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5/9 Feds Want to Get the Story on ENHANCE
Justice Department Requests Data on Schering's Vytorin ... The Department of Justice has asked Schering-Plough Corp. for information and documents related to its handling of a study of the cholesterol drug Vytorin .... [ WSJ ]

5/9 Dems Browbeat DTC Ads
New Rules on Drug Ads Sought ... Michigan Democrat Bart Stupak wants to lay the groundwork for future legislation to tighten controls on drug marketing, including giving the Food and Drug Administration the right to force changes in TV drug ads before they are broadcast .... [ WSJ ]
Drug companies defend TV ads critics call misleading ... TV marketing has become a pillar of the pharmaceutical business since regulators first loosened rules to allow the practice a decade ago. Companies spent roughly $3.5 billion on spots last year, and most blockbuster drugs of the last 10 years have been trumpeted by a heavy cycle of commercials .... [ USA Today ]

5/9 Risks Outweigh "Compassionate Use"
Why One Cancer Patient Is Fighting a Drug Company Working on a Cure ... If a dying patient took experimental treatment TNFerade under compassionate use and it hurt her somehow, the FDA could slow the entire approval process to investigate, costing the manufacturer GenVec money, and delay potentially thousands of people from getting a drug that otherwise would be ready. .... [ ABCNews ]

5/9 Insider Buying at the Top
Bristol-Myers Squibb CEO buys 100,000 shares ... James Cornelius purchased $2.3 million worth of stock on Wednesday for $22.70 to $22.92 a share .... [ Reuters ]

5/9 New Indication for Abilify
FDA OKs Abilify for secondary use against bipolar disorder ... Abilify now approved as a secondary therapy alongside lithium and valproate for treating bipolar episodes in adults .... [ AP ]

5/9 Public Citizen Takes on the Patch
US group wants FDA to pull J&J birth control patch ... Public Citizen's Health Research Group says the amount of estrogen released from the Ortho-Evra patch varies widely among individual women, and those who absorb too much were at greater risk for blood clots and and other painful side effects .... [ Reuters ]

5/9 Sloppy Pharmaceutical Care
Quarter of Disabled Seniors Use Risky Medications ... A quarter of disabled seniors in the United States have taken one of 33 medications regarded as ineffective or posing a high risk of side effects to the elderly. These drugs include Xanax, Demerol, Darvon and Procardia. .... [ HealthDay ]

5/9 Now, How Do I Turn This Thing Off?
Electronic Pillbox Helps Seniors Stick to Drug Regimens ... Older adults following a medication regimen are less likely to miss doses when reminded by an electronic pillbox that both beeps at the appointed drug-taking time and announces the number of pills to take and how to take them .... [ HealthDay ]

5/9 Heparin Supply Tight; Cost Up
Price of blood thinner has doubled since recall ... APP, the sole U.S. supplier after Baxter's recall, has tripled production in recent months. Costs for China-sourced crude heparin have risen 500% since early 2007, and APP claims that its recent price increases don't cover all of the higher expenses. .... [ USA Today ]

5/9 Strattera for ADHD Maintenance
Eli Lilly's Strattera approved for ADHD maintenance in kids ... Strattera is the first FDA-approved non-stimulant to treat ADHD in children, adolescents and adults .... [ AP ]

5/9 Internet Drug News
Miscellaneous Short Takes:
- S.Korea approves Zeltia cancer drug Yondelis
Reuters
- Mylan In Settlement Talks With Abbott On Generic Depakote
CNNMoney
- Court Won't Alter Ruling Blocking Generic Celebrex Until 2014
Dow Jones
- AstraZeneca Submits sNDA for SEROQUEL XR for the Treatment of Generalized Anxiety Disorder
Company news release

5/8 Eisai: Aquavan; Expert Panel Gives Thumbs Up For
Novel Sedative With Limitations
Eisai's Aquavan Should Be Approved, U.S. Advisers ...voted 8-2 that there's too little evidence the medicine could be used safely by health-care providers who lack training in general anesthesia…[Bloomberg]
FDA Panel Recommends Approval for Eisai's Sedative … fospropofol disodium, a sedative-hypnotic agent for use in patients undergoing diagnostic or therapeutic procedures such as colonoscopies… Six panel members voted to recommend approval, three voted against…[Wall Street Journal; $$$]
Editor's Note: Adds panel concerns regarding breathing difficulties linked to the drug & that special training may be needed; Adds that Aquavan was one of the fruits from its $3.9 billion acquisition of MGI.

5/8 Roche Our Byetta-Like Product Better Than Byetta
Roche Targets Diabetes to Replace Cancer Drug Sales … Roche says its product is a synthesized version of human GLP-1. The molecule is also smaller, allowing for a needle that can be hidden in a disposable pen-like device. Byetta's weekly version will need to be added to liquid and comes with a bigger needle and syringe…[Bloomberg]
Editor's Note: Adds that Sanofi, Novartis, Novo are also working on GLP-1 analogues.
Editor's Note: The GLP-1 battle will hinge on who has the best efficacy and weight-loss claim.  Weight loss is the ultimate patient benefit - people will cheerfully submit to injections and inconvenience if they believe the weight loss story.

5/8 Cannabinoid Blocker Linked To Brain Damage In Baby Mice
Weight-loss drugs may harm developing brain -study … disrupted wiring needed for brain development in young mice … behaved as if both eyes were open. This suggested the visual cortex was not adapting as it should…[Reuters]

5/8 Feds: Chantix = Most Effective Way To Quit Butts
Chantix recommended to quit smoking despite safety concerns … new guidelines mention the psychiatric risks but also say the popular Pfizer Inc. drug is the most effective at helping people get off cigarettes …[ NASDAQ]

5/8 Mylan Launches Generic Requip
Mylan Announces Final FDA Approval for Ropinirole Hydrochloride Tablets …  will be shipped immediately… 0.25 mg (base), 0.5 mg (base), 1 mg (base), 2 mg (base), 3 mg (base), 4 mg (base) and 5 mg (base) …[Mylan Press Release]

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5/8 Once-Daily Prograf Hit With 2nd Delay; FDA Needs More Data
Astellas Faces Setback Over U.S. Approval of Drug … Japan's second- largest drugmaker, said U.S. approval of a new version of organ transplant treatment Prograf was delayed for a second time…[Bloomberg]

5/8 "HSDD"  Boehringer Begins Diseasification Process
Regarding Women Who Don't Want Sex
Boehringer Ingelheim Committed to Advancing the Science of Hypoactive Sexual Desire Disorder … condition called Hypoactive Sexual Desire Disorder (HSDD) … prevalent yet under-diagnosed medical condition that can have a serious effect on women's lives, causing significant psychological distress and negatively impacting their relationships …[ Boehringer Ingelheim Press Release]

5/8 ABT-089: Abbott Hypes Experimental ADHD Med (Phase II)
Abbott Focusing On ADHD … targets neuronal nicotinic acetylcholine receptors … effective in treating the main symptoms of the disorder ... without the common side effects of other drugs that treat ADHD…[Forbes]
See Also: Medline search for "ABT-089"
See Also: ABT-089, A Neuronal Nicotinic Receptor Partial Agonist, for the Treatment of Att … 2 mg, 4 mg, or 20 mg of ABT-089 for 2 weeks each in a randomized, double-blind, placebo-controlled, 4 x 4 Latin square design …[ TE Wilens; Biol Psychiatry (2006) 0:]

5/8 Internet Drug News Miscellaneous Short Takes:
Bipolar Disorder Might Be Overdiagnosed
HealthDay
Par Buys Rights To Generic Imitrex Injection
Par Press Release
ZymoGenetics gets slap on wrist for misleading Recothrom promo materials
Reuters
Metformin Good As Insulin For Gestational Diabetes
Reuters
China steps up fight against virus sickening young kids
AP
Too much, too little sleep tied to ill health in CDC study
AP
Medtronic recalls certain disposables due to  contaminated heparin
Reuters

5/7 Target Responds To Wal-Mart $4 Formulary Update
Target Reduces Costs on Pharmacy and Over-The-Counter Drug Offerings … expanded assortment of $4 prescription drugs, 90-day supply of these medications for $10 and over-the-counter medications for $4 or less …[Target Press Release]
Editor's Note: Click Here To View Target's $4 Generic Formulary
Editor's Note: These $4 formularies are comprehensive: ace inhibitors, fixed combo ace/HCTZ pills, beta blockers, statins, metformin, sonfonylureas, three alpha blockers, thyroid hormone; no PPI's, atypicals or ARB's.

5/7 Chinese Insist No Direct Link Between Heparin & US Deaths;
Accuse Baxter Of Stonewalling Investigation
Chinese expert: No direct link yet between heparin and U.S. deaths ... further analysis needed to decide the relationship between heparin-like substance and the deaths … asked for the production records, samples and recalled heparins, but Baxter did not provide necessary cooperation ... [ ChinaView; Xinhua]

5/7 EU Revokes Symbicort For Smoker's Cough
AstraZeneca says European patent for Symbicort to treat smokers cough revoked … retains data exclusivity until August 2010 in some European markets …followed an appeal from generic manufacturers Healthcare and Generics UK  … [ Herald Tribune]

5/7 Fentora For Non-Cancer Pain Rejected;  Drug Abuse Fears
Wider use of Cephalon drug too risky-US advisers … recommended against approval in a 17-3 vote … 80 percent of Fentora's yearly prescriptions … given to patients without cancer…[Reuters]
See Also: Cephalon Press Release

5/7 Reverse Payments: FTC Refuses To Give Up
US trade agency wants to end deals delaying generics … reverse payments are made after a generic company files with the Food and Drug Administration (FDA) to sell a generic version of a drug still under patent…[Reuters]
Editor's Note: There have been several court cases validating the legality of these deals..

5/7 Bird Flu: Low Profile But Still Looming; Keep Eye On Indonesia
Pandemic flu threat remains substantial, health experts say … 382 people have come down with bird flu since 2003, and that 241 of them have died. Indonesia …[NY Times]

5/7 Sleep Aids: Expanded Use Uncovers New Breed Of Side Effects
To Cut Risks of Sleeping Pills, Hide Car Keys, Unplug Phone ...U.S. sleep-aid prescriptions grew 10% last year …  eat, walk, make phone calls or get behind the wheel … may act on brain circuits unevenly, leaving the parts that govern "automatic" behaviors like eating and driving active while shutting down the centers of judgment and control…[Wall Street Journal; $$$]

5/7 Internet Drug News Miscellaneous Short Takes:
Store Health Clinic Boom Slows
Wall Street Journal; $$$
JNJ data: risperidone is better than quetiapine for relapse latency
JNJ Press Release
Teva seeks judgment on Astra's Nexium patents
Reuters
Medtronic to cut about 1,100 jobs
Reuters
Lilly discovery could help control 'hunger hormone'
IndyStar
Novartis has high hopes for meningitis vaccine candidate
Chicago Tribune
Folic Acid Doesn't Help the Heart
HealthDay


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5/6 Cordaptive Fallout: Merck Forced To Fire 1,200 Reps
Merck Cutting U.S. Sales Force by 1,200 to Trim Costs … combined with 400 sales jobs eliminated last year, affect about 20 percent of the 8,500-person sales force …Sales people will be notified by the end of this month and will leave by the end of July…[Bloomberg]
Editor's Note: Adds 86,000 pharma jobs cuts in the 4 years through 2006.
See Also> Similar Merck Press Release

5/6 Aha
Whither Cordaptive? Merck May Have A Long Wait … laropiprant component of Cordaptive presumably had cardiovascular signals … FDA was unable to get past the notion that Merck couldn't explain why it happened …[Pharmalot]

5/6 Report: Step Therapy Illegal In NJ But They Do It Anyway
Doctors say insurers step over the line … Because Medicare Part D plans are regulated by the federal government rather than the state, insurers like RxAmerica can use step therapy to curtail costs …[Star Ledger]

5/6 Walmart Fires Salvo In Generic Price War
Walmart expands prescription drug program … third phase of its' prescription drug program … It will now offer 90-day prescriptions for $10 for 350 medications …[ABC]
Wal-Mart expanding its low-priced drug program … 1,000 over-the-counter items for $4 or less and selling some 90-day generic prescriptions for $10…[Reuters]
See Also: Click Here For Actual List Of Reduced Price Wal-Mart Meds
Editor's Note: This is big.  Walmart has become in effect, a cash-on-the-barrel-head PBM. 

5/6 DTC: Lipitor, Vytorin & Procrit In Washington Fishbowl
Ads for 3 drugs face U.S. lawmaker scrutiny ...commercials for cholesterol drugs Lipitor and Vytorin and for anemia drug Procrit at a Thursday hearing on whether such advertisements are deceptive or misleading … [Reuters]

5/6 Blogger: Chantix DTC To Resume
Pfizer "Re-Lighting" Chantix Ad Campaign For Smokers? ...Pfizer is "exploring" advertising Chantix again in various print and TV outlets … may also have something to do with the fact that sales of Chantix actually went down in the last quarter …[MSNBC]

5/6 FDA: Pre Approval Review Documents: Eisai Sedative Effective
Eisai's Sedative Appears Effective, Regulators Say … Eisai is promoting Aquavan as the first new drug for minimal to moderate sedation in more than a decade that doesn't require monitoring by an anesthesiologist…[Bloomberg]

5/6 FDA Study: Insulin Pumps Are Risky For Teens
FDA study: Insulin pumps linked to injuries, deaths in teens … deaths and more than 1,500 injuries  … malfunctioned, but other times, teens were careless or took risks … [AP]
Editor's Note: Adds that pumps do $1.4 billion in sales/year, cost $6,000 apiece and require $250/month to run.

5/6 Head Shrinkers Debate Cardio Testing ADHD Kids
Psychatrists Grumble About Cardiac Testing for ADHD Drugs …  debate about ADHD medication safety is far from over ..."Parents should get an EKG for their child before yelling at them…[Wall Street Journal; FREE]

5/6 Report: Prices Vary Within Same Chain
Costs Can Vary By $100 or More for Same Drugs  … not only for the same drug at different stores, but there were price differences within the same chain and the online price …[ Washington Post]
Editor's Note: Well, airlines do it.

5/6 Chinese Study: Pletal Effective In Stopping Stroke
Anti-Clotting Drug as Good as Aspirin at Stopping Second Stroke … cilostazol reduced the risk of recurrent stroke by 38 percent … causes less bleeding in the brain …[HealthDay]

5/6 Internet Drug News Miscellaneous Short Takes:
Concern voiced about proposed new version of OxyContin
AP
Ibuprofen Linked to Reduced Alzheimer's Risk
Washington Post
Men Need Regular Osteoporosis Screening, New Guidelines Say
Bloomberg
Epilepsy Seizures in Kids Lessened by High-Fat, Low-Carb Diet
Bloomberg
Roche to transfer 300 jobs from Indiana to Germany
BusinessWeek

5/5 New Oxy Designed To Be Abuse Resistant
OxyContin that's harder to abuse? FDA debates new version … plastic-like coating fuses to the tablet, making it harder to crush -- and turning into a gooey mess if abusers try to inject it … [AP]

5/5 Pfizer Payday For Bextra, Celebrex Plaintiffs
Pfizer reaches deal with some Celebrex users-WSJ … to pay as much as $500 million overall  .. $200,000 per client, on average, to settle his Bextra cases and an average of $40,000 to $50,000 per client to resolve Celebrex lawsuits …[Reuters]

5/5 Fentora: Non Cancer Use Nod Unlikely
FDA says wider use of Cephalon drug carries risks of misuse … FDA said granting wider approval could encourage "abuse and misuse, and increase the incidence of accidental exposures which ... could potentially have devastating effects …[FOX]
See Also: Similar Report From Reuters

5/5 Surfaxin Delayed But Approvable; Shares Circle Drain
Discovery Labs get FDA approvable letter for Surfaxin ... sets forth the remaining conditions that must be satisfied to gain U.S. marketing approval for Surfaxin …[Discovery Press Release]
See Also: Similar Report From Reuters … adds explanation of drug and disease state it attenuates; shares lose 50% of their value.

5/5 EV-71: Chinese Child Death Virus Update: Officials Hid Data; Downplay Lethality; 24 Dead, Spreads To Vietnam, Singapore
24 Chinese children die of virus; other countries affected … typically causes little more than a fever and rash has killed 24 children in China, and health officials fear the worst may be yet to come as outbreaks occur in neighboring countries …[AP]
Editor's Note: adds Chinese public health officials buried details of the outbreak just like they did when SARS broke out in their country in 2003. 
China's Anhui sees 622 new EV71 virus cases; total exceeds 5,100 … All kindergartens in Fuyang were ordered to remain closed following the May Day holiday that ended on Saturday, to help prevent the spread of the sometimes fatal virus …[ Chinaview.com]

5/5 Experts Nix IV Antibiotic Recommendation  For Lyme
Doctors to reassess antibiotics for 'chronic Lyme' disease … Cigna covers up to 28 days of intravenous antibiotic therapy for Lyme disease and, like many insurers, cites the Infectious Diseases Society's guidelines in its coverage plan …check backgrounds of the new experts looking at the guidelines will be checked for any potential conflicts … [AP/Yahoo]

5/4 Cough Medicine; Kids; Chronic Use Common
10% of U.S. Kids Using Cough Medicine Every Week … marketed in the United States, how frequently they are used had not been scientifically studied … overall use of cough and cold medications declined from 12.3 percent in 1999-2000 to 8.4 percent in 2005-2006…[Health Day]

5/5 Procardia, Zantac, Detrol Blamed;
Gramps' Accelerated  Mental Decline
Common Medications Could Cause Physical Impairment in the Elderly ...anticholinergic medicines cited in the study included the blood pressure medication nifedipine (Adalat or Procardia), the stomach antacid ranitidine (Zantac) and the incontinence medication tolterodine (Detrol) ..[HealthDay]

5/5 FDA: Merck's Un-Fairy Godmother
Streak of trouble with FDA, other problems, hits Merck … In barely a week, Merck has suffered a stunning streak of setbacks, including federal regulators rejecting two experimental drugs and publicly demanding the drugmaker clean up significant problems at its main vaccine plant …[Newsday]

5/5 Internet Drug News Miscellaneous Short Takes:
Sepracor Sinks In Face Of Lunesta  Double Digit Share Decay
AP
Washington Pharmacists Can Refuse to Morning After Pill
Wall Street Journal; FREE!!!
Night club drug Special-K (ketamine) could ease depression 
Reuters
J&J merges Ortho Biotech, Centocor sales, slashes 400 jobs
MM&M
LSD May Shed Hippie Image With Swiss Medical Study
Bloomberg
Bristol Sells Ostomy, Wound Carre Division For $4.1 Bln
International Herald Tribune
Medical marijuana user who was denied liver transplant dies
AP
CDC: Measles cases in US top 70, highest in 6 years
AP
Rotateq Label To Include Report Of Death
NASDAQ

Not Pharma But Gosh Darn Interesting
Teen girl's upside-down feet treated in NYC surgery
AP

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