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Pharmaceutical News Harvest ™

11/24 Fast Takes
Triclosan: Antibacterial Soap Ingredient Linked To Liver Damage, Cancer in Mice
LA Times
How nucleoside reverse transcriptase inhibitors may be able to treat blindness
FDA awards breakthrough status to Sanofi-Regeneron's dermatitis drug

Senate Panel Inquisition Regarding Generic Price Spikes
- Pharmacists forced to absorb price increases, lose money
Soaring generic drug prices draw Senate scrutiny …  doxycycline hyclate, rose more than 8,280 percent during a six-month period from an average of $20 per bottle to $1,849 per bottle … albuterol sulfate, a common asthma treatment, shot from an average of $11 per bottle in October 2013 to $434 per bottle in April, an increase of over 4,000 percent …[AP]
Editor's Note: Prices go up, that's a fact of life.  The bigger issue is that large PBMs who own mail order pharmacies take too long to update reimbursement prices,  forcing pharmacists to lose money on scripts or turn patients away.

Sanofi: No Plans To Jettison Inhaled Insulin; Hopes For Expanded Indications
MannKind's Afrezza Remains in Sanofi's Plans, RBC Says …  two or more oral agents and resisting moving on to injectable insulin and those who need meal-time … negotiations with the FDA over post-approval studies that could expand Afrezza …[Barrons]

Takeda: US Pharma Prez Is History: Quit? Fired?
Takeda Pharmaceuticals president quits … point in his career where he decided to explore his options … hired on at Takeda in 1992 as a sales rep and worked his way up … couldn't be reached for comment …[Crains]
Editor's Note: It's no secret that the recent Contrave launch was hobbled by bottlenecks associated with a direct delivery program.  The website was overloaded and potentially, some sales were lost.   

Sanofi Banks On Success Of Lantus Successor
Sanofi offers glimpse of next-gen. insulin strategy …   52% of US endocrinologists are aware of the drug …  77% say they're willing to prescribe Toujeo …  hopes to expand its patient base by a million new patients per year …[MM&M]
Editor's Note: Adds information regarding Afrezza launch strategy.

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 Purdue New Pain Pill: "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

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