Internet Drug News.com online since 1998
Pharmaceutical News & Information; Updated Daily;
See Also: Pharmaceutical Sales | Pharma Advertising Help Wanted | Advertise

Pharmaceutical News Harvest ™

11/20 Brilinta Filed with FDA
AstraZeneca bets on a blood drug with multibillion-dollar potential ... The Brilinta group in the study had an 18% relative reduction in death from any cause at one year; rival drugs that also prevent cardiovascular events have not significantly reduced mortality ... [DailyFinance]

11/20 Spiriva HandiHaler on Track for COPD Flareups Indication
US panel backs new claim for Pfizer lung drug ... The inhaled medicine already is approved for treating COPD but Pfizer and Boehringer Ingelheim want to specifically promote it for reducing exacerbations, a claim held by GlaxoSmithKline's rival drug Advair ... [Reuters]

11/20 Genzyme Can't Improve on Renvela
Genzyme gives up on phosphate drug ... The advanced phosphate binder "did not show a significant improvement" in a study comparing the product with Genzyme's Renvela ... [Boston.com]

11/20 Precious and Few Moments, Now Extended
Spray can prevent premature ejaculation: study ... The drug, called by the experimental name PSD502, is a combination of the numbing agents lidocaine and prilocaine.... The men in the study had, on average, climaxed less than a minute into intercourse before the spray. Using the spray for three months, 60 percent of the men lasted more than three minutes ... [Reuters]

11/20 Full Employment Act for AZ Lawyers
AstraZeneca Judge to Urge Return of Seroquel Cases to Courts ... AstraZeneca may face as many 6,000 trials of lawsuits claiming its antipsychotic drug Seroquel causes diabetes after a judge said she will recommend sending the cases back to their home courts ... [Bloomberg]

11/20 Potential Treatment for Downs Evaluated; Many Parents Don't Want It
New drug, L-DOPS, could treat Down's syndrome learning difficulties ... Learning difficulties in children with Down's syndrome could be treated with a drug that improves the brain's ability to form short-term memories ... [Times (U.K.)]

11/20 Crackdown on Counterfeits
FDA targets rogue Internet pharmacies ... The sites listed in the FDA letter were all affiliated with Rx-commission, one of the dozens of affiliate programs in existence today that handle everything from processing of purchases to order fulfillment. Affiliates use pre-fabricated templates to set up Web sites advertising various prescription drugs, promote these sites through search engine optimization techniques, and let Rx-commission handle the back end ... [Washington Post]

11/20 Older Med Still Better for Hypertension
Diuretics Still Best Treatment for High Blood Pressure ... The thiazide-type diuretic chlorthalidone outshone three other treatments -- a calcium channel blocker, an ACE inhibitor and an alpha-receptor blocker -- in most areas, especially in lowering the incidence of stroke and heart failure, according to the latest data from the ongoing ALLHAT study ... [HealthDay]

11/20 Round Up The Usual Suspects
Rising Prices of Drugs Lead to Call for Inquiry ... Wholesale prices of brand-name drugs rose about 9 percent in the 12 months that ended Sept. 30, the highest increase in years — even as the Consumer Price Index was declining during the same 12-month period.... Congress wants to know why ... [NY Times]

11/20 Armyworm-Produced Vaccine Sent Back for More Work
Flu Shot Made From Caterpillars Fails Safety Vote ... The shot, called FluBlok, is produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells ... [Bloomberg]

11/20 New Theory of GERD
Reflux might be immune condition, study finds ... Gastroesophageal reflux disease or GERD might be caused by immune system cells causing inflammation... it may not be caused by stomach acid at all... gastroesophageal reflux causes tissue in the esophagus to release immune chemicals called cytokines, which attract inflammatory cells. These cause the heartburn and chest pain that make GERD so distressing ... [Reuters]

11/20 Internet Drug News
Miscellaneous Short Takes:
Morphine May Help Tumors Spread in Cancer Patients
HealthDay
Genital Herpes May Never Go Dormant
HealthDay
Baby Boomers Don't Use Preventive Services
Medpage Today
EU panel blocks Merck KGaA's Erbitux in lung cancer
Reuters


11/19 To Your Health
Alcohol Cuts CHD Risk in Men ... Consumption of alcohol in almost any quantity is associated with a nearly one-third reduction in the incidence of coronary heart disease -- at least in men ... [Medpage Today]

11/19 Simvastatin Just As Good
Lipitor, Vytorin Prove No Better Than Generic at Cutting Hospital Visits ... Researchers with Prescription Solutions analyzed medical claims of 30,000 patients taking Lipitor or Vytorin or simvastatin. They found no difference in rates of heart attacks or stroke among the three groups ... [Bloomberg]

11/19 Avanafil Beats the Other ED Drugs to the Punch
Vivus Erection Drug Worked Within 30 Minutes in Study ... As many as 322 million men worldwide may have erectile dysfunction by 2025, according to a report by the American College of Physicians... Neither Cialis nor Viagra work as quickly as avanafil ... [Bloomberg]

11/19 Pneumococcal Vaccine Passes Panel
US panel backs Pfizer's newer Prevnar vaccine ... An FDA advisory committee voted 10-1 that the Prevnar 13 vaccine was safe and effective for infants and toddlers. The vaccine is the most important experimental product the company acquired in its recent purchase of Wyeth. ... [Reuters]

11/19 Nexavar Will Not Be Covered in Britain's NHS
UK's NICE says Bayer liver cancer drug too costly ... The $4,877 per month drug, also known as sorafenib, would cost about $14,000 per patient as it keeps them alive for just under four extra months on average, and Bayer has offered to give every fourth pack for free ... [Reuters]

11/19 One More Try at Healthcare Reform
Senate Dems Unveil $849 Billion Healthcare Bill ... The Senate bill would levy a surprising new 5% tax on elective cosmetic surgery and procedures. It also taxes device companies and drug companies ... [Medpage Today]

11/19 Pharma May Stop Drinking the Health Reform Kool-Aid
Congressional demands irk drugmakers ... Senior administration officials, including White House chief of staff Rahm Emanuel, are warning members of Congress not to antagonize deep-pocketed drugmakers at a time when a major victory appears to be within reach ... [Philadelphia Inquirer]

11/19 Effient Now Part of Major Society Recommendations
Prasugrel Incorporated into New STEMI Guidelines ... A 60-milligram loading dose of prasugrel (Effient) is now a recommended alternative to clopidogrel for patients with ST-elevation myocardial infarction STEMI who undergo primary percutaneous coronary intervention ... [Medpage Today]

11/19 Heart Meeting Roundup
Crestor shines, Vitamin D intrigues at AHA confab ... Among new developments: Thousands of annual deaths and hospitalizations from heart failure could be averted if doctors prescribed higher doses of an angiotensin-receptor blocker to those patients ... [Fierce Pharma]

11/19 Rituxan Leukemia Indication Stalled
Genentech, Biogen get FDA request on Rituxan ... Genentech and partner Biogen have announced that the Food and Drug Administration is withholding a decision to expand approval of Rituxan as a leukemia treatment, pending further discussion ... [AP]

11/19 Internet Drug News
Miscellaneous Short Takes:
Coalition of pharmacy, health groups urges Congress to address compliance
Drug Store News
Insurers Unlikely to Alter Policies in the Debate Over Mammograms
NY Times


11/18 Plavix Gets Label Update: Avoid Omeprazole + Plavix
FDA: Update to the labeling of Plavix to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC) … … patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine … Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction …  [FDA Communiqué]

11/18 UCB Plans 200+ Non-US Layoffs
UCB plans organizational changes in Braine-l'Alleud (Belgium) and Slough (UK) to strengthen its biopharma efforts … 174 positions in Braine-l'Alleud and 44 positions in Slough …[UCB Press Release]

11/18 Yaz Tests Waters With Googlized Prescription Drug Ad
Yaz pilots Google sponsored links format … headline linking to the product site, a line of text advising viewers to "Read important product info here," and a bottom line reading "Click to see full safety and prescribing information, including boxed warning …  [MM&M]
See Also: Image of ad (hat tip to MM&M)

11/18 Novartis: One Shot Of No-Adjuvante H1H1 Vaccine Does The trick
Novartis says lower H1N1 vaccine dose may suffice … data from about 4,000 individuals suggested that half a dose of its U.S.-approved unadjuvanted H1N1 vaccine met immune criteria …[Reuters]

11/18 FDA Worried About Safety Of Certain MRI Contrast Agents
US FDA sees varying risk from MRI agents … Some contrast agents used with magnetic resonance imaging scans appear to carry a higher risk of a potentially fatal skin disease …[Reuters]

11/18 Irony: Prominent Cardiologist Dies At AHA Meeting (While Jogging)
Brigham cardiologist, Newton resident struck, killed by car while jogging in Florida … died at age 63 after being struck by a car while jogging Monday morning in Florida, where he had traveled to attend a medical conference … [Boston.com]

Biotech Portfolio Manager : Genzyme CEO Sucks, Days Are Numbered
Genzyme's Termeer: Worst Biotech CEO of '09 …fed up with Termeer's schtick and would like nothing more than to see him resign. grip on Genzyme is strong and his board of directors is as spineless and ineffectual as the cadre of yes-men managers Termeer has working under him. … [The Street.com]

11/18 Genzyme,  Isis Drug Cuts LDL 25% But
Elevated Liver Enzymes Cast Shadow
Isis Cholesterol Drug Effective, but Safety a Worry: BioBuzz … cut levels of "bad" LDL cholesterol by 25% in patients with a rare genetic disorder … known as mipomersen, also caused elevated liver enzymes in 12% of patients…[TheStreet.com]
See Also:  Genzyme Press Release

11/18 FDA Reviews Spiriva Exacerbation Claim Thursday; Questions Linger
FDA staff question Pfizer lung drug data … Boehringer, Pfizer seek new claim for Spiriva … FDA notes statistical issues, safety concerns …[Reuters]

11/18 Internet Drug News Miscellaneous Short Takes:
Higher Dose of COZAAR®  Significantly Reduced Deaths, Hospitalizations Due to Heart Failure In Investigational Study
Merck Press Release
Analysts Upgrade Sanofi
Motley Fool
iPhone App Changing Medicine | Video
Forbes
Folic acid supplements raise cancer risk: study
Reuters
Canadian-made swine flu shots approved by US regulator
AFP
China: Two Die After Swine Flu H1N1 Vaccine
Time
Roche applies for Avastin advanced breast cancer use
Reuters

11/17 IRS Nukes Merck; Canucks Seek Their Pound Of Flesh
Merck Agrees to Pay IRS $2.3 Billion … one of the largest achieved in recent years … resolves all issues that had been in dispute between the parties for the tax years 1993-2001…[IRS]
Merck in $2.3 billion tax settlement with IRS … in a separate tax dispute with Canadian authorities who are seeking about $1.76 billion in additional taxes and interest from Merck for years dating to 1998 …[MarketWatch]
See Also: How Merck saved $1.5B paying itself for drug patents …[Archived; 9/28/06; Post Gazette; 2,040 word detailed report regarding Merck tax avoidance tactic that inflamed IRS.]

11/17 NY Times: Drugmakers Stage 9% Preemptive Price Increase
Drug Makers Raise Prices in Face of Health Care Reform …raised the wholesale prices of brand-name prescription drugs by about 9 percent …  at odds with the direction of the Consumer Price Index, which has fallen by 1.3 percent in the last year … [NY Times]

11/17 FDA Green Lights Pepper Spray Shingle-Pain-Patch
FDA Approves Qutenza(TM), First and Only Prescription Strength Capsaicin Product for Pain Reduction … single one-hour application, directly to the site of pain, Qutenza may reduce post shingles nerve pain for up to 12 weeks  … [ Company Press Release ]
See Also:  Qutenza PI

11/17 Sanguine Feedback, Efficacy Questions For Son-Of-Prevnar
FDA wants panel to probe Pfizer vaccine efficacy … overall results showed Prevnar 13 provided "a real and substantial benefit given its demonstrated ability to elicit immune responses"" …[Reuters]

11/17 Zetia: Will The Patients Actually Care?
Doctors gird for patient anxiety over Zetia data … The bad news is they think patient anxiety will cause its sales to drop ... good news for Merck's Zetia cholesterol fighter is that doctors do not seem unduly concerned about its latest setback …[Reuters]

11/17 Market Brushes Off Zetia Versus Niaspan News
Merck shares rise following Niaspin-Zetia study … stopped too early and more patients and data would have likely had an impact on the outcome … experts and Wall Street view the study as too limited to warrant patients switching treatments …[Business Week]
See Also: Similar Report From NASDAQ

11/17 Glaxo Buys Rights To Anti-Nicotine Jab
GSK deal draws smokers' vaccine closer … helps create antibodies that bind to nicotine molecules, preventing them from passing from the blood into the brain … halves the number of people returning to their habit compared with those given a placebo  …[FT.com]
GSK and Nabi Announce Agreement for NicVAX(R), a Vaccine for Nicotine Addiction … nicotine conjugate candidate vaccine (NicVAX(R)), an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse …[Nabi Press Release]

11/17 FDA Humiliates Genzynme; Icahn Announces $7.3 Bln Position
FDA delays approval of Genzyme drug … Lumizyme, its drug to treat the rare genetic disorder Pompe disease in adults, until the Cambridge biotechnology company solves persistent problems at its cell-culture manufacturing plant in Allston …[Boston Globe]
Eelated: Icahn Reports New Stakes In Genzyme, Forest Labs At Sept 30… [Wall Street Journal ]
Editor's Note:  Genzyme's manufacturing problems are unacceptable to half vulture, half lion Icahn.  He has the money and the power to turn Genzyme upside-down (including selling the company) to increase shareholder value.  If you are a Genzyme board member, yesterday's bad news just got a little worse. 

11/17 Plavix + PPI; Marker For  Increased  Post-Angioplasty Mortality
Certain Reflux Drugs Tied to Higher Post-Angioplasty Death Rate  … mortality increase shown by the study is not surprising, he added. "People who are older are the ones who get stents and tend to get ulcers and stomach problems [warranting use of PPIs] so we would expect them to have a worse prognosis …[BusinessWeek]

11/17 Experts Question Aspirin + Plavix Cocktail For Bypass Patients
Aspirin without Plavix as good after heart bypass … … duel clot-preventing therapy of aspirin and Plavix is standard during and after artery-clearing angioplasty procedures, some surgeons have begun using the combination after bypass surgery …[Reuters]

11/17 Par: final Approval For Generic Ultram ER
Par Pharmaceutical Receives Final Approval to Market Generic Ultram(R) ER … 100mg and 200mg strengths … 180 days of marketing exclusivity, commencing at launch, for being the first to file an ANDA … [PAR Press Release]

11/17 Internet Drug News Miscellaneous Short Takes:
FDA issues a Complete Response Letter for Human Genome Sciences' anthrax treatment, raxibacumab BLA
Human Genome Press Release
Study Touts Success With 'Female Viagra' Drug Flibanserin
HealthDay
Merck's Dick Clark Has Opportunities, but All Are Risky
Wall Street Journal
Picoplatin: Poniard Tanks 70% after cancer drug misses goal in lung cancer
AP

11/16 Niaspan Better Drano Effect, Fewer Heart Attacks Than Zetia;
Increasing HDL Trumps Lowering LDL To Subterranean Levels
AHA: Niacin Bests Ezetimibe as Add-On Therapy … more effective way of slowing atherosclerosis in high-risk patients on long-term statin therapy than seeking additional LDL cholesterol reductions by adding ezetimibe …[Medpage Today]
Niaspan Reverses Artery Narrowing Versus Zetia … extended-release niacin on top of standard therapy with statin drugs to lower cholesterol was more effective … compared changes in thickness of the carotid artery…[NASDAQ]
Niaspan tops Zetia in new setback for Merck drug … 5 times as many serious adverse events seen with Zetia … doesn't quite put the nail in the coffin for ezetimibe, but it pushes it way down on the list …[Reuters]
Vytorin trial shows little or no benefit against heart disease … second time in as many years that … key ingredient in the heavily advertised drug Vytorin provides little or no benefit in preventing heart disease compared with much less expensive generic …[LA Times]

11/16 Merck Downplays Arbiter-6 Trial results
Merck Backs Efficacy And Safety Of Cholesterol Drugs … study had "several limitations" ... results of the small ARBITER 6 study do not, in any way, change our view of Zetia and Vytorin as effective medicines for fighting high LDL " …[RTT]

11/16 Flibanserin: Boehringer Ingelheim Has Pill To Make Chicks Horny
Desire Drug May Prove Sex Really Is All in Her Head … searching for a depression treatment in the 1990s when it stumbled on the compound … researchers were startled when test subjects rated one measure of well-being, sexual appetite, consistently higher than the others….[Bloomberg]
Editor's Note:  Mechanism of action is that it blocks serotonin and boosts dopamine; ; as long as it doesn't increase desire to rob banks or walk through walls they may have a winner.  Mildly elevated dopamine levels are sometimes associated with untoward effects.

11/16 Brilinta™ Beats Plavix
AstraZeneca Drug Beats Plavix for Myocardial Infarction … ticagrelor resulted in a reduction of cardiovascular events (e.g., heart attack, stroke, cardiovascular death) for up to 12 months (ticagrelor vs. clopidogrel, 9.3% vs. 11.0%). Ticagrelor did not cause an increase in major bleeding (9.0%) when compared with clopidogrel (9.3%). Use of ticagrelor was also associated with an 18 percent reduction in all cause mortality at one year compared with clopidogrel  …[AZN Press Release]
See Also: AstraZeneca drug tops Plavix in sickest patients …[Forbes]
See Also: Similar Report From NASDAQ

11/16 AZN R&D Hotshot Defects To Lilly
Lilly snags AstraZeneca executive as new R&D head… underscoring the battle for talent in the pharmaceutical industry … Quitting Astra immediately, will join Lilly in new year…[Reuters]

11/16 Whistleblower Drug Rep Shoots Self In Foot By Not Testifying
J&J Wins Dismissal of New Jersey Whistleblower Suit … judge ruled that Powell failed to prove she engaged in whistle-blowing ... failure to take the witness stand prevented jurors from weighing her claims … "Without any testimony as to her intent, the jury is left to speculate." …[Bloomberg]

11/16 New: Non-Hormone Pill Reduces Heavy Menstrual Bleeding
FDA Approves Lysteda to Treat Heavy Menstrual Bleeding … first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot … [FDA]

11/16 More Fallout From AZN's Seroquel Robo-Writer Head Shrinker
AstraZeneca Allegedly Paid Psychiatrist to Over-Prescribe Anti-Psychotic Medication to Patients … allegedly paid Reinstein over $490,000… complaints from patients were so bad that a security guard had to accompany Reinstein on his visits to the nursing home …[InjuryBoard]

11/16 Nu? Dirty Particles In My $160,000 Per Year Medicine?
FDA finds bits of steel, rubber in Genzyme drugs … tiny particles of trash in drugs made by Genzyme, the second time this year the biotechnology company has been cited for contamination issues …[AP]
Genzyme Issues Letters to U.S. Healthcare Providers …  letters remind providers of the U.S. product labeling recommendations advising both visual inspection of vials and in-line filtration of enzyme replacement products to address the potential presence of foreign particles …[Genzyme Press Release]
Editor's Note:  Fabrazymw costs $5,369 per vial [ source = RxUsa.com]

11/16 Billion Dollar Continuing Ad In Fishbowl
How Industry Spends $1 Billion a Year on Continuing Medical Ed. … We may soon get more insight into how that money flows: A little-discussed provision in the House health care bill would require drug makers to disclose …[Wall Street Journal; FREE]
Health-Bill Disclosure Rule Is Resisted … drug companies are allowed to sponsor credit-qualified classes operated by for-profit concerns or by nonprofit academic medical centers .. Critics say that money taints the content …[Wall Street Journal; $$$]

11/16 Google: Just Say Yes To Drug Ads
[This Is Your Website; This Is Your Website With Drug Ads]
Google's Pitch to FDA for Online Drug Ads ...ants the FDA to create a standard template for the ads, which would include a link to the drug's main page, a warning about safety risks and a second link to more risk information ……[Wall Street Journal; FREE]
See Also: Example of proposed ads …[NPR]
Related: Day Two in DC: Can we police everything online? ...PhRMA's Jeff Francer said the trade group supports a scheme in which companies are responsible for monitoring their own sites, not any external sites, but must report adverse events found elsewhere.…[MM&M]

11/16 30,000 Ft View Of Pharma Layoff Hemorrhage Blues
Layoffs Sting Big Pharma ...Merck's workers can use a pep talk. One out of six of them--16,000 researchers, sales representatives and manufacturers--will lose their jobs as a result of the merger … [Forbes]

11/16 Internet Drug News Miscellaneous Short Takes:
Lilly's big cancer bet: seeking new blockbusters
IndyStar

FDA: Warning Letters go to Eisai [Dacogen],  Shire [Fosrenal]
Reuters
Bristol Myers Spinning Off Baby Formula Powerhouse Mead Johnson
Chicago Tribune
FDA extends review of Cadence's IV drug Acetavance
AP
FDA Investigates Safety of Caffeinated Alcoholic Beverages
Bloomberg

*****************************************************