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Pharmaceutical News Harvest ™

9/18 Plans Use Pharmacy Tiers to Drive Away Expensive Patients
How Insurers Are Finding Ways to Shift Costs to the Sick .... The Affordable Care Act bans insurance companies from discriminating against patients with health problems, but that hasn't stopped them from seeking new and creative ways to shift costs to consumers. In the process, the plans effectively may be rendering a variety of ailments "non-preferred"... .... [NY Times]

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9/18 Accompanying Medicines Drive Down Sovaldi Adherence
Rate of Sovaldi non-adherence points to need for patient support .... Researchers found that 8.1% of patients stopped taking the drug before finishing the regimen (prior to 12 weeks). While that number may not seem high on its own, it is quadruple what was observed in Sovaldi clinical trials .... [MM&M]

9/18 Panel Votes 20-1 to Slam the Brakes on Low-T Products
Testosterone Drugs May Need Further Study on Heart Risk .... Drugmakers should conduct new trials to assess the heart risks of testosterone therapies used by 2.3 million men last year .... [Bloomberg]

9/18 Deep Dive on How Drug Prices are Set
Drug pricing: A new prescription .... Rebates negotiated by payers (which are extremely secretive and occur when there are several drugs competing in the same category) bring down the net price of branded drugs to about 73 percent of the list price. By law, Medicaid gets further discounts from what payers get, bringing prices down to between 60 and 67 percent of the list price. .... [Boston Globe]

9/18 70,000 Children Hospitalized Each Year After Getting into Adult Meds
The 12 medications sending droves of kids to the ED .... 12 types of drugs accounted for more than 75% of the hospitalizations among all age groups. Three of the drugs were painkillers, while some of the others were for treating chronic conditions such as anxiety and diabetes .... [Advisory Board]

9/18 JAMA Study Outlines Best Practice for COPD
Combination Therapy Deemed Best for COPD .... A combination drug therapy of a long-acting beta agonist and inhaled corticosteroid appears to be the best treatment for older adults with chronic obstructive pulmonary disease (COPD), especially those with asthma .... [HealthDay News]

9/18 Bel-phen Touted as Safer Version of Fen-Phen
Doc Offers Glimpse Into Arena Pharma Weight-Loss Combination Therapy .... 12 weeks of the 800-calories-per-day diet regimen yields a similar, average 12% weight loss from baseline as the Bel-phen combination therapy in his study .... [The Feuerstein]

9/18 OK to Use Avastin, Skip Lucentis
Avastin safe in eye disease, says Cochrane .... Cochrane performed an analysis of nine clinical trials comparing the two drugs in the condition demonstrating that Avastin does not appear to increase deaths or serious side-effects compared with Lucentis, although there was a greater risk of gastrointestinal disorders in people taking Avastin .... [PMLiVE]

9/18 McKinsey Runs the Numbers on First-to-Market Advantage
First-to-market launch? Bonus--but double bonus if you're Big Pharma .... The first entrant tends to enjoy a bigger market share even 10 years later--6 percentage points higher than any rival, on average .... [Fierce Pharma Marketing]

9/18 Feds Want a Look at Ranbaxy's Pricing Data
Ranbaxy Medicaid Prices Questioned by Justice Department .... Drugmakers give Medicaid a discount on their products based on what they sell the drugs for elsewhere. It's up to drugmakers to report data that sets the discounts. .... [Bloomberg]

9/18 Internet Drug News Fast Takes:
Bad Vaccine Kills Up to 50 Children in Northern Syria
NY Times
Artificial Sweeteners May Disrupt Body's Blood Sugar Controls
NY Times
Blood Test Spots Adult Depression
HealthDay News
End-of-Life Care Needs Sweeping Overhaul, Panel Says
NY Times
Study identifies when and how much various prostate cancer treatments will impact urinary and sexual functioning
Fox Chase Cancer Center

9/17 State Sues Actavis Over 'Product-Hopping'
New York Files an Antitrust Suit Against the Maker of an Alzheimer's Drug .... New York State's attorney general filed an antitrust lawsuit on Monday seeking to stop a pharmaceutical company from forcing patients with Alzheimer's disease to switch to a new version of a widely used drug .... [NY Times]
See also: NY Attorney General Files Antitrust Suit Against Actavis Over Alzheimer's Pill [Pharmalot]

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9/17 Movantik Approved for Opioid-Induced Constipation
Nektar says FDA clears constipation drug Movantik .... Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by cancer .... [AP]

9/17 $500 Million Bet on Alzheimer's Drug
AstraZeneca, Eli Lilly to Partner on Risky New Alzheimer's Drug .... Drug could make up to $5 billion in sales but has just 9% success rate .... [WSJ]

9/17 Takeover Offer to Expand Men's Health Line
Endo offers to buy Auxilium Pharma for about $2.2 bln .... Auxilium's Xiaflex is marketed in the United States to treat men with bothersome curvature of the penis, a condition known as Peyronie's disease....Dublin-based Endo makes branded men's healthcare products including testosterone replacement therapy Aveed .... [Reuters]

9/17 In Northern Cameroon, Farmers and Their Cattle Take So Much Tramadol It Ends Up in the Tree Bark
Weirdly, Tramadol Is Not a Natural Product After All .... The farmers apparently take the drug themselves, at pretty high dosages, saying that it allows them to work without getting tired. Who decided it would be a good thing to feed to the cows, no one knows, but the farmers feel that it benefits them, too .... [In the Pipeline blog]

9/17 Home of Roche and Novartis Pushes for Cheaper Meds
Switzerland takes on its top drugmakers in price row .... Swiss per capita spending on pharmaceuticals is already significantly lower than that in other countries: at $562 it is almost half of the $1,010 spent in the United States and behind other European countries including Belgium, Germany, Ireland, France and Greece .... [Reuters]

9/17 Merck Has First PD-1 Inhibitor Approval, But BMS is Hard on its Heels
BMS striving to push Opdivo past Keytruda .... Keytruda's likelihood of receiving a first- line indication may spur BMS/Ono to more aggressively pursue its Opdivo (nivolumab)/Yervoy (ipilimumab) combo therapy .... [MM&M]

9/17 "Comb" Test May Be More Accurate Than PSA
Balding at 45 Spurs Higher Prostate Cancer Risks in Study .... Balding middle-aged men have a greater chance of getting aggressive prostate cancer later in life than those with a full head of hair, say researchers who suggest the result may one day help doctors predict the disease .... [MM&M]

9/17 Zinbryta Goes to FDA in 2015
AbbVie, Biogen to file MS drug next year .... Researchers found that 73% of Zinbryta patients were relapse-free after 96 weeks of therapy, compared to Avonex patients, of whom 59% were relapse-free within the same timeframe .... [MM&M]

9/17 Oxytocin-Blocker Could Be a Companion to Talk Therapies
Want more staying power in the bedroom? Drug that blocks the 'love hormone' could be the answer .... Treatment targets a hormone called oxytocin, which triggers ejaculation .... [Daily Mail]

9/17 Internet Drug News Fast Takes:
Urine test for cervical cancer virus offers alternative to smear
Schizophrenia not a single disease but multiple genetically distinct disorders
Washington University of St. Louis
Over a Quarter of Hospital Orders Classified As Defensive
HealthDay News
Baxter's Rixubis receives FDA nod
Drug Store News
Ebola outbreak 'out of all proportion' and severity cannot be predicated
University of Warwick

9/16 Fast Takes
The Meds Pharmacists Take When They Get Sick
Yahoo Health
Cheaper Generic Statins Beat Brand-Name Statins in Adherence and Outcomes

Takeda: Contrave (naltrexone and bupropion)  Launch Schematics
- Cross selling opportunities for reps who sell products for diabetics, many of whom are fat
Takeda backs Contrave with 900 sales reps …  … focusing on patients "who are ready to go on Contrave, [and] are in the right frame of mind…  sales representatives, some of whom will be making only Contrave-focused visits, while others will be able to talk about Contrave as well as Takeda's diabetes medications …[MM&M]

Diet Pills: Why Have They Not Taken Off?  Pharma's Elusive Golden Fleece
- Pharmaceutical graveyard crowded with dud slimming meds
Selling Obesity Drugs to Americans Shouldn't Be This Hard … large number of health insurance plans won't pay for the drugs, which often lead to only modest weight loss … Much of the resistance to the weight-loss medications stems from the disastrous safety record of diet drugs pulled from the market in the 1990s …[BusinessWeek]

Free E-Book; Patient Access
Free E-Book; PATIENT ACCESS … Insights to overcoming barriers to patient access … tale of two worlds--affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape … [Medical Marketing & Media]

Lawsuit: Actavis's Namenda XR Marketing Tactics Illegal
- Lawsuit claims Actavis of "product hoping" under pretext of patient benefits 
- Shortage of Namenda XR makes situation worse for patients
New York Files an Antitrust Suit Against the Maker of an Alzheimer's Drug … The tactic, called product hopping, is one of several ways brand-name drug manufacturers try to sidestep generic competition … Actavis, announced in February that it would stop selling the existing tablet form of the drug, Namenda, in favor of new extended-release capsules called Namenda XR that can be taken once a day instead of twice … [NY Times]
See Also: Antitrust Scrutiny of Pharmaceutical "Product Hopping" … [Antitrust; Vol. 28, No. 1, Fall 2013; American Bar Association; 5,000 words; scholarly publication]
Editor's Note: 2 excellent articles; thorough explanation of tactic known as "product hopping", whereby drugmakers make slight changes in their product, discontinue the old product in an effort to thwart generics.

Merck: Once Weekly Osteoporosis Drugs Effective But Side Effects Could Be Issue
Merck osteoporosis drug passes trial, but side effects hover … Five patients taking odanacatib developed atypical fractures of the thigh-bone, compared with none in the placebo group. … slightly higher incidence of death and atrial fibrillation … numerically higher incidence of strokes in the odanacatib group was not deemed statistically significant … [Reuters]

Gilead Deal to Sell Sovaldi in Poor Countries Meets Criticism
- Don't like provisions that thwart knockoffs
Gilead Deal to Sell Sovaldi in Poor Countries Meets Criticism … patient advocacy groups say the deals do not go far enough, because the deals exclude many middle-income countries - such as Brazil, China, Turkey … They've taken steps to make it difficult for Indian generic drug makers to sell  …[Pharmalot]
Gilead Licenses Hepatitis Therapy in India Amid Price Criticism …[Bloomberg]

Fixed Combo Of 2 Generic Drugs Finds New Used
- Already marketed as Neudexta. Drugmaker Seeks Alzheimer Indication
Avanir's Over-Priced Cough Syrup Touted for Role in Alzheimer's Agitation … combines an over-the-counter cough suppressant dextromethorphan with generic quinidine … already markets AVP-923 under the brand name Neudexta as a treatment to dull episodes of uncontrolled laughing and crying ….[Adam's Biotech Beat; The Street]

9/15 Fast Takes
Sanofi aims to grow Genzyme unit with new drugs and acquisitions
Hypoparathyroidism; NPS Pharma; FDA green lights treatment for rare glandular ailment
Pipeline Review
FDA Approves Baxter's HYQVIA for Treatment of Adults with Primary Immunodeficiency
Baxter Press Release
Pfizer, Ranbaxy win dismissal of lawsuit over generic Lipitor

Drug Company Corners Market On 26 Year Old Generic Drug, Raises Price 2,000%
- Used to be $1.50 per tab, raised price to $30 because they can
Retrophin, Gilead, And Our Healthcare Values … Thiola (tiopronin) is sold as 100 mg tablets used to treat a chronic illness called cystinuria … Retrophin has just increased the price to $30 a tablet, which represents a nearly 2000% increase …  Retrophin hasn't conducted any new trials, made any new claims about the drug, changed its formulation or delivery mechanism …[Forbes]
Editor's Note: Calling all politicians, regulators, Obama staffers:  Here is your once-in-a-lifetime opportunity to attack a superlatively slow-moving target.  Everyone else - click on the Forbes article and tweet it.

Gilead to raise price for new hepatitis C drug above $84,000
- More expensive per treatment day but shorter duration of therapy
- PBM execs experience ballistic vomitus after hearing news*
Gilead to raise price for new hepatitis C drug above $84,000 …  first all-oral treatment for the virus which is expected to launch next month … total cost of the current treatment is $95,000, which includes Sovaldi and two older medicines … [Reuters]
Related: Gilead Sciences: Sovaldi Sales Slip But Less Than Feared … Barron's
Editor's Note: Just kidding; corey nahman (dot com)  thought that was funny.

Quarter-Trillion Dollar Basket Of Biotech Drugs Face Generic (umm biosimilar) Threat
- Don't expect beefy savings but cheaper, yes.
$250 Billion in Biotech Drug Savings on Brink of Arrival … 4 expensive biotechnology medicines that have never before faced generic rivals in the U.S. are being targeted by drugmakers who want to sell imitations at cheaper prices … unclear how quickly they'll be ready and if they'll catch on with Americans. …[Bloomberg]

Experts: USA Cancers Overgiagnosed, Overtreated
- Scared out of your wits but you have nothing to worry about
- Unanticipated consequence of widespread screening
The Overdiagnosis of Cancer in America … surge of cancer screening in the U.S. has increased the detection of precancerous lesions that are often low-risk but treated with the same methods as invasive cancers. A group of experts now argue that cancer is being overdiagnosed and overtreated …[WSJ]
Editor's NoteV I D E O; 7 mins

Vascepa Rejected Again In Quest To Extend Use
Amarin plunges as FDA denies appeal on ANCHOR trial SPA … remains FDA approved and marketed for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia …[ThePharma Letter]
Editor's Note: Shares of Amarin, an Irish company, went down almost 20% on the news.  Amarin looking like a good target for inversionistas.

Lilly Cancer Drug Extends Survival; How Much Extra Survival?   Lilly Ain't Saying
- Lilly usually transparent; mystery why they refused to say
Lilly cancer drug fares well in late-stage study … Cyramza fares better than chemo alone in late-stage … did not detail the difference in improvements …[AP]

9/12 HIPAA, SCMIPAA — If You Need 100,000 People with Diabetes, Their Names Can Be Bought Easily Online
Did You Know You Had Diabetes? It's All Over the Internet .... Epsilon, which has data on 54 million households based on information gathered from its Shopper's Voice survey, has lists containing information on 447,000 households in which someone has Alzheimer's, 146,000 with Parkinson's disease, and 41,000 with Lou Gehrig's disease. The Irving, Texas-based company provides survey respondents with coupons and a chance to win $10,000 in exchange for information on their household's spending habits and health .... [Bloomberg]

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9/12 By 2025, 17% of Diabetics Could be on Costly U-500 Insulin
Price Tag on Old Insulin Skyrockets .... A single bottle of highly concentrated Humulin U-500 insulin that lasts a diabetes patient about one month costs $1,200 wholesale -- more than five times the $220 it cost in 2007. .... [Advisory Board]

9/12 Billionaire Physician-Entrepreneur Promises Medical Tricorder
Medicine's Manhattan Project: Can The World's Richest Doctor Fix Health Care? .... The potential and pitfalls of Patrick Soon-Shiong's medical Manhattan Project boil down to one statistic: 47 seconds. That's the amount of time, the doctor/entrepreneur promises, it now takes for his amalgamated "supercomputer" to complete genomics analysis, all the way to identifying the individual protein in someone's body that's amenable to drug treatment. .... [Forbes/Matthew Herper]

9/12 FDA Finds Comparative Ads Work Better for DTC
Comparative Claims in Advertising Make Drugs Seem Safer, More Effective .... Consumers subject to comparative claims viewed a drug as both more effective (5.64 vs. 4.92 on a seven-point scale) and safer (3.98 vs 4.90, on a 1-7 scale where 7 was the most dangerous) .... [Regulatory Focus]

9/12 Pfizer Needs Big Overseas Deal for Tax Savings, AZN or Not
Pfizer execs say they're locked-and-loaded on tax inversion, and open to targets .... With its cost-cutting program coming to a close, the company wants to slash its tax rate to get another efficiency boost--and to give it a better hand in playing for overseas M&A .... [Fierce Pharma]

9/12 Saxenda (Victoza for Weight Loss) Recommended at FDA Panel
Novo's Weight-Loss Shot Wins Backing of U.S. Advisers .... Novo's Saxenda should be approved based on an assessment of its risks and benefits, a Food and Drug Administration advisory panel has voted 14-1 at a meeting .... [Bloomberg]

9/12 Antibiotics Wasted in Hospitals
Unnecessary antibiotic use responsible for $163M in potentially avoidable hospital costs .... Researchers found that 70 percent of potential unnecessary therapies represented three specific drug combinations used to treat anaerobic infections. The drug combination metronidazole and piperacillin-tazobactam accounted for more than 50 percent of the variation .... [Medical Xpress]

9/12 Pension Cutback at J&J
J&J Plans for the Future by Trimming Pension Benefits for New Hires .... J&J's pharmaceuticals business, however, has been a stand out. In the second quarter, prescription drug revenue jumped 21%, thanks to sales of treatments for prostate cancer and psoriasis .... [Pharmalot]

9/12 Can Xtandi Knock Zytiga Out of Top Spot?
Xtandi duo boosts rep force for pre-chemo push .... Medivation drugmaker has expanded its sales force by approximately 50%, from 60 to a new total of 90 sales professionals, joining Astellas's 90 reps as the pair ramps up promotion .... [MM&M]

9/12 Best to Go to Bed Immediately after Dinner, and Avoid the Evening's Depression and Loneliness
What's the most anxious moment of our days? .... Patients are most likely to experience anxiety — in the form of stress, depression, loneliness, suicidal thoughts, and more — at certain times of day, according to research collected through not-for-profit Crisis Text Line .... [Advisory Board]

9/12 Internet Drug News Fast Takes:
AHA: Gaining Just 5 Pounds Can Raise Blood Pressure
HealthDay News
Surprising portion of seniors in ERs malnourished
NY Times
Baxter names biopharma spin-off Baxalta
Majority of nurses now using mobile devices on the job
Healthcare Dive
A medication management app seeks to balance transparency and privacy
MedCity News

9/11 Contrave Approved; Third New Obesity Pill
Orexigen Wins U.S. FDA Approval for Weight-Loss Pill .... The agency approved the drug for those who are obese or overweight based on their body mass index and have at least one related health issue such as Type 2 diabetes or hypertension .... [Bloomberg]

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9/11 Xtandi Approved for Use Before Chemo
FDA approves expanded use of Medivation prostate cancer drug .... U.S. health regulators approved the use of Medivation's and Astellas Pharma's advanced prostate cancer drug Xtandi in men who have not yet received chemotherapy, significantly expanding the potential patient population for the oral medicine .... [Reuters]

9/11 FDA Introduces the Purple Book
FDA comes out with 'Purple Book' to catalog biologics and biosimilars .... The FDA has published its first-ever "Purple Book" — a list of all FDA-licensed biologics and the biosimilars that can be used in their stead .... [MedCity News]

9/11 Merck Doesn't Want the Inversion Distraction
Merck's Frazier disses tax inversion strategy, at least for Merck .... Frazier told investors that "the size of transactions that would make us eligible for an inversion" were inconsistent with the company's strategy of doing deals to nab solid commercial and scientific prospects .... [Fierce Pharma]

9/11 Outlook Good for Hypoparathyroidism Treatment
FDA Staff: NPS Drug Effective; No Significant Safety Imbalance .... Natpara is designed to treat hypoparathyroidism, a condition in which the body's parathyroid gland does not secrete enough parathyroid hormone .... [Reuters]

9/11 Arixtra Sold to Mylan for $300 Million
Mylan acquires rights to Apsen's Arixtra injection .... Mylan has agreed to acquire the U.S. rights relating to Arixtra (fondaparinux sodium) injection and the authorized generic version of Arixtra from Aspen Global .... [Drug Store News]

9/11 FTC Makes Sharp New Attack on Generic Delay Deals
Federal Trade Commission Sues AbbVie, Other Drug Companies .... The FTC alleges AbbVie and partner Besins Healthcare Inc. filed baseless patent-infringement litigation against potential generic-drug competitors to delay copycat versions of AndroGel, a drug that has generated more than $1 billion annually in U.S. sales .... [Wall Street Journal]

9/11 Generics Makers Tally the Savings as Brands Go Off Patent
Big Pharma's patent cliff losses spawn $239B savings on 2013 drug spending .... And the savings are only set to keep growing when biosimilars hit the scene, providing cheaper rivals to the world's best-selling drugs. Currently, biosimilar developers have targets on products like Remicade, the Johnson & Johnson blockbuster anti-inflammatory that reaped $8.39 billion in 2013 sales .... [Fierce Pharma]

9/11 Chemotherapy Nausea Drug Filed with FDA
TESARO Seeks FDA Approval for NK-1 Receptor Rolapitant .... Rolapitant, which is a potent and selective neurokinin-1 (NK-1) receptor antagonist, is being evaluated for the prevention of nausea and vomiting induced by chemotherapy .... [Zacks]

9/11 Internet Drug News Fast Takes:
Trial to Begin for a Millionaire Pharmaceutical Executive Who Calls Her Son's Death 'Altruistic Filicide'
NY Times
Even small stressors may be harmful to men's health
Oregon State University
'Pocket' diagnosis for Parkinson's
Benzodiazepine Use Linked to Increased Alzheimer's Risk
HealthDay News
FDA approves Sanofi Pasteur's Menactra as a booster vaccine
Drug Store News
A single doorknob can contaminate up to 60 percent of people in a building in 4 hours
Washington Post

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