1 strain of the virus on Monday.
Australian firm to start trials of bird flu vaccine
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Australian company CSL Ltd will begin human trials of a bird flu vaccine next month as the government warned travelers on Thursday about an outbreak of the deadly virus in parts of Asia.
CSL is the world’s top maker of human plasma products and spokeswoman Rachel David said the vaccine against the H5N1 strain of avian flu would be tested on 400 human volunteers. Results are expected by the end of the year.
Diet pill peddler fined $600,000
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A WEIGHT-LOSS venture set up in jail by international fraud Peter Foster has been fined a record $1 million for price-fixing and he has been banned from the weight-loss industry.
Chaste Corporation, which charged sales recruits $40,000 to sell a diet pill called TRIMit, was fined $600,000 for misleading and deceptive conduct and price-fixing.
F.D.A. Rejects Pfizer Pain Drug
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Regulators have rejected the application from Pfizer Inc. to market an injectable drug similar to its withdrawn Bextra arthritis pill, the company said yesterday.
The injectable medicine is in the same class of drugs as the Celebrex arthritis and pain pill from Pfizer and the Vioxx arthritis and pain pill from Merck. Vioxx was taken from the market last September after being shown to double the risk of heart attack and stroke after long-term use.
Lawmakers spar over Medicare drug coverage
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Just days before Medicare officials in Washington unveil the private prescription drug plans that will be available to the program’s 43 million elderly and disabled beneficiaries starting next January, both liberals and conservatives in Congress are calling for a delay in the controversial program.
Conservatives in the U.S. House Wednesday unveiled “Operation Offset,” an effort to find budget cuts to help pay for relief needed to rebuild the states and cities decimated by Hurricane Katrina three weeks ago. Delaying the new Medicare benefit by a year is at the top of the list, primarily because it would save an estimated $30 billion over the next decade.
FDA steps up action on misleading drug ads
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U.S. Food and Drug Administration warnings to drug companies over misleading advertisements have more than tripled in the last year, an agency official said on Monday.
The agency sent 17 warning letters in the 12 months ending in August compared with an average of about four to five letters in recent years, Thomas Abrams, head of FDA’s Division of Drug Marketing and Communications, told food and drug regulatory lawyers at a conference in Washington.
Canadian online pharmacies a better deal for meds
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Americans could save hundreds or even thousands of dollars a year on brand-name prescription drugs if they use a Canadian Internet pharmacy instead of their local drug store, researchers reported Monday.
On average, their study found, Americans could save 24 percent on their prescriptions if they shopped at an online Canadian pharmacy rather than a U.S. drug chain. Depending on the type of drug and how many prescriptions a person has, the savings could add up to hundreds or thousands of dollars a year.
FDA knew of Guidant heart device failures
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Months before the U.S. Food and Drug Administration issued a safety alert in June about problems with Guidant Corp. heart devices, a company report to the agency showed that some of those units were short-circuiting, The New York Times reported on Monday.
But the agency did not make that data public at the time because it treats the information it receives in such reports as confidential, the newspaper said, citing FDA records.
Pfizer ready to monitor inhaled-insulin patients
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Pfizer Inc is ready to launch a patient-monitoring scheme to assess the safety of its novel inhaled-insulin drug Exubera if the product is approved for use, its worldwide head of development said on Thursday.
Exubera is being developed with Sanofi-Aventis SA and Nektar Therapeutics, and is due to be reviewed by a U.S. Food and Drug Administration (FDA) panel later on Thursday.
Sales of biogenerics in US, Europe to soar
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Copycat versions of expensive biotech drugs could see $16.4 billion in sales in the United States and Europe by 2011 once regulatory curbs on so-called biogenerics use are gone, a study showed on Monday.
To date, biotech drugs made using genetic engineering have been immune from generic competition, since regulators in these major markets have been slow to set clear approval rules and many are still patent-protected.
Co-pays, drug cuts to save Medicaid $11 bln:report
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A federal commission on Thursday recommended $11 billion in Medicaid savings over 5 years from raising prescription drug co-payments, drug pricing reforms and curbs against asset transfers to qualify for benefits.
The controversial Medicaid Commission, charged in May with finding $10 billion in immediate savings, delivered its first of two reports to Congress and Health and Human Services Secretary Michael Leavitt.
U.S. clears new flu vaccine, progress made on another
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U.S. health officials approved a new flu vaccine on Wednesday in hopes of bolstering supplies after last season’s shortage, but said more work is needed before another supplier may be able to resume sales.
The new vaccine, made by GlaxoSmithKline Plc, aims to fill the void left after rival Chiron Corp. lost its license and could not deliver half the anticipated U.S. supply during the 2004-2005 flu season.
Chiron says British flu vaccine plant passes test
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Chiron Corp., which last year suspended U.S. sales of its flu vaccine because of contamination problems at its plant in England, on Wednesday said it hopes to supply the vaccine in the 2005-2006 flu season following a favorable inspection of the plant by U.S. regulators.
The U.S.-based company’s manufacturing license for its Fluvirin vaccine was withdrawn last October because of contamination problems at the factory in Liverpool, depriving the United States of almost half the nation’s anticipated flu vaccine supply.
Painkillers can cause fatal stomach bleeding
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Approximately one third of all hospitalizations and deaths related to gastrointestinal bleeding can be attributed to the use of aspirin or nonsteroidal anti-inflammatory agents (NSAIDs) painkillers like ibuprofen, a study in Spain suggests.
Moreover, up to one third of these painkiller-related incidents may be due to low-dose aspirin.
FDA won’t ban diet drug Meridia
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The government won’t ban the prescription diet drug Meridia but, faced with reports of deaths, says it will closely monitor a European study designed to better assess the pill’s heart risks.
The consumer group Public Citizen had petitioned the Food and Drug Administration for a ban, citing Meridia users who died of heart problems as young as their 20s and 30s. Even before Meridia was approved for sale, the FDA knew it could increase users’ blood pressure, the group contended.
