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Pharmaceutical News Harvest ™

10/24 Pharma Asks Legal Safe Passage for Ebola Treatments
Drugmakers may need indemnity for fast-tracked Ebola vaccines .... GlaxoSmithKline Chief Executive Andrew Witty said a system of indemnity made sense given the unique situation in which companies are being urged by the WHO to fast-track the supply of novel vaccines in a matter of months rather than years .... [Reuters]

10/24 Lilly Sales Over the Cliff
Lilly Misses Estimates as Patent Expirations Cut Sales .... Lilly lowered the top end of its annual sales guidance, citing what it called rapid and severe declines in sales of Cymbalta and the osteoporosis drug Evista .... [Bloomberg]

10/24 Guest Columnist, Leading Cancer Doctor, Blasts Pharma Pricing
Could High Drug Prices Be Bad For Innovation? .... "The potential to affix this huge pricetag to Esbriet didn't spur the innovation, it spurred Roche to pay up for the company. Today's shareholders are super happy (and I'm glad for them), but how many of them were even around and invested in the company back when the high risk decision to develop Esbriet was made?" .... [Forbes/Guest Post]

10/24 Panel Likes Secukinumab
FDA committee unanimously recommends approval of AIN457 for psoriasis treatment .... The committee based its recommendation on the outcomes from 10 psoriasis phase 2/3 clinical studies including nearly 4,000 patients with the condition .... [Healio]

10/24 Otezla Off to Strong Start
Celgene's powerhouse Revlimid gets a little Q3 help from new friends Pomalyst, Otezla .... Otezla has nabbed favorable placement on formularies--most of which don't require previous therapy for patients to qualify--and won a new indication for psoriasis patients last month .... [Fierce Pharma]

10/24 Wanamaker's Question Answered: Know Which of Your Ads are Working
Is your DTC campaign working? New program tracks viewers from TV to pharmacy .... Nielsen Catalina and Crossix's new program, dubbed "AdVantics Rx," follows audiences as they watch ads on TV, and then determines whether a consumer visits a doctor or buys a prescription based on the ads they were watching .... [Fierce Pharma Marketing]

10/24 Addicts Want a 'Quick Fix' but Maintenance Works Better
For prescription drug addiction treatment, buprenorphine maintenance trumps detoxification .... The team found that patients in the detoxification group tested positive for illicit opioid use more often than those in the maintenance group. Patients who received ongoing buprenorphine were less likely to use illicit opiates. Few of the patients in the detoxification group stayed in treatment or were able to abstain after the medication was discontinued .... [Medical Xpress]

10/24 Study Summary: Comparative Ads Work
Consumers swayed by comparative drug claims .... When participants viewed a fictitious print or video ad mentioning branded competitors, or making a comparison to an unnamed competitor, "named competitors in print ads resulted in higher risk perceptions than unnamed competitors." .... [MM&M]

10/24 Abilify Not Losing Share to Generics
Claims show BMS's Abilify remains strong .... A review of patient-level claims data showed the medication captured "the second-highest patient share among atypical psychotics" prescribed for the disorder. .... [MM&M]

10/24 FDA Shaves 5 Months Off Typical Device Review Wait
FDA Approving New High-Risk Devices at Fastest Pace in Last Decade .... In 2012, FDA approved high-risk devices through its premarket approval application process in 297 days on average — faster than any year going back to the year 2000, when it approved PMAs in 252 days on average .... [Regulatory Focus]

10/24 Internet Drug News Fast Takes:
U.S. court upholds patents on Pfizer's cancer drug Sutent
Survey: Overwhelming Majority Of U.S. Doctors Seeing Patients With Drug-Resistant Illnesses
Americans Show Distrust of Medical Profession in Survey
U.S. Ranks Last Among Wealthy Nations in Access to Health Care
Arbor Pharmaceuticals Announces FDA Approval of Sotylize
Company news release

10/23 Drug Coupons Reduce Out-of-Pocket Costs by 60%; Help Adherence
Drug Coupons Shrink Patients' Costs Considerably .... Researchers found that drug coupons accounted for $21.2 million of patients' $35.3 million annual out-of-pocket costs in 2013. Coupons reduced monthly cost sharing to less than $250, a point at which patients were far less likely to abandon therapy .... [HealthDay News]
Don't mess around, go straight to the best:

10/23 Advair Formulary Loss Blamed for Layoffs
Advair sales slide triggers another $1.6B in cost cuts at GlaxoSmithKline .... The cuts will hit commercial operations, support functions, and pharma R&D and manufacturing, and come on top of last year's £1 billion. restructuring announcement .... [Fierce Pharma Marketing]

10/23 Wall Street Talking Up Amgen Split
Amgen's Boss Makes a Prime Breakup Target for Loeb .... If any company is amenable to a split, though, it's Amgen. Its biological drugs are hard to copy, so they are likely to face limited competition even when patent protection expires. That means revenue from established medicines ought to decline slowly .... [NY Times/Dealbook]

10/23 Millions of Bloodcurdling Medical Images Free for Your Phone
The Uncanny Language of Medical Instagram .... This is stuff that doctors either want to show their colleagues or need help with, so it's full of superlatives and oddities. .... [The Awl]

10/23 J&J Readies Two-Shot Ebola Vaccine with Partner Barvarian Nordic
J&J Says 250,000 Ebola Vaccine Doses to Be Ready by May .... J&J is committing as much as $200 million to accelerate and expand production of the vaccine .... [Bloomberg]

10/23 First PML Case on Tecfidera Frightens Biogen Investors
Biogen Falls After Patient on Top-Selling Drug Dies .... The patient, who had been taking Tecfidera for four years, had low levels of white blood cells, a risk factor for PML outlined in the drug's label .... [Bloomberg]

10/23 Most Common Error in Medications for Children: Double Dosing
Medication errors occur every eight minutes in kids .... An average of 63,358 children in the United States experienced a medication error each year between 2002 and 2012, according to a study published this week in the journal Pediatrics .... [Advisory Board]

10/23 Jardiance + Metformin Combination
FDA will review Lilly/BI diabetes combo .... Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor that removes excess glucose through the urine by blocking glucose reabsorption in the kidney, while metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilize glucose .... [Pharma Times]

10/23 Adherence Apps Claim 50% Boost in Patients Taking Meds
Take Your Medicine, Tap Your Phone And Collect A Prize .... Running through HealthPrize's blood are ties to Priceline and research in consumer motivation, casinos and gaming. "We understand consumers when it comes to Las Vegas, vending machines, lottery tickets," says CEO and founder Dr. Katrina Firlik .... [NPR Health Blog]

10/23 Patiromer Filed for Approval
Relypsa seeks FDA approval of drug for chronic kidney disease patients .... Patiromer, which is given twice a day, is a powder that mixes with water to create a tasteless, odorless, smooth liquid. As it passes through the digestive tract, it is not absorbed but instead binds to potassium and is excreted through the colon .... [San Francisco Business Times]

10/23 Internet Drug News Fast Takes:
A Poop Bank in Massachusetts Will Pay You $40 Every Day
Boston Globe
JAMA: When hospitals become 'for-profit,' quality doesn't change
Advisory Board
Some U.S. hospitals weigh withholding care to Ebola patients
More Insurers Put Spending Limits On Medical Treatments
NPR Health Blog
FDA Network Susceptible to Cyberattacks, OIG Audit Finds

10/22 Fast Takes
Convict Benefits: Can't Afford Solvaldi? Get Arrested, Go To Prison
Boehringer's New Lung Drug to Cost $96,000 a Year
Viagra Protects The Heart -- Now What?

Cost $11 Last Year - Now It's $434; The Rise Of Generic Prices
- OOPS; PBMs forget to raise their reimbursement rates
What's behind the huge price jump for some generic drugs? … albuterol sulfate. The average cost for a bottle of 100 pills was $11 last October, the pair said. The average charge by this April was up to $434 … Anafranil. Prices for each rose more than 650%  … generics are increasing in price by an average 10% a year …[LA Times]
Editor's Note: Stocks?  We don't need no stinkin stocks; we arbitrage generic pills.   Former Kinray owner Stewart Rahr made billions this way.  If you are a pharmacist, stockpile reliables - Atorvastatin, HCTZ, Augmentin, betamethasone, furosemide, etc. 

Analysts: FDA To  Officially Green Light Novo Diet Injection Before X-Mas
- Same active ingredient as Victoza, more milligrams per shot
Analysts see U.S. approval of Novo Nordisk's obesity drug by year-end … estimated peak sales of Saxenda at around $1.5 billion … FDA's silence on Monday should not cause concern …[Reuters]

Glaxo Ain't Doing So Well
- Respiratory franchise sputters: Breo shunned by Express, <1.5% share;
Anoro didn't even do $10 Mln In Q3
Glaxo Rising Star Connelly Under Pressure as Drugs Falter … U.S. pharmaceutical sales have fallen 16 percent since 2009 … cut its annual sales and profit forecast in July, and analysts predict earnings will tumble 17 percent this year … [Bloomberg]

JAMA: Parkinson Meds Need Black Box
- Dopamine agonists linked to compulsive shopping, gambling, sexual acting out
Parkinson's Drugs Need Warnings About Compulsive Behaviors: Study … known as dopamine receptor agonists, are more closely associated with these impulse control disorders  than has been demonstrated … authors are calling for stronger warnings - specifically, so-called Black Box warnings …[Pharmalot]

FDA Panel Recommends Expansion Of $550 Per Pill Cystic Firbosis Pill
- $33,000 per bottle med gets 500 new patients if FDA accepts recommendations
FDA panel votes to expand use of Vertex cystic fibrosis drug … voted 13-2 to recommend expanding approval of cystic fibrosis drug Kalydeco to include a wider range of patients …  experts said Kalydeco should be approved for patients ages 6 and older with a specific mutation of the R117H gene, of which there are about 500 people in the United  …[Reuters]

Ebola Patients Generate 440 Gallons of Medical Waste Daily
Another Ebola challenge: Disposing of medical waste … One Ebola patient treated in a U.S. hospital will generate eight 55-gallon barrels of medical waste a day … Even curtains, privacy screens and mattresses eventually must be treated as contaminated medical waste and disposed of …[LA Times]
Hey You:  In my next lifetime I am going into hazardous waste. 

Caremark Punishes Pharmacies Who Sell Cigarettes
- Predatory copay scheme targets Walgreens, others
Caremark to Charge Extra Co-Pay at Pharmacies Selling Cigarettes … require some customers to make an extra co-payment, in some cases up to $15, on any prescription that is filled at a pharmacy selling cigarettes and other tobacco products, according to sources … [Pharmalot]

Purdue Fights For Life - Oxycontin Lawsuit Could Be Curtains
- Billion here, billion there, pretty soon you're talking about real money
Drug Maker Warns That OxyContin Suit Could Be 'Crippling' … could result in a catastrophic $1 billion judgment against it, as well as the potential for punitive damages and interest …alleges that the company trained its sales force to falsely portray OxyContin as difficult to abuse … [Bloomberg]

Contrave: Try Some, Buy Some - Drugstore Has It In Stock (Hopefully)
- Naltrexone and bupropion combo pill officially in launch mode
Takeda's Contrave hits pharmacy shelves … 900 sales reps who would target an array of specialties including OB/GYNs, cardiologists and primary care physicians …  patient support encourages patients to pursue lifestyle changes, such as diet modification and exercise …[MM&M]
Takeda and Orexigen Announce Availability of CONTRAVE® (naltrexone HCI and bupropion HCI) Extended-Release Tablets for Chronic Weight Management in Obese Adults … for chronic weight management in adults with an initial body mass index (BMI) of 30 … [Company Press Release]
See Also: Prescribing InformationMedication Guide | HCP Site
Editor's Note: Good luck guys.   After all, Americans will try anything to lose weight (except exercise more and eat less.  Corey should know he takes up 2 seats at the movies.

16 Drug Companies Race To Put Out Ebola Meds
Ebola Clinical Trials: Big Name Players In The Ebola Race  … Here's BioSpace's guide to who's working on therapeutics or vaccines for Ebola and how those pipelines are progressing … [Biospace]
Editor's Note: Original Biospace content; 2,500 words; nice database article.  Product name, whether it is a drug or vaccine, who the developer is, who is the developer's partner and what phase the product is in.  Then you get 1-3 paragraphs on the drug company and a mini-monograph for each product.  Must see for policy makers, financial people, sell-side analysts.

AbbVie To Pay $1.64 Bln Penalty For Reneging On Shire Deal
- That's a lot of Humira; lawyers and accountants made out like bandits regardless
- Looks like it was a tax dodge after all unlike AbbVie initial assertions
IRS Blocks Inversions, So AbbVie Pays $1.64 Billion Kill Fee To Shire...And Deducts It … back out of its planned $55 billion deal with Irish-headquartered Shire … AbbVie's second thoughts on the deal and recent nixing of the transaction surprised Shire investors … [Forbes]
Shire Goes Shopping After AbbVie Deal Falls Through  … [Biospace]

Pssst: The Guy Sitting Next To You Makes More Than You Do
- Average pharma salary = $154K; huh?  Slowly I turn; Step by step; and then …
Career & Salary Survey: In Check … This year, the average salary for men was $154,700, versus the average salary of $116,700 for women … companies with annual revenues of less than $5 million reported average salaries of $115,200, while those at companies with annual revenues greater than $100 million recorded average salaries of $152,800 …[MM&M]

Lilly CEO Pleads For Tax Reform, Discusses Obamacare
Lilly CEO Sees Light After a Difficult Year … Eli Lilly & Co. is deep into what Chief Executive John C. Lechleiter calls the "toughest year" in the drug maker's 138-year history … WSJ: What effect is the Affordable Care Act having on Lilly and the industry? …[WSJ]

Fast Takes
GSK says Ebola vaccine development progressing at 'unprecedented rate'
Cegedim  Cool With Being Bought Out By IMS
IMS Press Release
The importance of vaccine perceptions in self-pay markets

Off-Label; Why Is FDA Playing God?
- How FDA twists law from 1938 to shackle Pharma's 1st amendment rights
Better Late Than Never? Congress, Courts May Address Limits On Disseminating 'Off Label' Medical Information … FDA has been reluctant to elaborate on the basic restriction forbidding the promotion of unapproved uses, even in the face of rulings that admonished the agency for being overly restrictive and failing to regulate in a way that is properly sensitive to free speech principles …[Forbes]

Germany: Anti Death Penalty Activists Put Pressure On Mylan
- Rocuronium bromide is hard to come by
Mylan faces investor pressures over use of drugs in US executions … only US-approved producer of  rocuronium bromide not to have imposed measures to prevent its use in lethal injections. The product is approved as a muscle relaxant during surgery but, at a high dose, can cause paralysis of the breathing muscles …[]
Editor's Note: Speaking for myself I would overdose on  drugs than have my brains cooked in the electric chair.  If the activists win the condemned lose.   (Click HERE to See Graphic Image of electrocuted murderer's head )

Regeneron's Eylea works better vs Avastin and Lucentis in study
Eylea beats Avastin and Lucentis for visual acuity in DME patients … better than expected because in addition to better efficacy, Eylea also showed better safety, especially compared to Lucentis for APTC and cardiovascular events …[Pharma Letter]

Rx Pill Deaths Down Heroin Overdoses Surge
- Cheap plentiful heroin replaces pricey pain pills
As Rx deaths dip, heroin overdoses surge … Fatal heroin overdoses rose 35% to 5,927, while deaths involving chemically similar prescription painkillers such as OxyContin and Vicodin dropped 5% to 16,007 … [LA Times]

Embeda Gets Highly Desirable Label
- Can differentiate itself as less likely to be abused; US launch expected early 2015
US FDA backs abuse deterrent labeling for Pfizer's Embeda ER …  Pfizer expects Embeda will be available in the US in early 2015 … updated label states that Embeda has properties that are expected to reduce abuse via the oral and intranasal (ie, snorting) routes …[Pharma Letter]
See Also: Click HERE for 7-day free trial subscription to Pharma Letter

Amgen Sues Sanofi, Regeneron To Block Revolutionary Anti-Cholesterol Drug
Amgen Files Lawsuit Against Sanofi And Regeneron For Patent Infringement … suit alleges that Regeneron and Sanofi are violating three Amgen patents with alirocumab, one of an emerging group of medicines that lower cholesterol by targeting a gene known as PCSK …[WSJ]

Feds Simplify  Opayment Data Interface
- Make it easier to look up doctor by name
Better Late Than Never: CMS Improves The Doctor Payment Website … lets you search by a physician's name, location or specialty, as well as by the names of teaching hospital and companies. The results list each individual payment, which can be sorted from high to low …[Pharmalot]

10/17 Chantix Keeps Black Box
FDA panel votes to keep severe warning on Pfizer anti-smoking drug .... A majority of the panel voted to keep the health regulator's most severe warning label on the treatment, in keeping with the recommendations of FDA staff two days earlier .... [Reuters]

10/17 Why Seniors Skip Their Meds
30% of Medicare Beneficiaries Not Adherent to Medications .... The reasons cited for nonaherence included forgetfulness (n=123; 73%); side effects (n=18; 11%); and feeling that the medication was not needed (n=17; 10%) .... [First Report Managed Care]

10/17 FDA Bypassing Standard Procedures to Meet Ebola Need
Ebola Has the FDA Working Overtime on Reviewing Experimental Drugs .... In the U.S., when physicians ask the FDA for permission to use experimental drugs on their patients, as they have recently in Dallas, the agency responds in a matter of hours—and often, less than one hour. .... [National Journal]

10/17 Harvard Business Review Picked the World's Best CEOs. Four of Top 10 Are Pharma
World's best CEOs? Gilead, Allergan, Novo and Valeant make top 10 .... HBR has a particular slant on CEO quality: It's about market cap growth and shareholder returns .... [Fierce Pharma Marketing]
Direct link: The Best-Performing CEOs in the World [Harvard Business Review]

10/17 21 Million Compounded Bioidentical Menopause Scripts Filled Every Year
Many U.S. women use custom-compounded hormones for menopause .... An estimated 1.4 million U.S. women take custom-compounded bioidentical hormone therapy for menopausal symptoms, and most are unaware that these drugs are not FDA-approved .... [Reuters Health]

10/17 Secukinumab Gets Favorable Staff Review
Novartis psoriasis drug benefits outweighs risk-FDA staff .... The injectable biologic, secukinumab, is part of an eagerly anticipated class of drugs called IL-17 inhibitors that have shown unprecedented success in plaque-psoriasis .... [Reuters]

10/17 Meet the Office of Pharmaceutical Quality
FDA Announces Major Agency Reorganization, With Focus on Drug Quality .... OPQ was envisioned as a way to oversee drug quality throughout the product lifecycle, instead of the fragmented pre-market/post-market approach now taken by FDA .... [Regulatory Focus]

10/17 ‘Shine The Light On Me — My Sugar's Too High’
New diabetes drug is activated with light .... A new drug for type 2 diabetes could be activated exactly when it's needed by shining a blue light on the skin, and might one day give patients with the disease more control over their blood sugar levels .... [Fox News]

10/17 Is 21 Days Quarantine Enough?
Study Questions 21-Day Quarantine Period for Ebola .... There could be up to a 12% chance that someone could be infected even after the 21-day quarantine .... [PTCommunity]

10/17 Can Stem Cells Work for ALS? CEO Gives an No-Hype or BS Look
Brainstorm CEO Offers Investors a Frank Outlook for ALS Therapy .... The laboratory culturing of mesenchymal stem cells into specialized cells documented to produce nerve growth factors sets NurOwn apart from other riskier attempts at stem cell therapy .... [The Street]

10/17 Internet Drug News Fast Takes:
Diet may influence ovarian cancer survival
Conventional medical centers may be unable to prevent spread of Ebola
Annals of Internal Medicine
NICE not recommending Dendreon cancer vaccine
Getting an Appointment With a Psychiatrist Often Difficult
HealthDay News
Parenthood May Push Cancer Patients to Seek More Treatment
HealthDay News

10/16 Esbriet (Roche); Ofev (Boehringer Ingelheim) Approved
FDA approves two treatments from Roche, Boehringer for fatal lung disorder .... The agency's decision marks a crucial milestone in the management of the disease, which affects about 100,000 people in the United States. .... [Reuters]

10/16 AbbVie Puts the Brakes on Tax Inversion Deal with Shire
AbbVie cools on $55 bln Shire deal after U.S. tax changes .... U.S. pharmaceutical company AbbVie said it was reconsidering its $55 billion takeover of Shire in the wake of U.S. government moves to curb deals designed to cut taxes .... [Reuters]

10/16 90% of Terminal Lukemia Patients Respond to Experimental Therapy
Last-resort leukemia treatment produces dramatic remission rate .... The ALL treatment involves training disease-fighting blood cells known as T-cells. Once removed from a patient's body, they are programmed to hunt cancer cells that have a telltale protein on their surface. The specially-trained cells are then re-injected into the patient. The re-engineering process currently costs about $25,000 .... [Reuters]

10/16 Search for "Chest Pain," and Google Might Pop a Live Doc on Your Screen with Help
Google trial lets you chat with doctors when you search for symptoms .... The company is testing a Helpouts-style feature which offers video chats with doctors when you search for symptoms .... [Engadget]

10/16 All Eyes on AbbVie's Pricing for Hep C
If AbbVie Discounts its Hep C Drug, Would Pricing Reach a Tipping Point? .... The cost per patient could fall to below $70,000, on average, across the spectrum of hepatitis C patients .... [WSJ/Pharmalot]

10/16 Lenvatinib Priority Review
FDA grants priority review designation for Eisai's Lenvatinib to treat advanced thyroid cancer .... Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a unique binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors .... [Pharmaceutical Business Review]

10/16 J&J to Scotland: 'If Our Drug Doesn't Work, You Get Your Money Back'
J&J offers goverment payer hep. C guarantee .... The drugmaker has proposed reimbursing the patient cost for those who are not cured after 12 weeks of treatment with Olysio (simeprevir) .... [MM&M]

10/16 Kinetica Errors Throw Approvals in Doubt
Software issue casts doubt over data used to approve some drugs .... The reliability of clinical tests used to win approval for some medicines -- particularly generic copies of original drugs -- could be in doubt due to an apparent software glitch that may mean data was calculated incorrectly .... [Reuters]

10/16 Copaxone Patent Before Supreme Court
Teva Gets Mixed Reception at U.S. High Court on Copaxone .... The justices suggested they will divide on a federal appeals court's decision to invalidate a patent that would protect Copaxone from rivals until September 2015 .... [Bloomberg]

10/16 Amgen Pipeline Preview
A Quick Look at Amgen's Drug Development Pipeline .... While Amgen has noted that it plans to deliver late-stage data on 10 experimental drugs between 2014 and 2016, there are three developing drugs that are the cornerstone to its future success .... [Motley Food]

10/16 Internet Drug News Fast Takes:
Poll: 40 Percent Of Americans Feel At Risk For Getting Ebola
FDA Wants to Study if Drug Color, Shape and Size Affect Patient Adherence
Regulatory Focus
This Man's Simple System Could Transform American Medicine
Biotech's Builder: How The Pharma's Landlord Could Benefit From The Drug Boom
Forbes/Matthew Herper
Was Celgene's Crohn's Disease Drug Worth The Price?
Investor's Business Daily

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