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3/24 Really, Really Targeted Advertising
Drug Companies Are Buying Ads on Shows They Know Donald Trump Watches .... The top trade association for U.S. drugmakers is spending more on television advertising than any other special-interest group, part of a multi-year campaign to repair the industry's reputation and counter President Donald Trump's claims that it's "getting away with murder" on pricing .... Bloomberg (autoplay video)

3/24 Bavencio Approved for Metastatic Merkel Cell Carcinoma, a Rare Skin Cancer; $13,000 Per Month
FDA approves Pfizer, German Merck immunotherapy for skin cancer .... Bavencio belongs to a new class of oncology drugs called PD-L1 inhibitors that block a mechanism tumors use to evade detection from the immune system. It marks the first immunotherapy approval for the collaboration of Pfizer and Germany-based Merck .... Reuters

3/24 Who Are the 1% of Doctors Prescribing a Half Billion Dollars Worth of Acthar Gel?
Something weird's going on with the doctors prescribing one of pharma's most controversial blockbuster drugs .... In 2015 the US government spent over half a billion dollars on a $38,000 non-lifesaving drug with a wide range of cheaper alternatives, making it one of the top 20 expenses for Medicare Part D, a prescription drug program .... Business Insider

3/24 CVS and ExpressScripts Offer Discounted Insulins, Direct to Consumer
New PBM programs bypass insurers to offer drug discounts directly to consumers .... Two PBMs have launched discount programs for patients to use outside of any insurance coverage they might have. It's a notable contrast to PBMs' main business serving as third-party administrators .... Modern Healthcare

3/24 Big Pharma Decides Youtube Isn't Brand-Safe
J&J, GSK pull ads from YouTube amid display concerns .... Major drugmaker Johnson & Johnson has halted all global advertising on the video-sharing site YouTube in response to concerns product marketing appeared next to offensive content such as hate speech. .... BioPharma Dive

3/24 Fevipiprant is Promising Once-Daily Oral for Severe Asthma; May Enter Market in 2019
Novartis aims to bring first oral asthma drug to market in two decades .... Fevipiprant is the first asthma treatment to use a dual pathway approach by inhibiting eosinophils while stopping inflammation in the airway lining and repairing any damage .... MM&M

3/24 Dupixent and Ocrevus Poised for Approval
Crunch week looms for Sanofi, Roche and GSK at U.S. drugs agency .... The two FDA decisions, due by March 28 and 29 respectively, mark important landmarks for both firms, since Dupixent and Ocrevus are expected to be the biggest new drug launches from the global pharmaceuticals industry in 2017 .... Reuters

3/24 Teva Cutting Staff; Company Says Rumored 11% Trim Not True
Teva to Cut Undisclosed Number of Jobs as It Seeks to Pare Costs .... The Israeli drugmaker is looking for a new chief executive to turn around the business after its $40.5 billion acquisition of Allergan Plc's generic business saddled the drugmaker with debt. The transaction came just as prices of cheap copycat drugs began to fall .... Bloomberg

3/24 "Right-to-Try" Laws in Place in 33 States
With patients demanding experimental drugs, 'right to try' is becoming the law of the land .... The new state laws, built on model legislation from the Goldwater Institute, seek to remove the FDA from the equation, allowing doctors, patients, and drug makers to strike their own deals for drugs that have cleared the safety phase of FDA testing .... Stat

3/24 "Social Media Market Intelligence Company" Tracks Drug Company Efforts, Reports What's Working
Big Pharma finds a hit with disease awareness social media posts in 2016 .... "all pharma companies saw the highest engagement when talking about the things that matter to their customers -- most importantly the disease or condition they're dealing with" (Lakshmanan Narayan, co-founder and CEO at Unmetric) .... Fierce Pharma

3/24 Internet Drug News Fast Takes:
Uncertain fate of Obamacare causes some hospitals to halt projects, hiring
Reuters
Cancer Is Partly Caused By Bad Luck, Study Finds
NPR Shots
Facebook exec: Purpose-driven marketing here to stay
Drug Store News
CANA/PHEN Aids Weight Loss in Obese Without Type 2 Diabetes
HealthDay News
Ex-FDA Commissioner Califf Returns to Duke, Chairs New PCORI-Funded Foundation
Genetic Engineering & Biotechnology News

3/23 340B Rule Enforcement Date Moved to May 22; Could Move to Oct. 1
Trump admin delays enforcement of 340B drug discount program rule .... Under the delayed rule, which HHS issued under former President Barack Obama, drugmakers that "knowingly and intentionally" overcharge providers for drugs purchased through the program will face a fine of up to $5,000 per offense .... Advisory Board Daily Briefing

3/23 Serelaxin Not Effective Against Heart Failure
Novartis Heart Medicine Fails in Late-Stage Clinical Trial .... The compound, serelaxin, didn't lower cardiovascular deaths or reduce worsening heart failure as expected .... Bloomberg

3/23 Adverse Events Reports Skyrocketing; Electronic Filing Prompted 300,000 New Reports
Reports of drug side effects increase fivefold in 12 years .... Researchers found that among the 10 drugs that accounted for the most reports, seven carry "black box" warnings, the FDA's most stringent alert for serious or potentially life-threatening side effects.... Those 10 drugs account for one out of every five reports filed since 2013 .... Milwaukee Journal Sentinel

3/23 A Browse Through Gottlieb's Industry Ties
Trump's FDA Pick Has Friends in Big Pharma. But Who Doesn't? .... The companies on Gottlieb's list have a strong track record in public health. "It's not an exaggeration to say that literally hundreds of millions of people owe their lives to these companies," says ex-FDA official David Gortler .... Wired

3/23 Norepinephrine Shortage Killed Hundreds
Drug shortage in 2011 tied to increased deaths .... The likelihood that hospitalized patients in septic shock would die was nearly 4 percentage points higher during the 2011 shortage of norepinephrine, compared to when hospitals had an adequate supply .... Reuters

3/23 Sanofi Has Aubagio and Lemtrada; Wants to Do More in MS
Note for those in MS: Ocrevus Approval Expected 3/28

Sanofi to be a leader in MS, but not yet .... The company currently has a Phase 1 molecule dubbed GLD52, a next-gen anti-CD52 antibody, which it is developing for relapsing MS .... Biopharma Dive

3/23 Cosentyx Shows Permanent Effect for Some
Novartis boasts a big new advantage for Cosentyx as data indicate the blockbuster can modify psoriasis .... New data show that in a full year following the end of treatment, 21% of patients retained clear skin. After two years, 10% were able to remain symptom free .... Endpoints

3/23 More Biologics on the Way for Asthma
Drugmakers target severe asthma patients with biologics, but payers raise pricing issue .... It'd be wise to keep an eye on expanded indications for Xolair as well as late-stage market challengers from AstraZeneca, Sanofi/Regeneron, and Novartis. While small molecules currently account for 98% of the products available in the asthma space, GBI Research found the pipeline consists of 12% mAbs and 17% non-mAb biologics .... MM&M
See also: Top 25 respiratory brands, by sales [MM&M]

3/23 Compounder Faces Long Stretch
Pharmacist guilty of fraud, not murder, in U.S. meningitis outbreak .... The co-founder of a now-defunct Massachusetts compounding pharmacy was found guilty of racketeering and fraud but cleared of murder for his role in a 2012 meningitis outbreak that killed 64 people .... Bloomberg

3/23 Overhaul the Anti-kickback Laws
Penn researchers call for better laws covering patient incentives to improve care .... Anti-kickback laws prevent hospitals from offering services that could potentially benefit patients, such as free rides to elderly or disabled patients to help them get to their appointments .... University of Pennsylvania School of Medicine

3/23 Internet Drug News Fast Takes:
Mylan recalls 81,000 EpiPens outside U.S. after reports of failure
Reuters
Ultragenyx seizure drug fails mid-stage study
Reuters
A boom in medical tourism to Mexico predicted if Obamacare ends
Yahoo News
Sanofi's Xyzal Allergy 24HR hits store shelves
Chain Drug News
Vitamin E, Selenium Don't Prevent Dementia in Older Men
HealthDay News

3/22 Newron's Xadago for Parkinson's
FDA approves drug to treat Parkinson’s disease .... The FDA has approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa and experiencing "off' episodes. .... FDA News Release

3/22 Application of Real-World Evidence: Eliquis Tops Warfarin in Efficacy and Cost
Bristol-Myers and Pfizer's Eliquis outperforms rivals versus warfarin .... Bristol-Myers and Pfizer's study relied on what's known as real-world evidence, in this case claims data from over 186,000 non-valvular atrial fibrillation patients age 65 and older in Medicare's database .... BioPharma Dive

3/22 83% of Initial PCSK9 Inhibitor Prescriptions Are Rejected
Data Show It's Hard to Fill PCSK9 Prescriptions, Confirming Cardiologists' Complaints .... Patients in Medicare have an easier time getting approved than those with commercial insurance; Medicare approved PCSK9 inhibitors 57% of the time, compared with a 30% approval rate for commercial payers .... AJMC

3/22 Head-to-Head Comparison of PBMs, Conducted by Drug Channels Guru Adam Fein
Which PBM Best Managed Drug Spending in 2016: CVS Health, Express Scripts, MedImpact, or Prime? .... All four PBMs reported that their drug trend percentages for 2016 were in low single digits. The unweighted average among them was a mere 3.5% .... Drug Channels

3/22 Valeant Has $30 Billion in Debt to Pay Down; Stock Price is Sinking
With Ackman Out, Valeant Confronts Rocky Road to Revival .... While CEO Joe Papa has talked up Xifaxan, the gastrointestinal drug that is the company's bestseller, the other big hope, the psoriasis drug, comes with a "black box warning" that suicidal thoughts have occurred in patients taking the drug .... Bloomberg (autoplay video)

3/22 DTC Works; Testosterone Supplement Ads Associated with 283,000 New Prescriptions
'Low T' television ads linked to surge in testosterone use .... Each additional ad men saw was associated with a 0.6 percent increase in testing as well as a 0.7 percent climb in new prescriptions for testosterone. There was also a 0.8 percent increase in new prescriptions that were not preceded by testing .... Reuters

3/22 House Leadership Tweaks Reform Bill
The 7 Big Revisions Republicans Made to Their Health Care Bill, and Why They Made Them .... Most of the changes will appeal to the party's right flank, including the Freedom Caucus -- which has voiced concern that the bill does not go far enough to undo Obamacare -- but there are also concessions to more moderate Republicans .... Axios

3/22 Ketamine Getting Larger Trials; Sparking New Research on Glutamate Neurotransmitter
Ketamine For Severe Depression: 'How Do You Not Offer This Drug to People?' .... A number of small studies have found that ketamine can do something no other drug can: it often relieves even suicidal depression in a matter of hours in patients who have not responded to other treatments .... NPR Health Blog

3/22 Nine Deaths Linked to Breast Implants, FDA Warns; Risk Linked Especially to Textured Shells
Breast Implants Can Cause Rare Form of Cancer, FDA Says .... The cancer is called anaplastic large cell lymphoma and the FDA is checking into more than 350 reports linking it with both silicone and saline breast implants .... NBC News

3/22 Sanofi/Regeneron Go to the Mattresses on Dupixent
Sanofi, Regeneron sue Amgen to protect eczema drug from patent claims .... The lawsuit, filed in federal court in Boston, was intended to preempt one expected to be brought by Amgen, which has previously sued Sanofi and Regeneron over their rival cholesterol drug Praluent .... Reuters

3/22 Auditors Will Study Orphan Drug Program, But Don't Hold Your Breath
GAO To Launch Investigation Of FDA's Orphan Drug Program .... Grassley's office said they expected the GAO to begin its work in about nine months. The delay is typical as the agency has a queue of requests it is pursuing. .... Kaiser Health News

3/22 Internet Drug News Fast Takes:
Esperion Therapeutics Sees Clear FDA Path For Its Heart Drug
Forbes/Matthew Herper
Popular Prostate Cancer Therapy Is Short, Intense and Unproven
NY Times
Health Insurance Lobby Backs Key Trumpcare Revisions
Forbes/Bruce Japsen
Could OTC medicines be the answer to alcoholism?
University of Miami Miller School of Medicine
How Sickweather Can Forecast OTC Sales
Linkedin Pulse

3/21 Fast Takes
Laugh Lines: Longer Lasting Juvederm Gets Another Indication
eMPR
CVS Health PBM clients achieve lowest drug trend in four years
Drug Store News
Pharma convinces FDA to delay a new rule on policing off-label marketing
Pharmalot; Free Trial Subscription Req.
For Sale: Nektar Therapeutics Plans to License Hot New Opioid Drug
BioSpace

3/21 Eli Lilly Becomes Latest To Reveal PBM Rebates, Discounts
- Middlemen get rebates/discounts of up to 50% off list
- List prices went up but net prices fell 2.4%
Eli Lilly Wants You to Know Its Price Hikes Don't Work … half the list price of its medicines back to insurers and pharmacy benefit managers, on average. It raised list prices by 14 percent, but only received 2.4 percent of that increase….[Bloomberg Gadfly]
Lilly takes a stab at pricing transparency, but is it enough of the right data? … rebates and discounts paid to middlemen are increasingly reducing the list prices charged for its drugs … increases in net prices -- after paying rebates and discounts -- fell to 2.4 percent from 9.4 percent in 2015 …[Pharmalot;
Free Trial Subscription Req.]
Related: Lower drug costs: The PBM role … In California, PBMs are projected to save public programs, employers and others that pay for prescription drugs $73.5 billion over a 10-year period. … [Opinion; Capitol Weekly]

3/21 SGLT2's: Cardioprotection Appears To Be A Class Effect*
- Jardiance' differentiating factor may not be unique to Jardiance
Diabetes meds from AZ, J&J and Lilly sharply cut death rates in real-world analysis … AZ's own Farxiga as well as Johnson & Johnson's Invokana and Eli Lilly and Boehringer Ingelheim's Jardiance--also reduced deaths from any cause by 51% … [Fierce Pharma]
*Editor's Note: Cardioprotection may be a class effect of SGLT2's but Jardiance is the only SGLT2 with cardioprotection in it's label.  That's a slam dunk for good formulary status.   JNJ reps and AZN reps are not supposed to talk about cardioprotection when they promote their SGLT2's, but their medical liaisons can.

3/21
Trash Talking Anonymous Pharma Blogger? What's His Motivation?
- Fake News?  Distort & short?
An anonymous blogger angers biotech investors. But are his posts illegal? … author typically intimates that a company's drugs are a "sham" or fake, even those that are in FDA-approved trials … Seeking Alpha, claims to know the actual identities of all …[Boston Business Journal ]
See Also: 14 caustic articles from above cited blogger …[Seeking Alpha]

3/21
Xarelto Beats Aspirin  For Recurrent Clots
Phase 3 Study Finds XARELTO® to Be Superior to Aspirin for Long-Term Prevention of Recurrent Blood Clots …  significantly fewer recurrent blood clots and similar rates of major bleeding compared to those taking aspirin 100 mg … XARELTO® 10 mg reduced the risk of recurrent VTE by 74 percent and XARELTO® 20 mg by 66 percent …[ JNJ Press Release]

3/21
Emflaza: Green Kryptonite Of Drugs Gets New Owner
Marathon's Hot Potato Is Now PTC's Problem … would be a typical orphan drug launch, requiring a small sales force; however, on a call today it admitted that its price had to be changed because it was "getting so much attention … [Seeking Alpha]

3/21
Prez Seeks "Competitive Bidding Process" For Drugs In Obamacare Redux
Trump says he wants provision to lower drug costs in Republican bill … "We're going to have a great competitive bidding process. Medicine prices will be coming way down," Trump told a rally …[Reuters]

3/20
Fast Takes
Heart attack while on Repatha? Amgen will give you your money back
Endpoints News
Why Are Drug Prices for Rare Diseases 5x higher than main-stream drugs?
Huff Post
$230M deal: AstraZeneca forms COPD drugs collaboration
Philly Business Journal
Novartis and a former employee are cleared of exaggerating drug claims in Japan
Pharmalot; Free Trial Subscription Req.
Pharma convinces FDA to delay a new rule on policing off-label marketing
Pharmalot; Free Trial Subscription Req.
Four former FDA commissioners urge Congress to reject importing drugs
Pharmalot; Free Trial Subscription Req.
FDA: 2nd Rejection In 12 months:  AstraZeneca Hyperkalemia drug gets dreaded complete response letter
BioSpace
Teva: Generic Minastrin 24 Fe Available
eMPR

3/20
Not Just Jardiance: Cardioprotection May Be Class Effect
- Heart Meetings: Invokana, Farxiga Demonstrate Cardio Protective Properties
Newer type 2 diabetes drugs show heart protective quality in study … data from more than 300,000 type 2 diabetes patients found the SGLT-2 drugs slashed the combined risk of hospitalization for heart failure and death from any cause by 46% …[ Reuters]

3/20 Repatha: Cardio Data Good News But Not A Home Run
Amgen Drug Prevents Heart Attacks, Not Deaths, Disappointing Experts … had been hoping that Repatha would reduce by as much as 30% ... result was just 15%, although the drug did better on reducing heart attacks and strokes …[Forbes]
Amgen's Repatha shows CV benefit, but falls short of expectations … no effect on cardiovascular death, mixed results which could spell continued sluggish uptake  … Amgen is willing to cut a deal with payers who will drop barriers to coverage which have limited Repatha's commercial success …[Biopharma Dive]
Related: A Heart Attack-Prevention Drug Disappoints …Wall Street …[Fortune]
Related: New cholesterol drug lowers heart attack risk, but costs $14K a year … [Tribune]
Related: 'We will likely be inundated with ads for Repatha' … [Philly]

3/20 Repatha: New Data Means CVS, Express May Ease Formulary Barriers
Express Scripts says Amgen data opens door to patients … more patients and more doctors wanting access to the drug and we are going to have to respond to that … [Reuters]
CVS Health says Amgen data may increase eligible patients by millions … new data appears to show that it would be helpful for about 4 million people … [Reuters]

3/20 Novartis Heart Failure Drug Slows Path To Insulin, Lowers A1C
- Entresto dropped A1C 0.26%
- Sales have been underwhelming thus far
Novartis heart-failure med Entresto cuts A1c, insulin starts in diabetics: analysis … 29% fewer diabetics in the Entresto arm needed to start insulin therapy … might spur conversion of white fat to brown fat, which is more metabolically active. … [Fierce Pharma]

3/20 Roche Announces Layoff As Meter Business Falters
- Joins Diabetes Titans Sanofi, Novo, JNJ; competition, slimmer margins force layoffs
Roche Restructuring Shows Trouble in US Diabetes Biz … lay off 157 employees in its U.S. diabetes care unit … revenues from its diabetes business fell 5% …[Investopedia]
Related: Roche trims workforce in struggling U.S. diabetes market …[Biopharma Dive]

3/20 80% Of Stroke Patients Do Not Get Needed Anti-Clotting Meds
Many at risk for stroke don't get anti-clotting drugs … More than four in five stroke patients with a history of heart rhythm problems didn't get any blood thinners, or didn't take enough to help prevent a stroke before they had one …[Reuters]

3/20 Trump: Pharma Not Paying Fair Share; Proposes Doubling Product Review Fees
- 'You benefit, you need to pony up'
FDA fees for product review would more than double under Trump budget … industries that benefit from the FDA's approval "can and should pay for their share … Most of the user fees collected are for prescription drugs - around $866 million estimated in 2017 - and generic drugs - around $324 million … [Reuters]

3/20 The Doctor Will (Not) See You Now
Doctor Wait Times Soar 30% In Major U.S. Cities … "Growing physician appointment wait times are significant indicator that the nation is experiencing a shortage of physicians … shortage of between 40,800 and 104,900 doctors by 2030. [includes]  a shortage of between 7,300 and 43,100 primary care doctors … [Forbes]


3/17 Repatha Results In: Cardio Risks Reduced 20%
UPDATED: Heart attack while on Repatha? Amgen will give you your money back .... If payers will just consider the benefits Amgen is demonstrating today and take down their elaborate barriers, company execs say they are not only willing to offer a refund when the drug fails, they'll also negotiate annual payment caps and risk sharing deals with insurers so payers can be sure to keep control of their budgets. .... Endpoints News
See also: Cholesterol-Slashing Drug Can Protect High-Risk Heart Patients, Study Finds [NY Times]

3/17 Never Mind on that New Money from 21st Century Cures Act
Trump's first budget seeks to slash $6B from NIH .... 20% budget cut to the NIH, the leading state-backed medical research body that had around $30 billion in funds last year.... A major re-jig at the NIH is also on the cards: "The spending plan calls for a 'major reorganization' of the 27 NIH institutes and centers..." (Washington Post) .... Fierce Biotech
See also: Trump Would Slash Research in Cut to Health Budget [Bloomberg]

3/17 FDA User Fees to Double
Trump budget to cost pharma industry .... The plan increases the medical product user fees paid by pharma and biotech companies to $2 billion, nearly double the current level. .... Biopharma Dive

3/17 Proposed FDA Rule Would Expand the Scope of Off-Label, Make Prosecution Easier
Industry groups petition the FDA over off-label rule .... Industry groups are taking aim at a rule created by the Food and Drug Administration that could restrict drugmakers' truthful and non-misleading promotion of its drugs -- commonly referred to as off-label promotion -- by expanding the evidence the agency can use to assert that a drug has been misbranded .... MM&M

3/17 157 Jobs Gone in Roche Diabetes Group
Roche trims workforce in struggling U.S. diabetes market .... Citing competitive pressures, Roche is laying off 157 employees, or more than 10% of the workforce in its U.S. diabetes care unit. That figure includes 133 full-time employees and 24 contractors .... Biopharma Dive

3/17 PTC Therapeutics Buys Emflaza from Marathon
In lucrative deal, infamous pharma company bails on drug it priced at $89K .... Marathon will get $140 million upfront from the sale. That will come as $75 million in cash and about $65 million in stock. Marathon is also eligible to receive royalties and a one-time $50 million sales-based milestone payment .... Ars Technica

3/17 DTC Ad Spending was $6.4 Billion Last Year in U.S.; Up 5%
Prescription drug costs are up; So are TV ads promoting them .... The effect of a ban [on DTC drug advertising] on networks would be a daunting, 8% loss of total ad revenue, and its impact would be most evident for programming popular with viewers older than 60 ­— for instance, evening news shows .... USA Today/Kaiser Health News

3/17 Cancer Drugs Near the Top of the DTC Ad List
Keytruda's head-to-head against Opdivo rockets meds to Nos. 2 and 3 in ad spending .... Merck and Bristol-Myers Squibb laid out a total of more than $33 million -- $17.6 million for Merck's Keytruda and $16 million for BMS' Opdivo -- in national TV ad placement buys for February .... Fierce Pharma

3/17 CVS Caremark Boasts 3.2% Drug Trend in 2016
CVS Health reins in prescription drug trend .... CVS Caremark clients saw their prescription drug trend fall to an average of 3.2% last year versus 5% in 2015. Of CVS Caremark commercial clients, 38% achieved a negative trend, spending less on their prescription benefit in 2016 than in 2015 .... Chain Drug Review

3/17 Giving Up on MACRA Already
Advisers Skeptical About New Medicare Doctor Pay System .... MIPS measures medical professionals so that those who offer higher-quality care will be paid more. But MIPS has a variety of structural problems.... For example, each clinician is judged by his or her own measures so scores aren't comparable. .... Bloomberg BNA

3/17 For Physicians, the Median Amount Received from Industry in 2014 Was $193
Two-thirds of patients are seen by doctors who got industry money .... Previous research had found that only 40 percent of physicians receive industry money.... The difference suggests that doctors who see large numbers of patients are more likely to receive payments .... Philadelphia Inquirer

3/17 Internet Drug News Fast Takes:
Pfizer's Arthritis Drug Xeljanz Gets Marketing Nod in China
Zacks
Saving Sigmund: Psychoanalysts fight to make their profession relevant
Stat
French biotech firm closes in on cancer that killed Steve Jobs
Reuters
Mylan releases Aromasin generic in U.S.
Chain Drug News
Over-The-Counter Birth Control Pills Would Be Safe For Teens, Researchers Say
NPR

3/16 Medicare Cancer Patients Spend an Average 11% of Their Incomes on Treatment — That's If You Have Supplemental. If No Supplemental, 23% of Income Goes to Cancer Care
Sticker Shock Forces Thousands Of Cancer Patients To Skip Drugs, Skimp On Treatment .... High drug costs are a particular problem for the elderly, half of whom have $13,800 or less in available assets, and many have more than one expensive chronic condition, such as heart disease, diabetes or emphysema. The median income for people on Medicare was $24,150 in 2014 .... Kaiser Health News

3/16 Gottlieb's Experience
By The Numbers: Trump's Choice For FDA Chief Is Versatile, Entrenched In Pharma .... Scott Gottlieb, 44, has worn many hats in a career that included two previous stints at the FDA, practicing as a physician, and writer/editor roles at prestigious medical journals .... Kaiser Health News

3/16 Statin Intolerance Found in Only 2% of Post-MI Patients, But Consequences Can Be Severe
Higher rate of second heart attacks in patients who can't tolerate statins .... Compared with patients who took their statins most of the time, those who couldn't tolerate statins were 50 percent more likely to have another heart attack and 51 percent more likely to have some other coronary event like needing to have a blocked coronary artery cleared or a coronary bypass operation .... Reuters Health

3/16 Lawmakers Stirring Up a Ruckus Over Emflaza OK for Duchenne; Drug Was Available from Overseas at $1000
Marathon's $89,000 Drug Scrutinized for 'Unusual' Approval .... Questions remain about the data used to evaluate Emflaza, a treatment for Duchenne muscular dystrophy, and why Marathon was given market exclusivity .... Bloomberg

3/16 Senator Wants PBMs to Open the Kimono
Middlemen's Secret Drug Rebates Targeted by Wyden's Bill .... The bill would require pharmacy benefit managers such as Express Scripts Holding Co. and CVS Health Corp. to reveal the aggregate rebates that they receive from drug companies for Medicare plans and post the amounts on a government website .... Bloomberg

3/16 Benzodiazepines Compound Risk of Overdose Death with Opioids
This Prescription Drug Is Implicated In Almost A Third Of All Opioid Overdose Deaths .... In 2001, 9 percent of opioid users also filled prescriptions for benzodiazepines, and that increased to 17 percent in 2013 .... Huffington Post

3/16 FDA Discovers Patients
FDA seeking feedback on new Office of Patient Affairs .... The agency wants to learn about patients' attitude toward the risk-benefit balance for new drugs and devices, wants to better understand how to most effectively solicit patient input, and wants to explore how to best support patients and their advocates in their efforts to understand regulation .... MobiHealth News

3/16 Viberzi Warning
FDA Warns of Increased Risk of Serious Pancreatitis with Allergan's Viberzi .... Following the death of two patients without a gallbladder on Allergan's irritable bowel drug Viberzi (eluxadoline), the FDA has warned about the increased risk of serious pancreatitis in such patients .... Regulatory Focus

3/16 Ibrance vs. Kisqali: Pundit Bets on Ibrance
Will Pfizer's Growth Be Threatened by Novartis' New Cancer Drug? .... Novartis is pricing Kisqali at an 18% to 20% discount below Ibrance's price, however. Could this lower price cut into Pfizer's sales? Maybe, but there's another important consideration. Kisqali can cause a heart rhythm disorder known as QT prolongation, which can result in fast, chaotic heartbeats and even lead to death .... Motley Fool

3/16 If You Hooked Your Vibrator Up to the Internet, You Might Get $10 Grand
Vibrator Maker To Pay Millions Over Claims It Secretly Tracked Use .... The makers of the We-Vibe, a line of vibrators that can be paired with an app for remote-controlled use, have reached a $3.75 million class action settlement with users following allegations that the company was collecting data on when and how the sex toy was used .... NPR

3/16 Internet Drug News Fast Takes:
Mayo to give preference to privately insured patients over Medicaid patients
Minneapolis Star Tribune
New UK drug cost rules leave companies fuming
Reuters
Research: Higher U.S. Physician Spending Doesn't Lead to Better Patient Outcomes
Harvard Business Review
Sanofi, Regeneron's Dupilumab Gets UK Early Access
Investopedia
Forget your GP, robots will 'soon be able to diagnose more accurately than almost any doctor'
Telegraph

3/15 New FDA Commish Policy Might Destroy PBM Formularies
Scott Gottlieb's Radical Idea for Disrupting U.S. Drug Channels: Implications for PBMs, Wholesalers, and Pharmacies .... Gottlieb's solution is to migrate brand-name pricing from today's formulary rebates to up-front discounts..... such a shift would radically disrupt the business models and economics of pharmacy benefit managers (PBMs), wholesalers, and pharmacies .... Drug Channels

3/15 Novo Nordisk CEO Says 59% of His Gross Sales Go to Rebates; He's Upset When Patients Have to Pay Full Sticker Price
Drug CEO Has Problem With U.S. Patients Paying His Prices .... Data shows that while nasal abuse has reduced with the Opana ER reformulation, intravenous abuse has increased .... Bloomberg

3/15 Panel Shifts on Abuse-Resistant Version of Opana
Risk of Endo's opioid painkiller outweigh benefits: FDA panel .... Data shows that while nasal abuse has reduced with the Opana ER reformulation, intravenous abuse has increased .... Reuters

3/15 Valeant Champion Drops Stake and Leaves
Ackman Sells Valeant Stake After at Least $2.8 Billion Loss .... After waging a costly and outspoken public defense of the controversial drugmaker, its once-biggest champion sold his entire stake in the company at a loss and said he will leave the board .... Bloomberg (autoplay audio)

3/15 "Doctor Cookies" Allow Cross-Site Comparison of HCP Interests
Digital IDs become focus as drugmakers seek to track doctors' behavior online .... The initiative will allow HCPs to use a single sign-on to access online content, including websites, portals, virtual events, or webinars, published across the websites of all of its member companies, rather than multiple sign-ons .... MM&M

3/15 Lynparza Extends PFS 14 Months
AstraZeneca ovarian cancer drug slows disease markedly in study .... Women with recurrent ovarian cancer and defective BRCA genes lived a median 19.1 months without their disease worsening when given Lynparza, against 5.5 months for those on placebo .... Reuters

3/15 Shingles Vaccine New Target for Trial Lawyers
Zostavax patients sue Merck, claiming shingles shot caused injuries and death .... Plaintiffs have sued in state and federal courts in Pennsylvania alleging that Merck's Zostavax--used to prevent shingles, the painful complication of varicella infection—caused serious side effects, including death .... Fierce Pharma

3/15 Drug Revenue Growth Slowing? A Look at the Top 15
Top 15 pharma companies by 2016 revenue .... Sales for the top 15 companies were up about 4% for the year combined.... Four companies in the top 15 saw their revenues fall .... Fierce Pharma

3/15 ORR of 69% Drives Keytruda Indication for Hodgkin Lymphoma
Keytruda Granted FDA Approval for Hodgkin Lymphoma .... The specific Keytruda regimens approved are 200 mg every three weeks for adults and 2 mg/kg (up to 200 mg) every three weeks for pediatric patients. This is the first FDA indication for Keytruda in a hematologic malignancy .... Cure

3/15 PBM Replies with Nastygram to Gilead's Comment on High Prices
Express Scripts executive requests Gilead lower price of Sovaldi, Harvoni .... Neville concluded his letter with four formal requests based on the assumption that Sovaldi is worth $50,000. .... Healio

3/15 Internet Drug News Fast Takes:
How a Major Drugmaker Plans to Cure Disease... Without Drugs
Motley Fool
Argos axes over a third of staff in retrench
BioPharma Dive
REMS programs help FDA, other stakeholders enhance drug safety
Healio
Dogged by setbacks and an air of crisis, Alexion Pharma opts to restructure, slashing staff
Endpoints News
Cystic fibrosis patients surviving longer in Canada than US
Fox News

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