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CLick HERE for Last Week's Pharma News Harvest
Pharmaceutical News Harvest
5/18 Xalkori Wipes Out Cancer in 7 of 8 Kids with Rare Tumor Type
Pfizer Lung Drug Stops Deadly Child Cancers in Study
...
Xalkori eradicated signs of malignancy in some kids with rare tumors of the nerves, blood and soft tissue
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[Bloomberg]
5/18 Zytiga Eliminates (or Nearly Eliminates) Prostate Tumors in One Third of Men Before Surgery
Trial Supports Earlier Use of a Prostate Cancer Drug
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Zytiga, added to standard therapy, eliminated or nearly eliminated tumors in about one-third of men whose disease had not yet spread beyond the prostate gland but was considered likely to do so
...
[NY Times]
5/18 US Agency Leads Drug-Approval Race
FDA's New Drug Approvals Outpace Canada, Europe
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Of the 510 applications for new drugs that were approved during this time, 225 were approved by the FDA, 186 by the EMA, and 99 by Health Canada
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[Family Practice News]
5/18 Predictor of Provenge Efficacy
Dendreon's Provenge Works Best for Patients With Low PSA
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Provenge patients lived longer than placebo patients at all levels of PSA, but the difference in median survival times was the largest among those with lower PSA scores
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[xconomy]
5/18 E-prescribing Poised to Take Over Market
Doctors ditching the prescription pad as more than a third of prescriptions now are electronic
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The new research examined 40 million prescriptions, a mix of paper, phoned, faxed or electronic ones — and found a 10 percent increase in patients who fill a prescription when it's e-prescribed.
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[Washington Post]
5/18 Specialty Spending Up 17.1% in 2011
Specialty drug costs a major employer worry
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For employers with more than 25,000 members, 58 percent named specialty costs as their top worry
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[Reuters]
5/18 Migraine Identified as Neurological, not Vascular, Disorder
Risk Factor Management Helps Prevent Migraine Attacks
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The basis for preventive treatment is understanding that underlying risk factors for migraine can be modified or eliminated before migraine attacks become more frequent
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[American Pain Society]
5/18 China, Others Outpacing US in Innovation Investment
Top Drug Lobbyist Says U.S. Losing Research Jobs Overseas
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Singapore, Ireland and South Africa are the leaders of a host of countries who are outpacing the U.S. with tax incentives, increases in government research spending and efforts to train pharmaceutical scientists
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[Business Week]
5/18 Gardasil Completion Rate Falling
Fewer girls completing all three HPV shots
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38 out of every 100 girls and woman who had received the first Gardasil innoculation went on to receive the second and third shots in the next year
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[Reuters]
5/18 First Stem Cell Drug
Canada OKs Osiris drug; first stem cell therapy
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Treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory Graft versus host disease
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[Reuters]
5/18 Internet Drug News Fast Takes:
NIH-led study finds genetic test results do not trigger increased use of health services
NIH/National Human Genome Research Institute
Internet Usage Patterns May Signify Depression
Missouri University of Science and Technology
Agilent Buys Dako for $2.2 Billion, Biggest Deal Ever
Bloomberg
Amgen Revives Defunct Drug as Old Therapies Seek New Cure
Bloomberg
5/17 Pharma Shed 7% of Reps in 2011
Sales forces shrank in 2011, but not everywhere
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Roche cut deepest among big pharmas, lopping off a third of its Full-Time Rep Equivalents, while Abbott and Sanofi were close behind, downsizing 23% of their FTEs
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[MM&M]
5/17 Generic Plavix Now Shipping
Plavix Set to Lose Patent Protection
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In the 15 years since it entered the market, Plavix generated $42.8 billion in sales for Bristol-Myers
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[NY Times]
See also: So long, Plavix, what a ride! Clopidogrel patent expires [heartwire]
5/17 Rituxan Leads Cancer Market
Top 10 Best-selling Cancer Drugs in 2011
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Finally, biologic treatments for cancer don't face generic competition on schedule as traditional drugs do, so even older drugs such as Herceptin don't have to contend with low-cost knockoffs
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[Fierce Pharma]
5/17 Mumbai Investor Buys Decision Resources
Billionaire Piramal Buys Drug Data Firm for $635 Million
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Decision Resources, based in Burlington, Massachusetts, has forecast $160 million in revenue this year, according to the statement. The researcher counts 48 of the world's top pharmaceutical companies as its clients
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[Bloomberg]
5/17 DEA Settlement with Cardinal on Painkillers
Cardinal Health agrees to suspension in Rx-drug battle
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The company will stop shipping controlled substances from its Lakeland facility for two years
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[Orlando Sentinel]
5/17 New Mechanism of Action — "Multi-modal Neurotransmitter" — for Phase 3 Antidpressant
Lundbeck Sees Lower Libido Risk With New Antidepressant
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The medicine has "almost a placebo-like side effect profile, with no negative impact on weight, sex or sleep" according to CEO Ulf Wiinberg
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[Bloomberg]
5/17 Smart Bombs for Cancer
Targeted Cancer Drugs With Punch: The Next Big Class of Antibodies
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Take a regular antibody, link it to a toxin, and design the combination so that it unleashes a killer payload on tumors. Done right, you ought to have a drug with more punch than traditional antibodies or chemotherapy
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[xconomy]
5/17 Europe's Experience with Biosimilars
The Op-Ed: Moore's Law And Biosimilars
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The law that allows biosimilars on the marketplace is two years old and the FDA has yet to receive an application
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[Pharmalot]
5/17 Never Mind on the Good Cholesterol
Doubt Cast on the 'Good' in 'Good Cholesterol'
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A new study that makes use of powerful databases of genetic information has found that raising HDL levels may not make any difference to heart disease risk
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[NY Times]
5/17 Azithromycin Tied to Heart Deaths
Study Links Antibiotic to Slight Rise in Heart Patients' Death Risk
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Over a five-day period, people taking azithromycin had a slightly increased risk of sudden cardiac death, compared with those not taking any antibiotics. Patients taking amoxicillin had no increase in death risk
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[HealthDay]
5/17 Internet Drug News Fast Takes:
Steroids cut sinus infection symptoms slightly
Reuters
CVS Caremark study: Focus on Rx adherence saved PBM clients $2.4B in 2011
Drug Store News
Republicans Probe Drugmaker Political Support for Health Law
Bloomberg
CRTX to acquire EKR Therapeutics for $125M cash, plus $25M in milestones
Medcity Pharma
Two-Drug Combo Helps Teens With Migraines
Health Day
FDA-approved drug makes established cancer vaccine work better
University of Pennsylvania School of Medicine
5/16 Genentech's Alzheimer's Drug Gets Big US-Funded Trial
Testing a Drug That May Stop Alzheimer's Before It Starts
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If the drug, Crenezumab, which attacks the formation of amyloid plaques in the brain, is shown to forestall memory or cognitive problems, plaque formation or other signs of brain deterioration, scientists will have discovered that prevention or delay of the disease is possible
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[NY Times]
5/16 Pundits Expect Only 13% Share in First Year for Tofacitinib
Payers likely to throw up hurdles to Pfizer's new RA drug
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More than three-fourths of payers said they'd require patients to fail on at least one TNF inhibitor, such as Abbott Laboratories' Humira and Johnson & Johnson's Remicade, before turning to Pfizer's new med
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[Fierce Pharma]
5/16 17-0 Approval Panel for OraQuick
FDA Panel Says Yes to Home HIV Test
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An expected 2.8 million people would use the OraQuick In-Home HIV Test, made by OraSure Technologies, each year.... the home-use test could lead to 45,000 new positive test results and could avert more than 4,000 HIV transmissions in a year
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[Medpage Today]
5/16 900 Cancer Drugs in Development — Which Ones Will Make It to Market?
ASCO Preview: Eight Cancer Drugs to Watch at the Big Show
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Health insurers now spend an estimated $80 billion a year on cancer care worldwide, and spending in the U.S. is expected to climb an eye-popping 42 percent by the end of 2013
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[xconomy]
5/16 8.4% of US Population Has Asthma
Asthma Cases Reach New High
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In 2009, asthma accounted for 3,388 deaths, 479,300 hospital admissions, 1.9 million emergency department visits, and 8.9 million visits to doctors' offices.
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[Medpage Today]
5/16 Who's Who in Big Pharma — Pfizer, AstraZeneca, Sanofi, Roche, Merck, and more — Chasing Amylin
Amylin Said to Attract Takeover Interest From Pfizer, AstraZeneca, Sanofi
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First-round bids are due in the next two weeks.... Amylin, the maker of the diabetes drugs Bydureon and Byetta, has a market capitalization of more than $4 billion and generated more than $650 million in revenue last year
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[Bloomberg]
5/16 ASCO Abstracts Online Today
Drug makers shifting towards targeted cancer drugs
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The American Society of Clinical Oncology will on Wednesday release summaries of more than 4,500 cancer studies, two weeks ahead of ASCO's annual scientific meeting
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[Marketwatch]
5/16 Bundled Dialysis Payment Led to Underuse of Meds
Unintended Consequence for Dialysis Patients as Drug Rule Changes
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The share of dialysis patients covered by Medicare who received blood transfusions in 2011 increased by 9 to 22 percent over the corresponding months in 2010
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[NY Times]
5/16 Too Many Meds, Not Enough Time
Orchestrating Drug Management
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Discontinuing unnecessary medications can improve patients' health, decrease their risk of an adverse drug event and save them money.... But doctors do not take this step often enough
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[American Medical News]
5/16 Olympics for Drug Reps Scheduled
UK's largest ever pharma salesforce competition to take place next month
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One hundred and seventy-five of the pharmaceutical industry's best medical representatives are set to attend the largest ever competency benchmarking exercise
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[Pharma Times]
5/16 Internet Drug News Fast Takes:
Petition Demands Novartis Lower US Gleevec Price
Pharmalot
Votrient Works as Sarcoma Salvage Tx
Medpage Today
Drug Companies Are Testing Health Technology
Forbes
Achillion gets FDA incentives for hepatitis C drug
Business Week
New Biomarker Test Predicts Arthritis at Much Earlier Stage
University of Missouri-Columbia
5/15 Gilenya: FDA Urges Caution In Certain Heart Patients
- FDA warns Gilenya associated with acute, transient bradycardia
Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod) ...FDA could not definitively conclude that Gilenya was related to any of the deaths
maximum heart rate lowering effect of Gilenya usually occurs within 6 hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose
f cardiovascular monitoring be extended past 6 hours in patients who are at higher risk for or who may not tolerate bradycardia
[FDA]
New Caution Urged Over Sole Oral MS Drug On the Market
Patients who have had a stroke or heart trouble within the past six months shouldn't take the drug
shouldn't be used in patients taking some kinds of medicines to treat heart arrhythmias ..[WSJ; FREE]
5/15 JNJ Punts Premature Ejaculation Drug
Furiex says J&J returns sexual dysfunction drug rights
The drug, Priligy, which is still not approved in the United States, is marketed by J&J unit Janssen Pharmaceutica in 15 countries
[Reuters]
Furiex Pharmaceuticals and Menarini Announce License Agreement for Priligy(R)
Priligy(R) (dapoxetine) is the first oral medication approved for "on-demand" treatment of PE. Priligy(R) is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI)
[Furiex Press Release]
5/15 Docs Oppose Behind-The-Counter Drugs Available Via Pharmacist
- Suprisingly (not) docs opposed to the idea
RX-to-OTC proposal gets mixed reviews
each of the various medical interest groups has its particular reservations
limited to drugs that treat chronic conditions, including high cholesterol, migraines, asthma and high blood pressure
[MM&M]
Editors Note: The doctors have a good point. Let's say a woman has been on Lipitor for 11 years, it's working and she has had no side effects whatsoever.
She is better off making an appointment with a doctor, hanging out in the waiting room for an hour, getting 3 minutes with a 24-year old P.A., and paying her deductible to get a prescription rather than going to the drugstore and buying the medicine from the guy who's been dispensing it to her all along.
People with a doctorate in pharmacy are not well suited to sell drugs to people who need them unless the prescription has been rubber stamped by someone.
5/15 Medical Apps Seen Huge Threat, Huge Opportunity For Pharma
- Got diabetes? There's an app for that (cancer too)
Prescribable Mobile Apps Huge Threat for Pharma
only a matter of time before healthcare providers would start prescribing apps as soon as apps proved to be as or more effective than prescription drugs
[Forbes]
Doctors prescribe apps to patients
chances of someone documenting glucose levels is much higher if is being done on a phone instead of hand-writing it
A prescriber chooses an app or apps to be prescribed to a patient
The apps include medication reminders, diet and exercise plans, glucose monitoring
[SmartPlanet]
Related: GoMeals App; Sanofi; calorie tracker; nutrition stats for 10,000 foods, includes restaurant meals.
Related: DoctorMole APP; take a picture of your mole and diagnose cancer in the privacy of your home.
Related: Hello Baby Pregnancy Calendar; Pampers; Procter & Gamble; self explanatory.
5/15 Avonex Launches Intramuscular Pen Injector Device
New AVONEX® Dosing Innovations for People with Multiple Sclerosis Now Available in US
first intramuscular (IM) autoinjector for chronic use, designed to enhance the self-injection process
single-use, once-a-week, fully integrated IM autoinjector for MS
[Biogen Idec Press Release]
5/15 Topical Diltiazem For Anal Fissures (For Real)
Ventrus Biosciences Announces Positive Results From Pivotal Phase 3 Trial of Diltiazem (VEN 307) in Patients With Anal Fissures
Diltiazem hydrochloride cream is applied perianally to treat pain
shown to normalize internal anal sphincter pressure
vasodilator activity has the potential to improve blood supply
[Ventrus Press Release]
Ventrus anal fissures cream meets goal; shares jump
[Reuters]
5/15 Internet Drug News Fast Takes
Researchers Test Laxative-Free Colon Scan
HealthDay
HIV/AIDS patients at higher risk of cardiac death
AFP
5/14 Gilead Quad HIV Pill Gets Nod
FDA Panel Backs Gilead's HIV 'Quad' Medicine
reviewed on Friday by the agency's antiviral drugs advisory panel ...voted 13 to 1 on a question that asked if the submitted clinical data supported approval ... vote amounts to a recommendation that the FDA approve the drug
FDA is expected to make a decision on or before Aug. 27
[Dow Jones]
FDA Advisory Committee Supports Approval of Gilead's Once-Daily Quad Single Tablet Regimen for HIV
elvitegravir 150 mg; cobicistat 150 mg, a "boosting" agent that enables elvitegravir once-daily dosing; and Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
[Gilead Press Release]
5/14 Atrial Fib: Study Says Pills Not As Good As Surgery
Heart Procedure More Effective Than Drug for Erratic Rate
cardiac ablation should be considered as an initial treatment for atrial fibrillation
more effective than drug therapy at keeping the erratic rate in check
52 percent of patients getting the ablation procedure had a recurrence, compared with 72 percent of those on drugs
[Bloomberg]
5/14 Reports Of Pills Made From Desiccated Fetuses, AKA "Baby Pills"
- Unlike baby-oil, "Baby Pills" made out of real babies (allegedly)
Dead Baby Pills Spark Customs Crackdown in Korea
Korean officials said capsules smuggled in from China were filled with powdered human baby flesh
made in northeastern China from dead babies whose bodies were chopped into small pieces and dried on stoves before being turned into powder
[NBC Chicago]
Human Flesh Pills: China To Investigate Dead Baby Capsule Claims
[Huff Post]
New wonder drug: Baby pills
Reporters had the pills tested and confirmed they contained 97 percent human remains
practice stems from a superstitious belief that eating the body parts of young infants imparts special physical strength
[LasVegas Review Journal]
5/14 $70 Mln Hoard Of Stolen Lilly Pharmaceuticals Recovered
Officials Recover Lilly's Pharmaceuticals Stolen in Connecticut
Lilly plans to destroy the products when they are no longer needed as evidence
stolen from its United States distribution center located in Enfield, Connecticut, on Sunday, March 14, 2010
[Tonairi Post]
Eleven Indicted in Pharmaceutical Thefts
Defendants Involved in Selling and Distributing More than $75 Million Worth of Stolen Pharmaceuticals and Other Goods
[US DOJ]
5/14 Indian Parliament Report Slams Drug Approval Process
- Unhealthy relationship between regulators and the companies they regulate
India Vows Reforms After Probe Slams Drug Approval Process
allegations that new drugs were approved without the necessary tests and that there will be greater scrutiny of clinical trials from now on.
India drugs inquiry could prompt new U.S. scrutiny
officials of India's drug regulator had been colluding with pharmaceutical companies to speed up approval procedures, allowing some drugs that are not permitted in other countries to go on sale
[Reuters]
5/14 Internet Drug News Miscellaneous Short Takes:
Stiefel receives US FDA approval of topical retinoid foam Fabior (tazarotene) 0.1%
Stiefel Press Release
Dr. Reddy's Revenues Cross $2 Billion Milestone* in FY12
MarketWatch
Let the Obesity-Drug Wars Begin
Motley Fool
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