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8/18 Big PBMs' 2018 Coverage for Inflammatory Conditions, TBA in September, Crucial for Biosimilars
Remicade Is a Litmus Test for PBMs .... The arrival of two Remicade copycats -- Pfizer Inc.'s Inflectra was introduced last November and Merck and Samsung's Renflexis in July -- should be an opportunity to reduce spending on the category. So far, PBMs and the market have been slow to embrace biosimilars .... Bloomberg Businessweek

8/18 100% Payer Coverage So Far for Radicava
Payers line up to back Mitsubishi Tanabe's pricey new ALS therapy Radicava .... The Japanese pharma's U.S. arm hasn't yet seen a commercial payer turn its back on the med. And more than 30 have come out with coverage decisions .... Fierce Pharma

8/18 Besponsa Approved for ALL; Course of Treatment Will Cost $168,300
FDA approves Pfizer's drug for rare blood cancer .... Besponsa was approved to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.... Besponsa will carry a boxed warning... saying patients treated with the drug were at a risk of severe liver damage .... Reuters

8/18 Sanofi, Who Initiated the Action, Gets a Piece of Mylan's Payout Over Fraud Charges
Mylan Wraps Up $465 Million U.S. Accord Over EpiPen Rebates .... The settlement resolves claims that Mylan was able to improperly avoid paying rebates owed to the government by classifying EpiPen as generic even though the company marketed it as a brand-name medicine .... Bloomberg

8/18 Broader Maintenance Indication for Lynparza; New Two-Tablet Dose
FDA approves expanded use of AstraZeneca ovarian cancer drug .... The FDA has expanded the use of Lynparza to include ongoing treatment of patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy .... Reuters

8/18 Shifting Tastes in Social Platforms
Pharma's social status: LinkedIn and FB up, Twitter down, Instagram finally appears .... Facebook is the go-to platform for pharma marketers. In a new study, 73% of pharma marketing teams say they plan to use the platform during the next two years.... Just 26% of pharma marketers planned to use Linkedin in 2013; this year, that grew to 55% .... Fierce Pharma

8/18 Price Hikes Hitting Medicaid Hard, Even for Older Established Drugs
Climbing Cost Of Decades-Old Drugs Threatens To Break Medicaid Bank .... Rising costs for 313 brand-name drugs lifted Medicaid's spending by as much as $3.2 billion in 2016.... In addition Medicaid outlays for 67 generics and other non-branded drugs cost taxpayers an extra $258 million last year .... Kaiser Health News

8/18 1 in 8 Over Age 12 Take Antidepressants; 25% for 10+ Years
Antidepressant use in U.S. soars by 65 percent in 15 years .... Women are nearly twice as likely as men to be taking the medications, the report found, with antidepressants used by 16.5 percent of females compared to just under 9 percent of males .... CBS/HealthDay

8/18 Dems See Red on MS Price Hikes
House Democrats Start Multiple Sclerosis Drug Price Probe .... Some pharmaceutical companies appear to be "setting new, higher prices in lockstep with competitors -- a strategy known as 'shadow pricing,'" Cummings and Welch said, noting that the average annual cost of therapy had increased to more than $60,000 in 2015 from about $16,000 in 2004 .... Bloomberg

Chart of the Day
Source: The cost of multiple sclerosis drugs in the US and the pharmaceutical industry [Neurology]

8/18 UR, Cold-Allergy-Sinus Sales Up 4% in Past Year
Upper respiratory, cold, allergy and sinus category sees 'impressive' growth .... Impressive growth of 7% from cold-allergy-sinus liquids in the drug channel was driven by manufacturer Reckitt Benckiser with 16% growth year over year.... The largest number of significant new products came from Pfizer in cold-allergy-sinus liquids .... Drug Store News

8/18 Internet Drug News Fast Takes:
Noninvasive eye scan could detect key signs of Alzheimer's years before patients show symptoms
Cedars-Sinai Medical Center
Alexion wins 3 new Soliris patents as Amgen works on biosimilar of pricey drug
Fierce Pharma
Common chemicals in cosmetics, soaps tied to poor semen quality
This app is certified in the EU as a form of birth control. Is the US next?
The Verge
Public Enemy (Transcripts from jury selection process at Martin Shkreli jury)

8/17 Novo's Weekly Oral Semaglutide Tops Trulicity in Phase 3
Novo Nordisk's diabetes drug succeeds in key trial .... Semaglutide (+metformin) was statistically significant in reducing glucose levels and body weight in about 1,200 patients suffering with type 2 diabetes, when compared with dulaglutide (+metformin) .... Reuters

Tweet of the Day

8/17 Insurer Sued for Talking About $1 Million/Month Patient
Hemophilia groups file complaint against Wellmark for revealing condition of patient receiving $12M in care annually .... The complaint claims Des Moines, Iowa-based Wellmark violated HIPAA when it publicly announced a patient with hemophilia — a genetic disorder keeping blood from clotting — receives $12 million worth of care annually. Wellmark said the cost contributed to premium hikes of between 38 percent and 43 percent for 2017. .... Becker's Hospital Review

8/17 Diplomat's DIR Numbers
Diplomat Sees Declining DIR Fee Impact—and Perhaps Readies a PBM Strategy .... DIR fees are now a major source of controversy and confusion in the pharmacy industry .... Drug Channels

8/17 ESRX Will Limit First Opioid Prescriptions to 7 Days; Current Average is 22 Days
Express Scripts to limit opioids, concerning doctors .... Analysis of 106,000 patients in ESRX's pilot program showed a 38 percent reduction in hospitalizations and a 40 percent reduction in emergency room visits, compared to a control group. The program is scheduled to take effect nationwide on Sept. 1 for Express Scripts members whose employer or health insurer has enrolled to participate .... Stat

8/17 New FDA Ad Studies Will Lead to New Rules, Drugmakers Fear
PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion .... PhRMA is taking FDA to task for proposing new studies "seemingly without fully appreciating its own previous research" and some proposed studies "are often unnecessary in light of existing data." .... Regulatory Focus

8/17 State Battlefields Open Up in Drug Price Fight
As federal efforts slow, states take up drug pricing pushback .... "We had upwards of 90 [drug price restraint] bills introduced in state legislatures this year and a number of them have actually been enacted," said Jane Horvath, a senior policy fellow at the National Academy for State Health Policy (NASHP) .... BioPharma Dive

8/17 Companies Not Crossing the 10% Price Increase Line
Has the Brent Saunders price-hike limit become a de facto pharma rule? .... Prices on 30 of the meds have gone up between 9% and 9.9% so far this year, according to Bernstein's data, while 40 have had price hikes between 8% and 9.9%. The figures could climb higher as the year goes on .... Fierce Pharma

8/17 Walgreens Center for Health & Wellbeing Research Site, with 25 Experts On Hand
Walgreens creates health and wellness research depot with new website .... The website that features more than 50 Walgreens outcomes studies completed over the past six years .... Drug Store News

8/17 Q&A with Lucinda Maine, CEO AACP: Demand Down for Pharmacy Training Slots
Job Market Shifting for Pharmacy School Grads .... By all accounts, our grads are still receiving offers of employment — more of them are seeking residency training before they go out into the job market. The demand right now for a limited number of positions is soaring .... Drug Topics

8/17 Hemsley leaves UnitedHealth at the Top; Annual Revenues $200 Billion
New CEO Named At UnitedHealth Group As Wichmann Succeeds Hemsley .... After more than a decade as CEO, the 65-year-old Hemsley will step down from the top job into a role as executive chairman of the company’s board .... Forbes/Bruce Japsen

8/17 Internet Drug News Fast Takes:
Alternative medicine for cancer more than doubles death risk
NY Daily News
FDA chief says drug makers are gaming the system to slow generic competition; vows action
USA Today
Biogen gains $1B in value after Goldman Sachs touts Alzheimer's drug
Boston Business Journal
Kline: Rx-to-OTC switch becoming more selective
Drug Store News
Jiangsu Hengrui Medicine passes U.S. FDA approval

8/16 Pharma Finds Sophisticated Models Needed to Contract on Outcomes
Biogen, Merck use predictive modeling to better negotiate value-based contracts .... Merck's simulated models, like Biogen's, are informed by claims data — specifically, Optum's integrated claims and clinical records. Through the collaboration, Merck aims to develop and use predictive models to better understand the different types of contracts it may want to strike with payers. Merck and Optum also plan publish their results .... MM&M

8/16 Tresiba Hits Price Resistance
The New Innovator's Dilemma: When Customers Won't Pay for Better .... For almost a century, pharmaceutical giant Novo Nordisk rolled out new products at higher prices. That strategy has come to a screeching halt .... WSJ $$

8/16 The Business of Showing You Stuff in the Doctor's Waiting Room Amounts to $23 Billion a Year
Point-of-care group rolls out guidelines .... The new guidelines include the development of auditing standards, updated ethical standards, and a comprehensive FAQs document for would-be buyers of point-of-care media .... MM&M

8/16 Cancer Drugs, Ranked by 2016 Sales
Top 25 oncology brands in 2016, based on U.S. sales .... As compiled by Evaluate Pharma .... MM&M

8/16 JAMA: Accelerated Approval Leaves Too Many Questions Unanswered
Flimsy evidence behind many FDA approvals .... Many drugs granted accelerated approval by the US FDA lack clear evidence of safety and effectiveness, and the same is true for most high-risk medical devices .... Reuters

8/16 Observational Study Finds RA Link to Occupation
Some jobs tied to higher risk of rheumatoid arthritis .... Compared with men working desk jobs, electrical workers had twice the risk of rheumatoid arthritis and bricklayers and concrete workers had roughly triple the risk.... For women, jobs in nursing carried a 30 percent higher risk than other careers .... Reuters

8/16 Biographical Sketch of Merck CEO Kenneth Frazier
From the son of a janitor to CEO of Merck: Meet Kenneth Frazier, who's getting praised after leaving Trump's manufacturing council .... Merck was one of only a handful of big pharmaceutical companies to disclose, alongside the list price, the net prices — or the amount Merck actually receives after factoring in rebates and other discounts that drugmakers pay out. In 2016, Merck raised prices by an average of 9.6%. But after factoring in rebates, that was just 5.5% .... Business Insider

8/16 Develop a Biodefense Drug, Win a Priority Review Voucher
How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs .... Under section 3086 of the Cures Act, the FDA must establish a new priority review voucher (PRV) program for material threat medical countermeasures, which are products that may be used in the event of a potential public health emergency.... If a company wins approval for such a material threat countermeasure, FDA will award the company a PRV that can be used or sold to another sponsor .... Regulatory Focus

8/16 New Data, Creative Contracting Speed Entresto Uptake
After a slow start, Novartis finally gains market traction with heart drug Entresto .... Only about 40% of Medicare patients need prior authorization to get the drug now — a vast improvement over the first quarter, when two-thirds of patients needed that green light .... Fierce Pharma

8/16 Patient Takeaway: If You're Diagnosed with Cancer, Get Whole Genome Sequencing So You Can Be Matched in Targeted Therapy Trials
A Cancer Conundrum: Too Many Drug Trials, Too Few Patients .... The logjam is caused partly by companies hoping to rush profitable new cancer drugs to market, and partly by the nature of these therapies, which can be spectacularly effective but only in select patients .... NY Times

8/16 Internet Drug News Fast Takes:
South Carolina sues OxyContin maker Purdue over opioid marketing
Bristol-Myers kidney cancer drug fails late-stage trial
IBM Watson Makes a Treatment Plan for Brain-Cancer Patient in 10 Minutes; Doctors Take 160 Hours
IEEE Spectrum
U.S. News Announces 2017-18 Best Hospitals
US News
Google buys Seattle health monitoring startup Senosis, bolstering digital health push
8/15 Fast Takes
Novo Nordisk A/S Continues Its Comeback
Motley Fool
Merck CEO Ken Frazier resigns from Trump council in protest, and the president swiftly attacks him on Twitter
Endpoints News
In a rare misfire, Regeneron scraps its RSV drug after a PhIII failure
Endpoints News
Specialty Pharmacy Association Launches Website That Attacks PBM's DIR fees
Choosing alternative cancer treatment doubles your risk of death
New Scientist News

8/15 Biosimilar Meds Are Hard To Sell;
After Approval Uphill Battle Begins
- Despite availability of biosims, brand names compete successfully
What's Harder Than Making Copycat Biotech Drugs? Selling Them … Payer pacts, wary patients vex the market for biotech copycats … Pfizer's recent sales of Inflectra latest example of challenge … "This we did not expect," Guharoy said. "If the insurance companies force us to use the branded product, of course our hands are tied." … [Bloomberg]

Here's How Amazon Could Break Into The PBM Business
Amazon could seek pharmacy partner to crack healthcare, Goldman Sachs says … speed up the drug delivery process - and home delivery. It would not be unlike what Amazon did with books … could move its Echo/Alexa into the clinical realm and build or buy telemedicine and remote patient monitoring technology … [Healthcare IT News]
Every health executive now needs an Amazon strategy … The specialty drug market is where Amazon is likely to play first, according to Tom Cassels, a partner at Advisory Board Consulting. That would pit Amazon most directly against Express Scripts, Walgreens and CVS … [CNBC]
Editor's Note: Above cited report queries 5 companies (McKesson, Cardinal, Express, CVS, Walgreens) that would be impacted if Amazon successfully disrupts the drug supply channel.  I don't see Amazon as a PBM; that infrastructure and human capital would be too costly to build from scratch. 

Amazon would be a great partner on the back-end of the PBM business; fulfilling the orders.  I could see PBMs farm out their fulfillment business to Amazon much the same way Amazon provides back-end cloud services for some of the industry's websites.

Plavix Class Action Suit: Lawyers Forced Back To Square One
- Plaintiffs wanted to cherry pick trial location; Supremes shoot idea down
A Supreme Court pharma case deals consumers a big loss … not be fair to BMS for the state court in California to hear the cases against the company because the nonresidents did not consume the drug in California and the drug was not designed, manufactured, or marketed to them in the state … [STAT]
Editor's Note: You can only sue a company in the state where you used and were injured by a  product.  Lawyers can no longer cherry pick a sympathetic jurisdiction  in which to try a liability action. 

Drug Reimportation: Bernie's Proposed Law
Bill to allow imported drugs from Canada aims to create competition …  8% of American consumers already buy prescription drugs from Canada and other countries because they are cheaper … increased competition from imported drugs could put pressure on drug companies to reduce the prices of their products in the U.S. … [ MM&M]

BioPharma Dive Special Report On Drug Pricing
Spotlight Topic: Drug Pricing … This is a five-article special feature from BioPharma Dive.  These articles offer a 30,000 foot view how drugs are priced, what drive these decisions and how government deals with ever escalating drug prices.  Highly recommended.

The Drug Expiration Myth
Most Drug Expiration Dates Are Bogus, and the FDA Knows It … hospitals trash nearly a billion dollars worth of perfectly safe and effective medicines every year … An official with the Department of Defense, which maintains about $13.6 billion worth of drugs in its stockpile… saved the department from replacing $2.1 billion in expired drugs… [Reason]
The Myth of Drug Expiration Dates … Hospitals and pharmacies are required to toss expired drugs, no matter how expensive or vital. Meanwhile the FDA has long known that many remain safe and potent for years longer … [ProPublica]

8/14 Fast Takes
Johnson & Johnson expected to keep battling talc claims despite losses: expert
Fierce Pharma
EpiPen Alternative Auvi Q Costs $4,500, But Many Get It For Free
CBS Boston
Chinese billionaire may get a monopoly on a cancer drug backed by U.S. taxpayers
Stat News
2017 On Track to be a Record Breaking Year for Orphan Drug Approvals
Rare Disease Report

One in 12 doctors has received money from drug companies marketing prescription opioid medications,
Washington Post
Generic Drug Prices Are Falling, but  Consumers Aren't Benefiting
NY Times

8/14 Pay For Delay Fine Melts Sun Pharma's Bank Account
- Provigil hanky panky was expensive lesson
Sun's profit crushed as it pays $150M to settle Provigil pay-for-delay case … decade-old pay-for-delay lawsuit, one of a host of issues that contributed to a 74% slide in its profit last quarter for India's largest drugmaker … [Fierce Pharma]

8/14 Novo Has High Hopes For Experimental Slimming Jab
16% weight loss? What's the Danish word for Booyah?
Can Novo's blockbuster push on obesity drug semaglutide succeed where others failed? … researchers tracked an average 17.8 kilogram (39 pound) weight loss from an average baseline weight of 111 kilos, or 244 pounds, for all the patients in the drug arm who completed the one-year trial. That's a 16.2% weight loss in the drug group, compared to 2.3% in the placebo arm. … [Endpoints News]

8/14 Epilepsy Families Panic As GSK Pulls Plug On  Potiga (Ezogabine Tablets)
Babies with a rare, severe form of epilepsy depend on this drug. The maker stopped selling it. … At the end of June, GlaxoSmithKline, the British drug company that sells Potiga, pulled it off the market because of declining sales, forcing families to stockpile supplies or wean their children off a drug that dramatically improved their quality of life … [Washington Post]

8/14 Teva Knew Financial Torpedo Was Coming But Failed To Warn Wall Street
- Kept silent 5 weeks regarding juicey price concessions to McKesson, WalMart
Teva Failed to Report Key Business Setback Before Its Poor Earnings Report … Negotiations with major wholesaler that resulted in big price cutbacks were completed at least five weeks before drug maker acknowledged … [Haaretz]

Worth A Click *********
Ed Silverman / Pharmalot Twitter Feed
- See something on Eds's twitter and 2 hours later its on Reuters, WSJ, Bloomberg, etc. 
- Updated several times per day, 50.5K followers

8/14 Insulin A Commodity? Novo, Sanofi Price War Possible
- Biosim glargine killed long acting insulin duopoly, disrupted margins
Novo Nordisk may drop US insulin price as Sanofi suffers … Novo Nordisk has warned it may have to drop prices of its insulin products in the US next year, facing pressure as rival Sanofi cuts prices of its mainstay Lantus due to biosimilar competition … [Pharmaphorum; Hat Tip Ed Silverman, Pharmalot ]

8/14 Mylan Execs Claim FDA Is Screwing Them On Generic Advair, Copaxone Knockoff
Mylan Badly Needs Help from FDA to Escape its Woes and Deliver These Key Drugs … FDA's timeline for approving the company's biosimilar to compete with Teva multiple sclerosis drug Copaxone has been changed several times despite there being "no pending scientific questions or any additional studies required … [The Street]

8/14 Read This To Learn Why It's So Hard To Find Generics In Mexico
- Mexican Red Tape: takes years to get generic green-light
Where have all the generics gone? You won't find many in Mexico …  A combination of regulatory failures and maneuvering by brand-name drug makers has contributed to a dearth of generics in the country … In Mexico, more than two years typically elapse between expiration of a patent on a brand-name drug and the launch of the first generic competitor. By contrast, the agency noted that the average lapse is seven months in the U.S. … [Pharmalot]
Mexico watchdog finds big pharma faces no competition on some drugs … [Reuters]

8/14 Amgen Loses Appeal To Stymie Pfizer's Biosim Epogen
- However, CRL means Pfizer still  has work to do before launch is imminent
Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar … win in court for Pfizer subsidiary Hospira does not mean that the biosimilar will launch in the US yet, as Pfizer reported on 22 June that it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the application … [Regulatory Affairs Professionals Society ]

8/14 Newly Approved ALS Drug Radicava (edaravone)  Now Available
Newly Approved ALS Drug Radicava (edaravone)  Now Available … approved by the US Food and Drug Administration (FDA) in May, 2017 based on a pivotal study showing it slowed the decline in physical functions by 33% in ALS patients … [Rare Disease Report]

8/11 The Health Catastrophe that is Cancer is Followed by Financial Catastrophe
Even Insured Patients Are Overwhelmed By The Cost Of Cancer Care .... On average, cancer patients in the Duke study were spending 11% of their household income on expenses related to their treatments.... patients in the study who reported the most financial distress were spending 30% of their household income on health care .... Forbes/Arlene Weintraub

8/11 80% of Employers List Specialty Drugs as Major Health Inflation Driver, Up from 6% Three Years Ago
Large employers say health plans will cost more than $14,000 for an employee in 2018 .... Employers will shoulder approximately 70 percent of those health costs, leaving employees on the hook for an average of $4,400.... an ongoing shift toward high-deductible plans will continue, with 40 percent of employers offering one as the only plan option next year .... Washington Post

8/11 Top 10 DTC Advertisers for July
Humira may spend most on TV, but Xeljanz, Taltz and Breo notch highest view rates .... The top 10 pharma TV ad spenders all notched 94% or higher average view rates for the month.... on average, the ads are watched at least 94% of the way through .... Fierce Pharma

8/11 ALS Docs Disappointed by Daily Dosing, Sticker Price of Infused Edaravone
New ALS drug Radicava comes with new questions as well .... Edaravone is administered by an intravenous infusion over 60 minutes in 28-day cycles. The initial cycle involves a daily infusion for two weeks, followed by a two-week period without infusions. Additional cycles consist of infusions for 10 days over two weeks followed by two-week drug-free periods .... ABCNews

8/11 Novo's Diabetes and Obesity Care Sales are Up 10%
Novo Nordisk leans on Victoza as competition increases .... Victoza's U.S. GLP-1 volume market share has dropped to 46% from over 60% in May 2014, whereas Eli Lilly's Trulicity (dulaglutide) has grown to a 34% U.S. market share since its launch in September 2014 .... BioPharma Dive

8/11 BMS Axes HIV Marketing Group
Bristol-Myers Squibb nixes 58 marketing jobs as HIV medications near patent cliff .... Six of the employees work at Bristol-Myers' Princeton Pike facility, and the other 52 are remote workers scattered across the country who report to managers located at Princeton Pike .... Fierce Pharma

8/11 Three Generations Built Cadila
Billionaire Father and Son Turn Drug Firm Into World Beater .... Cadila got a particularly big boost in June when it announced that because it had been first to file, the FDA had awarded it six months of exclusivity to sell a generic version of Shire PLC's $1.1 billion ulcer drug, Lialda, in the U.S. .... Bloomberg

8/11 Painkiller Maker Shifts to Launch Support
Egalet axes 40% of staff to focus on opioid education .... Arymo ER is now covered by one of the large payers and is available on formulary for 24 million people in the U.S., giving it access to 57% of the commercially insured population .... BioPharma Dive

8/11 Physician Services Inflation Drops to 0
For the First Time in Decades, Doctors Are Not Raising Their Fees .... (Item 5) Physician services inflation has collapsed. For the first time in decades, US doctors are not raising prices. This trend has been one of the factors contributing to slower core inflation in the past few months .... WSJ $$

8/11 Is There a Common Thread to These Callings?
The highest-paying job in each US state .... To find the highest-paying jobs in each state and Washington DC, we sifted through the US Bureau of Labor Statistics' Occupational Employment and Wage Estimates survey. .... Business Insider

8/11 Internet Drug News Fast Takes:
Gushing red ink, biotech billionaire Soon-Shiong slashes staff at NantHealth by 300, sells assets
CMS's 340B Proposal Is Likely Unlawful — Here's Why
Morgan Lewis (h/t @drugchannels)
Batten Disease Treatment Gets Orphan Drug Designation
Rare Disease Report
Trump Plans to Declare Opioid Epidemic a National Emergency
NY Times
CVS Health sets sights on recruiting older workers
Drug Store News
Instagram photos may help predict depression

8/10 After Missing PFS Goal in Mystic Trial, AZN Hopes OS Will Show Drug Combo's Benefit
AstraZeneca Takes a Long Shot on Lung Cancer Drug Study .... AstraZeneca executives [said] that crossovers could eventually help. That's because of the way trials are structured. Mystic patients whose cancer progressed after getting the experimental cocktail will receive chemotherapy, an approved drug for lung cancer. The length of the lives of those patients would be credited to the combination group in measuring overall survival .... Bloomberg

8/10 No One Can Unthread Complicated Payment Paths Better than Drug Channels
Follow the Dollar Math: How Much Do Pharmacies, Wholesalers, and PBMs Make From a Prescription? .... [The graphic] shows that the drug channel—pharmacy benefit managers (PBMs), wholesalers, and pharmacies—receive more than $37 in gross profit for a brand-name drug with a $300 list price. PBMs capture about half of this amount. .... Drug Channels

8/10 Radicava (edaravone) Now Available
Newly Approved ALS Drug Now Available .... The drug is administered intravenously and depending on the patient's health plan and their doctor's preference, it can be administered at an ALS center, physician's office, free-standing infusion center, hospital outpatient department or through a home infusion provider. .... Rare Disease Report

8/10 FDA's Office of Generic Drugs Gets More Staff and New Motivation to Maximize Competition
Spurred by Gottlieb, FDA on track to the most generic drug OKs ever in 1 year .... According to the latest version of the activities report of the generic drug program, FDA has approved 633 generic drugs in FY 2017, which compares with a total of 651 approvals in FY 2016 .... Endpoints

8/10 Newspaper's Investigative Report Triggers Procedure Changes at Big Chains
Pharmacy chains make sweeping changes to prevent drug interactions .... The new rules state that when the pharmacy's computer system flags a serious interaction, CVS pharmacists must warn the patient, consult with the prescribing doctor, or both. The computer system now prevents medication from being sold until pharmacists have taken these steps .... Chicago Tribune

8/10 Dr Michael Sherman: Outcomes-Based Contracts Offer More Than Cost Saving Benefits

.... AJMC

8/10 Valeant's Sky-High Prices for Intensive Care Drugs Drove Millions in New Costs
Hospitals Slashed Use Of Two Heart Drugs After Huge Price Hikes .... The number of patients getting nitroprusside, which is given intravenously when a patient's blood pressure is dangerously high, decreased 53 percent from 2012 to 2015. At the same time, its price per 50 milligrams jumped thirtyfold, from $27.46 in 2012 to $880.88 in 2015. .... Kaiser Health News

8/10 Mortality Rate for Patients with Certain Diabetic Wounds Higher than Breast or Colon Cancer
When Wounds Won't Heal, Therapies Spread — To The Tune Of $5 Billion .... According to some estimates, Medicare alone spends at least $25 billion a year treating these non-healing wounds. But many widely used treatments aren't supported by credible research. .... Kaiser Health News

8/10 FDA Dirty Laundry
Top FDA official accused CDER chief Woodcock of appearing biased, browbeating reviewers in demanding eteplirsen OK .... Not only did John Jenkins object to Woodcock's handling of eteplirsen, a drug which had the vocal support of the Duchenne community, he also told Califf that he had delayed his retirement specifically because Woodcock intended to take his place after he left .... Endpoints

8/10 Leading Urologist Runs Open Payment Numbers; Finds Payments to Docs Don't Move the Needle
Can Pharma Influence Physician Prescribing? Unleashing New Data Using Prostate Cancer Drugs .... The median amount of prescribed drugs was exactly the same between those doctors who received money from the pharmaceutical companies and those that did not. .... Forbes/Benjamin Davies MD

8/10 Will Other Companies See the Appeal of Medical Aesthetics?
Allergan's Brent Saunders Is Charging Into Medical Aesthetics. Should Others Follow? .... Twenty-six out of 75 (35%) of Allergan's pipeline programs are devoted to treatments such as forehead lines, fillers for chins, breast augmentation, acne, and androgenic alopecia.... [Though] Allergan has multiple programs in Alzheimer's (4), depression (4), NASH (3), cancer (2), and anti-infectives (2) .... Forbes/John LaMattina

8/10 Internet Drug News Fast Takes:
Marijuana use holds three-fold blood pressure death risk
Mylan cuts forecasts on delays in new drugs, weak prices
More than half of women who got an abortion last year were using contraception
Americans Support Price Shopping For Health Care, But Few Actually Seek Out Price Information
Health Affairs
FDA'S Generic Drug Labeling Rule Delayed Again
Bloomberg BNA

8/9 Big CVS Jump into Disease Management
CVS Moves Deeper Into Doctors' Turf .... The company will expand a program in which it marshals pharmacists, hundreds of on-site medical clinics and its vast data network to help people manage chronic diseases including asthma and high blood pressure .... WSJ

8/9 Consumer Ripoff Lawsuit; PBMs Charge Higher Copays than Cash Price
CVS Health Is Sued Over 'Clawbacks' of Prescription Drug Co-Pays .... CVS, the largest U.S. pharmacy chain, overbilled consumers who used insurance to pay for some generic drugs and wrongfully hid the fact that the medicines' cash price was cheaper... [one consumer] paid $166 for a generic drug that would have cost only $92 if she'd known to pay cash .... Bloomberg

8/9 Drug Development is So Risky and Expensive that Even a Company with Multiple Blockbusters in its Pocket Has Many Skeptics
For Vertex Pharmaceuticals, Can One Billion-Dollar Breakthrough Beget Another? .... Vertex had to try out 2,000 different potential drug molecules to find Kalydeco. For the new combo drugs, it tested 30,000 different molecules. Now it just has to choose among three, all of which appear to work. Drug companies often like to talk about how their high drug prices go toward additional research.... For Vertex it's clearly true .... Forbes/Matthew Herper

8/9 Sanofi Has PD-1 Lung Cancer Treatment in Stage 3; Trial May Run Four Years
An Also-Ran in Cancer Drugs, Sanofi Sees Chance to Close the Gap .... Treatments can target either PD-1 or PD-L1 proteins, which bind together and prevent the body's own T cells from attacking cancer cells....AstraZeneca and Roche are working on PD-L1 ....Sanofi's work suggests that treatments focusing on PD-1 may be more effective .... Bloomberg

8/9 Glybera: 1 Dose Sold; Strimvelis: 2 Doses Sold — High Prices Stymie Demand for Gene Therapy
Drugmakers' hopes for gene therapy rise despite tiny sales in Europe .... The lack of sales for the two drugs already launched to treat ultra-rare diseases in Europe highlights the hurdles ahead for drugmakers in marketing new, extremely expensive products for genetic diseases .... Reuters

8/9 FDA is Choosing Wisely in Which Drugs Get Expedited Review
Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process .... Drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs) .... Health Affairs

8/9 Employers Will Stay the Course with Health Benefits
Big Employers Say They Will Continue To Offer Health Plans To Their Workers .... 65 percent of big companies say they expect to offer health benefits in a decade. And 92 percent say they are very confident a company-based health plan will exist in five years .... NPR/Kaiser Health News

8/9 Less May be More When it Comes to DTC Warnings
FDA Officials Study Alternative Approach to Presenting Risk Info in TV Drug Ads .... Limiting the risk information to only serious and actionable risks combined with a disclosure letting viewers know that not all the drugs' risks were presented also improved participants' recognition of the drugs' benefits and improved their overall processing of the ad .... Regulatory Focus

8/9 Medical Science Liaisons Now Key Players in Trials, Launches
Pharma companies, now marketing high-science drugs, rely more on medical affairs .... [In a recent pipeline project] advisory boards found that physicians were concerned about efficacy and safety, while nurses were interested in patient-reported outcomes. has become the job of medical science liaisons to package such information into usable, readily digestible materials for patients, regulators, doctors, and insurers. .... MM&M

8/9 Lilly's Other Migraine Drug Potential Filing Mid-2018
Lilly's turn to pain gathers momentum .... In the SPARTAN study, acute treatment with the highest dose of lasmiditan nearly doubled the percentage of patients who were migraine pain-free two hours after administration compared to those on placebo .... BioPharma Dive

8/9 For Your Retirement, Making the Tough Hawaii vs. Iowa Decision
2017's Best & Worst States for Health Care .... WalletHub's analysts compared the 50 states and the District of Columbia across 35 measures of cost, accessibility and outcome .... Wallet Hub

8/9 Internet Drug News Fast Takes:
Valeant Is Done Selling Off Units to Pay Down Debt, CEO Says
Bloomberg (autoplay audio)
Roche unloads some rights to drug hopeful after asthma trial disappointment
MyoKardia seeks accelerated development for heart drug
BioPharma Dive
Generic Drug Prices Are Falling, but Are Consumers Benefiting?
NY Times/Propublica

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