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11/21 U.S. Per Capita Drug Spending to Hit $1409 by 2018
World's Drug Bill Will Reach $1.3 Trillion in 2018 .... IMS forecasts Americans will pay an average of $1,409 a person in 2018, up from $1,075 last year, a faster rate of growth than the expansion of the population .... Bloomberg

11/21 Sanofi Parades 18 New Products in Pipeline for Next Five Years
Sanofi's Sluggish Diabetes Growth Nips at Ambitious Product Plan .... Next year, Sanofi starts losing patent exclusivity on its top-selling product, Lantus insulin, increasing the pressure to boost growth with new treatments such as Praluent for cholesterol and the world's first dengue vaccine .... Bloomberg

11/21 Hysingla ER Fights Abuse with Gel Formulation
Purdue Pharma Wins Approval for Abuse-Deterrent Pain Pill .... FDA has cleared the drug Hysingla ER with a label that indicates the tablet is difficult to abuse via injection or snorting .... Bloomberg

11/21 Former Merck Cancer Research Boss Gary Gilliland to Head Research Center
New 'Hutch' Director Aims To Push Toward Cancer Cures Based On The Immune System .... The exciting thing about drugs like Merck's PD-1 blocker, which is now approved for melanoma patients who have failed other drugs, is that they actually result in some patients having durable responses in tough diseases like melanoma and lung cancer. .... Forbes/Matthew Herper

11/21 Cost of Drug Brands Typically Used by Older People Up 13% in 2013
AARP: Brand name drug prices jump .... The increase is more than eight times the 1.5 percent inflation rate, and the highest annual increase since 2004, the group said. And the price of seven brand name drugs rose by more than 30 percent. .... Greenville Online

11/21 Running the Numbers on New Novartis HF Drug
How to prep for a 'megablockbuster' launch? Novartis lines up cost-savings data .... The experimental med cut ER visits by 30% and reduced hospitalizations by 16%, compared with an older standard treatment, elanapril. .... Fierce Pharma Marketing

11/21 Need to Save on Sovaldi But Don't Care for Cairo? Hop a Plane to Paris
France negotiates lowest price in Europe for Gilead Sciences Sovaldi .... The Economic Committee for Health Products fixed the price for a 28-tablet pack of Sovaldi at 13,667 euros ($17,138), which is 5000 euros ($6269) lower than the original price, while a 12-week course of treatment will cost 41,000 euros ($51,411), compared with 56,000 euros ($70,220) previously. .... First Word Pharma

11/21 Diabetes Costs Top $1,000 for Every American
Cost of Diabetes Care Keeps Climbing .... The total includes $244 billion in medical costs -- including doctor's office and hospital visits, prescription drugs, and other health conditions such as hypertension and kidney complications -- and $78 billion in lost work productivity .... HealthDay News

11/21 Three Month Version of "Invega Sustenna" Goes to FDA for Review
Janssen files four-times-a-year schizophrenia shot .... It is hoped that the new three-month version will go even further in boosting treatment adherence rates compared to the monthly version .... Pharma Times

11/21 Systematic Review of Adherence Literature Finds Few Solutions
Only half of patients take their medications as prescribed .... Many stop taking medication all together and others do not follow the instructions for taking it properly. This has been the case in many different diseases for at least the last half a century. .... Medical Xpress

11/21 Heavy Drinking Kills 88,000 People a Year, Even if They Are Not Alcoholic
Most heavy drinkers are not alcoholics, U.S. study finds .... Contrary to popular opinion, only 10 percent of U.S. adults who drink too much are alcoholics .... [Reuters]

11/21 Internet Drug News Fast Takes:
U.S. states get more, spend more on Medicaid under Obamacare
Six physician personas every executive will recognize
Advisory Board
Woman finds herself trapped in CVS drug store
11-country survey of older adults: Americans sicker but have quicker access to specialists
Health Affairs

11/20 Single Infusion of Specially Tailored Virus Defeats $250,000/Year Hemophilia
Gene therapy found effective in hemophilia B .... Ten patients with severe hemophilia B have remained cured of the inherited bleeding disorder for as long as three years thanks to gene therapy .... [Reuters]

11/20 Critics Say Open Kimono Law Doesn't Go Far Enough
U.S. government proposes more transparency in clinical trials .... U.S. health officials on Wednesday proposed significantly expanding what researchers are required to report about clinical trials of drugs, devices, and other interventions .... [Reuters]

11/20 Otezla for Psoriatric Arthritis Matches Methotrexate + a Biologic
ACR: Otezla Benefit Durable in PsA .... Among patients receiving 20 mg of apremilast twice daily for 2 years, 20% improvements on the criteria of the American College of Rheumatology (ACR20) were seen in 64.8%, and among those given 30 mg twice daily, 57.3% had ACR20 responses .... [Medpage Today]

11/20 Accelerated Review Voucher Now Worth $125 Million; Buyer Won't Disclose for What Drug
Gilead Buys Shortcut For FDA Drug Review For $125 Million .... In an auction, Gilead Sciences, a maker of HIV and hepatitis medicines, just bought a coupon good for the accelerated review of a drug of the company's choice from Knight Therapeutics .... [Medpage Today]

11/20 Land of the Bean and Cod Draws Another Company
'More Biotechy?' Shire to Move US HQ and 500 Jobs to Greater Boston .... Shire, which is best known for selling ADHD pills such as Adderall XR, will move all of its R&D and commercial operations from Chesterbrook, Pa., to Lexington, Ma., which will become its new U.S. headquarters .... [Pharmalot]

11/20 FDA Still Has Nagging Fear That You Don't Pay Full Attention to Drug Ad Warnings
FDA Plans Huge Study on How Public Understands Drug Risk .... The proposed study will test more than 10,000 patients in a bid to examine how they assess drug risk independently of other products. FDA will test patients in eight groups (four chronic pain ads and four hypertension ads) split between a population of those with hypertension or chronic pain and those from a "general population." .... [Regulatory Focus]

11/20 If LDL = 50 is Good, is LDL = 40 Better?
Will The IMPROVE-IT Results Impact The Thinking of The FDA And Payers on LDL-Cholesterol Lowering Drugs? .... The FDA might require an IMPROVE-IT type outcome study for each PCSK-9 inhibitor before approving these drugs in order to demonstrate the long-term benefits and safety of such unprecedented LDL lowering .... [Forbes/John LaMatinna]

11/20 Payers Putting The Brakes on Hard on Harvoni
Payers' hep C delay tactics work: Coverage hurdles may be dampening Harvoni script growth .... While everyone gets access to the treatment eventually, he said, about 90% fail to get approval on the first attempt, and it typically takes two to four weeks for patients to actually start a regimen .... [Fierce Pharma]

11/20 NPs and PAs Get Rep Attention
Pharma deploys reps with helping hands to target stealth prescribers .... Mid-level healthcare professionals like nurse practitioners and physician assistants often play an integral role in physician prescribing. Their names just don't show up in prescription data that drugmakers use to target sales pitches .... [Fierce Pharma Marketing]

11/20 Medicaid Inflation Rebate May Tempt Drugmakers to Aim High in Pricing
Congressional Research Service wants to know: Is Medicaid rebate contributing to high drug prices? .... The rebate program could invite gamesmanship, encouraging higher launch prices that will effectively offset or recover the cost of Medicaid rebates by reducing the additional inflation rebate, especially for drugs such as Solvaldi that have a backlog of demand and no competition .... [BioWorld]

11/20 Internet Drug News Fast Takes:
Royalty Pharma buys royalties on Vertex Pharma drugs for $3.3 bln
A Lack of Bacteria Can Make You Overweight
AZ seeks leg up in antiplatelet market with Brilinta antidote
This IoT Device Is Actually FDA Approved
Heart Drug, Losartan, Falls Short of Promise in a Study
NY Times

11/19 How Much Does Developing a New Drug Really Cost?
Tufts: average drug costs $2.6 bln to develop; critics wary .... The center said its updated estimate of $2.56 billion is based on data from 10 drugmakers on 106 drugs tested from 1995 to 2007 .... [Reuters]

11/19 Painkiller Suit Details Promotion Tactics
Painkiller marketing secrets? Check Chicago's unredacted suit against Endo, Purdue, Cephalon, et al. .... Actavis trained reps and physician-speakers to say that opioid doses could be raised during long-term use, without ever hitting a dose ceiling--and that long-term use of opioids was safer than long-term therapy with drugs like acetaminophen or NSAIDS, which include aspirin and ibuprofen .... [Fierce Pharma Marketing]

11/19 Soriot Touts AZN's Oncology Line-Up
AstraZeneca trumpets solo strength in cancer drugs, snubbing Pfizer .... AstraZeneca's showcase event came eight days before British takeover rules allow Pfizer to renew its pursuit, an option some investors now see as unlikely after the U.S. company signed a major cancer drug deal with Germany's Merck KGaA .... [Reuters]

11/19 Actavis CEO Has Done $99 Billion in Deals in His Career
Actavis Surges to Top Drugmaker Ranks With Acquisitions .... The plan is to cut $1.8 billion in annual costs and use its sales force, focused on primary-care doctors, to generate more revenue from Allergan drugs like Botox, which have been traditionally marketed to specialists. .... [Bloomberg]

11/19 Fight Over Thousand-Dollar Pain Creams
Drug Compounders Sue Express Scripts Over Rejected Claims .... Express Scripts is targeting or blocking 1,000 compounding ingredients, part of a plan it said would save clients 95 percent of their costs while affecting 0.6 percent of patients served .... [Bloomberg]

11/19 Dissatisfied Women Find Advocate
Is Pink Viagra a 'Sham Drug'? .... The LA Times op-ed reports that #WomenDeserve and were developed by Sprout Pharmaceuticals, which has been seeking FDA approval for its female sexual dysfunction drug flibanserin. .... [Yahoo]

11/19 Insider Responds to Pharma-Bashing on Prices
The Real Cost of "High-Priced" Drugs .... Given the prices after patents expire, innovative drugs essentially become ongoing "gifts" to society .... [Harvard Business Review]

11/19 Zetia Works, But Alirocumab Works Even Better
PCSK9s stalk Merck's Vytorin .... A head-to-head trial with Zetia showed that the PCSK9 "produced significantly greater LDL-C reductions versus ezetimibe” after 24 weeks of treatment .... [MM&M]

11/19 Pradaxa Studies Released at AHA
Analyses support Pradaxa safety profile .... The DOD analysis showed that patients taking Pradaxa were less likely to have a stroke and major bleeding issues compared to those taking warfarin, but the Pradaxa group experienced more incidents of risk for lower gastrointestinal bleeding.... Brigham and Women's Hospital's study observed that Pradaxa patients also had fewer strokes, but exhibited fewer major bleeding events in all areas compared to warfarin patients .... [MM&M]

11/19 Generic-Blocking Petitions Dropping Off
FDA Cracking Down on Attempts to Delay Entry of Generic Drugs .... DA is now out with its sixth report since the passage of FDAAA, and agency records show that petitions meant to delay approval of other drugs—505(q) petitions—appear to be at an all-time low .... [Regulatory Focus]

11/19 Internet Drug News Fast Takes:
Men who 'monitor' their prostate cancers have high quality of life
New blood test detects Alzheimer's—10 years before you get it
Deaths From Heart Disease Down, Up for Blood Pressure, Irregular Heartbeat
HealthDay News
Number of pregnant women on narcotic painkillers, heroin doubles
Medical Xpress
Agios Cancer 'Metabolism' Drug Clears Bone Marrow of Leukemic Cells
The Street

11/18 Fast Takes
AstraZeneca lupus drug produces positive results in trial
Pfizer Strikes $850 Mln Pact with Merck Could go Up To $2.9 Bln
The Street
Large Japanese Trial Casts Further Doubt On Aspirin To Prevent A First Heart Attack
Teva Canada Announces the Launch of Teva-Celecoxib, a generic of Celebrex®
Teva Press Release
Reckitt Benckiser Plans December Spinoff of Pharmaceutical Arm
NY Times

11/18  It's Official: Actavis Buys Allergan
- Actavis pays $219 a share, Valeant was offering $200
- Former small generic house Actavis is not a major player
Actavis to Buy Allergan for $66 Billion, Topping Valeant Bid … grown Actavis from a mid-size generic drugs company into a diversified pharmaceutical operation with brand name and generics medicines. That includes the purchase of Forest as well as the $8.5 billion acquisition of Warner Chilcott Plc last year …[Bloomberg]
Ackman Reaps $2.5 Billion From Allergan Even in Loss to Actavis …  leaves the billionaire hedge-fund manager without the deal he wanted -- and with a profit that could exceed $2.5 billion … [Bloomberg]

Zetia, Vytorin: At Long Last, Large Study Shows Moderate
Cardio Benefits Compared To Simvastatin Alone
- 2% decrease in heart attack; 34.7% Versus 32.7%; 6.4% relative decrease
Study lifts cloud over heart drugs Zetia, Vytorin … modestly lower the risk of heart attacks and other problems in people at high risk for them -- evidence that's been missing for more than a decade as the drugs racked up billions in sales … [Reuters]
Surprise! Vytorin Works. Here Are Five Things You Should Know … word that came up regularly during interviews with 15 cardiologists and industry executives, "modest." No deaths were prevented by using the $7-a-day Vytorin pill instead of a 25-cent generic …[Forbes]
After Years Under Attack, Merck's Vytorin Proves Effective … [Forbes]

Novartis Experimental CHF Drug Is Darling Of Heart Meeting
Novartis heart failure drug provides host of benefits - study … It's almost too good to be true … reduced death and hospitalizations also curtailed worsening of symptoms, need for additional therapy and emergency room visits …[Reuters]
Related [Archived 8/30/14 Novel Heart Failure Drug Cuts Mortality … [MedpageToday]

Fast Takes
Pharma's top 10 M&A deals of 2014's first half
Fierce Pharma
FDA Officials demand more inspectors for China drug factories
Truvada: AIDS Group Wages Lonely Fight Against Pill to Prevent H.I.V, frame it as "party drug"
NY Times

Mylan Boss: Mylan Better Off If Foreigners Owen It
- Smells like she's 'urgin for inversion
Mylan's Bresch Backs Inversion as Shield Against Takeover … What's patriotic is making this country a place that allows you to thrive, grow your industry versus handcuffing you and making you a sitting target" to be acquired by a company based elsewhere …[Bloomberg]

Zetia: A Day Of Reckoning Approaches For Merck And Its Critics
A Day Of Reckoning Approaches For Merck And Its Critics … A dozen years after Zetia was approved and two years before the patent expires, it will provide the first proof whether or not Zetia actually prevents heart attacks and strokes like it's supposed to …[Forbes]
Editor's Note: Zetia = ezetimibe + simvastatin in a fixed combo dose.   To date, no trial has demonstrated a reduction in cardiovascular events with ezetimibe plus a statin vs. a statin alone. This question is being examined in the IMPROVE-IT trial, which will compare treatment with ezetimibe vs. placebo on top of a background regimen of intensive statin therapy in people who have had recent episodes of acute coronary syndrome …[Wikipedia]

Sanofi; Lemtrada FDA Flip Flops - Approves Much Anticipated MS Drug
In reversal, FDA approves Genzyme's bid to sell MS drug in US … Eleven months after rejecting a powerful multiple sclerosis drug considered key to the future of Cambridge biotech Genzyme, federal regulators Friday reversed themselves and approved  …[Bostron Globe]
FDA reverses an embarrassing rejection of Sanofi's Lemtrada, OKs MS drug … priced at a premium to the rival drug Rebif. Lemtrada will be sold for $158,000 for a two-treatment regimen, compared to about $135,000 for a similar course of Rebif from Merck KGaA …[Fierce Biotech]

Actavis Is White Knight In Battle Against Valeant
To Buy Botox Maker Allergan
Actavis Said Near $62.5 Billion Deal for Allergan … transaction that would help the maker of Botox rebuff a hostile advance from Valeant Pharmaceuticals … rying to strike a deal before an investor meeting on Dec. 18 …[Bloomberg]\

Generic Drug Price Hyperinflation In The News
- Lack of competition means orphan drug price model is new paradigm
To the Moon: Will Rising Prices For Some Generic Drugs Never End? … in this year's third quarter, pharmacies paid more for 37% of all generics than they did in the previous quarter, and 3% of 2,535 generics more than doubled in cost …they've spent so many years telling consumers to switch to generics and don't want to go back on that … [Pharmalot]

Pfizer Hungry For A Deal, But Not AZN
AstraZeneca not only game in town for deal-hungry Pfizer … need for a deal remains, however, given its vulnerability to cheaper generics and its relatively weak line-up of experimental medicines …[Reuters]

Opioid Crackdown Unanticipated Consequences: 
Docs Get Rich On B.S. Drug Screens For Grandma
- Want pain pills?  Gotta screen ya for Angel dust even if you are 95
Doctors Cash In on Drug Tests for Seniors, and Medicare Pays the Bill … Urine drug testing is how I pay the bills … Medicare payments for drug testing have eclipsed their income from treating patients … doctors switched to high-tech testing methods with fewer billing restrictions, chiefly mass spectrometry …[WSJ]

Contrarian Investment Bankers Interested In Glaxo Old Hag Cash Cows
Reuters: Apollo interested in GSK's entire $3B package of mature drugs … antidepressant Paxil, migraine treatment Imitrex, stomach acid-reducer Zantac and nausea fighter Zofran--drugs expected to have combined 2014 sales of around $1.6 billion but face competition from cheap generics …[Fierce Pharma]

11/14 Retailers Begin to Disrupt Primary Care
Attention shoppers: There's a special on flu shots and corn chips in aisle three .... Retailers have begun to act deliberately to take on more substantial portions of the primary care market—adding capabilities to diagnose and manage chronic care patients, provide routine blood testing, and even offer insurance counseling .... [Becker's Hospital Review]

11/14 Invega Sustenna Approved for Schizoaffective Disorder
FDA Approves Schizoaffective Disorder Drug .... FDA has approved paliperidone palmitate (Invega Sustenna) as either monotherapy or adjunctive therapy to treat .... [Pharmacy Times]

11/14 Trial and Error Has Found More Good Drugs than Rooms Full of Gene Sequencers
Why Are So Few Blockbuster Drugs Invented Today? .... For every billion dollars spent on research and development since 1950, the number of new drugs approved has fallen by half roughly every nine years, meaning a total decline by a factor of 80 .... [NY Times]

11/14 Rebif Maintains Sales Against Tecfidera
Merck KGaA Raises 2014 Forecast as Sales of Rebif Climb .... Revenue from Rebif, which accounted for 17 percent of Merck's 2013 sales, climbed 1.7 percent, even amid competition from Biogen Idec's Tecfidera .... [Bloomberg]

11/14 Generic for Concerta Knocked Off Market
Mallinckrodt ADHD Drug Hits FDA Trouble .... The FDA is no longer recognizing Mallinckrodt's generic ADHD drug as equivalent to the original, which would essentially knock it out of the market .... []

11/14 When Competition Goes Away, Generic Drugs Get Expensive
Why some generic drug prices are skyrocketing .... A recent analysis by Pembroke Consulting found nearly 10 percent of generics more than doubled in price in the past year .... [CBS News]

11/14 Negative Effects for "Smart" Drugs
"Smart" Drugs Don't Work If You're Already Smart .... Modafinil actually impairs the performance of students who use the drug before taking an exam .... [Fast Company]

11/14 Down the Hatch! Tips and Tricks for Swallowing Pills, Tablets, and Capsules
Trouble swallowing pills? You're probably doing it wrong .... About two-thirds of those who said they had trouble swallowing tablets reported improvement while using the pop-bottle method .... [Medical Xpress]

11/14 Valeant Winning Friends the Old-Fashioned Way
Valeant, Allergan Scuffle for Doctors .... Valeant paid for the physicians' airfares, two-night stays at luxury hotels and meals. The company also agreed to provide consulting fees that could amount to as much as $30,000 .... [$$WSJ]

11/14 Accountable Care Models to Dominate in 5 Years
Health providers are embracing value-based care .... Value-based care with some form of value measurement will make up two thirds of the market by 2020, up from one third today .... [MM&M]

11/14 PV-10 Moves to Phase III
Eye-dye melanoma try: Provectus phase III plan for injectable with FDA .... In the 80-patient phase II melanoma study, an objective response (OR) turned up in 49 percent of subjects, with 71 percent achieving locoregional disease control (stable disease or better) in their injected lesions. A mean PFS of 11.7 months was observed among the patients with ORs .... [BioWorld]

11/14 Internet Drug News Fast Takes:
Puma Biotech says cancer drug fails mid-stage study
Implants on the Adriatic: Balkans Lure Medical Tourism
How an iPhone Can Lead to Broken Bones for Young Children
The Upshot/NY Times
Does Your Spouse Affect How you Perceive Drug Safety?
Regulatory Focus

11/13 Fate of Zetia and Vytorin Hanging on AHA Results
Merck Braces for Study on Medicines Worth $4 Billion a Year .... What's unclear is whether by combining Zetia and generic simvastatin, Vytorin can also lead to fewer heart problems than just taking simvastatin by itself. .... [Bloomberg]

11/13 Expanding Indications Drove Abilify to Top Sales Spot
US spends most on this drug... and no one knows how it works .... Once the drug was able to be marketed as an add-on for depression, its sales soared. (BMS spends $121 million on promoting Abilify each year...) .... [RT News]

11/13 Takeda's Direct Save Provides Contrave at Predictable Cost
Contrave demand swamps Takeda's direct-delivery discount program .... Fewer than three weeks into the launch, more than 5,000 prescriptions had been sent into the Direct Save system. The program's website couldn't handle the volume of registrations .... [Fierce Pharma Marketing]

11/13 Tchochkes Are Out, Screens for Doctors' Offices Are In
Whatever Happened to Pharmaceutical Swag? .... A quick perusal of eBay unearths a mug promoting Klonopin, a highly addictive anxiety medication, a Viagra clock, a Nexium swiss army knife, and an Ambien plush doll. .... [The Atlantic]

11/13 Payers Hold Tight Rein on Harvoni
Demand for Harvoni limited by insurance reimbursement .... KOLs say that 90% of their patients fail to get approval on the first attempt, and that it typically takes 2-4 weeks for patients to actually start a regimen .... [MM&M]

11/13 Evolocumab Filed
FDA to review Amgen's cholesterol drug .... US regulator accepts first in new class of PCSK9 inhibitors .... [PMLiVE]

11/13 Valeant May See Allergan Snatched Away by Higher Bid
Actavis in Talks to Acquire Allergan for Over $60 Billion .... The maker of anti-wrinkle treatment Botox is seeking more than $210 a share while Actavis wants to pay closer to $200 .... [Bloomberg]

11/13 Fosbretabulin Gets Positive Phase 2 Results
Oxigene Faces Challenges for Ovarian Cancer Drug Even With Encouraging Data .... The study achieved the primary endpoint with a 31% reduction in the risk of tumor progression or death favoring fosbretabulin+Avastin over Avastin alone. However, the benefit was just barely statistically significant with a p value of 0.049 .... [Bloomberg]

11/13 Internet Drug News Fast Takes:
U.S. gene study raises hope for Merck cholesterol drug Zetia
Ebola To Have A Global Burden Of $5.9 Billion By End Of 2016
Pharmacy deserts contribute to access issues
News UK finds tablet ads as memorable as print

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