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Next update: Tuesday, February 21

2/17 $504 Million for Acthar Gel in Part D? How Did That Happen?
We dug into the drug company Martin Shkreli sold out to the feds, and man is it ugly .... The main problem Acthar is supposed to treat afflicts infants, but the program that is spending hundreds of millions of dollars on it is Medicare Part D, which assists elderly people. Looking at the numbers, you're left with more questions than answers .... Business Insider

2/17 Retail Clinics Joining Insurance Networks; Health Systems Opening Own Urgent Care Facilities
Retail Clinic Check Up: CVS Retrenches, Walgreens Outsources, Kroger Expands .... Clinic growth stalled in 2016. From 2010 to 2015, the number of retail clinics grew by nearly 70%, to more than 2,000 locations. As of January 2017, the number of retail clinics was unchanged compared from the 2016 .... Drug Channels/Adam Fein

2/17 Critics Think 21st Century Cures Was a Step Backward
21st Century Cures Act Lowers Confidence In FDA-Approved Drugs And Devices .... Section 3037 of the statute provides a safe harbor for the promotion to payers of off-label health care economic information, as long as the information relates to an approved indication of a drug. In effect, this provision allows drug manufacturers to promote to payers economic information, including clinical data, about uses of drugs that go beyond product claims within the FDA-approved label .... Health Affairs

2/17 Soliris Looks Maxed Out; Kanuma Has No Traction
Alexion Needs New Bets .... Soliris is expected to pass $3 billion in revenue next year, but the drug is not immune to setbacks. Further sales growth may depend on extending its use, and the drug missed goals in two different trials last year .... Bloomberg Gadfly

2/17 Fear of Senior Stupor
More U.S. seniors taking multiple mind-altering drugs .... Nationwide, the number of annual doctor visits involving patients 65 and older who started or were already taking at least three psychotropic drugs surged from 1.5 million in 2004 to 3.68 million in 2013 .... Reuters

2/17 Prospects for Emicizumab
Roche gears up to enter loaded hemophilia A drug market .... Investors have predicted blockbuster status for emicizumab. They believe the primacy of Shire's hemophilia portfolio could be challenged by the new contender. With the hemophilia market rumored to be in the $11 billion range, the payout potential is huge. .... MM&M

2/17 Xeljanz on the Way to Blockbuster Status Despite Missed Indications, But Humira Far Ahead
Pfizer's solo Xeljanz can't match AbbVie's Humira in big RA head-to-head miss .... Xeljanz, one in a new class of JAK inhibitors, has matched Humira when both drugs were paired with methotrexate. On its own, though, Xeljanz didn't measure up to the world's best seller, missing the study's primary endpoint of non-inferiority. .... Fierce Pharma

2/17 Flu Vaccine This Year About Average; Better Than 2014–2015
CDC: Current Flu Shot's Effectiveness Pegged at 48% .... In the 2016-2017 season, the percentage of deaths from pneumonia and influenza ranged from 5.6% to 7.9% of all U.S. deaths, which exceeded the epidemic threshold for three weeks in January .... Medpage Today

2/17 Meet the 'Association for Accessible Medicines'
Generics trade group rebrands, emphasizing 'accessible' medicines .... The trade group will also have a new chairman. Jeff Watson, who heads Apotex's global generics business, will succeed Mylan's CEO Heather Bresch, who has been in the spotlight over the EpiPen pricing controversy. .... BioPharma Dive

2/17 The Art of the Deal Gone Sour
Behind the scenes of J&J's $30B Actelion buyout: Walkouts, Sanofi's blunder and a $230M sweetener .... Even though the two final bids were almost equivalent, Actelion decided to stick with J&J CEO Alex Gorsky, who they trusted more, and Sanofi was shoved away for the last time .... Endpoints

2/17 Actually Pharma-Related: CRISPR Will 'De-Extinct' the Mammoth — But Will It Have Friends?
Woolly mammoth on verge of resurrection, scientists reveal .... "De-extincting" the mammoth has become a realistic prospect because of revolutionary gene editing techniques that allow the precise selection and insertion of DNA from specimens frozen over millennia in Siberian ice. .... Guardian

2/17 Internet Drug News Fast Takes:
Medicaid expansion possibly reduced 'medical divorces'
University of Kansas
Trump's pick to lead health agency calls EpiPen issue 'disturbing'
Doctors May Be Able to Predict Autism Risk Much Earlier
Michigan Blues to cover only generic version of EpiPen allergy reaction drug
Crain's Detroit Business
CVS's decision to stop selling cigarettes improved nation's health
Drug Store News

2/16 National Health Expenditures Will Continue to Outpace Inflation; Will Hit 20% of Economy
National Health Expenditure Projections, 2016–25: Price Increases, Aging Push Sector To 20 Percent of Economy .... Growth in national health expenditures through 2025 is projected to average 5.6 percent, outpacing average growth in gross domestic product by 1.2 percentage points .... Health Affairs

2/16 East Coast–West Coast CRISPR Feud Ends With East Win
Broad Institute prevails in heated dispute over CRISPR patents .... The US patent office has ruled that hotly disputed patents on the revolutionary genome-editing technology CRISPR-Cas9 belong to the Broad Institute of Harvard and MIT, dealing a blow to the University of California in its efforts to overturn those patents .... Stat News

2/16 Specialists Write More Expensive Drugs
Cost of skin creams and ointments may depend on who gives prescription .... Dermatologists and other specialists are three times more likely than primary care providers to prescribe brand name versions of drugs known as topical immunomodulators, which includes treatments such as corticosteroids, calcineurin inhibitors and vitamin D analogs .... Reuters

2/16 Big Pharma Doesn't Want to Blow Up FDA Approval System Either
Pharma industry shuns Trump push for radical shift at FDA .... During high-level discussions with Trump advisors, drug industry lobbyists urged the administration not to name a new commissioner of the Food and Drug Administration who would act rashly to speed up the agency's approval of new medicines .... Reuters

2/16 Site Digs Up Manufacturer Info for Emflaza (deflazacort), the $89,000 DMD Treatment
Will a Spanish drug, retailing for under 10 euros, get sold in the U.S. for $89,000/year? .... While Marathon got approval for the 6 mg, 18 mg, 30 mg and 36 mg tablets along with an oral suspension containing 22.75 mg/mL of the active substance, Faes Farma markets the 6 mg and 30 mg tablets along with the oral suspension of the same dosage strength in Spain under the brand name, Dezacor .... Pharma Compass

2/16 PhRMA Fixing to Kick Out Marathon
Pharma Lobby May Boot Company That Introduced High-Priced Drug .... Marathon's "recent actions are not consistent with the mission of our organization," Steve Ubl, chief executive officer of PhRMA, said in an e-mailed statement .... Bloomberg

2/16 Liquid Biopsy Market Projections: $20–100 Billion
Liquid biopsies: The next frontier in cancer? .... One immediate challenge with liquid biopsies is detection. Circulating tumor DNA is relatively rare compared to the number of hematological molecules found in a blood sample. Circulating tumor cells are even less common .... BioPharma Dive

2/16 Valeant's Siliq Approved for Psoriasis
FDA approves new psoriasis drug .... Siliq's active ingredient (brodalumab) binds to a protein that causes inflammation, inhibiting the inflammatory response that plays a role in the development of plaque psoriasis. ....

2/16 Table of Leading Rare Disease Drugs
Top 25 rare disease brands, by sales .... Ranked by 2016 sales .... MM&M

2/16 AMAG is Hiring
AMAG to hire 150 new sales reps to tout newly licensed women's health med Intrarosa .... The company plans to tout Intrarosa's safety profile to set it apart from established estrogen-based treatments such as Pfizer's Premarin cream and Estring vaginal ring .... Fierce Pharma

2/16 Bristol-Myers Took a Shot at Broader Indication for Opdivo, and Missed
How biomarkers cost Bristol-Myers the lung cancer market .... Bristol-Myers opted to target a broad patient population, hoping for the widest approval for Opdivo possible. It was suggested in early 2016 — that despite no data or approval in the first-line setting — physicians were already prescribing Opdivo off label to about 20% of first-line NSCLC patients .... BioPharma Dive

2/16 Internet Drug News Fast Takes:
Aetna CEO: Obamacare in 'Death Spiral'
Today in Obamacare: Trump's big new Obamacare regulation, explained
With Trump in Office, Senators Again Urge Importing Meds From Canada to Fight High Prices
Stat, via Real Clear Health
Questions Remain Over Suicide Death of Genentech Lobbyist
The Perplexing Psychology of Saving For Health Care
NPR Shots Health Blog

2/15 PBMs Want to Take a Hunk Out of Pharma (Before It Happens to Them)
PBMs launch attack on drug companies .... PCMA, a trade association for PBMs, has sent the Trump administration a list of proposals for lowering drug prices. With a few exceptions, it reads like a drug industry nightmare. The list includes reducing biologic exclusivity to seven years, eliminating pay-for-delay deals and ending tax deductions for expenses related to direct-to-consumer advertising .... Biocentury

2/15 Endpoints Runs the Numbers on What Marathon Spent to Bring $89,000 Deflazacort to Market
The scoop: Marathon's R&D program for Duchenne MD drug likely came in at a bargain basement price .... In shaping healthcare policy, Price always has physician interests in mind. “He will first and foremost look at how public policy will affect the practice of medicine,” according to Julius Hobson, a senior policy advisor in a Washington law firm .... Endpoints

2/15 Amyloid Hypothesis Takes Another Hit
Merck Stops Alzheimer's Study After 'No Chance' of Benefit .... Merck's drug and others target a plaque, called amyloid, thought to be a cause of the disease. While more such treatments are in development..., many researchers now believe that administering drugs after amyloid has built up in the brain may be too late .... Bloomberg

2/15 Affordable Care Act Made a Big Difference for Those with HIV
Obamacare significantly expanded insurance for people with HIV .... Nationwide, Medicaid coverage of people being treated for HIV rose to 42 percent in 2014, up from 36 percent in 2012, the year before the law went into effect .... Reuters

2/15 BMY Shares Moving on Chatter
Bristol-Myers Squibb: Takeover Target? .... Analysts have begun speculating about the possibility that Bristol-Myers could be a takeover target, and now we have rumors, reported by, that Roche, Novartis, and Pfizer are actively exploring a takeover, while Gilead Sciences might be considering the idea .... Barrons

2/15 Bictegravir Matches Tivicay; 97% Virus Suppression
Gilead challenges GSK with strong HIV drug data .... Gilead's bictegravir, another so-called integrase inhibitor drug, delivered 97 percent virus suppression, making it just as effective as GSK's dolutegravir .... Reuters

2/15 Patient Groups Don't Want to Blow Up FDA Approval System
Often Advocates of Faster FDA, Patient Groups Wary of Trump Deregulation .... As for a more moderate, "ramp it up faster" approach to drug evaluation, "it seems like it's already faster...." The perception of the FDA as a bottleneck changed under President Obama's first FDA commissioner, Margaret "Peggy" Hamburg, who oversaw new programs to streamline reviews and—of no small importance—helped boost the agency's budget .... xconomy

2/15 How Will Price Run HHS?
Price will defer to physicians, says ex-AMA lobbyist who's known him since '94 .... In shaping healthcare policy, Price always has physician interests in mind. “He will first and foremost look at how public policy will affect the practice of medicine,” according to Julius Hobson, a senior policy advisor in a Washington law firm .... MedCity News

2/15 Will Perjeta Be Effective Enough to Take the Place of Patent-Expiring Herceptin?
Roche fights Roche in bid to preserve $9 billion drug business .... For the test, dubbed Aphinity, Roche has added a drug called Perjeta to the Herceptin regimen widely used after breast surgery, and success would likely bolster sales of both. About 70% of Roche's $6.8 billion in Herceptin revenue last year came from patients who might benefit from the combination being tested .... Bloomberg

2/15 A Lot of Shouting About Price Increases, But a Look at the Numbers Show Utilization is Climbing Too
Express Scripts Reveals What Really Drives Drug Spending—And Why the Government May Do No Better .... Utilization was a significant driver of spending. A major component of spending growth can be attributed to the growth in the number of people being treated and the number of prescriptions being dispensed. For 2016, utilization was a major factor behind drug pricing. The 7.1% utilization increase for specialty drugs was the major factor behind the 13.3% spending increase .... Drug Channels/Adam Fein

2/15 Loyalty Card Users Aren't Loyal Any More
Accenture finds shift in shopper expectations for loyalty programs .... Millions of loyalty points are sitting dormant, and the majority of U.S. consumers (78%) are retracting their loyalty at profit-crushing rates. In fact, 54% of U.S. consumers have switched providers in the past year .... Drug Store News

2/15 Internet Drug News Fast Takes:
Veterans Affairs secretary confirmed 100-0
Cigna ends merger with Anthem, sues for more than $14B
Fierce Healthcare
Humana becomes first major insurer to quit Obamacare exchanges
Where You Get Hurt May Depend on What State You're In
NBC News
J2 Global considers divesting parts of Everyday Health

2/14 Fast Takes
'Pharma Bro' Martin Shkreli invited to speak at Harvard University
Daily Mail
SEC plans to review some pharma industry accounting practices
Diabetes drugs pop on January's TV ad spending list, but AbbVie's Humira stays at the top
Fierce Pharma
China: Major Bird Flu Outbreak
Teva seeks CEO with pharma background to lead recovery efforts

2/14 Bernie Sanders, Elijah Cummings Excoriate Marathon
(The company with the $89K Corticosteroid Pill)
- Pharma websites Pharmalot, Endpoints News cited as proof sources in Congressional letter
Marathon CEO tries to call a time out on controversy as lawmakers rip into $89K deflazacort price …  "We believe that Marathon is abusing our nation's orphan drug program …  not [meant] to provide companies like Marathon with lucrative market exclusivity rights for drugs that have been available for decades … [Endpoints News]
Marathon backpedals on launching pricey drug after rebuke from Sanders … harshly worded letter, blasting Marathon for "unconscionable" pricing … benefits managers, which negotiate prices on behalf of health plans, the cost will drop from the $89,000 list price to $54,000 … [Pharmalot]
See Also: Click here to read Sanders/Cummings letter to Marathon CEO.

Allergan Continues Foray Into Beauty Medicine
- Buys company that claims it can remove love handles, double chins, chubby thighs
Botox-maker Allergan is betting that zapping your fat is worth $4 billion … Allergan's newest acquisition is the 'Botox of the body contouring market,' one executive said … non-invasive fat freezing product called CoolSculpt, which uses cold temperatures to target what the company calls "stubborn fat bulges …[MarketWatch]
Allergan is buying CoolSculpting provider Zeltiq for $2.48 billion … nonsurgical system cools fat cells to trigger their controlled elimination without affecting the surrounding tissue, according to …[LA Times]

Report: Gilead Ready To Acquire Someone
- Hep C drugs work so well, return customers are rare; they're running out of patients
- Incyte, Vertex names as possible targets
All Signs Have Gilead Gearing Up for a Much-Needed Acquisition … Speculating on who Gilead Sciences might or should buy is a hobby for many … issue is the company's faltering hepatitis C franchises, caused largely by the dichotomy of selling a drug that cures the disease … [BioSpace]

Sanofi Offloads Stable Of  OTC Meds For $88 Million
Drugmaker Ipsen to buy some products from Sanofi for 83 million euros … sale arose as part of a requirement from the European Commission to sell off certain assets from an earlier deal between Sanofi and German drugmaker Boehringer Ingelheim … [Reuters]

Purdue Lobbies Canadian Government For Pain Pill Monopoly
Purdue seeks rule that would give it edge in Canadian painkiller market … sells the only tamper-resistant, long-acting opioids in Canada, … urging government officials to enact a rule that would give it an effective monopoly on long-acting narcotic painkillers … [Reuters]

JNJ Settles 200 "Tylenol Damaged My Liver" Claims
J&J Subsidiary Settles in Tylenol Liver Damage MDL … claimed taking Tylenol caused liver damage--and in some cases death … litigation which began in 2013 was being prepared for trial … [Legal Intelligencer]

Here's Why Sanofi Is Confident It Will Prevail In PCSK9 Legal Battle
Praluent Maker Digs in for Long Battle … cited the example of statins -- the pioneer in that field, Merck, never asserted broad rights over the entire class. As a result, a variety of other statins were introduced … [MedPage Today]

Fast Takes
Humana places limits on coverage for $750K Biogen muscular dystrophy drug Spinraza (nusinersen)
Biopharma Dive
Sanofi confident in case to overturn Praluent ban
Biopharma Dive
Regeneron gets wrapped up in federal patient assistance investigation
Fierce Pharma
PBMs counter pharma's pricing blame with proposals to cut $100B in drug costs
Fierce Pharma

Proposed Georgia Law: 5 Day Supply Max For Certain Drugs
- ADHD kids would need 6 new prescriptions per months
Georgia bill would require new ADHD prescriptions every 5 days …  prescribers will only be able to write 5-day prescriptions and will have to review their patients in a database every 90 days. That would require getting a new prescription weekly … [CNN]
Editor's Note: We checked, it's not fake news.

Outrage Grows Against Privately Held Company That Raised Drug Price 6,000%
- Costs between $1K to $2K In Canada, will cost Americans $89K
Why Did That Drug Price Increase 6,000%? It's The Law … not only did Marathon have to go through the process of getting it approved as a new drug, but that it gets the benefit of laws Congress has passed to encourage drug companies to develop new medicines for rare diseases … [Forbes]
Marathon's cheap, old steroid breezes through the FDA for Duchenne MD, and gets priced at $89K … like other cases involving price gouging, the company went on to defend the price, saying that insurers will cover most of the price … [Endpoints News]
Marathon's Drug Pricing Is Playing With Fire … at a time when President Trump and others are focused on high prices, Marathon is creating substantial political and commercial risk for itself and its peers …[Bloomberg]

$89K Steroid Pill: Not The 1st Time Marathon CEO Mutilated Pharma's Reputation
- CEO Aronin no stranger to sticker shock pricing; in 2008 he faced FTC lawsuit alleging price gouging, illegal monopoly; FTC ultimately lost lawsuit
Marathon CEO, who was praised by Martin Shkreli, causes a new stink over drug pricing …  in 2014, Sanders wrote a letter to Aronin about the "escalating" prices for two life-saving heart drugs … On the day that Marathon bought Nitropress in December 2015, the company raised the list price from $5.45 to $214.83, and the list price for Isuprel climbed from $997.50 to $4,488.75 …[Pharmalot]

Senate Acts To Close Loopholes In Orphan Drug Laws
- Allegations that certain drug companies game the regulations to make lots of money
Grassley opens investigation into loopholes in orphan drug law … some drugs may have been submitted for FDA approval with the ultimate intention of being used more broadly than if they were designed only for the rare disease populations … [Pharmalot]
Related: Another biotech games the system, and everyone gets to pay for the fallout … [Endpoints News]

Expect To See More Cancer Drug Commercials
- Not everyone's happy
Merck's DTC ad for Keytruda hints at more cancer brands turning to TV … Before 2013, when the first Provenge DTC aired, it was unheard of for brands to use direct-to-consumer advertising for oncology drugs … actors portraying lung cancer patients playing with babies and watching Little League games" would be uplifting "if it weren't so utterly misleading and exploitative." … [Mm&M]

2/13 India Drugmaker Responds To Trump Rhetoric;
Plans Ramp Up Of U.S. Operations
Aurobindo Eyes U.S. Plant in New Jersey As Trump Calls for Local Drug Production …  India's fourth largest drugmaker … expecting to expand the New Jersey site to include manufacturing of injectables. Currently the site is used to make tablets … [BioSpace]

GSK Prepares For Advair's Rivals
GSK ready for Advair's rivals …  Advair and the possibility of a generic Advair have been a little bit of an obsession… U.S. patent on the Advair "Diskus" inhaler technology expired in August, and GSK's financial modeling includes provisions for a rapid decline in Advair sales … [News Observer]

Allergan Doubles Down On Double Chin Dissolving Drug
Allergan to boost investment in DTC for Kybella …  plans to increase its investment in DTC for its chin-fat reducing injection, Kybella, to "an even higher level," after the drug's sales slowed at the end of 2016 … [Medical Marketing & Media]

2/10 FDA Authorizes 99% of Single-Patient Access Requests; Drugmakers See Dangers
Dying Patients Have Pence's Backing on 'Right to Try' Policy .... Existing right-to-try state laws bypass FDA scrutiny as long as the drugs have completed early safety tests. Yet drugmakers don't like leaving the FDA out of the equation. They don't have to provide the medication under right-to-try regulations and they often decide not to .... Bloomberg

2/10 Brawl Over Drug Prices Will Catch PBMs in the Fray
The heat on pharmacy benefit managers is building .... The pharmacy benefit management industry is going to have a tough time explaining the value of its companies to the public, especially since their business model relies on secrecy and that consumers have little knowledge of what pharmacy benefit managers are .... Axios

2/10 Opioid Control Measure Makes ADHD Maintenance Impossible
Georgia bill would require new ADHD prescriptions every 5 days .... A bill meant to curb the abuse of prescription opioids in Georgia has stirred outrage in the ADHD community because a provision requires adults and children on medications for attention deficit hyperactivity disorder to get new prescriptions every five days. .... CNN

2/10 Since Targeted Oncology Meds Often Don't Need Large Trials, Why Can't They Be Brought to Market Without Big Pharma Overhead and Towering Prices?
Academics call time on $100,000 cancer drugs .... Rather than simply licensing discoveries to Big Pharma, academic groups should in future consider working with smaller companies that commit to capping prices, low-cost generic drug companies or non-profit organizations .... Reuters

2/10 Digital Health Startups Merge; Goals is Better Mgmt of Meds for Patients
GoodRx And Iodine Quietly Merge To Help Consumers Find The Right Drugs .... Since it was founded in 2013, Iodine has raised more than $2 million to develop a website and suite of free mobile apps that help consumers compare medications, communicate with each other, and track their side effects.... GoodRx lets consumers to compare drug prices at different nearby pharmacies to ensure they get the best price .... Fast Company

2/10 Emflaza Maker Hits Jackpot with DMD Approval, Priority Review Voucher, and Orphan Designation
An old steroid breezes through the FDA for Duchenne MD, a disease that has confounded developers .... Deflazacort won a priority review from the agency as a new therapy for Duchenne muscular dystrophy -- cutting 4 months off the regulatory process -- along with an orphan drug designation and rare pediatric disease status .... Endpoints

2/10 Dollar-a-Pill (in Canada) Deflazacort Will Cost $89,000/Year in U.S.
Northbrook company's muscular dystrophy drug wins FDA approval .... Deflazacort already is used to treat Duchenne outside the U.S., where it's approved for other uses. But until now it hasn't been widely available in the U.S. because it wasn't approved by the FDA. Duchenne affects about 15,000 boys in the U.S. .... Chicago Tribune

2/10 FDA, OMB, Puzzling Over Executive Orders
Trump's 'Two Out, One In' Regulatory Policy May Apply to Some FDA Guidance .... A look back at what significant regulatory actions were released from the US Food and Drug Administration (FDA) in the past year offers a glimpse of what types of regulations President Donald Trump and his EO will eliminate at FDA (Trump said last week he wants to cut 75-80% of all FDA regulations) .... Regulatory Focus

2/10 Promises Quick Updates on Safety Data
New FDA Database Ensures Timely Access to Drug Safety Labeling Changes .... Lest readers imagine that drug safety label changes are a rare event managed the FDA, numbers tell the real story: Between January 2015 and July 2016 more than 1,650 safety label changes were administered .... AAFP

2/10 Regeneron Prospects
Regeneron pins hope on eczema drug as Eylea sales slow .... Regeneron is betting on two key treatments -- Dupixent for eczema and Sarilumab for rheumatoid arthritis -- to diversify its revenue stream. A U.S. regulatory decision on Dupixent is expected by March, while the company hopes to resubmit a marketing application for sarilumab this quarter .... Reuters

2/10 Deep Dive into Reciprocal Approval of Drugs, and What It Would Mean for U.S.
New Data In The FDA Deregulation Debate .... Our historical review shows that rubber-stamping drugs approved elsewhere would have mainly benefitted a small number of U.S. patients with rare diseases, while likely exposing the wider population to additional safety risks .... Forbes/Frank David

2/10 Anthem's Machine Learning Algorithms Will Allow the Company to Deny Care, Reject Claims, and Tell Your Doctor What to Do on an Automated Basis
Machine intelligence: Technology mimics human cognition to create value .... As the system's continuous learning capabilities monitor how adjudicators successfully resolve issues over time, the system will correlate specific issues with proper courses of action to continuously improve its automated resolution accuracy and efficiency. .... Deloitte University Press

2/10 Internet Drug News Fast Takes:
The Next Big Brain Cancer Drug Could Come from Marijuana
Fortune (autoplay video)
AARP threatens to sue Trump administration over ObamaCare change
The Hill
Cancer genes hide outside chromosomes
San Diego Union Tribune (autoplay video)
GlaxoSmithKline and Gilead to face off at HIV meeting next week
Internal HHS Memo: Some FDA Employees Will be Exempt From Trump Hiring Freeze
Regulatory Focus

2/9 Praluent Gets Reprieve
Regeneron, Sanofi win stay of order blocking cholesterol drug sales .... A U.S. appeals court on Wednesday has stayed an order that would have blocked Regeneron Pharmaceuticals Inc and Sanofi SA from selling their cholesterol drug, Praluent, later this month while they appeal .... Reuters

2/9 Xarelto Study Halted Early; Drug Prevents Heart Attacks and Strokes for Those With CAD and PAD
Bayer's blood thinner also effective for artery disease .... The drug could potentially be used on 30 million patients with coronary artery disease or peripheral artery disease, in addition to the roughly 25 million patients it sees in the atrial fibrillation market .... Reuters

2/9 How Would an Obamacare Repeal Affect a Large Drug Chain?
Walgreens is just like the rest of us: In the dark about Obamacare's future .... The new administration just nixed a Health Resources & Services Administration recommendation that would have put new restrictions on the 340b Drug Pricing Program, which gives cheaper drugs to providers who care for low-income patients. Walgreens is the largest 340b pharmacy provider in the country.... The program represents "a pretty hefty chunk"--about 10 percent--of Walgreens' revenue .... Crain's Chicago Business

2/9 FDA Reviews French Sanofi Manufacturing Facility; Formal Inspection to Come
Sanofi Plant, Key to New Drugs, Wins Tentative U.S. Backing .... Two new experimental therapies slated for U.S. regulatory approval this year -- sarilumab for rheumatoid arthritis and dupilumab for a severe form of eczema -- are processed at the plant .... Bloomberg

2/9 Swipe Right for PrEP
Gilead to use dating sites, Tumblr, and Snapchat in Truvada strategy .... Using platforms like Tumblr and Snapchat may help the company raise awareness about the drug among a population of people who don't engage with the healthcare system in traditional ways.... Cities in which Gilead hopes to promote Truvada include New Orleans, Baltimore, Washington D.C., Oakland, and Newark. .... MM&M

2/9 Medicaid Expansion Fed Opioid Epidemic
Pharmacies Thrive Selling Opioids For Depressed Small Town Pain .... Drug manufacturers and distributors have pumped prescription opioid painkillers into rural America, in response to demand -- much from it from adults who had become physically addicted. The expansion of Medicaid through the Affordable Care Act increased the percentage of Clay County, Ky residents with Medicaid and gave more of them access to free prescription drugs, including pain pills .... Kaiser Health News

2/9 Deep Dive into Latest Express Scripts Drug Trend Report
Three kinds of drugs, like those that treat RA and diabetes, drive increase in spending .... Employers paid $3,587.83 for each inflammatory drug prescription, and patients covered by those plans paid $118.21 in out-of-pocket costs per year, a 26.5% spending increase compared to 2015.... Diabetes patients paid on average $108.80 [o-o-p] in 2016, a 19.4% increase from 2015. Oncology patients paid 21.5% more [o-o-p] in 2016, $60.70 compared to $49.50 in 2015 .... MM&M

2/9 Rundown of Legislative Proposals on Drug Prices
No Dearth of Legislation on Tackling High Drug Costs .... Some lawmakers have already introduced legislation or said they plan to introduce legislation on this issue .... Bloomberg BNA

2/9 Pundit Says All Pharma Should Take the Pledge — Limit Price Increases to < 10%
How Pharma Can Get Trump Off Its Back .... A 10 percent increase is still four times consensus U.S. inflation expectations for 2017. That's not much of a sacrifice. But it's the type of concession, if adopted broadly, that might let a very image-conscious president take a victory lap and leave the industry mostly alone .... Bloomberg Gadfly

2/9 Tesaro in Play
The next PARP buyout? Tesaro shares surge on latest buzz about a buyout .... With its PARP drug niraparib under review at the FDA, Tesaro has become one of the most frequently cited takeover targets in biotech, where promising late-stage assets can be hard to find .... Endpoints

2/9 Internet Drug News Fast Takes:
Lundbeck gives up on Alzheimer's drug, rival to Axovant pill
Tetraphase antibiotic could reach $700 million in annual sales
Sanofi creates vaccine growth in 2016 despite lifeless Dengvaxia launch
Fierce Pharma
Key Conservative Lawmaker Opens Door to Obamacare Insurer Payments
Morning Consult
New study finds Tamiflu 'cost-effective' in most pandemic scenarios
Drug Store News
'I know they are going to die.' This foster father takes in only terminally ill children
LA Times

2/8 Medicare Price Negotiation is Back in Play
Trump Sinks Pharma Stocks on Medicare Drug Price Negotiation .... Trump has given conflicting signals in the past weeks on whether he would let the government intervene directly in drug prices to reduce health-care costs. The Medicare program for the elderly is the biggest purchaser of health services in the country, and bidding for its business could have a major impact on Big Pharma's profits .... Bloomberg

2/8 Vigodman Gone from Teva
Teva CEO out, board chairman steps in as interim chief .... Generics giant Teva Pharmaceutical Industries has announced its chief executive Erez Vigodman would step down, to be replaced by the chairman of the board Yitzhak Peterburg on an interim basis .... BioPharma Dive
See also: The Pharma Job From Hell: Low Salary to Fix a Sinking Giant [Bloomberg]

2/8 Parsabiv Approved to Combat Serious Side Effect of Dialysis
FDA approves Amgen drug for secondary hyperparathyroidism .... The drug, etelcalcetide, will be sold under the brand name Parsabiv... it is the first new therapy approved for the condition in 12 years. It is designed to be administered intravenously three times a week at the end of a dialysis session .... Reuters

2/8 Gilead's Hep C Drugs Are Running Out of Patients; 50% Discounts Given Off List Prices
Gilead's Biggest Blockbusters Are Fading Fast, Biotech Warns .... Revenue from the company's drugs for the viral infection will be $7.5 billion to $9 billion in 2017, Gilead said in a statement. That's far below the $11.6 billion analysts had projected .... Bloomberg

2/8 CDC Sees Low Immunizations Rates; Suggests Reminders and Alert Systems
CDC Issues New Vaccine Guidelines for Adults .... Officials from the U.S. Centers for Disease Control and Prevention's advisory committee on immunization practices released new recommendations for hepatitis B, influenza and HPV vaccines today as part of its annual vaccination guidelines. .... ABC News (autoplay video)

2/8 FTC Charges ViroPharma for Legal Blitz Against Generic
FTC sues Shire ViroPharma for fighting generic entry of Vancocin .... ViroPharma flooded the agency with 46 petitions and other filings between 2006 and 2012, when a generic version was finally approved, the FTC said in its complaint. The FDA had been prepared to approve a generic version in 2010 but was slowed by the blizzard of filings by a full two years .... Reuters

2/8 Affordable Care Act Cut Unaffordable Prescriptions from 21% of Population to 18%
Study: Drug costs lead many people to forgo prescriptions .... About 45 million U.S. adults, or 18% of Americans over age 18, didn't fill a prescription last year because of high drug costs.... the percentage of adults not filling prescriptions because of cost in 2016 was 10% in Canada, 9% in Switzerland, 6% in Australia, 6% in New Zealand, 6% in Sweden, 4% in France, 4% in the Netherlands, 3% in Norway, and 2% in the United Kingdom .... Chain Drug Review

2/8 Pharma Brands Wait-and-See on Facebook Video
With Facebook pushing long-form video, should pharma jump in? .... The trend in videos over the past year has been moving from standard 30-second spots to three- to four-minute-long video experiences driven by consumers who not only want choices but also the ability to immerse themselves in a story—even a branded one—when they want .... Fierce Pharma

2/8 Instagram Recommendations
How can drugmakers tell better stories? Try Instagram .... What makes Instagram so potentially valuable to pharma and healthcare marketers is its visual story-telling capability.... The average Instagram user spends 21 minutes per day in the app, and users upload more than 95 million photos per day, which garner more than 3.5 billion likes. .... MM&M

2/8 Critics Says Faster, Looser FDA Approvals Will Bring More Cases Like Tarceva
This $7,800-a-month cancer drug caused rashes and rarely worked. Now Trump could make FDA approvals even easier .... Over the years, thousands of patients were prescribed a drug that had no chance of helping them but could frequently cause terrible rashes covering their faces and bodies, according to prescription data and adverse event reports. Some patients with the most aggressively growing cancers died before trying other treatments that may have lengthened their lives .... LA Times

2/8 Internet Drug News Fast Takes:
Data on a man's pacemaker helped lead to his indictment, police say
Stat News
FDA lifts clinical hold on Northwest Bio cancer vax trial
Fierce Biotech
GE Healthcare to Shutter Maryland Plant, Nearly 200 Employees Affected
The A1C Blood Sugar Test May Be Less Accurate In African-Americans
NPR Health Shots blog
Common pain relievers may increase heart attack risk during respiratory infections
Medical Xpress

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