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10/20 Drug Price Hikes Blamed on Fear of Coming Regulation
Data shows drug prices spiked seven percent last year .... Yale economist Fiona Scott Morton said a new class of powerful drugs — sometimes called biologics — could be helping fuel costs. .... Marketplace

10/20 HPV Recommendation Eased; Two Shots Only, Further Apart
Preteens need only 2 HPV shots — not 3, CDC says .... A government panel has recommended that preteens get two shots instead of three and space them further apart. The Centers for Disease Control and Prevention immediately made the change .... AP

10/20 Abbott Sales Strong, But Deals Gone Sour Wreck Bottom Line
Abbott Posts Surprise Net Loss as Value of Mylan Stake Tanks .... Abbott became Mylan's biggest shareholder last year after selling its generic drugs unit in Europe and developed markets to the drugmaker, and still holds a 13 percent stake .... Bloomberg

10/20 Panel Passes Nocturia Pill
FDA panel backs Allergan's drug for frequent nightly urination .... SER120 is a low-dose nasal version of desmopressin, a drug used to treat a variety of conditions, including diabetes insipidus, a rare disorder that causes an imbalance of water in the body .... Reuters

10/20 18th Approval This Year: Lartruvo for Soft Tissue Sarcoma
Eli Lilly wins a quick OK for new sarcoma drug olaratumab .... Lilly plans to sell the drug as Lartruvo to a slice of patients for frontline use -- the first such approval to come along in decades for this disease .... End Points

10/20 Twitter Jockeys Link Coffee to Happiness; Map Areas with Healthier Food and Lifestyles
What do tweets say about our health? .... At the state level, more positive mentions of physical activity and healthy foods, as well as happiness, were associated with lower all-cause mortality and the prevalence of chronic conditions like obesity and diabetes .... Reuters

10/20 Winning Their Hearts and Minds for Biosimilars: Merck Launches Website
Merck primes the market for its biosims with online effort targeting docs, patients .... Biosimilars Clarified is an educational website where patients, caregivers and healthcare professionals can "get the information they want and need about biosimilars in a clear, straightforward manner" .... Fierce Pharma

10/20 Requests for Orphan Drug Designation Have Doubled Since 2010
FDA Drowning in Orphan Drug Applications .... For years, the Office of Orphan Products Development has issued initial decisions within 90 days, but that time frame is no longer possible.... The reviewers now aim for 120 days and try to review at least 75% within that period .... Medscape

10/20 Generics Makers Tout the Money They've Saved for Us
QuintilesIMS Institute report: Generics brought $227 billion in 2015 savings .... Mental health in particular saw $34.4 billion in savings, the most of any therapy area, and nearly $10 billion more savings than the second-ranked area, hypertension, which saw $25.8 billion in savings in 2015. Adults 40-65 years old see 45% of the generics savings, with seniors 65 years and older seeing 34% of the savings. Young adults 20-29 saw 14% of the total savings, and children 0-19 years old say 7% of the savings .... Drug Store News

10/20 Richest Pharma Execs
4 US pharma execs make Forbes 400 list .... Patrick Soon-Shiong, founder of the NantWorks network, had the highest net worth among healthcare execs in 2016, with a net worth of $9.2 billion .... BioPharma Dive

10/20 Internet Drug News Fast Takes:
Mylan's Settlement With DOJ Not Tough Enough, Senator Says
'Cadillac Tax' Repeal a Possibility Next Year
Medpage Today
Two-thirds of HCPs access drug data online every week
FDA awards 21 grants for orphan drugs
The 50-plus consumer is driven by curiosity and wonder, finds Ketchum study

10/19 Shares Shift in Insulin Market
Medicare formularies add to the squeeze on key Novo Nordisk, Sanofi insulins .... New Medicare formularies were published late last week, and while they maintained coverage for Sanofi's behemoth Lantus and its new follow-up Toujeo, Novo's basal insulins lost ground .... Fierce Pharma

10/19 Mark Thierer, CEO of OptumRx Defends PBM Role
Q&A: 'We don't set the price. Pharmaceutical manufacturers set the price.' .... Thierer: "At OptumRx that our model is really a pharmacy care services model. Underneath every decision we make is a data play that's focused on taking everything we know about a member--their entire condition including their prescription drug usage--and making a decision about the next best clinical action." .... Modern Healthcare

10/19 Androgen Deprivation Therapy Linked to Dementia
Prostate cancer hormone therapy tied to higher dementia risk .... Overall, 7.9 percent of men who received hormones developed dementia within five years, compared with 3.5 percent of men who got other treatments, researchers report in JAMA Oncology .... Reuters

10/19 Bayer's Has High Hopes for a Mesothelioma Treatment Still in Phase 1
Bayer's Euphoria Around New Cancer Medicine Meets Skepticism .... The German conglomerate is relying on positive signs in early human trials to predict more than 2 billion euros ($2.2 billion) in annual sales for anetumab ravtansine should it win regulatory clearance for using the medicine in treating multiple cancers .... Bloomberg

10/19 Xeljanz Grows Hair on Many with Alopecia
Drug reverses one baldness type; is male pattern next? .... More than half of the alopecia areata study subjects who received Xeljanz saw hair regrowth. A third recovered more than 50% of their lost hair. In a separate study, nine of 12 patients with alopecia areata recovered more than 50% of hair regrowth using a similar drug, Jakafi, which is approved for cancer treatment .... CNN

10/19 Complaints to HHS Say Insurers 'Red-lined' Out HIV Sufferers
7 Insurers Alleged To Use Skimpy Drug Coverage To Discourage HIV Patients .... Working with local AIDS groups in several states, the Harvard center examined hundreds of silver-level plans sold on the marketplaces to gauge whether their formularies would allow access to six treatment regimens that are the current standard of care for treating people who are newly diagnosed with HIV. In addition, they looked at the plans' cost-sharing requirements .... Kaiser Health News

10/19 What's in the Alzheimer's Pipeline?
Alzheimer's Remains a Top Priority for Big Pharma .... Big Pharma and biotech kicked off 2016 with a noteworthy 77 experimental compounds in development for AD.... Among this diverse list of clinical hopefuls, Eli Lilly and Biogen's beta-amyloid plaque-busting antibodies -- solanezumab and aducanumab, respectively -- have garnered the most attention .... Motley Fool

10/19 Many Other Heart Medications Interact with Statins
Statins Often Interact With Other Heart Drugs .... The most common issue... is that the other drugs boost statin levels in the blood. That, in turn, raises the risk of muscle-related side effects. .... Health Day

10/19 Tecentriq Approved, Anti-PDL1 Immunotherapy
FDA Approves Genentech's Cancer Immunotherapy TECENTRIQ® (Atezolizumab) for People with a Specific Type of Metastatic Lung Cancer .... First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small cell lung cancer (NSCLC) .... Company news release

10/19 FDA Wants to Know What Breakthroughs Are Coming in the Next 5-10 Years
A Look Into the Future: FDA Wants to Know What's Coming for Scientific Advances .... FDA is formally asking interested parties to offer some fresh perspectives on emerging technologies and cross-cutting scientific advances that could be of importance to FDA .... Regulatory Focus

10/19 Exercise Helps with ED, But Pills Probably Help More
Erectile dysfunction may improve with exercise .... Overall, men who exercised had their scores increase by an average of 3.85 points (on a scale of 5 to 25), compared to men who did not exercise .... Reuters

10/19 Internet Drug News Fast Takes:
Common household chemicals hurt our health ... and cost us billions
Analysis: Just how big is the vitamins, minerals and supplements market?
Chain Drug Review
White House To Announce Big Push For Cancer Blood Tests
Forbes/Matthew Herper
Upsher-Smith acquires 20 generics from Sandoz
Drug Store News
"Don't Touch My Medicare!" Is the beloved program on its last legs?

Fast Takes
Mylan Now Likely An Acquisition Target With 100% Upside Possible
Seeking Alpha
Sleep apnea may up risk of type 2 diabetes
Follow the Dollar: Measuring Who Profits From a Brand-Name Prescription
Drug Channels
DOJ to Gain Access to Anthem, Cigna Internal Communications
The Street

10/18 Regeneron Teva: Unexpected Side Effect Causes FDA To Pull Plug On
Monoclonal Antibody For Back Pain (For Now)
- Regeneron shares dip 2% (market cap down $80 Million)
News Of Clinical Hold For Fasinumab Weighs On Regeneron, Teva Shares … investigational Nerve Growth Factor antibody in clinical development for osteoarthritis pain and low back pain … adjudicating arthropathy in a patient, who got high dosage of fasinumab …[Benzinga]
See Also: Company Press Release

Clinton Policy Wonk Gloats, "We Started War On Pharma"
Clinton campaign's 'war with pharma!!' went official with last year's stock-busting tweet: WikiLeaks … series of proposals to control drug prices, and one of her follow-up tweets in August triggered another selloff in biotech shares … campaign staff reacted with glee … [Fierce Pharma]

Pfizer Begins Shipping Biosim Version Of Remicade Next Month
Pfizer to launch cheaper version of J&J immune drug Remicade … late November at a 15 percent discount to current wholesale prices. … Pfizer version, called Inflectra … J&J's biggest selling drug with U.S. sales of $5 billion  … [AP]

FDA Torpedoes Lannett Generic Concerta Dreams; Shares Hammered 13%
- FDA concerned that generics not as good as brand regarding time release
Why Lannett  Shares Got Pummeled Today … generic versions were released in seven to 12 hours depending on the patient. The FDA told the companies that they had six months to confirm the bioequivalence of their generics or voluntarily withdraw their products from the market …[Motley Fool]

Valeant Cuts Ties With  Mail-Order Pharmacy That Pushed Wellbutrin
- Marketing relationship drove fills for wildly overpriced antidepressant; Valeant raised price 11 times in 2 yrs
Valeant Cuts Ties With Pharmacy That Distributed Antidepressant … … deal made Wellbutrin XL available through lower co-pays, or even free, while doctors were promised that prescriptions would be honored without any problems …[Bloomberg]
Editor's note: Valeant has cornered the market for brand name extended release buproprion.  Valeant's  Wellbutrin XL current list price is $40 per pill.  One Wellbutrin XL pill cost almost as much as 2 months worth of the generic.  Valeant's other  extended release version of buproprion is called Aplenzin.  One Aplenzin 348 mg pill retails for $112.  One Aplenzin pill costs about as much as a 5-month supply of the generic equivalent. 

FDA Staffers: Allergan Nocturia Bladder Drug Not Adequately Studied
FDA staff flags concerns about Allergan, Serenity Pharma urinary drug …  "clinical meaningfulness" was unclear when compared with a placebo …  "clinical meaningfulness" was unclear when compared with a placebo …[Reuters]

EU: Aspen Pharma Fined For Scheme To Manipulate Cancer Drug Price
Drug maker fined for shorting supplies of cancer drugs in order to raise prices … halting supplies of several cancer drugs as a negotiating tactic designed to boost prices by as much as 1,500 percent.We are dismayed by this kind of pernicious practice which puts profits before consumers' health …[Pharmalot]

Fast Takes
Clinton, Kerry & pals pressured FDA to OK experimental drug for Dem donor
Teva Rolls Out Generic Equivalent to Bayaz Birth Control Pill
As Insurers Drop Obamacare, White House Steps Up Sales Pitch
These 10 Drugs Are Busting Hospital Budgets

Cigna, United Accused Of Overcharging Drug Customers
- 10's Of Thousands of patients would have been better off paying cash!
Cigna Accused Of Cheating Prescription Drug Buyers …  complicit in a system that forces pharmacists to charge customers unjustifiably high co-pays … in the cases of dozens of widely prescribed drugs, are double or more than cost of the entire prescription … [Hartford Currant]
Cigna Accused of Prescription Drug Overcharging Scheme … complaint alleges, patients paid $20 for a medication that cost Cigna less than $2, with the remaining $18 kept by the insurer …[Bloomberg BNA]
Editor's Note: This lawsuit was launched as a result an investigative report from a New Orleans Fox affiliate.

Biosims Set To Disrupt Insulin Market
- Lower prices for patients far from certain
The insulin market is heading for a shakeup. But patients may not benefit … Basaglar will hit the market on Dec. 15. The company hasn't set a price yet, but analysts expect Basaglar to carry a list price 10 to 20 percent lower than Lantus, which is listed at about $250 per vial …[Stat News]
Editor's Note: When Basaglar launches in 2 months, it will be the 5th long acting insulin on the market.  According to David Kliff of Diabetes Investor, insulin has become a commodity. 

Valeant Again Accused Of Price Gouging
- 7,200% price increase for heavy metal chelating agent EDTA
US Costs For Valeant's Lead Poisoning Drug Are 33,000% More Than Canada's … $500 for a packet of six ampules (6 grams) before 2012 … experts now say that US centers pay about $5000 per gram for the drug …[Forbes]

Trending On Cafι Pharma
Novo Nordisk anonymous message board - layoffs announced
Sanofi anonymous message board - rumor mill says layoffs coming

Price Control Measure Has Good Chance Of Passing In California
- Scheme would mandate state agencies pay same rate as Veterans Affairs
The Biggest Pharma Election Risk Is in California …  Such a law in the country's largest state would make other voters--and politicians--take notice. That may once again chill investor enthusiasm for the sector …[WSJ]
Bernie Sanders to stump for California drug pricing law … [Pharmalot]

Generation Adderall
Generation Adderall … Adderall's very name reflects its makers' hopes for an expanding customer base: "A.D.D. for all" is the phrase that inspired it … 16 million Adderall prescriptions were written for adults between ages 20 and 39 in 2012 … [NY Times]

10/14 Samsung and WuXi Want to Make a Name in Biologics
China, Korea Eye the Latest Multi-Billion Blockbuster Drug Market .... The reigning champions in the business of contract manufacturing biologics are both European: Switzerland's Lonza Group and a unit of Germany's Boehringer-Ingelheim GmbH. But two players in Asia are now racing ahead to gain a slice of the global business, with plans to raise billions in the coming months .... Bloomberg

10/14 "Imagine a Theater with 1,000 People:" Visualization Shows Risk and Benefit Probabilities of Treatment
How Tiny Are Benefits From Many Tests And Pills? Researchers Paint A Picture .... The researchers ask patients to picture a hall of people getting a test, operation or prescription. Patients might be shocked at how few in the crowded room get any benefit out of the expensive care. Their "benefit-risk characterization theater" images vividly show the odds, based on solid research .... Kaiser Health News

10/14 Learnings from a Deep Dive into 15 Million Consumer Prescription Records
A Data-Driven Approach to Customer Retention .... In analyzing customer retention, it appears that emotion drives motivation. When consumers feel a connection to a pharmacy that is based on accountability and mutual trust, they are much more likely to return. This is largely a matter of interpersonal engagement .... Drug Store News

10/14 MedPAC Members Boost Biosimilars
Medicare Advisers Support Easing Access to Biosimilar Drugs .... The coverage gap discount program (CGDP) requires manufacturers to provide a 50 percent discount on brand drugs dispensed during the coverage gap. Both the manufacturer's 50 percent discount and the beneficiary's out-of-pocket costs count toward true out-of-pocket costs (TrOOP). The CGDP doesn't apply to biosimilars in the coverage gap .... Bloomberg BNA

10/14 Frustrated by Lack of 'Right to Try'? Blame Pharma, Not the FDA
What experimental drug? Most companies don't post compassionate use policies .... Just 19 percent of 100 drug makers publicly post policies about their programs for obtaining experimental drugs, which are known as compassionate use. Moreover, only one of those companies posted information about specific procedures for making requests, and this company did not list any contact information. .... Pharmalot/Stat

10/14 Sermo and Everyday Health Trade Access
Sermo and Everyday Health partner in advertising-research deal .... Sermo is responsible for all market research projects across the combined Sermo and Everyday Health Professional panel, its HCP platform.... As part of the deal, Everyday Health Professional will handle all advertising on Sermo .... MM&M

10/14 Inhaled Levodopa Works More Quickly
Inhaled Version of Parkinson's Drug May Help Keep Symptoms at Bay .... The inhaled drug was rapidly absorbed and was detectable in the bloodstream within five minutes, compared with 20 minutes after taking levodopa orally .... Health Day

10/14 These Meds Hit Uncle Sam's Wallet Especially Hard
7 biggest price hikes for Medicare's costliest drugs .... The seven biggest price increases among the 20 costliest drugs for Medicare. Together, these drug price hikes added almost $2 billion in costs for Medicare. .... CBS News

10/14 Doctors and Hospitals Looking to Pharma Playbook to Beat Insurer Pressures
Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry .... The analogy between value-based purchasing in pharmaceuticals and the new frontier of alternative payment models for health care providers is relatively straightforward. Insurers are increasingly demanding steep discounts from providers in exchange for inclusion in more limited networks or placement on favorable tiers .... NEJM

10/14 Niraparib Could Be Used in Two Thirds for Ovarian Cancer Patients
Tesaro's niraparib threatens Lynparza after acing ovarian cancer trial .... A phase III trial showed a significant improvement in PFS regardless of the patients' BRCA status, giving it an edge over Lynparza .... PMLiVE

10/14 Internet Drug News Fast Takes:
IBM Workers to Use Watson Supercomputer to Find Cancer Treatments
Pfizer Loses U.K. Patent Appeal Over $4.8 Billion Lyrica Drug
Calcium Supplements May Be Detrimental to Heart Health
HealthDay News
With CRISPR, scientists correct genetic mutation that causes sickle cell disease
LA Times
What do Americans fear? Chapman University's 3rd Annual Survey of American Fears released (#10 is Obamacare)
Chapman University

10/13 Adderall Addiction: A Personal Account
Generation Adderall .... In 2012, roughly 16 million Adderall prescriptions were written for adults between ages 20 and 39, according to QuintilesIMS.... Adderall has now become ubiquitous on college campuses, widely taken by students both with and without a prescription. .... NY Times

10/13 Valeant Goes Back to the Price Hike Playbook; Lead Poisoning Drug at $27,000/Package
Huge Valeant price hike on lead poisoning drug sparks anger .... Before Valeant took control, the list price for a package of vials had been stable at $950. But in January 2014, Valeant boosted the price to $7,116. By December 2014, several more increases took the price to $26,927 .... Stat/Pharmalot

10/13 Legislator Proposes Drug 'Price Gouge' Penalties
House Dem to introduce sweeping drug pricing bill .... The bill from DeLauro would create a new intergovernmental Price Review Board, which would have the power to impose penalties on drug companies that it determines "price gouge" consumers .... The Hill

10/13 Pay for Performance Comes to Diabetes Market; Merck-Aetna Deal on Januvia/Janumet
Merck inks pay-for-performance deal to boost diabetes drugs .... Merck has signed a deal with Aetna to link rebates for its diabetes drugs Januvia and Janumet to treatment outcomes among type 2 diabetes patients .... BioPharma Dive

10/13 Drug Coupons Prop Up High Brand Prices
Drug Coupons: Helping a Few at the Expense of Everyone .... According to the NEJM study, when drug companies offered a coupon for the brand-name version, more patients stuck with the more expensive brand-name drug, and the company raised the prices on such drugs faster than it did for drugs for which no coupon was available .... NY Times

10/13 SSRI Pregnancy Risks Studied
SSRI Use During Pregnancy Tied to Speech Issues in Offspring .... Mothers who filled a prescription for an SSRI at least twice during their pregnancy were 37 percent more likely to have a child with a speech/language disorder than those who did not take the antidepressants .... Health Day

10/13 Taltz Begins DTC Effort
Eli Lilly's new psoriasis treatment Taltz launches first ads, chasing Novartis' Cosentyx lead .... In the first three weeks of the campaign, Eli Lilly has already spent more than $9 million on TV ads.... Cosentyx has spent more than $51 million on its TV ad "See Me," since launch in January 2015 .... Fierce Pharma

10/13 Researchers Demonstrate Patients Focus on Benefits and Ignore Risks of Medications
University of Tennessee professor studies drug website risk warnings .... To determine how much attention the people paid to the risk warnings, the researchers used eye tracking to see how where and how long they looked; survey questions asking the participants how much of the risk information they read; and a post-task interview to revisit the website and review how they read the information .... Fierce Pharma

10/13 Flu Costs the US Economy $6 Billion per Year
Unvaccinated adults cost the US more than $7 billion a year .... Vaccine-preventable diseases among adults cost the U.S. economy $8.95 billion in 2015, and unvaccinated individuals are responsible for 80 percent, or $7.1 billion, of the tab .... University of North Carolina at Chapel Hill

10/13 Certain Hypertension Drugs Increase Risk of Hospitalization for Mood Disorders
High blood pressure drugs impact depression, bipolar disorder .... People prescribed beta-blockers and calcium antagonists were at twofold increased risk of hospital admission for mood disorders, compared with patients on angiotensin antagonists. .... Medical News Today

10/13 Average Part D Discount: 35.3%
New Study: Substantial rebates negotiated in Medicare Part D .... Across the 12 therapeutic classes widely used in Part D, net costs to plans ranged from 31 to 54 percent.... Even in a protected class, such as antidepressants, there are substantial rebates of around 34 percent .... PhRMA

10/13 Internet Drug News Fast Takes:
Humana Drops After Ratings for Its Medicare Plans Decline
Study finds high rate of overdiagnosis from mammograms
Are Prisoners Getting Medicare Benefits?
Bloomberg BNA
IPG Mediabrands launches Healix media buying agency for pharma clients across agency network
Fierce Pharma
DEA Gives Up on Banning Kratom After Internet Backlash

10/12 FDA: Xarelto OK Despite Trial Doubts
FDA clears Xarelto blood thinner despite faulty trial device .... The FDA has determined the widely-used blood thinner Xarelto to be safe and effective for patients with the heart condition atrial fibrillation after serious doubts arose over the major study used to gain approval of the drug .... Reuters

10/12 Keytruda Advertises to Doctors; Opdivo Advertises DTC: Which is Better Stategy?
Merck outspends Bristol-Myers Squibb on journal ads for Keytruda .... Merck has spent more than double what Bristol-Myers Squibb has spent on Opdivo to promote Keytruda in professional journals targeting doctors. BMS has chosen a different route, electing to make huge splashes in direct-to-consumer advertising .... MM&M

10/12 Not Just Consumers — Hospital Whacked by Drug Price Hikes.
- Hospitals spend $990 average per admission on drugs
Rising drug prices are making hospitals feel ill .... Between 2013 and 2015, the average annual drug spending for patients who stay in community hospitals increased by of 23.4 percent, from $5.2 million to $6.5 million. And on a per admission basis, hospital spending on drugs jumped nearly 39 percent, to $990. .... Stat/Pharmalot

10/12 Docs Go Over Older Patients' Prescriptions with Fine-Tooth Comb; Strike Unneeded and Harmful Meds
When Patients Take Too Many Pills, Doctors Deprescribe .... Medication use can start to pile up in middle age or earlier, especially in patients being treated for diabetes, heart disease or cancer. People may see different doctors who don't coordinate care with each other. Soon, they are in a situation known as polypharmacy, defined as five or more drugs .... WSJ

10/12 US Breast Cancer Costs Could Be $1 Billion Less on Cheaper (But Just as Effective) Therapies
Breast cancer chemo costs vary despite similar effectiveness .... Costs, and variation, were greatest for chemotherapy regimens built around trastuzumab (Herceptin) a targeted biotech therapy for women with one type of aggressive tumor .... Reuters

10/12 Internet Drug News Fast Takes:
Doctors beat online symptom checkers in diagnosis contest
After 7 days, readmissions are mostly beyond hospitals' control
Advisory Board
For the very ill, legally ending life is increasingly costly

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