Drug News
U.S. FDA plans tracking of drug safety reviews
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The U.S. Food and Drug Administration needs a way to track the hundreds of internal safety reviews completed each year about drugs already on the market, an agency official said on Tuesday.
Dr. Paul Seligman said building such a system would be one of his priorities as he takes the newly created position of associate director for safety policy and communication in the FDA’s Center for Drug Evaluation and Research.
Analysts in the FDA’s Office of Drug Safety provide about 600 reports a year about potential concerns from marketed prescription drugs to officials in another office, the Office of New Drugs.
Cheap way to produce expensive malaria drug well on the way
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U.S. researchers say a cheap way to produce an expensive but effective malaria drug is well on the way.
The researchers have created a modified form of the yeast Saccharomyces cerevisiae that is capable of producing large amounts of artemisinic acid, which is needed to make the anti-malaria drug artemisinin.
Artemisinin is currently expensive to manufacture, and is out of reach for many in the developing world.
FDA staff questions Cephalon drug for ADHD
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Some U.S. Food and Drug Administration staff reviewers have raised questions about Cephalon Inc.‘s bid to market its Sparlon drug to treat attention deficit hyperactivity disorder (ADHD), according to documents made public on Wednesday.
The staff reports were released ahead of an FDA advisory panel meeting on Thursday to discuss the new use of the drug, which is already sold as Provigil to treat sleep disorders.
Protein differences may explain drug reaction
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Differences between a cell signaling protein in humans and animals may explain the unexpected severe reaction in six young men given a new drug in a clinical trial in Britain, an expert said on Sunday.
The previously healthy men were the first humans to receive the drug, designed to treat leukemia and chronic inflammation disorders. Shortly after receiving the treatment last week, they suffered massive inflammation and excruciating pain.
Two are still critically ill, one is on organ support, and the other three are recovering.
FDA chief says unique generics get priority
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The U.S. Food and Drug Administration is taking steps to eliminate a backlog of more than 800 pending generic drug applications by focusing on those offering the first cheaper alternative therapy, the agency’s acting chief told Congress on Tuesday.
Acting FDA Commissioner Dr. Andrew von Eschenbach defended efforts to bring cheaper drugs on the market by telling lawmakers the agency aimed to ensure “that there’s at least one generic available” for most conditions, giving preference to the first one submitted.
Drug trial goes wrong and six end up intensive care
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After taking part in a clinical trial of a new drug six men are now seriously ill in a north London hospital in the UK.
Health officials say the volunteers became ill after taking a drug being developed to treat chronic inflammatory conditions and leukaemia.
Relatives are apparently at the bedside of the patients who apparently suffered multiple organ failure. Some lives are said to be in danger.
New hepatitis drug may be more effective
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Entecavir, a new drug designed to battle frequently fatal hepatitis B, is more effective than a rival drug, according to a pair of research studies financed by the drug’s manufacturer Bristol-Myers Squibb Co.
The two studies on long-term liver disease, published in this week’s issue of The New England Journal of Medicine, found that entecavir, also known as Baraclude, does a better job than GlaxoSmithKline’s drug, Epivir (lamivudine).
Scientists create new type of ‘bio-gel’
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Scientists at The University of Manchester have created a new type of ‘bio-gel’ which provides a pH neutral environment for culturing cells in 3D, as published in the journal Advanced Materials.
The gel is the first pH neutral material made from combinations of dipeptides (pairs of amino acids) to provide an environment in which cells can be cultured under physiological conditions.
Uniquely, the gel mimics the properties of cell scaffolds which naturally occur in the body and has potential applications for wound healing and tissue engineering.
Pfizer sues P&G over mouthwash ads
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Pfizer Inc. the maker of Listerine mouthwash on Friday sued Procter & Gamble Co. for falsely claiming in television ads that four out five dentists would recommend its rival brand Crest Pro-Health mouthwash.
“P&G’s false and misleading claims concerning Crest Pro-Health cause a substantial number of consumers to believe that this product is recommended by the vast majority of dentists—which is false—and that these dentists are recommending it for specific product-related reasons—which also is false,” the lawsuit filed in U.S. District Court in Manhattan, said.
Many U.S. post-approval drug studies unfinished
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Nearly two thirds of more than 1,200 post-approval drug studies promised by the manufacturers have yet to start, according to U.S. government statistics released on Friday.
An annual report by the Food and Drug Administration showed little change from recent years in the percentage of studies that remain unfinished, officials said.
“The percentages of open commitments, pending, ongoing, delayed, terminated and submitted (studies) are all in the same ballpark range,” Dr. John Jenkins, director of the FDA’s Office of New Drugs, told reporters.
FDA grants priority review for Revlimid
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Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has granted a Priority Review designation to its Supplemental New Drug Application (sNDA) for REVLIMID (lenalidomide) for the treatment of relapsed or refractory multiple myeloma.
The Prescription Drug User Fee Act (PDUFA) date is June 30, 2006. The Company is seeking approval to market REVLIMID in combination with dexamethasone as a proposed indication for the treatment of multiple myeloma patients who have received at least one prior therapy subject to FDA review and approval. Priority Review is granted to a pharmaceutical product that, if approved, would be a significant improvement compared to existing marketed products or approved therapies in the treatment, diagnosis, or prevention of a disease.
Length of time using Vioxx seen key in Merck trial
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Opening arguments in the next Vioxx liability trial start on Monday as Merck & Co. faces the lone lawyer who has beaten the company in one of these cases - this time representing two long-term users of the painkiller who say it caused their heart attacks.
So far, two juries have found Merck not liable, while Mark Lanier, a flamboyant Texas lawyer, helped secure a $253 million judgment for the widow of a Vioxx user last August.
The trial, set to begin next week in New Jersey Superior Court in Atlantic City, marks the first involving plaintiffs who took the painkiller for more than 18 months.
Japanese researchers find new way to make Tamiflu
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A team of Japanese researchers has developed a new way of producing the anti-flu drug Tamiflu that does not rely on natural ingredients and may help ensure more stable supplies, the head of the team said.
Tamiflu, produced by Swiss-based pharmaceutical company Roche Holding AG, is considered one of the best defenses against bird flu in humans, and there are fears of a possible shortage in the event of a global flu pandemic.
New chest pain drug set for March launch, co. says
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CV Therapeutics Inc. Chief Executive Officer Louis Lange said on Thursday that the company’s recently approved drug for chest pain is on track to be in 30,000 pharmacies by the end of March.
Palo Alto, California-based CV Therapeutics last month received U.S. Food and Drug Administration approval of Ranexa for treatment of chronic angina, the chest pain caused by an insufficient supply of oxygen to the heart.
Lange said the company’s 250-person sales force plans to begin marketing the drug at a major meeting of cardiologists next month in Atlanta and shipments will start shortly thereafter.
Drug prices rise under US Medicare plan
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Prices for some of the most popular medicines used by seniors have jumped an average of 4 percent under the new Medicare drug benefit since it began last month, according to a report released on Tuesday.
The report, released by the Democratic staff of the House of Representatives Government Reform Committee, found prices for Pfizer Inc.‘s pain reliever Celebrex, Merck Inc.‘s cholesterol drug Zocor and eight other top drugs offered by 10 major plans rose during the controversial program’s first seven weeks.
In some cases, drug prices rose 10 percent, it also found.
