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Pharmaceutical News Harvest (TM)

10/17 Fast Takes
Regeneron-Sanofi drug succeeds mid-stage study
Merck targets high-risk military veterans for hepatitis C lessons
Fierce Pharma
Roche kicks antibiotic development into Warp Drive
BioPharma Dive
Report: Trump's Pick for Drug Czar Helped Hinder Opioid Crackdown
Daily Beast

10/17 Mind Blowing Unintended Consequences Of California Price Law
- Hospitals and pharmacies will benefit, not John Q. Public
- 60 day price hike warning will crater supply chain dynamics
California! SB17 Will Trigger Massive Speculative Buying, Windfall Pharmacy Profits, and Supply Chain Disruption … mandating advance notice of price increases will benefit pharmacies and hospitals, not third-party payers. The new law also ignores what we've learned from the wholesale channel's evolution more than a decade ago … [Drug Channels]
Editor's Note: Dr. Fein is to the pharma industry as Albert Einstein was to physics; he's never wrong.

10/17 Whistleblower: Congress Undermined DEA To Help Pharma Industry
60 minutes report reverberates in Washington; Trump appointee may lose out
- Certain DEA officials pooh pooh accusations
The Drug Industry's Triumph Over The DEA … virtually impossible for the DEA to freeze suspicious narcotic shipments from the companies … Congress, allied with the nation's major drug distributors, prevailed upon the DEA and the Justice Department to agree to a more industry-friendly law … [Washington Post]
DEA responds to explosive "60 Minutes" report about opioid crisis  … 46 investigators, attorneys and supervisors from the DEA, including 32 directly from the division that regulates the drug industry, have been hired by the pharmaceutical industry since the scrutiny on distributors began … [CBS]
The government's shameful role in the opioid crisis … [Washington Post]

Novo's Weekly GLP1 Jab Ready To Face FDA Panel;
Beat Trulicity In Head-to-Head Trial, Retinopathy could be concern
- Retinopathy stats don't worry analysts
FDA digs into semaglutide CV benefits, eye safety ahead of Novo Nordisk drug's panel review …  semaglutide beat Trulicity in a head-to-head trial, boosting its prospects when and if it can make its market debut. … semaglutide patients who suffered several of complications was more than double those on placebo  …[Fierce Pharma]

Judge Rebukes Allergan Scheme To Transfer Patent Rights To Mohawk Tribe,
Invalidates Patents
- Generic could arrive as early as 2019
Patents For Restasis Are Invalidated, Opening Door to Generics … "Sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities … [NY Times]
Judge invalidates Allergan patents and criticizes deal with the Mohawks …Federal judge invalidated the patents on its Restasis eye treatment, the latest twist in a captivating controversy over the fate of the best-selling medicine … [Pharmalot]

Report: Docs Who Take Pharma Money More Likely To Write Brand Name
Doctors With Strong Financial Ties To Pharma Are Found More Likely To Prescribe Brand-Name Drugs … A small number of doctors take a whole lot of money -- hundreds of thousands of dollars … The stronger a physician's financial relationship with industry, the more likely that physician will be to prescribe expensive brand-name

10/16 Fast Takes
We may soon have our first $1 million drug. Who will pay for it? And how?
Janssen Announces Approval of Stelara® (ustekinumab) for Adolescent Plaque Psoriasis
Jannsen Preee Release
FDA advisory committee backs Aerie's Rhopressa glaucoma drug
Drug Delivery Business
With a year left before generics hit, Pfizer nabs FDA approval for new-and-improved Lyrica
Fierce Pharma

10/16 AZN CEO: Certain Data For Experimental Cancer Drug Acalabrutinib Was Faked
- One of 25 clinical trials found to be faked by dishonest researchers
Cancer drug study data was falsified, says AstraZeneca … under ­development for treating blood cancers and solid tumours. More than 2,000 patients are taking part in more than 25 acalabrutinib clinical trials … early lab study supporting a cancer drug bought by British drugmaker AstraZeneca was falsified, the company has admitted … [Telegraph]

60 Minutes Lambastes Drug Industry, Distributors Regarding Opioids
- Cardinal, McKesson, AmerisourceBergen shares hammered
Drug Distributors Fall Ahead of '60 Minutes' Report on Opioid Crisis … Joint '60 Minutes,' Washington Post story to air Sunday … details how the Drug Enforcement Administration's efforts to address the outbreak that has led to thousands of overdose deaths was undermined and derailed. A story will simultaneously appear in the newspaper …[Bloomberg]

Incyte Claims Staffer Stole Drug Secrets For Billion Dollar Cancer 
Drug That Benefited Bristol Myers
That $1.25B Bristol-Myers IDO1 drug? Incyte claims a former staffer stole it … claimed that Jordan Fridman, a scientist in its ranks, had systematically lifted its IDO1 cancer drug secrets before making his way to Flexus … [Endpoints News]

Congress' Personal Pharmacy Claims: Some Lawmakers Take Alzheimer's Meds
An old-school pharmacy hand-delivers drugs to Congress, a little-known perk for the powerful … 800 prescriptions leave its doors every day, filled by some three dozen pharmacists, technicians, and support staff … Washington's oldest community pharmacy, Grubb's … Wow, they're making the highest laws of the land and they might not even remember what happened yesterday.'" …[Stat]

Mohawk Tribe Fights Back In Bid To Shield Allergan's Restatsis  Patent
- Claim proposed bill to abort patent babysitting violates their sovereign rights
How Racism Is Fueling a Pharma Scandal Over a Billion-Dollar Patent … tribe has accused McCaskill of enforcing a "double standard." … "It is cruelly ironic that Indian tribes, with the highest unmet health care needs in the entire country, are being attacked for exercising their sovereign obligation … [Newsweek]
STAT Plus: Mohawks argue Allergan patent deal doesn't deserve Senate scrutiny … government "should not force Indian Country to bear the consequences of partisan disagreements about how to control drug prices and deliver affordable healthcare [Pharmalot]

Why Express Is Buying Benefits Manager For $3.6 Billion
Express Scripts drops $3.6B for healthcare management company … pharmacy is an industry with approximately $400 billion in annual spend. Healthcare spend represents nearly $3.4 trillion.  … eviCore, which employs about 4,000 and manages medical benefits for 100 million people, to operate as a standalone business under its new ownership … [Biopharma Dive]

10/13 Nuedexta Widely Prescribed in Nursing Home for Dementia and Alzheimer's
The little red pill being pushed on the elderly .... The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe .... Reuters

10/13 If You Only Read One Article This Week, Make It This One
How the Elderly Lose Their Rights .... Guardians can sell the assets and control the lives of senior citizens without their consent—and reap a profit from it .... The New Yorker

10/13 Waiting Room Ad Company Appears to be Cheating Advertisers
Outcome, a Hot Tech Startup, Misled Advertisers With Manipulated Information, Sources Say .... Some Outcome employees provided inflated data to measure how well ads performed, created documents that inaccurately verified that ads ran on certain doctors' screens and manipulated third-party analyses showing the effectiveness of the ads .... WSJ$$
See also: In-office medical advertising startup Outcome Health reportedly misled advertisers [Techcrunch]

10/13 Panel Endorses Luxturna (Gene Therapy) 16-0
FDA experts offer a unanimous endorsement for Spark's pioneering AAV gene therapy for blindness .... An approval here could well be the first of many to come, as a group of players advance treatments that use a benign virus to introduce a corrected gene to fix a wide range of conditions .... Endpoints News

10/13 Merck Ends Work on Cholesterol Treatment
Merck Will Not Seek Approval for CETP Inhibitor Anacetrapib .... Detailed data from a large phase III cardiovascular outcomes study (REVEAL) announced in August showed that anacetrapib and a statin reduced the risk of major coronary events (composite of coronary death, myocardial infarction and coronary revascularization) by 9% relative to placebo .... Zacks

10/13 Extended Release Lyrica
With a year left before generics hit, Pfizer nabs FDA approval for new-and-improved Lyrica .... A once-daily tablet, Lyrica CR is now cleared to treat pain caused by shingles or diabetic peripheral neuropathy, though not for fibromyalgia as the original Lyrica formula is, according to a Thursday release .... Fierce Pharma

10/13 Dsuvia, a Painkiller, Gets CRL
FDA rejection blocks another AcelRx drug from US market .... The agency explained in a complete response letter how it needed more safety data on the maximum dose of Dsuvia included in the drug's proposed label. The FDA also suggested changing the administration instructions to make them clearer .... BioPharma Dive

10/13 Horizon Succeeds by Focusing Krystexxa on More Severe and Treatment-Resistant Gout
Krystexxa shows signs of life as Horizon keeps pushing sales force expansion .... Horizon execs are celebrating the delayed implementation of changes to Medicaid 340B, a program shift that would cost the company a one-time step-down that would wipe out about a quarter of Krystexxa sales, with certain hospitals reimbursing at just one cent per vial .... Fierce Pharma

10/13 City Council Measure Mandates Breaks for Pharmacists
Chicago moves closer to easing pharmacist workload .... The measure that would allow Chicago pharmacists to fill prescription orders for no more than 10 patients per hour, as well as guaranteeing meal and washroom breaks. .... Chicago Tribune

10/13 23andme Deep Dive: History and Prospects
The rise and fall and rise again of 23andMe .... With more than 2 million customers, the company hosts by far the largest collection of gene-linked health data anywhere. It has racked up 80 publications, signed more than 20 partnerships with pharmaceutical firms and started a therapeutics division of its own .... Nature

10/13 Internet Drug News Fast Takes:
Jamp;J Blames Jury Misconduct for $417 Million Talc Verdict
Bloomberg (reg.)
As Power of Name Brands Wanes, CVS Is Betting On Private Labels To Revive Sales
Johnson & Johnson files U.S. marketing application for prostate cancer med apalutamide
Seeking Alpha
NIH partners 11 drugmakers to accelerate cancer therapy research
Workers at smaller companies less likely to be screened for cancer
American Cancer Society

10/12 FDA Workup Pre Panel Supports Rhopressa
Aerie's glaucoma drug effectively lowers eye pressure: FDA review .... The FDA agrees with Aerie's overall conclusion that Rhopressa, when given once a day, effectively lowers pressure inside the eye.... the agency said the product was less effective when given twice a day in people with the highest pressure .... Reuters

10/12 Small Ruckus Ensues When Pharmacy Implies Some in Congress are Treated for Alzheimer's
An old-school pharmacy hand-delivers drugs to Congress, a little-known perk for the powerful .... Nearly every day for at least two decades pharmaceutical drugs have been brought by the carload to the Capitol — an arrangement so under the radar that even pharmacy lobbyists who regularly pitch Congress on their industry aren't aware of it. The deliveries arrive at the secretive Office of the Attending Physician, an elaborate medical clinic where Navy doctors triage medical emergencies and provide basic health care for lawmakers who pay an annual fee of just over $600 .... Stat
10/12 Patients Feel Safer with Full List of Risks Rather than Abbreviated List of the Most Severe Risks
DTC Drug Ads: New Study Finds Perception of Risks Diluted by Lengthy Side Effects List .... Subjects that heard the shorter version of the ad with fewer minor side effects rated the drug to be riskier than those who heard the full list, "suggesting that the mention of the minor side effects diluted the perception of the overall severity of the side effects." .... Regulatory Focus

10/12 Why Exactly Did Express Scripts Buy Evicore?
Express Scripts' $3.6 billion deal is 'a necessity' to fend off competition .... Beyond the competitive pressure from new entrants and old rivals like CVS and UnitedHealth's Optum Rx, Express Scripts faces a major contract headwind in 2019. That's when it is expected to lose health insurer Anthem as a customer.... [ESRX] also faces four other key renewals with large regional Blue Cross/Blue Shield insurers in 2019 .... CNBC

10/12 Top Ten Branded Medications for 2016, as Compiled by Quintiles
Humira Again Top-Selling Drug In U.S. .... Spending on Humira, an anti-inflammatory, has tripled from $4.5 billion in 2012. It is the fifth straight year Humira topped the list of all drug sales. Levothyroxine, for thyroid conditions, was the most commonly prescribed drug, as it has been for each of the 5 years .... WebMD

10/12 Big Pharma Not Sure They Have Enough Money to Develop the Next Generation of Medicines
What keeps pharma execs up at night? Apparently a lot, says new report .... Even if a drug gets commercialized (only 1 in 10 do), estimates say the manufacturer still spent about $2 billion to $2.5 billion to develop it in the first place. Accessing enough capital to fund such research has become another key focus, and dilemma .... BioPharma Dive

10/12 Tardive Dyskinesia Market Exceeding Expectations; Docs Favor Ingrezza
New Neurocrine, Teva meds win doctors' praise, fueling bigger sales expectations .... Surveyed doctors projected a market split in Ingrezza's favor—66% to Austedo's 34%—once the meds reach peak penetration .... Fierce Pharma

10/12 Relugolix, in Trials, Reduces Estrogen in Women and Testosterone in Men
This drug may be able to treat both women's health disorders and prostate cancer .... Myovant's Relugolix could be effective in uterine fibroids, endometriosis and prostate cancer, diseases with large markets .... Marketwatch

10/12 Tough Days at Trevena; Company Will Double Down on Olinvo
Battered by mixed PhIII data, Trevena axes R&D staff and hunkers down around lead pain drug .... Twenty-one staffers largely from the research arm are being cut — 30% of its total workforce. And chief scientific officer Michael Lark is headed to the exit as well in mid-December .... Endpoints News

10/11 Internet Drug News Fast Takes:
Trump names Eric Hargan as acting Health Secretary
Big Pharma Gets Boost as China Speeds Up New Drug Approvals
Health insurers, hospitals and generic-drug makers ask Congress to examine Allergan patent deal
A picture of you, in federal data
Research identifies brain chemical abnormalities in earliest stage of psychosis
Biological Psychiatry

10/11 Pfizer to Sell Off Consumer Brands Like Centrum, Advil; Nestle Touted as Possible Buyer
Pfizer weighs $15 billion sale of consumer healthcare business .... Pfizer's consumer healthcare business, whose brands include painkiller Advil and lip balm Chapstick, had revenue of about $3.4 billion in 2016. Industry experts said it could fetch some four times sales .... Reuters

10/11 Rules of the Formulary Game Might Be Rewritten in the Third Circuit
Shire, Pfizer antitrust lawsuits could rewrite the rules for formulary contracts: report .... [Bernstein analyst Ronny Gal] predicts that if the verdicts go against bundling and other common practices, it will be a net negative for large incumbents that are set in their ways. But such decisions would likely help new entrants to well-established markets .... Fierce Pharma

10/11 Ph 3 Verzenio Offers No OS Improvement in NSCLC; Trials Continue
Lilly's breast cancer drug fails to help lung patients .... Lilly's recently approved breast cancer drug failed to meet a late-stage trial's main goal of improving overall survival in patients with non-small cell lung cancer .... Reuters

10/11 FDA Releases Adverse Events Watch List
Cancer Drugs Dominate New FDA Watch List .... The seven cancer drugs on the latest watch list are imiquimod cream, alemtuzumab, imatinib (Gleevec, Novartis), pomalidomide (Pomalyst, Celgene), docetaxel, and two programmed cell death 1 (PD-1) inhibitors: pembrolizumab (Keytruda, Merck) and nivolumab (Opdivo, Bristol-Myers Squibb) .... Medscape (Reg.)

10/11 EviCore, a Healthcare Benefits Management Company Bought by ESRX
Express Scripts to Buy Medical Gatekeeper for $3.6 Billion .... Express Scripts will pay $3.6 billion to acquire closely held EviCore Healthcare, a company that preapproves scans and other costly medical tests for health plans .... Bloomberg

10/11 $1 Million Eye Treatment Before FDA Panel
Spark Therapeutics faces a grilling as FDA ponders a pioneering OK for gene therapy .... At the top of the heap of considerations are questions about the durability of this eye therapy, the possibility that patients will need multiple treatments in order to preserve vision gains, the right age to use it and the use of a completely novel endpoint for the primary goal when standard visual acuity achievements fell far short of the goal on statistical significance .... Endpoints

10/11 Startups Play Where the Sun Doesn't Shine
Here's how a loophole in a transparency law can distort medical practices .... A company is not required to report payments if it does not yet market a medicine approved by the Food and Drug Administration. This means that a slew of small companies can fly under the radar as they line up allies in the medical community on their way to the marketplace .... Pharmalot/Stat

10/11 Paul Hanly Taking Another Charge at the Painkiller Makers
A veteran New York litigator is taking on opioid makers. They have a history .... When Hanly was asked whether he foresaw the full extent of the opioid crisis from his earlier work, he said one development that surprised him was that "other drug companies would be so foolish as to adopt essentially the same marketing tactics that Purdue had adopted." .... Stat

10/11 Price Competition Anticipated in Certain Cancer Classes (ie PARP Inhibitors)
Cancer-Drug Prices Are at a Tipping Point .... A set of three different cancer drug classes are set to face price competition in the coming years .... Bloomberg

10/11 Zilretta — Extended Release $570 Injection for Knee Arthritis; First FDA Approval for Biotech
Flexion secures US approval for osteoarthritis drug .... The drug, which will be marketed as Zilretta, combines the commonly used corticosteroid triamcinolone acetonide with a drug delivery system designed to provide extended pain relief over three months .... BioPharma Dive

Tweet of the Day

10/11 Internet Drug News Fast Takes:
Doctors may fear losing their license for seeking mental health care
Health-care workers in short supply, forcing employers to chase talent with sweeter rewards
CNBC (autoplay video)
The Painful Side Of Positive Health Care Marketing
NPR Shots Blog/KQED
FDA Commissioner Wants Closer Look at Health Claims on Packaging; Prefers to Stay in Current Job

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