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Pharmaceutical News Harvest (TM)

9/19
Fast Takes
Cancer Immunotherapies Expected to Reach $1 Billion in Sales in 2017
Motley Fool
Paxil:
GSK Loses Bid For New Trial in Attorney Suicide Case
Bloomberg
Smaller sales forces get the job done in rare disease
BioPharma Dive
Sanofi and Regeneron's Dupixent scores a potential sales boost as AbbVie candidate threatens
Fierce Pharma
Exclusive: FDA plans new compounding pharmacy policy, agency head says
Reuters

9/19 Many PBMs Make It Hard To Get Less Addictive Painkillers Despite Epidemic
- Example: Morphine usually Tier One, Lyrica commonly step edited
Amid Opioid Crisis, Insurers Restrict Pricey, Less Addictive Painkillers … Drug companies and doctors have been accused of fueling the opioid crisis, but some question whether insurers have played a role, too …[NY Times]

9/19
Biosimilar Drug Sales: Back Room Deals, Legal Maneuvers Prevent Uptake
- You'd expect biosims to cannibalize brand name sales but that almost never happens
FDA Clears Biotech Drug Copycats, But Buying Them Isn't So Easy … Amgen version of Roche drug approved, has no sales date, price … end result has been lackluster sales of the new drugs … physician can't just switch easily a patient to a biosimilar …[Bloomberg]

9/19
Employers  Fret Over 2018 Specialty Drug Prices
- Specialty drugs coming out rapidly; none of them are cheap, some cost 100s of $1000s
Costly drugs to weigh on U.S. employers' expenses in 2018: survey … Between 40 and 50 new specialty drugs are set to hit the market each year in the next five years, which could increase costs by $25 billion … cancer, multiple sclerosis and hepatitis C is expected to rise more than 7 percent …[Reuters]

9/19
Nevada Drug Price Inches Forward Despite Industry's Best Efforts
Drug Industry Denied Fast Relief in Nevada Price Law Challenge … requires drugmakers and pharmacy benefit managers to disclose pricing and rebate information for diabetes drugs … became effective this summer but hasn't yet been implemented …[Dana A. Elfin; Bloomberg BNA]
Related: Pharma Keeps Ignoring Its Price Problem … [Bloomberg Gadfly]

9/19
Sanofi, Amgen Hype PCSK9 Cardio Benefits
For Diabetics In Quest For Better Uptake
- Biggest cardio benefits seen in Type 1 diabetics
Sanofi and Amgen, eyeing boost for PCSK9 use, tout benefits for diabetes patients … Much of the additional benefit for diabetes patients came from a reduction in bypass surgeries … lipid levels need to be reduced to cut "macrovascular" problems, i.e., heart attacks and strokes … Type 1 benefits were most notable …[Fierce Pharma]

9/19
Novel, Pleuromutilin Antibiotic Kills Hospital MRSA Pneumonia Bugs  As Good As Moxifloxacin
- Inhibit protein synthesis in bacteria; shares rise 100% in one day
Nabriva novel antibiotic meets goals in late-stage bacterial pneumonia study … lefamulin achieved the primary and secondary endpoints in a phase 3 study … clinical trial in patients with hospital-acquired pneumonia  …[Pharmalot]

9/19 Fast Takes
FDA clears orphan drug backlog ahead of schedule
Biopharma Dive
First Oral Drug for Type 1 Diabetes Could be Available in 2018
Xtalks
Hollywood director from Avatar making an ad for Pfizer; What it's like
STAT
FDA commish cheers on biosimilars as Amgen, Allergan score OK for knockoff of Roche's Avastin
Endpoints News
Commentary: Martin Shkreli Jailed Over Clinton Hair Bounty
Onion
Glaxo's Shingles Candidate Gets Positive FDA Committee Vote
Yahoo Finance

9/18
Recent Keytruda Deaths Have FDA Scientists Scratching Heads
- Multiple myeloma cocktail not going well
FDA adds two Roche studies to its growing list of partial clinical holds in wake of Keytruda deaths … imbalance in deaths among patients taking a combination of Keytruda with Celgene's Pomalyst and Revlimid could represent a threat in that whole class of checkpoint combos … [Endpoints News]

9/18
Think Tank: Drug Sales To Hit $1.3 Trillion By 2020
- Biotech, Cancer Alzheimer's is where the big bucks will be
Which of These 5 Will Be the Best-Selling Drug Worldwide in 2020? …  top honor in 2020? … guess is Humira retains its crown despite biosimilar competition, with Revlimid nipping at its heels. However, look for Revlimid to ascend to that top spot by perhaps 2021 or 2022 …[Motley Fool]

9/18
Teva Wants Out Of Female Health Care Business
Cash-strapped Teva closes in on women's health sale No. 2: report … portfolio, which contains mostly European products, could be valued at about $800 million … deal would follow up on Teva's $1.1 billion sale of intrauterine copper contraceptive device … [Fierce Pharma]

9/18
First Price Gouging Law Goes Live Soon
Drug industry on tenterhooks as Maryland price-gouging law nears …  applies only to older, off-patent drugs. Generic copies of branded products, usually much cheaper than the originals, account for around 89 percent of U.S. prescription volume, but only 26 percent of total drug spending … [Reuters]
Related: California is close to passing legislation to tackle the rising cost of prescription drugs … [Business Insider]

9/18
High Profile U.S. Senator Slams Allergan Native-American Patent Switcharoo
U.S. senator slams Allergan patent deal with Native-American tribe … Ohio Democrat said he will look at how Congress can "close loopholes that drug companies exploit to avoid competition." …[Reuters]




9/15 Health Plans Curbing Copay Coupons
Insurers cutting back on drug coupons amid concerns over consumer costs .... Blue Cross and Blue Shield of Illinois told its members with individual plans this year they can still take advantage of the discounts, but they won't get credit toward their deductibles or out-of-pocket maximums. Cigna only allows coupons to be used for specialty drugs -- medications used to treat rare or complex conditions. .... Chicago Tribune

9/15 Mvasi, Biosimilar for Avastin Approved — First Biosimilar for Cancer
Amgen challenge to Genentech $6 billion cancer drug OK'd by FDA .... The drug regulator's approval allows it to be used to treat metastatic colorectal cancer and types of lung, kidney, cervical and brain cancers. .... San Franciso Business Journal

9/15 Cancer Drug Cost Problem Will Just Keep Getting Worse
Pharma Keeps Ignoring Its Price Problem .... The U.S. health-care system may strain to pay $156,000 or more for cancer drugs. According to pharmacy benefit manager Express Scripts Holding Co., the median cost of a cancer prescription last year was $7,890 for commercially insured patients, about 60 percent of the monthly cost of one IO drug .... Bloomberg Gadfly

9/15 Aliqopa OK'd for Non-Hodgkin Lymphoma Type
U.S. FDA approves Bayer drug to treat follicular lymphoma .... The drug, Aliqopa, known also as copanlisib, is a kinase inhibitor that blocks certain enzymes that promote cell growth. It is designed for patients who have received at least two prior treatments .... Reuters

9/15 Promising Xtandi Results Could Double Market Opportunity
Pfizer, Astellas eye wider market for prostate cancer drug .... Results showed adding Xtandi to androgen deprivation therapy (ADT) improved metastasis-free survival compared to ADT alone .... BioPharma Dive

9/15 FDA Jacks Up Review Prices for New Drugs
The FDA just unveiled its new, pricier fee schedule to review new drugs .... For prescription drugs requiring clinical data, the price for FY 2018 will be about $2.4 million, which is nearly $400,000 more than in 2017. For prescription drugs not requiring clinical data, the fee will be about $1.2 million, which is about $192,000 more than 2017 .... Endpoints

9/15 Disappointing Savings After LOE for Xeloda
Generic Chemo Is Too Expensive To Help Curb Cancer Spending .... Xeloda lost its patent protection in 2013, after which its average price should have plummeted, the authors expected. But by 2016, the price of capecitabine had dropped only 36% to $2,328 for a one-month supply, despite the fact that four generic drugmakers had jumped in to vie for a slice of the market .... Forbes/Arlene Weintraub

9/15 Antidepressants Block Serotonin Absorption in Heart, Liver, Lungs, and Kidneys
Antidepressants associated with significantly elevated risk of death, researchers find .... Researchers reviewed studies involving hundreds of thousands of people and found that antidepressant users had a 33% higher chance of death than non-users. Antidepressant users also had a 14% higher risk of cardiovascular events, such as strokes and heart attacks .... Medical Xpress/McMaster University

9/15 AACR Report: Five Year Cancer Survival Rates Up to 69% from 49% Four Decades Ago
U.S. cancer death rate continues to fall .... The cancer death rate dropped 35 percent among children and 25 percent among adults from 1991 to 2014. That translates to slightly more than 2 million fewer cancer deaths.... Total number of case will rise due to demographic shifts (Baby Boomers) .... Health Day

9/15 Sotagliflozin Effective in Phase 3; Oral for Type 1 Diabetes
Lexicon, Sanofi drug could be first oral for type 1 diabetes .... 400 mg of sotagliflozin significantly lowered A1C levels in patients with type 1 diabetes versus placebo, reducing blood sugar by 0.46% on a placebo-adjusted basis .... BioPharma Dive

Tweet of the Day


9/15 Internet Drug News Fast Takes:
Challenge of Allergan tribal patent deal in uncharted legal territory
Reuters
Prosecutors Identify Insys Founder as Unindicted Co-Conspirator in Opioid Case
Reuters via NY Times
Sanofi: Patient-Driven Insulin Titration Better for A1C
AJMC
The FDA just approved the first app for treating substance abuse
CNBC
Selena Gomez Reveals Her Best Friend Gave Her a Kidney: 'She Gave Me the Ultimate Gift'
MSN




9/14 Shingrix Gets 11-0 Panel Upvote
FDA panel unanimously votes to recommend GSK shingles vaccine .... An FDA advisory panel has voted 11-0 that the safety and efficacy of GlaxoSmithKline's shingles vaccine warrants approval for its use in adults aged 50 and over .... Reuters

9/14 Half of Large Hospitals Now Run a Specialty Pharmacy
Why Manufacturers and PBMs Should Worry About the Growth of Hospital-Owned Specialty Pharmacies .... In 2016, 8.7% of hospitals had a specialty pharmacy operation. Larger hospitals were much more likely to have a specialty pharmacy than were smaller hospitals. Nearly half (47.1%) of the hospitals with more than 600 beds operated a specialty pharmacy .... Drug Channels/Adam Fein

9/14 Gottlieb to Restructure Orphan Drug Process
FDA Moves To Guard Against Abuse Of 'Orphan Drug' Program .... Gottlieb announced plans to close a loophole that allows manufacturers to skip pediatric testing requirements when developing a common-disease drug for orphan use in children .... Kaiser Health News

9/14 Value-Based Contracting Not Really Changing Market Dynamics — Outcomes Tracking Too Difficult and Expensive
Drug Companies Tie Costs to Outcomes .... Interviews with the drug companies and insurers suggest there is little evidence that outcomes-based contracts are bringing down drug prices.... Information provided by the companies shows little money changing hands as a result of the contracts .... WSJ

9/14 State Legislatures Whacking at PBMs
Drug Plans Are Fighting States to Keep Prices in the Dark .... The California fight is just one battle in a nationwide struggle between lawmakers who want more light on drug plans' practices and the companies, who say that increased regulation will disrupt their ability to seek lower drug costs .... Bloomberg

9/14 Science is Sloppier (and More Biased) Than You Think
Discrepancy between trial goals, results may mask treatment risks .... More than one-third of the 113 clinical trials researchers examined for the study were never registered. Only 64 of the trials, or 57 percent, were published. One in five trials didn't define a primary outcome, or clear protocols for determining if the tested treatment had achieved its main goal .... Reuters

9/14 Cosentyx Delivers Long Term Efficacy; 44% of Patients Get Lasting Completely Clear Skin
Novartis touts 5-year Cosentyx data as it works to hold top spot in psoriasis .... Novartis said Cosentyx responses remained steady from year 1 to year 5, with 89% and 69% of patients scoring at a PASI 75 or PASI 90, respectively .... Fierce Pharma

9/14 'Bedside' Manner Key to Doc Approval; Long Waits a Strong Negative
What Makes People Like (and Dislike) Their Doctors? .... Patients review providers positively when they project warmth, knowledgeability and empathy. On the other hand, negative reviews are more likely to be associated with long wait times and battles with insurance .... Priceonomics

9/14 ICER Second Downgrade of Repatha Value
ICER analysis latest salvo in debate over Repatha price .... In an updated analysis of a previously published report, the Institute for Clinical and Economic Review revised down its value-based price benchmark for Repatha to between $1,725 and $2,242 a year -- a steep discount to the drug's current annual list price of near $14,500 .... BioPharma Dive

9/14 Internet Drug News Fast Takes:
Amicus's Scioderm Deal Flops as Skin Drug Fails in Phase 3
xconomy
The great nutrient collapse
Politico
Former CDC chief launches $225 million global health initiative
Washington Post via Chicago Tribune
Study Linking Early Miscarriage to Flu Vaccine Puzzles Doctors
NBC News
Facebook held a special breakfast for drug marketers about recruiting people for clinical trials
CNBC
Fitbit CMO Tim Rosa: 'We know consumers don't want the internet on their wrists'
MM&M

9/13 The End of Phase I through Phase III? Gottlieb Has Big Plans for FDA
WATCH: Scott Gottlieb vows to shake up the FDA, backing a trend toward faster drug development .... Gottlieb committed the FDA to backing up more efficient drug development programs with new measures to clear the regulatory path for developers barreling ahead to relatively swift pivotal data in search of an accelerated OK .... Endpoints

9/13 Biosimilar for Rituxan Files with FDA
Novartis says biosimilar rituximab accepted for review by FDA .... Rituximab, made by Novartis' unit Sandoz, has been proposed as a biosimilar to Roche's reference medicine Rituxan .... Reuters

9/13 Small Group of Docs Writes $1 Billion in Acthar Gel Scripts a Year, Almost All to Medicare/Medicaid
Expensive drug driving up Medicare expenditures without evidence of greater efficacy .... Medicare spent more than $1 billion over a five-year period on a high-priced drug that has not been proven more effective for a collection of inflammatory conditions than much less expensive corticosteroids .... Oregon State University

9/13 It's Better in Boston, Alexion Says
Alexion to Cut Workforce by 20%, Shift Headquarters to Boston .... Moves follow a management shake-up resulting from a controversy concerning sales practices .... WSJ

9/13 Akathisia, a Common SSRI Side Effect, Leads to Plaintiff Win in Suicide Case
Lawsuit Over a Suicide Points to a Risk of Antidepressants .... A group of psychopharmacologists who reviewed over 100 studies found the reported rate of what they broadly called "jitteriness/anxiety syndrome" -- which they defined as a worsening of anxiety, agitation and irritability -- ranged from 4 percent to 65 percent among patients initiating treatment with selective serotonin reuptake inhibitors, or S.S.R.I.s, the popular class of antidepressants to which Paxil belongs .... NY Times

9/13 Radicava Termed "Mediocre and Costly"
Facts about the new ALS drug Radicava that you're unlikely to see in news stories .... While Radicava was FDA-approved in May for all ALS patients to help slow disease progression, it will probably only help a small percentage of them--roughly 7% of patients--who fall into a specific set of symptom characteristics .... Health News Review

9/13 Sanofi Wants to Pull a Silk Purse Out of a Sore Nose
Sanofi indicates dupilumab could be used to treat nasal polyps .... Asked if nasal polyps would be dupilumab's next use, Sanofi's chief executive Olivier Brandicourt replied: "We are in phase 3 (trials) so it is difficult to give you any insight there but, clearly, (nasal polyps) is one of those comorbidities." .... Reuters

9/13 Oncologists' Tweets Lack COI Disclosures
Doctors who take pharmaceutical money use Twitter to hype drugs .... Of the 156 hematologist-oncologists in the study, 81 percent mentioned at least one drug from a company that gave them money, and 52 percent of their tweets mentioned the conflicted drugs .... Reuters

9/13 Brexanolone Stumbles in Super Refractory Status Epilepticus Trial
All Eyes on Depression Trials as Sage Neuro Drug Flunks Epilepsy Test .... Brexanolone didn't fare much better than a placebo at helping wean patients in its trial off of anesthetics, and stay off of them without suffering another seizure for at least 24 hours. In the study, 43.9 percent of patients on brexanlone were successfully weaned off other drugs, compared to 42.4 percent of those on placebo .... xconomy

9/13 AARP Analyzes Senior "Market Basket" for Prescriptions; One Specialty Drug (Avg: $52,486) is 3x Avg Social Security Benefit
AARP: Specialty drug retail pricing escalates .... For the specialty drugs examined in the study, retail prices jumped by an average of 9.6% between 2014 and 2015, the highest increase since at least 2006.... Though retail prices for generics declined overall in 2015, 11% of generic drugs experienced price gains, with some topping 100% .... Chain Drug Review

9/13 Big Raise for 23andMe; Skunk Works Investigating Oncology, Skin Conditions Based On Gene Info
23andMe Is Mining Your DNA For The Next Big Drug. It Just Raised $250 Million .... The round, led by Sequoia Capital, will help 23andMe reach more new customers and double down on its efforts to develop drugs based on customers' genetic data. .... Buzzfeed

9/13 Internet Drug News Fast Takes:
Apple is working with Stanford and American Well to test whether its watch can detect heart problems
CNBC (autoplay video)
Hospital Watchdog Gives Seal of Approval, Even After Problems Emerge
WSJ $$
Meningitis B Vaccine's High Price Tag Poses A Health Care Conundrum
Kaiser Health News
A Billion Here, A Billion There: Selectively Disclosing Actual Generic Drug Prices Would Save Real Money
Health Affairs blog

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