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Fast Takes
What makes a Phase II drug worth up to $665M? Researchers spell it out for Novartis
Endpoints News
Ecstasy to treat PTSD by 2021? US FDA approves Ph III trial
In Pharma Technonogist
CVS Changes Direction With Surprise OptumRx Deal
Drug Channels
Merck Is Getting Serious about Animal Health
Market Realist

12/6 PBMs Reveal What Lies Behind Green Curtain
- Claim they keep 4% commission off the top
- Industry trade group offers peek at often opaque PBM drug price schematics
PBMs Save 40-50% on Prescription Drug Costs … Of the $268 net cost, PBMs get an
average $12 or 4% for their services … Without PBMs and the savings they … generate costs would be more than $2,100 per person per year … Payers and Patients Spend $1 on PBMs to Save $6 … [PCMA via Visante]
Editor's Note: Previously, PBM ROI and rebate policies were a closely guarded secret.  This historical document reveals specifics.  They claim their business model is this: They negotiate discounts on the list price of drugs, then pocket a 4% commission of the net price as a transaction fee.   

Therefore - don't they make more money on expensive drugs?  What's their motivation to get big discounts if they're only pocketing 4% of the net.  Are they that altruistic that they will cut their own throats to save their customers money?  Something's fishy.  One thing is for sure; PBM execs make beacoup money.  In 2015, Express CEO Tim Wentworth  made $8,464,903 in total compensation.  CVS Caremark CEO Larry Merlo made an impressive $12,110,000.  CEO of United Health  (the company that owns Optum Rx and Catamaran). 
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Glaxo Continues Exec Shuffle As Witty Departure Approaches
More Glaxo 'musical execs' as Waterhouse tapped to replace ViiV Healthcare CEO … Dominique Limet, head of HIV unit ViiV Healthcare, would step down at the end of March 2017 … He'll be replaced by Deborah Waterhouse, who currently serves as GSK's SVP of primary care … [Fierce Pharma]

Lilly Salespeople Brace For 2017 Layoff
- Sales force linked to failed Alzheimer drug  susceptable
Eli Lilly to Begin Axing Hundreds of Sales Jobs Early 2017 … terminated employees will be given a three-month relocation period to seek other jobs within the company … sales force reduction was also affected by the "expectation of upcoming patent expirations [of Cialis, Effient and Strattera]
See Also: Eli Lilly Cafι Pharma Message Board

Novo Promises Kinder, Gentler Price Increases
- Blames recent drug price sticker shock on new high deductible plans
Novo Nordisk becomes second major drug maker to limit price hikes … President Jakob Riis promised not to raise the list price of any medicine by more than single-digit percentages annually … high-deductible health insurance plans are partly to blame, since consumers absorb more upfront costs … [Pharmalot]

Testosterone Therapy Patients Had 63% Higher Risk Of Blood Clots
- After 6 months of treatment, risk abates; observational study
Higher blood clot risk after starting testosterone treatment … Compared with men who hadn't used testosterone, current users had a 25 percent higher risk of clots … After six months of treatment, the risk returned to levels similar to what men had before starting testosterone … [Reuters]

Fast Takes
Mylan CEO defends EpiPen strategy, questions pricing model in the U.S.
Medical Marketing & Media
Eli Lilly People Braces For Layoff
Indy Star
Novartis says 82 pct of leukemia patients in remission after CAR-T
Xultophy® non-inferior With Reduced Risk of Hypoglycaemia and aSuperior Weight Profile Compared to Basal-Bolus Therapy
Novo Press Release

12/5 FDA: Jardiance Gets Cardioprotection Indication
- 3 year study says it reduces cardiovascular death, neutral on n0n-fatal heart attack.
- Only SGLT2 to have 2 indications
FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes …
Jardiance Wins CV Prevention Indication … FDA approves claim that diabetes drug reduces cardiovascular death risk … that can help people live longer by reducing the risk of cardiovascular death is an important advance for adults with type 2 diabetes … [MedPage Today]
Jardiance® (empagliflozin) reduced the risk of cardiovascular death in adults with type 2 diabetes … reduced the risk of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo. Risk of cardiovascular death was reduced by 38 percent
Editor's Note: The online PI has already been updated.  In addition to the indication   to improve glycemic control in adults with type 2 diabetes mellitus, it now has a second incication: "to reduce the risk of cardiovascular death in adult patients with type 2diabetes mellitus and established cardiovascular disease".  Huge marketing advantage over  dapagliflozin (Farxiga in US), canagliflozin (Invokana) and empagliflozin (Jardiance).  PBM's would hard pressed not to give Jardiance preferred formulary status without forcing BI and Lilly  to give deep discounts. 
Pharma Factoid: SGLT2's are sometimes referred to as "gliflozins"

Elizabeth Warren , Others Attack Drug Coupons
Thanks, Mylan. Your EpiPen pricing saga puts pharma's winning copay coupons under interrogation … copay moves are only part of the "complex shell game" … costs are eventually passed on to consumers in the form of higher premiums."… [Fierce Pharma]

Pfizer CEO, Regeneron CEO Quarrel During Drug Price Pow Wow
- Regeneron CEO lashes out against Pfizer CEO
Pharma CEOs in Shouting Match Over Prices: 'It's Ridiculous' … Someone's mad about drug price hikes. For once, it's not Bernie Sanders or Hillary Clinton -- it's the CEO of a big U.S. biotech company. …
The Numbers Behind a Pharma CEO Shouting Match … Regeneron has managed to grow revenue from $400 million to more than $4 billion in five years without a price hike … Pfizer has a long-running tendency to take annual or biannual price increases … particularly aggressive with older drugs such as Viagra …[Bloomberg Gadfly]
Related: Four Pharma CEO's assess landscape under President Trump … [Drug Delivery Business]

Led By Gilead Hep C Pills, 2015 Drug Spending Surges
Prescription drug spending rises 9% in 2015, to $324 billion … faster than any other healthcare service in 2015 tracked by the CMS … Overall healthcare spending grew by 5.8% to $3.2 trillion in 2015, the largest increase in eight years … [Medical Marketing & Media]

Sanofi, Merck, GSK, Pfizer: Big 4 Have Firm Grip Vaccine Market
- Hard to produce, no generics, profitable, sparce competition,
Breaking the Big Four: vaccine oligopoly unlikely to be challenged, analyst … Long lead times and high barriers to entry will restrict competition in the vaccines market, leaving GSK, Sanofi, Merck  and Pfizer dominant … [Biopharma Reported]

Valeant Doubles Down: Plans "Significant" Scale Up As Salix Deal Withers
Takeda: Asking Price Too Expensive
Valeant Said to Keep Salix After Takeda Deal Falls Apart …
discussions broke down mainly because of disagreements over the price … announced on Tuesday that it was making a "significant" expansion in the size of the sales force for two Salix products, gastrointestinal treatment Xifaxan and constipation treatment Relistor … [Bloomberg]
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Ugly Side Of Immunotherapy Cancer Drugs
- So-called checkpoint inhibitors linked to acute onset diabetes; unchecked immune system can wreak havoc on healthy organs
Immune System, Unleashed by Cancer Therapies, Can Attack Organs …  blood pressure plummeted, his potassium levels soared and his blood sugar spiked to 10 times the normal level … unleashed immune system can attack healthy, vital organs: notably the bowel, the liver and the lungs, but also the kidneys, the adrenal and pituitary glands, the pancreas and, in rare cases, the heart … [ NY Times]
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11/29 Fast Takes
Does a Trump presidency mean changes for pharma advertising?
Fierce Pharma
Leukemia: Juno and the FDA screwed up. People died. What now?
Endpoints News
Genentech's Shocking $2 Billion 340B Revelation
Drug Channels
JNJ Hep C Pill Inches Forward
Guru Focus
India Drug Regulators: 27 medicines sold by top firms 'fail' quality tests
India Express

Novo Shamed Into Removing Ads From Conservative Website Breitbart
- Move sparked by advertising gadfly "Sleeping Giants" 
Novo Nordisk Yanks Ads Off of Conservative Site Founded by Trump's New Chief Strategist Stephen Bannon … Novo Nordisk was unaware its ads were appearing on Breitbart. The Danish drugmaker thanked both Sleeping Giants and another user with the handle Frank the Fink…. [Biospace]

Teva Inks Deal With Medical Marijuana Inhaler Company
Teva inks trailblazing cannabis pact with Israel's Syqe Medical … will make it the only distributor in Israel of local company Syqe Medical's cannabis inhaler … patients spending an average $100 per month on cannabis, the revenue potential is there for Teva if the company can get the inhaler selling … [Fierce Pharma]
See Also: Video explaining how metered dose cannabis inhaler works

Pfizer Pulls Plug On $425 Factory Expansion Due To PCSK9 Flop
Pfizer cancels €400m Dublin expansion after drug setback …  two rival drugs had been struggling to meet sales targets. As a result, it decided to discontinue development of the drug … failure of bococizumab is the second high-profile flop in the last decade for Pfizer in the area of cholesterol. In 2006, the company abandoned another drug, torcetrapib … [Irish Times]

JNJ In Talks To Acquire Swiss Biotech Actelion For $20 Billion
- Actelion has 2 potential pulmonary hypertension  blockbusters
Johnson & Johnson Bids on Swiss Biotech Firm Actelion … soon-to-be-acquired biotech company has launched two lung treatments recently that are expected to be extremely successful in the next few years … [Economic Calendar]
Editor's Note: Adds information on Actelion's 2 new-ish pulmonary hypertension drugs Opsumit (macitentan) an endothelin receptor antagonist with a list price of $7,500 for 30 tablets and Uptravi® (selexipag) a  prostacyclin receptor agonist with a list price of  $21,700 for 140 tablets.  Since there are so few treatments for PAH and the ailment is relatively uncommon, Actelion does not have to discount these products heavily to the PBMs.

Says Good Time To Buy Lilly?
- Recent sell off due to Alzheimer's flop could create buying opportunity
One Battered Stock To Buy As The Market Continues To Surge … hammered down to a 52-week low of $68 a share … We see continued strong sales for new products, incuding Trulicity and Cyramza … Jardiance in particular "looks poised to hit peak sales projections of over $5 billion based on strong cardiovascular data …[Forbes]
Editor's Note:  It has a decent dividend; current yield = 2.6%

Fast Takes
8 Things to Know About Biosimilars
The FDA's Historic Caution On Abuse Deterrent Labeling

Lilly CEO Expresses His Distress At Failed Alzheimer's Drug
Eli Lilly CEO Lechleiter 'Disappointed,' after Alzheimer's Drug Fails … Shares of Eli Lilly  were sinking by 13.36% in pre-market trading … Shares of Eli Lilly were sinking by 13.36% in pre-market trading … [The Street]

Yet Another HIV Vaccine Trial Begins In Africa
New HIV Vaccine Trial to Start in South Africa … All participants will receive five injections over a year. … largest and most advanced HIV vaccine clinical trial to take place in South Africa … based on a 2009 trial in Thailand, that was found to be 31.2 percent effective at preventing HIV … [Bloomberg]

FDA Green Lights Test Of Cuban Lung Cancer Vaccine
Fidel Castro-Supported Lung Cancer Vaccine To Be Tested In U.S. Clinical Trials … FDA has approved an IND to conduct clinical trials with the Cuba-manufactured vaccine for non-small cell lung cancer … CIMAvax was developed to starve lung cancer cells of this growth stimulator … [Forbes]

Drug Prices Defy The Invisible Hand
- High prices don't reduce demand, low prices don't drive demand
Drugmakers Find Competition Doesn't Keep a Lid on Prices … "You're not rewarded for having a low price and for the most part, the market doesn't punish a high price,"  … Makers of Viagra, Cialis show how rivals tend to raise prices in tandem, a reason for the surge in U.S. prescription-drug spending … [WSJ]

11/18 Differentiation Key to Market Success
What puts a new drug launch in line for victory? Ask Gilead, Biogen and J&J .... The most successful meds advanced treatment significantly. In essence, they were clearly different from existing drugs. But consulting firm Trinity Partner's analysis also showed that a strong marketing strategy--and commercial execution--could put less innovative meds over the top. And price made a difference, too, with more-expensive specialty drugs outperforming less pricey primary care meds .... Fierce Pharma

11/18 Valeant and Philidor Execs Arrested on $40 Million Fraud and Money Laundering Charges
Valeant Defrauded in Philidor Kickback Scheme, U.S. Says .... Valeant Pharmaceuticals was the victim of a multimillion-dollar fraud by an executive who engaged in a hidden kickback scheme with the chief executive of a mail-order pharmacy company that sold its drugs .... Bloomberg (autoplay audio)

11/18 Crazy Chicago Pharma Rep Licensing Law Passes; $750 Annual Fee; Report All Contacts with Docs
Chicago will license pharma sales reps to fight opioid overprescribing .... The ordinance will require sales reps to undergo training for ethics, marketing regulations, and applicable laws. Reps will also have to file reports with the city that disclose the names of doctors they visit as part of their work, the number of visits, and any samples, materials, or gifts provided, along with their value .... Stat/Pharmalot

11/18 Guselkumab for Plaque Psoriasis Filed with FDA
J&J takes one of its top blockbuster prospects to the FDA, in search of a big approval .... Based on Phase III data showing that IL-23 drug guselkumab handily beat out Humira in treating severe plaque psoriasis, J&J has submitted the drug for approval at the FDA .... Endpoints

11/18 70 Providers in U.S. Write > $10 Million per Year in Prescriptions; 514 Write > $5 Million per Year
A Growing Group Of Doctors Are Big-Money Prescribers In Medicare .... Most of the doctors atop the spending list prescribed Harvoni or Sovaldi, relatively new drugs that cure hepatitis C. Other providers on the list prescribed pricey drugs to treat cancer, multiple sclerosis and rheumatoid arthritis .... NPR Health Shots/Pro Publica

11/18 Don't Miss: Results from CMI/Compas Survey of Media Habits of Medical Professionals
Physicians still rely on medical journals but turn to the web when they have only 10 minutes .... The number one factor that influences physicians' treatment decisions across all specialties, except neurologists, is clinical efficacy data, the survey found. Neurologists ranked a drug's safety and tolerability profile as the number one issue, followed by strong clinical efficacy data .... MM&M

11/18 Patient Education Company Extends Poster Capability
ContextMedia to acquire AccentHealth to grow its position in the point-of-care market .... AccentHealth develops programming, including content from CNN's Dr. Sanjay Gupta, and health education posters for roughly 30,000 physician exam and waiting rooms .... NPR Health Shots/Pro Publica

11/18 Vaginal Insert with DHEA Approved for Postmenopausal Painful Sex
FDA OKs Prasterone for Dyspareunia in Postmenopausal Women .... The efficacy of Intrarosa was demonstrated in two 12-week placebo-controlled clinical trials involving 406 healthy postmenopausal women reporting moderate to severe pain during sexual intercourse.... "Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse" (FDA) .... Medscape

11/18 Biosimilar Filed for Avastin
Amgen, Allergan step up to challenge Roche's Avastin with FDA biosim filing .... Amgen and Allergan have based the application in part on a Phase III study of patients with non-squamous non-small cell lung cancer, which turned up no significant differences between the Avastin and their biosimilar candidate ABP 215 in terms of efficacy, safety and immunogenicity .... Fierce Pharma

11/18 Internet Drug News Fast Takes:
Americans want Trump to focus on healthcare first: poll
BIO Chair: Trump Should Re-Appoint Califf to Head FDA
Regulatory Focus
Amgen On Track For 2018 Migraine-Drug Launch, Beating 'Crowded Field'
Investors Business Daily
22% of patient visits to in-network EDs had out-of-network doctors
Advisory Board Daily Briefing
Survey: Doctors embrace biosimilars, but with caution
Drug Store News

11/17 Oral Insulin Technically Possible But No Go Because It Would Be Too Expensive
How drug price pressure helped sink Novo's insulin pill .... Delivering a protein like insulin as a pill is hard because it risks being destroyed in the stomach. Novo scientists overcame this obstacle to a degree but still needed to deliver around 50 times more insulin in a tablet than in an injection, to ensure a sufficient dose .... Reuters

11/17 Game of Musical Chairs Plays On as GSK Builds New Labs
Two years into an R&D overhaul, GSK plans $250M lab project near Philly for another migration of US staffers .... GSK is spending $250 million to make over its lab facilities in Upper Providence Township northwest of Philly. By 2018 the site will host 3,200 R&D staffers, twice what it is right now .... Endpoints

11/17 Doctors' Group Comes Out for Value-Based Pricing
AMA embraces value-based drug pricing .... The organization believes prices should be set by objective, independent agencies that use evidence and data. Processes to set those prices should be transparent, not burden physicians or patients and maintain affordability for patients .... Modern Healthcare

11/17 Erenumab Reduces Migraine Days 40% on Higher Dose in Phase 3
Amgen's migraine drug succeeds in late-stage trial .... Patients receiving 70 milligram of the drug, erenumab, experienced reduction of 3.2 days from baseline in monthly migraine days, while those on 140 milligram experienced reduction of 3.7 days. Those in the placebo experienced a 1.8-day reduction .... Reuters

11/17 Viewpoint: Let Germany, France, and Britain Help Pay for the High Costs of Drug Research
How to Make Drug Prices Fair to U.S. Consumers .... Congress should pass a law empowering U.S. health agencies to use a best-price clause in their purchases of (or reimbursement for) prescription drugs that are sold both in the U.S. and in other wealthy developed nations -- nations that should be helping to shoulder R&D costs .... Bloomberg View

11/17 Better Drugs Through Chemistry: Australia Company Has Dozens of Ways to Make Drugs Work Better
One CEO's Push to Make Cancer Drugs and Condoms Great Again .... Starpharma is using its technology on the chemotherapy medicine docetaxel to enable the delivery of more drug molecules to cancer cells to better target the diseased tissue .... Bloomberg

11/17 Weekend Long-Read: The Whistleblower Who Brought Down Theranos Was Grandson of Company Director
Theranos Whistleblower Shook the Company--And His Family .... Tyler Shultz, now 26 years old, was among several Theranos employees who tried to voice concerns inside the company about what they saw as troubling practices, and Mr. Shultz was the first to blow the whistle to a state regulator. He says he wanted to expose the problems to protect the health of patients and his grandfather's reputation .... WSJ

11/17 Woodcock Slams Eteplirsen Research But Defends Final OK
FDA regulator defends decision to OK Sarepta drug .... "You can have a pretty bad development program, and if you cross the finish line we might approve it anyway," Woodcock said, who added that Sarepta has been ordered to conduct follow-up studies on patients. .... Boston Globe

11/17 Confirming Phase 3 Study for Ibrance; Survival Without Side Effects Doubles from 10.2 Months to 20.2 Months
Drug combination therapy for estrogen-receptor–positive breast cancer passes critical step for worldwide approval .... UCLA researchers have confirmed that the "breakthrough" drug palbociclib when used in combination with the traditional hormonal therapy letrozole delays progression of advanced breast cancer significantly and without the harsh side effects seen in some women prescribed letrozole alone .... UCLA

11/17 Ninja Star Pill Delivers Medicine for Two Weeks
Star-shaped drug dispenser stays in gut to deliver medication for weeks .... Wrought in polymer materials and packed into a gelatin capsule, the device unfurls its six arms once it has made its way to the small intestine.... While food and drink moves by, the drug-delivering star stays put and continues to release steady doses of medication .... LA Times

11/17 Internet Drug News Fast Takes:
Roche, Bristol-Myers cut cancer drug prices to win UK approval
CRISPR gene-editing tested in a person for the first time
Amazon to offer delivery from Bartell Drugs
Chain Drug Review
Apple Is Researching How iPhones Can Be Used To Monitor Parkinson's Patients
Fast Company
One Employer Fights Against Prescription-Drug Abuse

11/16 Repatha Glagov Study Points Way to Cardiovascular Benefit Claim
Amgen's Repatha Unclogs Arteries in Good Sign for Future Sales .... Fewer patients getting Repatha suffered cardiac complications such as heart attacks and needed artery-clearing surgery, though the study was too small to determine if the differences were meaningful .... Bloomberg

11/16 Ten Trend Charts: Medicare, Medicaid, Out-of-Pocket Costs, Drug Spending and More
10 charts that show the health care challenges Trump's White House will face .... As Trump and his transition team continue to scope out his health policy agenda, it's worth examining how recent trends in health care could affect the Trump administration's approach to the industry .... Advisory Board

11/16 FDA Top Brass Has No Enthusiasm for Off-Label Communications
FDA Questions Need for Looser Off-Label Promotion Restrictions .... Califf asked whether allowing companies to share information about their products outside their approved labeling could lead to companies not publishing their data in peer-reviewed publications .... Regulatory Focus

11/16 German Merck 3Q Profits Up 24%
Merck KGaA Raises Profit Forecast Aided by Health-Care Unit .... Merck KGaA aims to launch one new drug a year starting next year; its strategy hinges on the approval of avelumab, which would be its first cancer drug since Erbitux .... Bloomberg (autoplay audio interview with CFO)

11/16 Just Because It's Generic Doesn't Mean It's Affordable
Generic heart failure drug costs too high for many uninsured .... Researchers, collecting prices in the St. Louis area, found that the combined cost for a month's supply of three commonly prescribed generic heart failure drugs ranged from $12 to $400, with an average price of about $70 .... Reuters

11/16 Market Forces Crunch Down Drug Prices No Matter Who is President
Donald Trump Can't Prop Up Drug Prices .... Companies raising the list prices of their drugs give most of those price hikes back relatively quickly via discounts .... Bloomberg Gadfly

11/16 Inclisiran, A New PCSK9 Inhibitor with 2–3x Per Year Dosing
Long-lasting cholesterol lowering seen with Medicines Co drug .... One 300 mg dose of inclisiran led to an average lowering of LDL by 51 percent at Day 60, which was maintained over three months. Two 300 mg injections given on Day 1 and Day 90 on average took LDL down by 57 percent at Day 120, and maintained its effectiveness over six months .... Reuters

11/16 One Stop Programmatic Shopping for Pharma Brands
PulsePoint launches health vertical for programmatic advertising .... The platform has a contextualizer feature, which seeks to ensure that search results are relevant to healthcare and specific diseases and conditions.... it has sentiment tools that listen specifically for health terms and brand names to understand what people are saying about brands .... MM&M

11/16 Kite's CAR-T Therapy Isn't Approved Yet, Nor Is It Priced Yet, But the Company is Thinking About How They Will Roll It Out When the Time Comes
Kite Pharma to keep anticipated CAR-T launch 'controlled' and targeted at certain hospitals .... The slow rollout of CAR-T is meant to be a form of quality control. That launch will target 72 institutions, including more than 40 clinical trial sites and 27 national cancer hospitals and national cancer care network centers .... MM&M

11/16 Drug Take-Back Programs Little Help for Opioid Abuse
Organized prescription drug collection programs may have minimal impact .... "Similar to other studies, we found that only about 5 percent of the collection from take-back events and drop boxes consisted of controlled medications susceptible to abuse," said the study's lead author, Kathleen Egan, M.S. .... Medical Xpress

11/16 Internet Drug News Fast Takes:
Why the FDA Wants More Control over Some Lab Tests
Scientific American
Patients with a 'medical home' more likely to take their meds
Statins may help those with cardiovascular disease live longer
Washington Post
Teva's Scale Needs to Start Paying Off Soon
Bloomberg Gadfly
New drug beats standard therapy in advanced kidney cancer
Dana Farber Cancer Institute
Top e-commerce trends that will impact retail in 2017
Drug Store News

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