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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

4/23 60% Of Seniors Don't Know They Have A Doughnut Hole 
Medicare Prescription Drug Benefit Shows Mixed Results … sickest patients are still skipping meds due to burdensome costs … Only 40 percent of respondents knew that the new drug plan had a coverage gap (the "donut hole") …[Health Day]

4/23
Antipsychotics, Nursing Homers, Pneumonia Linked
Antipsychotic Drugs Linked to Pneumonia in Elderly … 60 percent more likely to develop pneumonia in the short term than … risk is greatest during the first week after patients start taking the medications … [Washington Post]

4/23
Wyeth Strategy:  Pristiq Price Lower Than Effexor XR,
No Dose-Price Premium
Wyeth Goes for Bargain Price on Replacement for Effexor … 20% discount to its older blockbuster antidepressant, Effexor XR…  flat $3.41 per tablet for both mid- and high-dose…[Wall Street Journal; FREE]
Wyeth says to shift focus from Effexor to Pristiq … analysts have dismissed Pristiq as a "me, too" drug, with few distinguishing characteristics and modest sales potential …[Reuters]
Editor's Note: Adds that impending generic Effexor tabs from India will not have AB rating to the brand. 

4/23
GAO Slams FDA's Non-USA Drug Factory Oversight;
Dingell Freaks, Totally Disrespects FDA Boss:
A
UDIO; NPR: Heparin Hearing on Capitol Hill Turns Feisty … head of the Food and Drug Administration testifies before a House subcommittee about planned improvements to oversee the foreign manufacture of drug ingredients … [NPR; All Things Considered]
Editor's Note: John Dingell screams at FDA boss; GAO director explains that: FDA will spend $11 million on overseas inspections, needs $70 million to get the job done … 4 mins; recommended.
FDA Commissioner Isn't Doing His Job, Lawmaker Says ...``You simply are absolutely incapable of addressing your responsibilities.'' … hasn't asked for enough money to inspect overseas drugmakers…[Bloomberg]
See Also: 29 image slide show regarding heparin mess; includes snaps of today's meeting; highly agitated Dingell looks like an aging John Glenn, von Eschenbach's got this weird hairdo going on; more.

4/23
Bayer Legal Acrobatics Delay Yasmin Clone Up To 30 Months
Bayer Sues Watson, Sandoz Over Generic Yasmin Pills … delays U.S. Food and Drug Administration approval for Watson and Sandoz for as long as 30 months, or until a court resolves the dispute…[Bloomberg]

4/23
Two 800 Lb Gorillas Renew Their Vows
Medco inks key deal with UnitedHealth … extension of its contract to provide pharmacy benefit services to insurer UnitedHealth Group through 2012…[Reuters]

4/23 L
anti-TNFa Cimzia Approved For Crohn's Disease
Cimzia® Approved in the US for the Treatment of Moderate to Severe Crohn's Disease … available in the US within the next 48 hours … Cimzia® is dosed subcutaneously every four weeks after initial dosing …[UCB Press Release]
FDA Approves Cimzia to Treat Crohn's Disease
certolizumab pegol … injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks … Because Cimzia affects the immune system, it can lower the body's ability to fight infections, such as tuberculosis and other opportunistic  … [FDA Press Release]
See Also: What is a TNF inhibitor? [Wikepedia]

4/23
Glaxo To Acquire Biotech Firm Sirtris
Glaxo to Buy Sirtris, Maker of Red Wine-Based Drug … based in Cambridge, Massachusetts, focuses on developing drugs that activate sirtuins, a class of enzymes involved in aging … lead drug candidate, SRT501, could come to market as soon as five to seven years …[Bloomberg]
Glaxo to Acquire Red-Wine Pill Maker Sirtris … [Wall Street Journal; FREE]

4/23
Generic Trust Rift Widens
Inexact Copies: How Generics Differ From Brand Names … Generics can produce blood levels as much as 20% below or 25% above that of the original drug and still be considered "bioequivalent," according to Food and Drug Administration guidelines…[Wall Street Journal; FREE]

4/23
Cancer Pipeline Runneth Over
Healthy pipeline for cancer treatments: PhRMA … report delivered by industry trade group PhRMA has found a record 750 potential cancer treatments in the US research pipeline … [MM&M]

4/23
Internet Drug News Miscellaneous Short Takes:
Wait & Watch on Santarus
Zacks
Pfizer To Launch Champix (Chantix) In Japan
Pfizer Press Release
JAMA Commentary Pans FDA Proposal to Ease Off-Label Rules
Wall Street Journal; FREE
Merck And Schering's Uneasy Alliance
Forbes

4/22
AHA: Kids Need EKG Before Getting Hyperactivity Meds
Kids With ADHD Need Heart Tests Before Taking Drugs-Group … diagnosed with ADHD receive an electrocardiogram to rule out heart abnormalities ...children currently taking stimulant drugs who didn't have an ECG prior to treatment should receive the test…[CNN]
Heart Check Urged for Children With Attention Deficit  … One-third of children with the most severe congenital heart defects have attention deficit … In healthy school-aged children, research suggests 2 percent may have serious undiagnosed heart conditions…[Bloomberg].

4/22
WellPoint Follows FDA On EPO Restrictions
WellPoint likely to follow FDA on anemia drugs … biggest U.S. health plan, will likely follow the lead of U.S. regulators, who are moving toward restricting the use of widely used anemia drugs …[Reuters]

4/22
Heparin: Chinese Deny Contaminant Caused Adverse Reactions
U.S. and China Dispute Conclusions About Tainted Heparin … contaminant has been found in more than 10 other nations, but none has reported a similar spike in harmful allergic reactions …[Washington Post]
U.S., China spar over heparin contaminant's role … tested batches of heparin used by patient who reported health problems and only some of these batches contained the contaminant…[Reuters]
Editor's Note: Nobody gets executed until they figure out what happened and who to blame it on. 

4/22
Patanase; Alcon's Answer To Astelin Approved
Alcon gets OK for nasal spray … same main ingredient -- olopatadine hydrochloride -- as Alcon's Patanol and Pataday drops for eye allergies. "It's based on the same molecule …[ Star Telegram]
See Also: Image of Pantase package

4/22
Lilly Report Card
Lilly profit falls short, shares slump .. disappointing sales of its Byetta diabetes drug overshadowed growing demand for its other medicines … Humalog jumped 20 percent to $407 million … …[Reuters]
Editor's Note: Adds detailed sales stats for other core products - Cialis, Zyprexa, Humulin, Cymbalta, Evista.

4/22
Invisible Hand Likes Novartis' New Gestalt
Novartis Rewarded for Cost Cuts, Sales Gains ... saved $160 million so far as part of its plan to cut 2,500 jobs  … turnaround appears to have stemmed from better-than-expected sales of Diovan and Gleevec …[Smart Money]

4/22
Analyst: Treximet Formulary Problems Likely
Pozen shares wobble after analyst questions Treximet sales … predicted limited success ...due to generic competition and reimbursement questions …[Forbes]

4/22
Pfizer Report Card
Pfizer Is Still Floundering … Sales of Pfizer's smoking cessation treatment Chantix are booming, it is using its cash to buy up a bunch of drugs in development, and generic competition continues to eat into its  top product, Lipitor, and other former blockbuster drugs … [Motley Fool]
Editor's Note: Adds stats regarding good news/bad news sales stats for Chantix.

4/22
Internet Drug News Miscellaneous Short Takes:
Alpharma yanks experimental pain drug Embeda
Reuters
Pfizer Gets FDA Wrist Slap For Online Viagra Ads
Reuters
Mylan unit gets Final Nod for generic Plendil
Pittsburgh Business Times
Avastin study fails to show improved lung cancer survival
Reuters
Erbitux seen challenging Avastin in lung cancer
Reuters
Theravance to lay off about 115 people
SF Business Times
Biogen CEO Mullen receives $10.5M in 2007
AP
Watson Files For Generic Yasmin
Watson Press Release
High-Dose Lipitor Lowered Heart Attack, Stroke Risk In Patients with Chronic Kidney Disease
Pfizer Press Release

4/21
NY Times On Specialty Drugs;
PBM's Secretive, Lucrative Deals Don't Pass Smell test
Benefit Managers Profit by Specialty Drug Rights … lucrative side businesses seemingly at odds with that best-price mission … CVS Caremark, meanwhile, sold nearly $6 billion in specialty drugs last year through …[NY Times FREE]
Editor's Note: Adds details regarding H.P. Acthar Gel; specialty med that went from $1,600 per vial to $23,000 per vial.  Adds comments from CVS Carenark, Express; includes anecdotes of employers demanding givebacks.

4/21
Crestor Wants To Prove It's Better Than Lipitor,
BUT Invisible Hand Fears It Could Backfire
Crestor research program weighs on AstraZeneca shares …  uncertain result is one reason shares are down 26 percent … designed to prove Crestor ... can cut heart disease better than Lipitor …[Bloomberg/Boston.com]

4/21
Harvard MD's Oppose Proposed Massacheussets Anti-Rep Law
Harvard Docs: Bring On the Drug Reps … taking as little as a pen or a slice of pizza from Big Pharma could end up paying $5,000 in fines and serving two years in jail …[Wall Street Journal; FREE]
Conflicts don't sicken health care … The real intent of these critics goes far beyond food and trinkets, and its true purpose is to curtail strictly or even eliminate all contacts between physicians and private industry…[Boston Herald]

4/21
Amylin: 30,000 Foot View
VIDEO: Amylin Shoots For Diabetes Dominance … Inhaled insulin looks dead and that's good news for this San Diego-based bio-tech …[Forbes]

4/21
Wetness Drugs Dry Bladder, May Fry Memory
Incontinence Drugs May Hurt Memory … may speed age-related memory loss, researchers said yesterday … those who took the drugs lost their memory faster than those who did not …[Wall Street Journal; FREE]
See Also> Similar Report From Boston Globe ; adds IMS data on above cited drugs.

4/21
Abilify Could Help Dry Out ETOH-ics
Aripiprazole may be effective for alcohol addiction …  increases the sedative effects of alcohol, while decreasing its euphoric effects … dopamine receptors in the brain - areas thought to have a role in mood and addiction…[Reuters]

4/21
AZN Deal With Indians Protects Nexium Patent Until 2014
AstraZeneca agrees deal with Indian generic firm over key drug … agreed to a deal that would enable top Indian generic drug firm Ranbaxy to produce its own version of heartburn treatment Nexium from 2014 …[AFP]

4/21
Copaxone Data Hints Superiority
Study shows Teva's Copaxone besting other MS drugs … significantly less brain-tissue loss than similar patients treated with three other leading RRMS drugs as part of the new study …[Kansas City Business Journal]

4/21
Analyst Forcasts Pfizer Buy Spree
Pfizer Cash Rich, Catalyst Poor … expect the company to look to do a number of significant deals in the pharma and biotech industry in 2008 in order to build the franchise and invest for the future …  [Zacks]

4/21
Early Data; P.O. Psoriasis Drug; Efficacy; ISA247
New Psoriasis Pill Appears Effective … ISA247, which is a calcineurin inhibitor, significantly improve symptoms of psoriasis. Calcineurin is a protein that helps regulate inflammation …[HealthDay]
Editor's Note: ISA247 is a cyclosporine analogue.
See Also: The novel calcineurin inhibitor ISA247: a more potent immunosuppressant than cyclosporine in vitro …[Transpl Int. 2005 May;17(12):767-71. Epub 2005 Apr 13]
Editor's Note: Other transplant drugs used for psoriasis such as Tacrolimus  [when taken orally] carry a notable side effect burden

4/21
Internet Drug News Miscellaneous Short Takes:
Novartis Still Plans To File Oral MS Drug Before End '09
NASDAQ
North Dakota's Largest Hospital Bans Samples
In-Forum News
Money Tip: Three prescriptions for lower drug costs
Post Gazette
Pfizer wins Norvasc drug patent decision in Canada
AP
Lipitor No Help for Dementia of Alzheimer's Patients
Wall Street Journal; FREE
ViroPharma abandons experimental hepatitis C drug plan
Philly.comd
Novel Xeloda(R) Dosing Schedule May Offer Well-Tolerated Alternative for Treatment of Advanced Breast Cancer
Roche Press Release
Pfizer wins blood-pressure drug patent decision in Canada
CNN

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