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11/17  Fast Takes

Fentanyl Billionaire John Kapoor To Plead Not Guilty In Opioid Kickback Case

Forbes
You want to charge $1M for that gene therapy? Here's where you're wrong
Endpoints News
With only 2 warnings in 2017, pharma's ad police hits historic low
Fierce Pharma
Roche nabs blockbuster FDA approval for Hemlibra, big label expansion for Gazyva
Fierce Pharma
Kids still get risky  codeine after surgeries despite FDA safety warnings
Reuters


11/17
Testim: Endo Cleared Of Liability In Low T Lawsuit #1
- Heart attack victim was sick dude to begin with; couldn't prove Testim was at fault
Endo unit cleared of liability in first testosterone replacement trial … unable to prove that Testim caused his heart attack, citing his "numerous medical conditions that put him at risk for cardiovascular disease." … AbbVie is the only other company that has faced trials over its testosterone replacement drug AndroGel. It lost both those trials …

11/17
2018 Pipeline Cornicopia: CAR-T's, Gene Therapy = Bright Spots
Pharm Exec's 2018 Pipeline Report … Analysis shows that persistence is paying off for drug developers, driven by the rise of CAR-T and other gene therapy, newly discovered cancer targets, better patient identification methods--and the realization that failures have their place in shaping the pipeline of tomorrow … [Pharm Exec]

11/17
Despite 2 Years Of Meetings, FDA Marketing Guidelines,
Off-Label Rule Changes Stuck In Neutral

FDA Explores Flexible Drug Marketing Policies … Agency leaders go slow in weighing changes to DTC ads and off-label marketing … While marketers maintain they can provide truthful information on drug uses without undermining product safety, no one expects radical change in the current political climate …[PharmExec]

11/17
President Trump Hires Same Pharma Honchos That Candidate Trump Vilified
He rails against the drug industry. But Trump is turning to its ranks to fill his administration … Scott Gottlieb … longtime industry investor and adviser to GlaxoSmithKline and Bristol-Myers  … Health and Human Services  … Keagan Lenihan, joined the administration after running the lobby shop for McKesson … Gilead lobbyist, Joe Grogan, reviewing health care regulations at the Office of Management and Budget. The chief of staff at HHS, Lance Leggitt, lobbied for a whole host of drug clients, even last year …[Pharmalot]

11/17
How Big Pharma Sandbags Generic Competition
How Big Pharma Sandbags Generic Competition … From denying samples to pushing 'citizen petitions,' drug companies are clever. But Congress can help … whatever the industry's excuses, shenanigans like these cannot be justified as aiding innovation …[WSJ]

11/17
Public Citizen: Ban Azor, Benicar,Tribenzor Over Weird GI Syndrome
Petition to the FDA to Ban Olmesartan-Containing Hypertension Medications … severe gastrointestinal disorder that leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss … [Public Citizen.org]
FDA urged to ban a blood pressure medication with troubling side effects …  "overwhelming evidence" that the treatment causes severe sprue-like enteropathy, which is similar to celiac disease but does not improve with a gluten-free diet …[Pharmalot]

11/17
Cardiac-Related Death Linked with Uloric (Febuxostat)
Cardiac-Related Death Linked with Uloric … already has a warning and a precaution about cardiovascular events, because in preapproval clinical trials, there was a higher rate of heart attacks, strokes, and heart-related deaths than with allopurinol … [Medpage Today]

11/17
Blue Cross Teams Up With Google Parent Alphabet To Manage Diabetes
Blue Cross Plans Partner With Alphabet Venture To Manage Diabetes …. will begin with a pilot program early next year offered by Anthem and two other Blue Cross companies  … want to know how a personalized and more convenient approach can improve care, reduce costs …[Forbes]

11/17
Lilly Faces Similar Lawsuit Novo Faced Regarding White Coat Sales Reps
Lilly used nursing services as kickbacks to boost insulin prescriptions, lawsuit claims … After Novo Nordisk settled a lawsuit alleging it marketed certain drugs under a "white coat" sales scheme, fellow diabetes drug giant Eli Lilly is …[Fierce Pharma]


11/16 Adam Fein Takes Apart NPC Study on PBMs: Employers Don't Trust PBMs, Don't Think They Perform Well
If Employers Are So Unhappy with Their PBMs, Why Can't They Change the Model? .... Seven out of ten employers would "welcome an alternative to a rebate-driven approach to managing costs." Less than one in five employers believe that rebates are effective for driving down net price .... Drug Channels

11/16 Feds Say Astellas' Co-pay Assistance Broke the Rules
Astellas faces U.S. probe over patient assistance charity support .... Astellas said the Justice Department was investigating potential violations of healthcare fraud law and other criminal statutes, as well as potential civil claims under the False Claims Act. .... Reuters

11/16 The Man Who Brought Together Allergan and the St. Regis Mohawk Tribe
Why Is Allergan Partnering with the St. Regis Mohawk Tribe? .... If Congress limits tribal immunity, intellectual-property lawyer Michael Shore could easily shift the patent portfolios to state universities. Shore says that he's in talks with several underfunded state-run historically black colleges and universities. .... The New Yorker

11/16 7 Sepsis Cases, 5 Deaths in Phase 3 Tozadenant Trial
Acorda Takes Another Hit, Reports Patient Deaths in Parkinson's Study .... 890 total patients have gotten tozadenant, and 234 a placebo. Seven of the patients on Acorda's drug have suffered sepsis. Five of those patients died, and four of the sepsis cases were associated with arangulocytosis. No sepsis or arangulocytosis cases have been reported among placebo patients .... Xconomy

11/16 Marketing Plan for Fasenra; Infrequent Dosing Seen as Advantage
AstraZeneca goes to battle with GSK with nod for Nucala challenger Fasenra .... For the first year of treatment, the annual price will be $38,000.... In a maintenance year the annual price will be $28,000 or $33,000 for 6 or 7 doses .... Fierce Pharma

11/16 First Personalized Cancer Vaccine Made and Delivered
This $5 Billion Startup Made Its First Cancer Vaccine—For Just One Person .... For [first patient] Cleaver, Moderna's software produced a list of 20 protein targets specific to her cancer. Then its scientists assembled DNA building blocks to create the recipe for her treatment. Those DNA templates were sent to Catalent Biologics in Madison, Wisconsin, where they were transcribed into mRNA and packed as a string of instructions into a little glass vial. .... Bloomberg

11/16 The Best Congress Money Can Buy
Follow The Money: Drug Industry Campaign Contributions .... Of the $62.7 million contributed by pharmaceutical and health-product companies, 54 percent went to Republicans. The funds were split in three roughly equal categories: contributions from political action committees, contributions from individuals, and so-called "soft" money .... Tarbell

11/16 Proposed New Laws and Procedures to Break Through Brand Roadblocks
How Big Pharma Sandbags Generic Competition .... Some brand-name companies are patenting their REMS. This puts generic manufacturers in a tough spot, since FDA regulations require the generic label to mirror the brand label, which includes the REMS.... Case law and the relevant statute suggest that REMS should not be patentable. .... WSJ $$

11/16 Parity Laws for Oral Cancer Meds Don't Make a Dent in Skyrocketing Out-of-Pocket Costs
Study Gives Mixed Reviews On Laws To Equalize Cancer Patients' Out-Of-Pocket Costs .... The proportion of prescriptions filled in plans subject to parity that cost more than $100 out-of-pocket per month increased from 8.4 to 11.1 percent, the study found. That figure declined slightly for prescriptions in plans that weren't subject to parity, from 12 to 11.7 percent .... Kaiser Health News

11/16 Purdue's Cancer Pipeline
Purdue pivots to oncology amidst opioid crisis .... The pipeline includes four drugs in development for a number of different cancer types, including refractory advanced biliary tract cancers, blood cancer and solid tumors. Two of the drugs are in preclinical development, one is in Phase 1 and one in Phase 2 .... BioPharma Dive

Tweet of the Day

11/16 Internet Drug News Fast Takes:
As Humana Moves Doctors To Value-Based Pay, Medicare Costs Fall
Forbes
FDA clears electronic earpiece to block opioid withdrawal symptoms
Stat
Five questions for CVS Health's Troyen A. Brennan, MD, MPH
Managed Healthcare Executive
Centers for Medicare and Medicaid Services puts $900m IDIQ up for bid
MM&M
Drug Labels: Experts Note Importance of Faster Updates
Regulatory Focus



11/15 Paying Too Much for Drugs? It's the Insurance Companies' Fault — Ask HHS Designate Alex Azar
Drug Costs in the Spotlight With Trump's Pick for Health Secretary .... The drug executive President Donald Trump has picked to lead the Department Health and Human Services isn't likely to shy away from the topic of sky-high medication prices -- but it may be insurers and drug plans that feel the heat as much as his former industry .... Bloomberg

11/15 Big Stakes Battle on 340B; Advantage PhRMA at the Moment
Hospitals and PhRMA face off over drug prices and 340B program .... Nearly 160 organizations, almost all drug companies, hospitals and community health centers, reported lobbying on 340B last quarter, spending a combined $41.8 million, according to a review of lobbying disclosure forms .... Politico

11/15 Benralizumab (Fasenra) Approved
FDA approves AstraZeneca's asthma drug .... The U.S. FDA has approved drug benralizumab, as an add-on treatment for patients with severe asthma aged 12 years and older .... Reuters

11/15 Amazon PBM Theory Takes on Water
Amazon to regulators: We won't use state licenses to sell prescription drugs .... Amazon will not use pharmacy licenses it obtained from Tennessee and Indiana to sell prescriptions, but will use them to sell medical devices and supplies instead, the company has told regulators. .... CNBC (Autoplay video)

11/15 New Pill Texts Your Doc When You Swallow It
First Digital Pill Approved to Worries About Biomedical 'Big Brother' .... Patients who agree to take the digital medication, a version of the antipsychotic Abilify, can sign consent forms allowing their doctors and up to four other people, including family members, to receive electronic data showing the date and time pills are ingested .... NY Times

11/15 Legal Challenge to Renflexis Removed; Can Biosim Get Share?
J&J abandons Remicade patent fight against Samsung and its Renflexis biosim .... Pharma giant Johnson & Johnson is determined to defend Remicade against a growing biosimilar attack, but now the company has dropped its lawsuit accusing Samsung Bioepis of infringing patents on the blockbuster immunology drug .... Fierce Pharma

11/15 Loxo Partners with Bayer on Promising Drug Candidate
Loxo Sells Bayer Rights To Rare Cancer Drug For More Than $1 Billion .... Loxo's medicine, larotrectinib, caused tumors to shrink in 36 of 50 patients whose tumors showed mutations in a gene called TRK .... Forbes/Matthew Herper

11/15 'Indiana Mafia' Taking Key Jobs in Trump Administration
Pence’s health care power play .... The vice president is driving a White House agenda dominated by the conservative, anti-regulatory policies he embraced as Indiana governor. .... Politico

11/15 The New Number Two at PFE
Pfizer rejigs executive roster to put Albert Bourla at Read's right hand .... He'll oversee global product development, sales and strategy across the company .... Fierce Pharma

11/15 A Conversation with the FDA's Top Brass
FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches .... Janet Woodcock, director of the Center for Drug Evaluation and Research, reiterated a claim that the clinical trial system is "broken" and not sustainable because of the expensive ways in which trials are run .... Regulatory Focus

11/15 Internet Drug News Fast Takes:
The Apple Watch can accurately detect hypertension and sleep apnea
Tech Crunch
Spain's Almirall warns of delay in approval for psoriasis drug
Reuters
Allergan receives FDA approval for use of Vraylar in maintenance treatment of schizophrenia
Reuters
An A.I. designed to guide humans through the end of life is already among us
CNBC
Targeted by an addiction treatment center, union workers feel trapped as their benefits are drained
Stat

Which Will Pfizer Buy? Biogen or Bristol-Myers Squibb
Barron's
Here's why investors in Geron, Puma Bio, Intrexon, and Ziopharm should worry
Adam Feuerstein
via STAT
Doctors take various tacks to respond to online reviews
STAT
[forum discussion] Allergan employees discuss impending cost cuts announced by CEO Saunders
Cafepharma Message Boards

11/14
Trust Trump Pick For HHS Secretary Stirs Distrust For Some
Trump's HHS pick a pharma insider as drug prices skyrocketed … "Given Alex Azar's professional background, there are concerns on whether he can fairly execute any significant effort to lower drug prices … Bernie Sanders, I-Vermont, has ac … [CNN]
Who Is Alez Azar? Trump's new HHS secretary Pick Lobbied For Big Pharma  …  When Azar joined Lilly, seven states were suing the company for allegedly pushing for off-label uses of a drug for treating bipolar disorder and schizophrenia … Before that, for six years, the Yale Law School and Dartmouth graduate worked … [Newsweek]

11/14
AHA Issues New, Tougher Blood Pressure Guidelines
Used to be 140/90; Now it's 130/80
Under New Guidelines, Millions of Americans Will Need to Lower Blood Pressure … previous guidelines defined high blood pressure as 140/90 … hypertension, will be defined as 130/80 millimeters of mercury or greater for anyone with a significant risk of heart attack or stroke …[NY Times]

11/14
Senators Come Out To Fight Large Eyedrop Size, Oversize Liquid Drug Packaging
Senators introduce bill to reduce "completely preventable waste" … how drug companies force patients to pay for expensive liquid medications, such as eyedrops and cancer drugs, which are produced or packaged in ways that lead to waste. Drug companies have known for decades that eyedrops are larger than … [Salon]

11/14
Novartis Hypes Late Stage Pipeline
- Four sure-to-be-expensive monoclonal antibodies, including a migraine treatment
Novartis spotlights its top 4 blockbuster late-stage pipeline projects … [eye] drug not only lined up well against Regeneron's Eylea in wet AMD, but also looked better in some respects regarding disease modification … partnered with Amgen on this CGRP migraine drug … ACZ885 (canakinumab): Novartis' dark horse, the cardio drug …[Endpoints News]
Related: Novartis' eye drug clearly works, but edging out Eylea won't be easy … [BioPharma DIVE]

11/14
451 Million Earthlings Have Diabetes
- Annual costs approach $1 Trillion (That's Trillion With a "T")
Cost of diabetes epidemic reaches $850 billion a year … total number of diabetics is now 451 million and is expected to reach 693 million by 2045 … one in 11 adults worldwide have the condition … [Reuters]

11/13 
Fast Takes
Doctor who refuses to use computers loses medical license
FOX News
Allergan employees discuss impending cost cuts announced by CEO Saunders
[forum discussion]  Cafι Pharma

Valeant is providing the media with an earnings metric that the SEC told it to stop using
Market Watch
5 Irresistible Reasons to Buy Celgene Stock Right Now (Hint: 1 Is that It's Dirt Cheap)
Motley Fool
The Insanity of Taxpayer-Funded Addiction
NY Times
Novo Nordisk cutting 185 jobs, adding another 70 in commercial revamp
Fierce Pharma
Controversy erupts over plan to let Pentagon authorize unapproved drugs for battlefield use
Wash Post

11/13
Mylan's $53 Million Man Accused In Massive Price Fixing Scandal
How One Of The Nation's Top-Paid Drug Executives Got Embroiled In A Price-Fixing Probe … At 56, Malik is Mylan's second-highest ranking executive and was paid $53.8 million between 2014 and 2016… Last week 45 states accused Malik of engaging in an illegal conspiracy to fix the prices of drug … [Forbes]

11/13 G
eneric Advair Delayed Again
- FDA has issues with climnical endpoint studies
Hikma FDA dispute lines Novartis' Sandoz up for Advair coup … After receiving a May rejection of the knockoff from the FDA, Hikma now says the partners are locked in a dispute with the agency that won't be resolved until next year's first quarter … [Fierce Pharma]

11/13
Dynavax 2-Dose Hepatitis Vaccine Gets FDA Not After 2 Failed Attempts
- Will compete against 3-dose Industry best seller from SSK
Dynavax's hepatitis B vaccine gets FDA nod on third try, shares up … The two-dose vaccine ... is really a game changer," Xu said, adding that Heplisav-B could capture 80 percent of the market over the next couple of years. ...will compete directly with Glaxo's Engerix-B, a three-dose vaccine that currently dominates the market … [Reuters]

11/13
3rd PSCK9 Product Could Start Price War
Medicines Company experimental PCSK9 not due out for several years
The Medicines Company Is Making A Dangerous Bet On A Drug To Lower LDL Cholesterol … They don't really care about a drug dosed twice a year vs. one dosed twice a month … What they DO care about is price. Will The Medicines Company be willing to charge significantly less than the price currently commanded by Repatha and Praluent? Perhaps, but then again, early signs are that this isn't going to be a huge market. … [Forbes]

11/13
AZN's China Business Doing Well Unlike GSK
AstraZeneca rides China wave as rival GlaxoSmithKline struggles … China is now the world's second-biggest drugs market after the United States, with more cases of cancer and diabetes than any other nation,  … AstraZeneca has added sales representatives to cover more of China but GSK has yet to recover fully from a bribery scandal … [AP]


11/10 Sage Expects to File Brexanolone for Postpartum Depression in Mid-2018; Positive Ph 3 Trials
Sage shares boom on success of postpartum depression drug .... Treatment with brexanolone led to mean reductions of between 14 to 20 points from baseline scores on a rating scale known as HAM-D. In both studies, a statistically significant effect was measured at 60 hours, and among patients with moderate PPD that benefit extended out through 30 days .... BioPharma Dive

11/10 Heplisav-B Approved; Two-Dose Vaccine for Hepatitis B; Peak Sales $600 mm Forecast
Dynavax's hepatitis B vaccine gets FDA nod on third try, shares up .... The vaccine will compete directly with GlaxoSmithKline Plc's Engerix-B, a three-dose vaccine.... .... Reuters

11/10 Average Family Deductible Tops $4500; Drugs Increasingly a Separate Deductible
Shopping for Prescriptions: How Deductibles Will Reshape the Pharmacy Industry .... A third of workers in high-deductible plans now face a separate prescription drug deductible. These plans shift 100% of the prescription cost to the patient until the deductible is met .... Drug Channels

11/10 Anthem Moves Exondys51 Off 'Investigational' Status to Medical Necessity
Health insurer Anthem eases restrictions on Sarepta's Duchenne treatment .... Among the other large U.S. health insurers, Aetna, Cigna, and UnitedHealth have more restrictive policies than Anthem.... while Humana's is similar.... the Anthem change should help Sarepta sales .... Reuters

11/10 AstraZeneca Sales Down 3% in Q3; Down 11% in H1 2017
AstraZeneca sales decline slows as it waits for medicine to work .... But the company has been encouraged by impressive data from two lung cancer trials, involving the drugs Tagrisso and Imfinzi.... last week it won early U.S. approval for Calquence, marking its first entry into the blood cancer market .... Reuters/CNBC

11/10 Diabetes Patients Want More Support (And Lower Medication Prices)
Half of providers tie diabetes treatment success to managing patient's emotions .... 42% of diabetes patients surveyed reported they feel guilty or anxious when they get off track with their diabetes management, and almost one-third of diabetes patients feel overwhelmed by their disease state. As many as 30% of patients surveyed believe that diabetes takes up too much of their mental and physical energy every day .... Drug Store News

11/10 Shifting Goalposts: Pay-for-Performance Drug Contracts Key on Adherence
Armed with predictive analytics, PBMs push adherence as a stand-in for outcomes .... Pharma has long tried to boost adherence rates, but that new analytics tools help them "get a lot of patient-level data to figure out when they're going to drop off their regimen." .... MM&M

11/10 Big New Bet on MS for Sanofi
Sanofi bolsters its position on multiple sclerosis with a $765M BTK licensing deal .... PRN2246, which just entered Phase I clinical trials, is a BTK inhibitor designed to access the brain and spinal column by crossing the blood-brain barrier. Once there, it's meant to impact immune cell and brain cell signaling .... Endpoints News

11/10 FDA Amps Up Generic Competition; Will Prioritize All Contenders
FDA Expands Generic Drug Priority Reviews .... "Today we're expanding this competition-focused policy to prioritize any application that can meet the FDA's approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine." (FDA Commissioner Scott Gottlieb) .... Regulatory Focus

11/10 Internet Drug News Fast Takes:
Special-needs families may get squeezed by tax reform
CNBC
Haegarda Reduces Attack Frequency in HAE Patients
Specialty Pharmacy Continuum
U.S. drug agency to toughen stance on illicit fentanyl analogues
Reuters
Is it an emergency? Anthem makes patients question ER visit
AP
Teva's stock and bonds walloped after Fitch downgrade to junk
MarketWatch
Recurrence Risk Lasts Decades After Breast Cancer Treatment
MedPage Today (reg.)



11/9 Surescripts to Provide Point-of-Care Drug Pricing and Prior Auth
Surescripts to Offer Online Rx Benefit Data Next Year .... When Surecripts' "real-time prescription benefit" service goes online, "prescribers will be able to see what a medication will cost their patient, based on their specific health plan coverage, and pick the most affordable medication that meets the patient's therapeutic need." .... Medscape (reg.)
See also: Surescripts News Release

11/9 Big Pharma Might Be Willing to Sacrifice Orphan Drug Tax Credit If It Means Lower Overall Rates
Congress Weighs Repeal of Tax Credit for Rare Disease Drugs .... The tax credit is part of the popular 1983 Orphan Drug Act, and is one of a host of incentives that supporters say have led to the approval of more than 500 new and much-needed drugs for those rare diseases that each affect fewer than 200,000 people .... NY Times

11/9 Alex Azar, Former Lilly US Head Has Inside Track on HHS
Ex-pharma exec Azar is top choice to run U.S. health agency .... Azar has served on the board of directors of the Biotechnology Innovation Organization, a drug industry lobby, for several years, and his nomination would raise questions about the administration's seriousness about lowering drug prices .... Reuters

11/9 Kisqali Builds Case for Pre-Menopausal Breast Cancer Indication
Novartis takes fight to Pfizer's Ibrance with new Kisqali data .... A late-stage trial showed Kisqali, in concert with hormonal therapies, halted the advance of hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer in pre-menopausal women for longer than in women getting hormonal therapy alone .... Reuters

11/9 Prevymix Approved; $195–$270/Day x 100 Days to Prevent Cytomegalovirus
FDA OKs drug to block infection after marrow transplant .... The FDA has approved sales of Merck's Prevymix to prevent infections with cytomegalovirus, a common virus. It ... strikes at least half of transplant patients .... ABC News

11/9 Proposed NJ Physician Payments Law Has CE Sponsors Scouring the State for $15 Meals
Limits on pharma payments to doctors back on policy menu .... A mini wave of state-level rule-making has thrust the issue of restrictions on pharma payments to medical professionals back into the spotlight. .... MM&M

11/9 Weaker Pediatric Exclusivity Rules Feared
Amgen Challenge of FDA Decision on Pediatric Exclusivity Could Have Wider Implications .... A mini wave of state-level rule-making has thrust the issue of restrictions on pharma payments to medical professionals back into the spotlight. .... Regulatory Focus

11/9 Adherence Rates for Biologics Range from 40–70%; Will No-Needle Delivery Help?
Takeda pursuing needle-free delivery for its top-selling biologic .... The device uses pressurized liquids for drug delivery.... First up is the ulcerative colitis (UC) and Crohn's disease (CD) drug Entyvio (vedolizumab) .... Biopharma Dive

11/9 'No Access' Rates Climbing — 32% of Family Docs Can't See Reps
Pharma reps not welcome? More hospitals, practices granting 'no access' to salespeople .... More than 55 percent of health system-owned physician practices banned commercial visits last year .... Healthcare Finance

11/9 Patients Not Benefiting From Biosimilars, Either Financially or Clinically
Future of Biosimilars Uncertain .... Beyond clinical data, the price reductions are not reaching patients, which is a large hurdle for biosimilars. Currently, 58% of insurers do not cover biosimilars for infliximab and other inflammatory disease biologics .... Specialty Pharmacy Times

11/9 Internet Drug News Fast Takes:
Handing pharma a win, Ohio voters overwhelmingly reject drug pricing measure
Fierce Pharma
Of 3,500 Eli Lilly Worldwide Job Cuts, 2,300 in U.S. Took Voluntary Severance
Biospace
Thousands of Drugs at Risk if No Brexit Deal, Companies Warn
Reuters/NY Times
Why Tesaro's $2 Million Cancer-Drug Miss Prompted Its Rivals To Topple
Investors Business Daily
Clinical trial examines online care for mood, anxiety disorders in primary care
JAMA Psychiatry

11/8 BMS Cancels $20mm Contract with Outcome Health After Fraud Accusations
Drug Advertisers Suspend Deals With Outcome Health .... Several major advertisers are halting their business with Outcome Health following allegations that some employees of the prominent Chicago startup misled clients .... WSJ$$

11/8 Dept. of Defense Wants to Bypass FDA Red Tape; Furor Ensues
Lawmakers defend 'unprecedented' Pentagon health panel, which could undermine FDA .... Section 732 of the Senate's version of the National Defense Authorization Act creates a new regulatory structure that would allow the Pentagon to sign off on unapproved devices and drugs for emergency use on military personnel and others in harm's way .... Politico

11/8 Six Gamechangers Amazon Could Bring to Drug Sales and Distribution
This Is How Amazon Could Invade the Pharmacy Business .... One obvious priority for Amazon will probably be to improve the consumer experience in shopping for drugs online or on mobile devices. For refills, using Alexa, Amazon's voice-activated virtual assistant, would be just the start .... Bloomberg (autoplay video)

11/8 It's the Prices, Stupid
Rising Cost of Healthcare in US Driven By Rising Prices in Absence of Rising Demand .... A new study finds that the main driver of rising health costs in the US is the prices of goods and services. But prices are rising as demand is decreasing. .... Methods Man blog/F. Perry Wilson

11/8 Insurers Cutting Off Acthar
Mallinckrodt dives as sales of main drug Acthar disappoint .... Acthar — which contributes 42 percent to Mallinckrodt's overall revenue — generated sales of $308.7 million in the third quarter ended Sept. 30, missing analysts' average expectation of $326.6 million .... Reuters

11/8 CVS Health (The PBM Part) Sales Up 8.1%; Same-Store Retail Store Sales Down 3.2%
CVS to offer nationwide next-day delivery in preemptive shot at Amazon .... CVS spokeswoman Erin Pensa declined to say how the company would handle the logistics of packaging and shipping, but said it would be handled by "a national partner." Products will be shipped from local pharmacies, not from a warehouse .... USA Today (autoplay video)

11/8 Rebrand for Big Data/CRO Firm
Say it with us: IQVIA is the new Quintiles and IMS Health .... The decision to merge two otherwise disparate operations signaled a new direction for the clinical outsourcing industry, where consolidation and expansion into new data-driven markets is the name of the game now .... Endpoints News

11/8 FDA Broadens Alecensa Use
Alecensa Approved as First-Line Tx in ALK-Positive Metastatic NSCLC .... Compared to crizotinib, Alecensa significantly reduced the risk of disease worsening or death by 47% as assessed by independent review committee. Median progression-free survival was 25.7 months for the Alecensa arm compared with 10.4 months for those who received crizotinib .... MPR

11/8 Coinsurance Gaining on Copayments, Especially in Higher Tiers
Employer Pharmacy Benefits in 2017: More Cost-Shifting to Patients As Tiers and Coinsurance Expand .... In 2017, the four-tier design became the most common option, used in 44% of employer-sponsored plans. In 2004, only 3% of covered employees were in plans with four or more tiers .... Drug Channels

11/8 Tylenol and Motrin Do Just as Well on Pain Scales as Opioids in ER
Drugstore pain pills as effective as opioids in ER patients .... Long-term opioid use often begins with a prescription painkiller for short-term pain, and use of these drugs in the ER has risen in recent years.... [opioids] are prescribed in nearly one-third of ER visits and about 1 out of 5 ER patients are sent home with opioid prescriptions .... Stat News

11/8 Internet Drug News Fast Takes:
McKesson to buy RxCrossroads from CVS for $735 million
Chain Drug News
P&G slashed the number of sites it ran ads on by nearly 70% after YouTube brand safety scandal
MM&M
Humira back on top of TV spending list for October, ahead of Lyrica and Victoza
Fierce Pharma
The Dialysis Machine: How Medicare steers low-income and minority kidney patients toward the hell of dialysis — and keeps two big companies rolling in profits
Washington Monthly
Why Major Hospitals Are Losing Money By The Millions
Forbes/Robert Pearl, MD

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This site is supported by click advertisements, banner advertisements and affiliate arrangements.  All ads are properly labeled as such.  If you have any questions regarding how we make money please e-mail the webmaster with your questions.  All advertisements shall be clearly distinguished from content.

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