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4/25 Overwork and Costcutting Blamed for Plant Errors FDA report shows problems at Merck vaccine plant ... Inspectors from the U.S. Food and Drug Administration spent 30 days at Merck's Montgomery County, PA plant between November and January and cited 49 areas of concern, including a failure to follow good manufacturing practices ... [ Philadelphia Inquirer ] 4/25 FDA Approves Relistor Wyeth, Progenics bowel drug wins US approval ... Relistor is the first medicine approved to treat opioid-induced constipation. Sixty-two percent of patients given Relistor had a bowel movement within four hours of their first dose, compared with 14 percent who got a placebo ... [ Reuters ] 4/25 No Quick Route to Patient Adherence Patients Often Don't Take What the Doctor Ordered ... Patients often do not take the medicines their doctors prescribe, and a new review of existing research suggests that there is no proven way to get them to follow directions for long periods ... [ Cochrane Database of Systematic Reviews ] 4/25 Doctors Treating HIV Can Trust Their Observations to Manage Meds Clinical Symptoms Enough to Switch Drug Regimens for HIV Patients ... Decisions regarding drug treatment for HIV can be based on symptoms and, when available, CD4 cell count, rather than viral load, which requires expensive laboratory testing. This finding is most useful in lower-income countries, where the second-line AIDs treatments have not been used because of the need for monitoring. ... [ HealthDay ] 4/25 HPV Vaccines Predicted to Succeed in Britain British students take up HPV vaccine ... A pilot study in the city of Manchester, Great Britain, suggests enough parents will agree to have their teenaged girls vaccinated to make the program work when it begins nationwide. Vaccine uptake was 70.6 percent for the first dose and 68.5 percent for the second dose ... [ Reuters ] 4/25 Through Thick and Thin Drugmakers bond goes beyond Vytorin ... Merck Chief Executive Richard Clark said the fallout from the ENHANCE controversy won't result in any changes to an eight-year-old partnership with Schering-Plough to make cardiovascular medicines ... [ Star-Ledger ] 4/25 Saved by the Enbrel Amgen 1st-Quarter Net Rises 2% on Enbrel Sales Growth ... Enbrel, a treatment for rheumatoid arthritis and psoriasis, generated $951 million in revenue in the first quarter, a 30 percent increase from a year earlier. Enbrel rose because of increased demand and higher prices, Amgen said. Wholesalers also stockpiled $120 million worth of Enbrel in the first quarter ... [ Bloomberg ] 4/25 Not a Nice Decision for U.K. Arthritis Sufferers New arthritis drug rejected over cost ... Figures from Bristol-Myers Squibb show that an average dose would cost the NHS £9,334 (US $18,400) a year. The company has said this is similar to the cost of other anti-TNF drugs ... [ Telegraph ] 4/25 Tykerb Gets EU Nod EU backs Glaxo's breast cancer drug with warnings ... Tykerb is one of Glaxo's big new drug hopes, and the first of several cancer medicines that it hopes to have approved by 2010. Studies of the product are also underway to treat early-stage and inflammatory breast cancers, as well as head and neck, gastric and lung cancers ... [ Reuters ] 4/25 Autism, Mercury Linked Again Study Links Autism Risk to Distance from Power Plants, Other Mercury-releasing Sources ... A newly published study of Texas school district data and industrial mercury-release data, conducted by researchers at The University of Texas Health Science Center at San Antonio, indeed shows a statistically significant link between pounds of industrial release of mercury and increased autism rates. It also shows—for the first time in scientific literature—a statistically significant association between autism risk and distance from the mercury source. ... [ University of Texas Health Science Center at San Antonio ] 4/25 Internet Drug News Miscellaneous Short Takes: - Wyeth's Poussot to replace Essner as chairman Reuters - Shire agrees to buy orphan drug candidate Boston Globe - FDA approves Biovail's Aplenzin, a new formulation of bupropion Reuters - Procter & Gamble gets approval for new Actonel dose Reuters 4/24 Vyvanse for Adults Shire's ADHD drug cleared to treat adults ... Of 4.9 million US adults with ADHD only about half have been treated, creating a much bigger market for Shire's drug because most children diagnosed with the condition are already receiving treatment. ... [ Guardian ] 4/24 Chemo-brain Explained Brain damage link to cancer drug ... 5-fluorouracil, a drug widely used to treat cancer, may cause brain damage, with the effects lasting for years after the end of treatment ... [ BBC ] 4/24 Baxter May Bail Baxter weighs whether to reintroduce recalled heparin product in U.S. market ... Heparin generates only $30 million of Baxter's more than $11 billion in annual sales, and Wall Street analysts asked CEO Robert Parkinson last week whether it was worth the legal risks and liability to remain in the business given that sales are so small ... [ Chicago Tribune ] 4/24 My First Boss Was Right: If You Don't Set a Deadline, Nothing Ever Gets Done Drugmakers Didn't Begin 1,044 Promised U.S. Studies ... The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA. ... [ Bloomberg ] 4/24 Part D Gets B's and C's on Report Card Medicare Prescription Drug Benefit Shows Mixed Results ... Medicare beneficiaries are less likely to forego basic needs such as food to pay for medicine, but the sickest patients are still skipping meds due to burdensome costs ... [ HealthDay ] 4/24 Silver Bullet for Trachoma Antibiotic Can Wipe Out Blinding Eye Infection ... Researchers in Tanzania treated 98 percent of the residents in the town of Kahe Mpya, Tanzania, with Zithromax and gave a second dose two years later. Infection dropped to 0.1 percent two years after first treatment from 9.5 percent. Eye inflammation in children fell to 2.6 percent from 16 percent within 5 years ... [ Bloomberg ] 4/24 Rough Quarter for GSK Glaxo First-Quarter Profit Falls on Avandia, Generics ... Sales of Avandia, once Glaxo's second- best-selling drug, declined 56 percent... Bestsellers such as Coreg for high blood pressure and antidepressant Wellbutrin faced pressure from generic versions ... [ Bloomberg ] 4/24 Long-term Fallout from Plavix Deal Drug Executive Is Indicted on Secret Deal ... Andrew G. Bodnar, a doctor and former vice president at BMS, is accused of making a false statement to the Federal Trade Commission in describing a 2006 agreement between Bristol-Myers and Apotex, a Canadian maker of generic drugs. Dr. Bodnar had led negotiations to stop Apotex from selling its own version of Plavix ... [ NY Times ] 4/24 Bad Year for Schering, Good Year for Fred Schering-Plough CEO pay rises to $24.7M despite loss in 2007 ... The bulk of CEO Fred Hassan's compensation, $18.4 million, came from stock and stock options awarded in 2007, more than double the amount from such awards in 2006 ... [ AP ] 4/24 Researchers Harshing Your Mellow to Find New Anxiety Meds High Anxiety? ... Right now, about half of all people who take medicine for an anxiety disorder don't get much help from it. And doctors have no definitive way to predict who will benefit from each prescription they write. Doctors at the University of Michigan are searching for clues as to how anxiety treatment could be tailored to the individual patient ... [ University of Michigan Health System ] 4/24 Internet Drug News Miscellaneous Short Takes: - Wyeth pulls Europe application for pneumonia drug Tygacil Reuters - Risk of depression dims hopes for anti-addiction pills AP - Schering-Plough selling animal health products AP |
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