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4/18 Big Pharma Sees Tightened Marketing Regs from New Administration
Drug Makers Push Easing Off-Label Rules
...
Drug-industry representatives are descending on the capital to protect their freedom to advertise their wares directly to consumers and to push for looser government restrictions on their ability to promote off-label uses of their medicines
...
[ WSJ ]
4/18 Promising Psoriasis Treatment
Researchers find immune drug safely treats psoriasis
...
Isotechnika's new drug candidate ISA247 worked safely to relieve some of the symptoms of psoriasis, and did not cause significantly more side-effects than placebo. Researchers found an almost linear relationship between drug dose and response
...
[ Reuters ]
4/18 Alzheimer's Vaccine Hits Stumbling Block
Wyeth, Elan Suspend Early Alzheimer's Vaccine Trial
...
Wyeth and Elan Corp. suspended clinical study of a vaccine against a suspected cause of Alzheimer's disease after a patient developed open sores and spent 13 days in the hospital. This is the second time an active immunization against the protein, beta amyloid, has provoked serious side effects in patients
...
[ Bloomberg ]
4/18 "It may be better to use diapers and be able to think clearly than the other way around"
Study links incontinence drugs with memory problems
...
Study subjects (average age 75) who took anticholinergics had a 50 percent faster rate of cognitive decline compared to those who didn't take any
...
[ AP ]
4/18 New Label Info Sought
Democrats propose country of origin rule for food, drugs
...
Drug labels would have to identify the source of a medicine's active ingredient and its place of manufacture. Labels for all medical devices would have to show country of origin, as well.
...
[ AP ]
See also> FDA fees eyed to boost food, drug safety [ USA Today ]
4/18 Brazil Rolls it Own Malaria Treatment
Brazil launches cheap new malaria pill
...
Brazil's state-run drugmaker Farmanguinhos is working with the Drugs for Neglected Diseases Initiative (DNDi), a non-profit group based in Geneva, to bring the fixed-dose combination, known as ASMQ, to market at a target price of $2.50 for a full adult treatment
...
[ Guardian ]
4/18 Stockpiles of Tamiflu High, Sales Down
Flu Drug Sales Falter For Roche
...
Sales of the antiviral drug Tamiflu dropped sharply compared to the same quarter a year ago because most governments already have built up their stockpiles against a feared bird flu pandemic.
...
[ Forbes ]
4/18 Kindler Sees No Need for a Big Merger
Pfizer CEO Stands by His Plan, Frustrating Investors
...
Sales of the antiviral drug Tamiflu dropped sharply compared to the same quarter a year ago because most governments already have built up their stockpiles against a feared bird flu pandemic.
...
[ Bloomberg ]
4/18 AstraZeneca Goes All In on Crestor
AstraZeneca Bid to Supplant Lipitor Not Curing Stock
...
AstraZeneca has set off on a multi-year research program designed to prove that Crestor's superior cholesterol-lowering ability means it can cut heart disease better than Lipitor. AstraZeneca needs a clear win to persuade insurers to pay for Crestor when lower-priced, generic forms of Lipitor flood the market in 2010
...
[ Bloomberg ]
4/18 Viruses 2, Scientists 1
Flu vaccine effectiveness lower than usual
...
People who were vaccinated with this year's vaccine were 44 percent less likely to get influenza than unvaccinated people, the U.S. Centers for Disease Control and Prevention said. That compares to typical vaccine effectiveness of around 70 percent or higher
...
[ Reuters ]
4/18 Internet Drug News
Miscellaneous Short Takes:
- Overuse of Codeine, Oxycodone and Barbiturates Increases Risk of Chronic Migraine
American Academy of Neurology
- New drug Lapatinib shrinks breast cancer
Times (U.K.)
4/17 Indianapolis to Lose Some Lilly Jobs
Lilly Plans to Cut as Many as 500 Indianapolis Jobs
...
Lilly plans to cut as many as 500 jobs in its home city of Indianapolis after abandoning development of inhaled insulin. The reductions, through voluntary buyouts, will affect manufacturing of insulin products Humalog and Humulin as well as the osteoporosis drug Forteo
...
[ Bloomberg ]
4/17 Generic Wellbutrin Gets New Review, Passes
FDA review finds generic Wellbutrin safe, effective
...
Teva Pharmaceutical's generic version of a popular antidepressant is safe and effective, despite a spate of recent consumer complaints, according to the FDA
...
[ AP ]
4/17 Express Scripts Tries a Spoonfull of Sugar, and More, to Make the Medicine Go Down
Express Scripts Studies How to Sway Customers
...
The national average for PBMs converting consumers to generic simvastatin use is 4%, whereas Express Scripts has converted more than 12%. Express Scripts has been a major innovator in the use of "behavorial economics" — the study of how to produce greater changes in behavior than a simple payment or charge can produce
...
[ WSJ ]
4/17 Average Total Prescription Cost Edges Up, But Less Sticker Shock at the Register
Prescription drug copays drop in 2007
...
Express Scripts' 2007 Drug Trend Report shows that the average copay dropped 25 cents to $13.20, while the average total cost of a prescription rose to $55.93 from $55.01
...
[ Houston Chronicle ]
4/17 Another Reason for that Statin
High Cholesterol in Your 40s Increases Risk of Alzheimer's Disease
...
The study found people with total cholesterol levels between 249 and 500 milligrams were one-and-a-half times more likely to develop Alzheimer's disease than those people with cholesterol levels of less than 198 milligrams
...
[ American Academy of Neurology ]
4/17 More Frequent Chemo Doses Better for Breast Cancer
Weekly Taxol best for followup breast cancer care
...
The chance of surviving and being free of breast cancer after five years was 27 percent higher among women who received 12 weekly treatments with Taxol, known generically as paclitaxel, compared to standard care with the drug being given every three weeks for 12 weeks
...
[ Reuters ]
4/17 Please Train Your Computer to Do Your Job, Then Pack Your Bag and Get Out
Internet vs. Sales Reps: Which Do Docs Prefer?
...
47 percent of doctors feel that e-promotion is the same as face-to-face detailing...21 percent feel that feel that e-detailing is superior to live detailing...ten percent of doctors opted for electronic detailing instead of in-person sales calls with pharmaceutical reps
...
[ Pharma Marketing Blog ]
4/17 Roche & Piramed
Roche acquires UK biotech Piramed for $160 million
...
Roche is buying privately owned British biotechnology company Piramed for $160 million to acquire its treatments against cancer and immune inflammatory disorders like arthritis and asthma
...
[ Reuters ]
4/17 U.S. Drug Sales Growth Slowing; EU, Asian Markets Take Up the Slack
Global drug sales grew 6.4 pct in 2007
...
Cancer medicines pulled ahead of cholesterol-lowering drugs as the top worldwide therapeutic category last year with sales of $41.4 billion to $33.7 billion, according to IMS. Cholesterol drugs remained tops in the U.S. market.
...
[ Reuters ]
4/17 Now Your Lipitor Can Call You During Church
Verizon Adds 'Pill Phone' Drug Reminder App
...
For $3.99 a month, Verizon subscribers can program their phones to vibrate or ring when it's time to take certain prescriptions. Friends or family of Pill Book users can also receive an online alert after medication has been taken or if that person has not responded to the alerts
...
[ PC Mag ]
4/17 Internet Drug News
Miscellaneous Short Takes:
- ViroPharma, Wyeth stop development of hepatitis C drug
AP
- Results from Largest Statin Study of Patients with Alzheimer's Disease Show Lipitor Has No Significant Impact on Disease
Company news release
- Sales of Trimeris' HIV drug Fuzeon drop 34%
Triangle Business Journal
- Pfizer licenses Avant vaccine against brain cancer
Reuters
- AstraZeneca might seek drug alliances with peers
Marketwatch
4/16 JAMA Slams Merck; Claims Long Cover-up of Vioxx Dangers
Researchers charge Merck misrepresented Vioxx data
...
Merck failed, according to the JAMA article, to disclose an internal analysis that found Alzheimer's patients taking Vioxx had a three times greater risk of death than patients taking a placebo
...
[ Reuters ]
More> Reports Allege Merck Misrepresented Vioxx Research [ Washington Post ]
See also:
4/16 The World Discovers Pharmaceutical Publication Planning
Ghostwriters Used in Vioxx Studies
...
The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article published in JAMA
...
[ NY Times ]
More> Merck Masked Vioxx Risk, Hired Research Ghostwriters [ Bloomberg ]
4/16 Naproxen + Imitrex = Treximet, Soon to Hit the Market
FDA approves migraine drug from Glaxo, Pozen
...
Treximet, is expected to be available in U.S. pharmacies by the middle of May,
...
[ Reuters ]
4/16 Our Man in China
US health official plans for food, drug inspectors in China
...
The purpose of the move is to build relationships with Chinese regulators and to have eyes and ears on the scene in China
...
[ AP ]
4/16 WellPoint's Safety Sentinel
WellPoint developing drug safety monitoring system
...
WellPoint's Safety Sentinel System should be able to uncover health risks that might crop up once drugs are being used by the general population more quickly than the FDA, doctors or drugmakers
...
[ Reuters ]
4/16 Baseball Players Can't Take the Juice but Maybe Your Broker Should
Testosterone May Drive Traders to Risks, Riches
...
Testosterone creates feelings of confidence and encourages risk-taking that can lead to profit, while another hormone, cortisol, prompts risk aversion when markets are volatile
...
[ Bloomberg ]
4/16 AZ Fends Off Ranbaxy's Generic Nexium Till 2014
AstraZeneca, Ranbaxy Reach Settlement in Drug Patent Case
...
As part of the deal, AstraZeneca is allowing Ranbaxy to start making a portion of AstraZeneca's Nexium supply in May 2010, and to start supplying AstraZeneca with the active pharmaceutical ingredient used to make Nexium in May 2009
...
[ WSJ ]
4/16 Diversification Pays Off for J&J
J&J Profit Rises on Consumer Sales, Exchange Rates
...
Revenue from Zyrtec, Sudafed cold pills, Nicorette smoking- cessation gum and Listerine helped J&J weather a 23 percent drop for the anemia drug Procrit and a 24 percent decline for the Cypher stent
...
[ Bloomberg ]
4/16 Cancer Therapy Costs Expected to Take Off Again
Generics Dampen Cost Increases in Cancer Care
...
The average annual drug cost per cancer patient was $13,113 as of Jan. 1 of this year, up from $6,490 in 2001, according to a report by Cancer e-search
...
[ WSJ HealthBlog ]
4/16 This Week's Great Cancer Hope, Courtesy of 60 Minutes
The Kanzius Machine: A Cancer Cure?
...
John Kanzius is a former businessman and radio technician who built a radio wave machine that has cancer researchers so enthusiastic about its potential they're pouring money and effort into testing it out
...
[ CBS News ]
4/16 Internet Drug News
Miscellaneous Short Takes:
- CV Therapeutics gets $175 mln from investment firm
Reuters
- Biogen says no new brain infections with Tysabri
Reuters
- Biotech drug sales may disappoint in 1Q
AP
- US FDA approves Alcon allergy nasal spray
Reuters
4/15 Co-Insurance Drives Co-Pays To New Heights
Co-Payments Soar for Drugs With High Prices
abandoned the traditional arrangement that has patients pay a fixed amount
Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent
[ NY Times; Free Registration Required ]
Editor's Note: Adds example of woman who's MS drug copay went from $20 to $325.
Even the Insured Face High Prices for Expensive Drugs
[Wall Street Journal; FREE]
Editor's Note: Don't blame the PBM - blame your boss. Most people don't realize that the employer is the entity that determines if co-insurance will be instituted; PBM's offer the option but the employers make the call.
4/15 FDA Will Focus On Depression As Drug Side Effect
FDA looks at link between medications, depression
Moving forward, the agency will require developers of many new drugs to test for psychiatric side effects that could tip the balance between a new medicine's risks and benefits
[LA Times]
4/15 Statins Reduced Blood Pressure In Prospective Trial
Reduction in Blood Pressure With Statins
randomized, double-blind,placebo-controlled trial with equal allocation to simvastatin, 20 mg; pravastatin sodium,40 mg
Reductions in SBP and DB
[Arch Intern Med. 2008;168(7):721-727
Statins found to lower blood pressure in US study
consistent but modest improvement
effect was beginning to emerge at one month of treatment
[Reuters]
4/15 Experts: Spike In Heparin Prices Was Impetus For Adulteration
Experts: Price spike should have raised alarm on heparin ...supply shortage and the steep price increase offered an obvious opportunity for people "who don't play by the rules" to make windfall profits by adding cheaper materials to the raw heparin as a way to meet the demand
[Chicago Tribune]
4/15 Supremes Refuse To Hear Zoloft-Made-Me-Kill Appeal
Court Won't Hear Young Killer's Appeal ...unsuccessfully argued the slayings were influenced by the antidepressant
shot his grandparents with a shotgun, then set fire to their home and drove off in their car
[CNN]
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4/15 Co-Insurance Drives Co-Pays To New Heights
Co-Payments Soar for Drugs With High Prices
abandoned the traditional arrangement that has patients pay a fixed amount
Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent
[ NY Times; Free Registration Required ]
Editor's Note: Adds example of woman who's MS drug copay went from $20 to $325.
Even the Insured Face High Prices for Expensive Drugs
[Wall Street Journal; FREE]
Editor's Note: Don't blame the PBM - blame your boss. Most people don't realize that the employer is the entity that determines if co-insurance will be instituted; PBM's offer the option but the employers make the call.
4/15 FDA Will Focus On Depression As Drug Side Effect
FDA looks at link between medications, depression
Moving forward, the agency will require developers of many new drugs to test for psychiatric side effects that could tip the balance between a new medicine's risks and benefits
[LA Times]
4/15 Statins Reduced Blood Pressure In Prospective Trial
Reduction in Blood Pressure With Statins
randomized, double-blind,placebo-controlled trial with equal allocation to simvastatin, 20 mg; pravastatin sodium,40 mg
Reductions in SBP and DB
[Arch Intern Med. 2008;168(7):721-727
Statins found to lower blood pressure in US study
consistent but modest improvement
effect was beginning to emerge at one month of treatment
[Reuters]
4/15 Experts: Spike In Heparin Prices Was Impetus For Adulteration
Experts: Price spike should have raised alarm on heparin ...supply shortage and the steep price increase offered an obvious opportunity for people "who don't play by the rules" to make windfall profits by adding cheaper materials to the raw heparin as a way to meet the demand
[Chicago Tribune]
4/15 Supremes Refuse To Hear Zoloft-Made-Me-Kill Appeal
Court Won't Hear Young Killer's Appeal ...unsuccessfully argued the slayings were influenced by the antidepressant
shot his grandparents with a shotgun, then set fire to their home and drove off in their car
[CNN]
4/15 HRT Offered Protection Against Macular Degeneration
Hormone Replacement May Cut Risk for Age-Linked Eye Disease ...Postmenopausal women who take hormones have a lower risk of developing advanced age-related macular degeneration
[ HealthDay]
4/15 Pharmaceutical Care Cut CHF Hospitalization Rates
Evidence for Adding Pharmacists to Primary Care Mix
Regular consults with pharmacists significantly reduces hospitalization rates for people with heart failure, according to an analysis of 12 randomized trials
[Wall Street Journal; FREE]
4/15 Experts: Diuretics Not Used Enough In Refractive Hypertension
New Guidelines Issued for Hypertension that Defies Treatment
guidelines advise maximizing diuretic therapy. Specialty clinics have consistently found that treatment resistance was caused, in part, by a lack of, or underuse of, diuretic therapy
[Medpage]
Editor's Note: BP = Heart Rate x Stroke Volume x Resistance
4/15 Vasogen Lays Off Most Workers In Face Of Celacade Failure
Vasogen cuts 85 per cent of workforce in strategic restructuring ...after the company announced it faced delays in clinical trials of its Celacade treatment for heart failure
[ Candaian Press]
4/15 Internet Drug News Miscellaneous Short Takes:
Canada Flummoxed by High Drug Prices for Rare Diseases
Wall Street Journal; FREE
Celebrex-Lipitor combo may fight prostate cancer
Reuters
Patent court affirms Perrigo's Pepcid win
AP
Drug combination reduces colon cancer risk: study
Barrons
Dr Reddy Buys Italian Generic Drug Distributor Jet Generici Srl
Dr. Reddy's Press Release]
4/14 Experimental Breast Cancer Vaccine Offers Hope
For Certain Patients
Breast Cancer Vaccine Cut Death Risk for Patients ...experimental treatment to stimulate the immune system against breast cancer appeared to cut the risk of death in half for women with a gene mutation in a small clinical trial conducted by the U.S. military
[Bloomberg]
4/14 Medicare Advantage: Critics Say HMO's Reap Unfair Windfall
US watchdog looks anew at Medicare Advantage plans
Democrats and other critics of the private plans are calling for cutbacks to these payments
government is paying these MA group plans 16 percent more than it would pay under traditional Medicare, Harrison told the commission in a presentation
[Reuters]
4/14 Congressmen Imply Schering/Merck Backdated Vytorin Papers
The Vytorin Letters
e-mail was forwarded to Enrico Veltri, the Schering-Plough executive helping run the trial. Veltri wrote to a colleague, "Soren is a prick. How's that for staying calm. Tell him to f--- off
investigation puts the focus squarely on an expert panel that met on Nov. 16, 2007
[ Forbes;Matthew Herper ]
Vytorin minutes disputed: Firms wrote experts' meeting notes later
appear to have fabricated minutes of a meeting of an independent panel of experts hired by the companies after a congressional investigation of the drug was begun
[ TMC Net]
See Also> Similar Report From Wall Street Journal; FREE
4/14 Nektar: Inhaled Drugs Still The Way To Go
Inhaled insulin flops, but field may hold promise
many companies are still working to develop drugs that are delivered through the lungs
way to deliver high concentrations of medication to the target organ
[Reuters]
4/14 Researcher: Halted Cancer Trial Data
Often Used To Support NDA's
Cancer Drug Trials Often Halted Early
Of 14 trials halted early and published between 2005 and 2007, the researchers found that 11 (79 percent) of them were used to support drug approval applications submitted to the European Medicines Agency and the U.S. Food and Drug Administration
[HealthDay]
4/14 Amgen Cancer Pipeline Robust
Amgen has 6 cancer treatments in the pipeline
market for cancer drugs has doubled in the past four years, and will be worth $67 billion worldwide in 2012
[Bloomberg]
4/14 Internet Drug News Miscellaneous Short Takes:
Takeda Dangles Bonuses to Keep Brainiacs at Millennium
Wall Street Journal; FREE
Novartis Hires 100 PDI Contract Reps To Sell Mystery product
PDI Press Release
Court Grants Teva 6-Month Monopoly On Generic Risperdal
Teva Press Release
Novartis says Aclasta better at boosting bone mass
Reuters
Mankind (MNKD) Decimated By Inhaled Insulin Debacle
Seeking Alpha
Genzyme Recalls 100,000 vials of Thymoglobulin
Wall Street Journal; $$$
4/11 Big Biotech Deal; Takeda Gets Velcade
Takeda Pays $8.8 Billion for Millennium Pharmaceuticals ... set off speculation that other biotechnology companies might be acquired at high valuations, particularly by foreign companies ... [ NY Times ]
See also> Takeda Faces Generic Threat Even With Millenium Buy [ Bloomberg ]
4/11 Letting It All Hang Out
Drug companies to reveal grant practices ... A dozen of the nation's leading drug and device makers have announced plans to publicly disclose grants to outside groups
postings will include grants for continuing medical education as well as to patient advocacy groups .... [ AP ]
4/11 Transplant Drugs Link to
Progressive Multifocal Leukoencephalopathy
US probes Roche, Novartis drugs on rare disorder ... FDA is reviewing whether Roche's CellCept and Novartis' Myfortic trigger a potentially fatal disease called progressive multifocal leukoencephalopathy (PML) .... 16 reports of PML in CellCept patients since 1995, including some deaths ... [ Guardian ]
4/11 Regadenoson, an Improvement on Adenoscan
CV Therapeutics, Astellas Heart-Monitor Drug Approved ... Regadenoson will be used for stress tests in patients not fit enough for a traditional exercise test on a treadmill ... [ Bloomberg ]
4/11 Promising Treatment for Cancer Patients
New drug can protect healthy cells during radiotherapy ... A single dose of CBLB502 given to mice and monkeys just before a big dose of radiotherapy significantly reduced damage to gastrointestinal cells and prolonged the animals' lives. ... [ Guardian ]
4/11 Avastin Misses Sales Target, But Genentech Dodges Bullet
Genentech 1st-Quarter Net Income Rises 12% on Avastin ... Revenue in the quarter rose to $3.06 billion, led by U.S. sales of Avastin, which chokes off blood flow to tumors. Avastin sales rose 13 percent to $600 million from $533 million ... [ Bloomberg ]
4/11 Connecticut Biotech Hangs Tough
Neurogen To Get Lifeline ... After losing money for most of 20 years -- more than $50 million last year -- the drug development company has bet the house that a drastic restructuring will give investors enough promising information to keep ... [ Hartford Courant ]
4/11 E-Pedigree: Factory-to-Mouth Monitoring
of Every Prescription for Safety
All Eyes on FDA for Drug E-Pedigree ... California has extended its electronic-pedigree deadline to 2011
Food and Drug Administration could become the first governing body to issue e-pedigree requirements for protecting the pharma supply chain ... [ RFID Journal ]
4/11 Novartis Upgrades Bosses
Novartis promotes pair to top U.S. posts ... Ludwig Hantson has been promoted to chief executive of Novartis Pharmaceuticals US...Gary Rosenthal becomes president and chief executive of all U.S. Novartis operations, not just pharmaceuticals ... [ Reuters ]
4/11 Abbott to Continue on Inhaled Insulin
Abbott: No Lung-Cancer Signals In Inhaled-Insulin Trials ... "We've seen no signals of lung cancer in our trials," said an Abbott spokesman ... [ CNNMoney ]
4/10 Final Nail in Exubera's Coffin Lung Cancer Link
Pfizer warns of lung cancer with inhaled insulin ... six of the 4,740 Exubera-treated patients versus one of the 4,292 patients not treated with Exubera developed lung cancer. One lung cancer case was also found after Exubera reached the market. ... [ Reuters ]
See also> Pfizer Warns Exubera Patients About Lung Cancer Risk; Nektar Cancels Inhaled Insulin Program [ AP ]
4/10 Lawsuit Shields Repel Challenge
Pfizer, GlaxoSmithKline Win Ruling on Lawsuit Limits ... can't be sued for suicides blamed on the use of those drugs because the FDA had reviewed and approved the labeling and had specifically rejected strong suicide warnings ... [ Bloomberg ]
See also> Appeals Court Backs Drugmakers in Antidepressant Suicides [ WSJ Health Blog ]
4/10 Obeastity: The Burgeoning Health Problem
Obesity Costs U.S. Employers $45 Billion a Year ... associated with a 36 percent increase in spending for health-care services -- more than smoking or problem drinking... Medication spending is 77 percent higher for obese patients ... [ Bloomberg ]
4/10 ENHANCE Moves Markets
Merck And SGP's Vytorin/Zetia: Doctors Writing Fewer Scripts? ... Vytorin scripts will fall from 16 percent market share to nine percent ... Deutsche Bank's analyst expects a total Vytorin and Zetia "unit decline" of 32 percent this year. ... [ CNBC ]
See also> AstraZeneca's Crestor 'to benefit most' from ENHANCE statin study [ CNNMoney ]
4/10 200 Croak from Medical Errors Every Day
Medical Errors Resulted in 238,337 Preventable Deaths from 2006-08 ... The overall medical error rate was about 3 percent for all Medicare patients, which works out to about 1.1 million patient safety incidents during the three years included in the analysis. ... [ HealthDay ]
4/10 The Best Scientists Money Can Buy
Sen. Grassley Knocks Psychiatrist's Funding from AstraZeneca ... lead author of a 2002 study that concluded kids did well on AstraZeneca's antipsychotic Seroquel has received hundreds of thousands of dollars from the company since then, according to Sen. Charles Grassley ... [ WSJ Health Blog ]
4/10 No One Appreciates Preparedness Till It is Too Late
States fall behind on buying flu drugs ... Two and a half years into the national stockpiling program, states and other entities have bought 71% of the 31 million courses of anti-virals the federal government targeted them to buy.... [ USA Today ]
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