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Fast Takes
FDA declines expanded approval (skin cancer) for Bristol-Myers' Opdivo drug
Martin Shkreli's new pharmaceutical company is up another 80%
Business Insider
Amgen files for U.S. approval of Biosimilar to Humira
Lyrica for post-traumatic neuropathic pain lays an egg misses goal
Roche pulls out of 'superbug' antibiotic project
4 Weeks,
4 Key FDA Decisions Expected By Year End
24/7 Wall Street
Sandoz Warned About Manufacturing Issues at Indian Facilities

Biomberg BNA;[
Journalist = Bronwyn Mixter; November, 2015]

11/30 Hep C Pills Medicaid Denial 50% In Certain States
- Denial Rates for Medicaid 10X  Higher Than Part D, 5x Higher Than Commercial
Medicaid Denial for Hep C Drugs Nearing 50% in Some States …   Delaware, Maryland, New Jersey, and Pennsylvania denied nearly half of all claims …  most often cited "incomplete data to determine medical need" and "lack of medical necessity" …[Medscape]
Editor's Note:  37 states (88 percent) had reimbursement restrictions based on drug or alcohol use. Eight states (19 percent) required that all 21 states (50 percent) required a period of abstinence from drugs or alcohol use or abuse for all patients…  [Bloomberg BNA]
Editorial Statement:  Do we deny diabetes pills to fat people? Do we deny bypass to smokers?  Let's say some poor schmoe contracted Hep C from a blood transfusion in Viet Nam during the 70's, is it right to make him jump through hoops?  How about the  mom with 4 kids and no job who got Hep C from an infected tattoo needle when she was a teenager.  It's cruel to punish the poor for being sick, it's discriminatory and unconstitutional  … Will you cast the 1st stone? Think about this next month when  you're drinking eggnog, unwrapping presents.
Editor's Note: There are laws law against this.  What's your opinion?  We'd like to know.

Cancer Drugs End Of  Blank Check Mentality Approaches
- Diabetes drugs next (in our opinin)
Insurers Don't Want to Pay for Pricey Cancer Meds … High-priced cancer drugs are increasingly being placed in the highest tiers of insurers' drug formularies.
… High-priced cancer drugs are increasingly being placed in the highest tiers of insurers' drug formularies … patients are paying millions of dollars more every quarter than they would be spending if these drugs were covered more favorably with fixed co-pays….[Motley Fool]
Editor's Note:  Diabetes drugs are next.  It seems like you don't get a lot of bang for the buck regarding diabetes drugs.  Insurers are tired of paying $15 a pill for a new diabetes drug that is no more effective than a 50 cent generic metformin pill or a $170 bottle of OTC NPH insulin (compared to a $375 bottle of analogue insulin) 'You bill us $1,400 a month for an insulin anologue in a pen,  a GLP1 shot and a $14 pill, that's fine, but you need to pony up 25% of the cost.  If your A1C comes down 2 points we give you your money back'.  Mark my words this will happen.  There have been many new diabetes drugs introduced in the past 10 years however diabetes related death rates   remain stagnant.    In fact, number of patients achieving A1C greater than 9 is frightening.  A1c numbers are declining a few percentage points, mortality is flat buy prices are on a logarithmic growth track.  It's not sustainable.

Skin Drug Price Increases Outpace, Alarm
- Rapid price increase strategy has politicians, media Target Valeant
Study: Skin Care Drug trategyPrices Up 401 Percent Since 2009 … Valeant accounted for four of them: Targretin, Carac, Retin-A Micro for acne and Oxsoralen-Ultra for psoriasis. … Targretin gel rose to about $30,320 this year, 18 times as much as the $1,687 in 2009 … Carac cream, rose to $2,865 this summer, 18 times the 2009 price of $159 … [NY Times]
Pharmaceutical Karma: Valeant shares are down 73% in the last 3 months. 

Valeant Faces Potential $860 Billion Fine For Captive Pharmacy Business Model
Valeant: Based On The Novartis Settlement, Philidor Legal Exposure Could Be $860MM …  allegedly involved using the identification numbers of affiliated pharmacies in order to fill prescriptions … Philidor allegations claim that it was also using identification numbers of affiliated pharmacies to fill prescriptions. That said, revenue generated by Philidor and affiliated  …[Seeking Alpha]

Tax Dodge Merger May Hurt Pfizer Reputation But Legally Teflon
The reason Pfizer doesn't have to care what politicia … Even if one of the candidates who has taken a stance against tax inversion were to get elected, the merger will have been finalized for months before a January 2017 inauguration … not much they can do apart from damaging Pfizer's reputation … Killing it on the basis of the tax dodge will probably take an act of Congress, and that's not forthcoming … [Reuters]

Portrazza (necitumuma) Lilly lung cancer drug wins FDA Despite Questionable Efficacy
- Value based pricing to keep price down; life extension attributed to product measured in days
Lilly's middling lung cancer drug wins FDA approval with a restrictive label … extended patients' lives by just 1.6 months compared with the old chemotherapies alone, and Portrazza's positive effect on progression-free survival amounted to less than a week …[Fierce Biotech]
Related: Low Price Suggested for Necitumumab, Even Before Launch … Despite the fact that most new cancer drugs now cost in excess of $10,000 a month, the authors of a new study say that necitumumab should be priced between $563 and $1309 per cycle, as determined on the basis of a value-based pricing system …[Medscape]

Bird's Eye View Of China Diabetic Drug Market
- Biosimilar Lantus approved, 151 million diabetics by 2040
Beijing aims to refill medicine chest with 'Made in China' drugs … more diabetics than any other in the world, with numbers expected to hit 151 million by 2040 … Novo Nordisk By dominated 63 percent of China's insulin market. But it has recently been losing ground to local competitors cheered on by Beijing … Local rivals are selling both cut-price basic insulin and sophisticated modern versions, including a Biosimilar copy of Sanofi's Lantus …[Reuters]
Editor's Note: Adds that Chinese are opposed to branded generics,

11/24 CVS, Walgreens: Make Millions Off You, You Save Money On Toilet Paper
- Download their app; your personal health information in exchange for modest discounts
At Walgreens and CVS, a push to collect customer health data by dangling discounts … personal information, ranging from daily fluctuations in their weight to their progress in quitting smoking to their real-time location every minute of the day … n exchange for modest discounts, he said, patients are giving up "very, very valuable" information and leaving themselves open to a barrage of advertising about potentially sensitive health conditions … [StatNews]

New Jersey Permits Pharmacy-Level Substitution Of Biosimilars
New Jersey Governor Chris Christie has signed a bill legislating for the pharmacy-level substitution of biosimilars for innovative biologics … Within five business days, the pharmacist must tell the prescriber the name of the manufacturer and brand of the product they gave to the patient … substituting a biosimilar for a reference product carries no additional liability …[Biopharma Reporter]

Eli Lilly Drug Rep Killer Finally Convicted  Of 1st Degree Murder
Jury convicts Reginald Potts Jr. in 2007 murder of Nailah Franklin … Jurors deliberated just two hours before convicting Potts … intercepting her as she walked to her car, strangled or smothered her and put the body in the trunk of her company car … [Chicago Tribune]

Pharmaceutical Rep Assures Doctor He Personally Tries Every Drug He Promotes
Pharmaceutical Rep Assures Doctor He Personally Tries Every Drug He Promotes … Saying he could vouch for the quality of every one of his company's products, Eli Lilly pharmaceutical sales representative Geoffrey Klein reportedly assured a local primary care physician Thursday that he personally tries every single drug he promotes….[ Onion;

Pols Demand Canadian Drug Reimports As Elections Loom
Senators want Canadian imports when drug prices go too high … lawmakers are asking the Obama administration to expand the legitimate importation of medicines from Canada …  has been kicked around for years. And various lawmakers regularly introduce this legislation …[Pharmalot]

Medical Marketing & Media: 2016 Crystal Ball Foresees Cornucopia Of Approvals
The Pipeline Report 2016: Big-Time Upside …  A peek at 159 aspiring agents, with profiles on 17 that could shoot to stardom … cancer therapies employing the immune system, PCSK9 inhibitors targeting cholesterol and biosimilars angling to upset biologics' market share … latest in clinical data, revenue forecasts, expected launch dates and success likelihood …[MM&M]
See Also: Click Here For E-Zine Format | Click Here To download 7-page 4,900 word Report

11/24 Hep C: Experts Say Nip It In The Bud - Don't Wait For End Stage
- Insurer rationing policy is poor clinical practice
Expensive new Hep C drugs may be cost-effective even for early disease … using Harvoni to treat people with any evidence of liver damage from HCV, compared to giving it only to people with more severe disease, added about one year of healthy life for less than $50,000 … [Reuters]
See Also: Cost-effectiveness of Early Treatment of Hepatitis C Virus Genotype 1 by Stage of Liver Fibrosis in a US Treatment-Naive Population …[ JAMA Intern Med; November 23, 2015. doi:10.1001/jamainternmed.2015.6011]

Basket Of Common Generic Drugs:  Price Hikes  Slows To Zero
- However group of outliers outrageously skyrocket
Common Generic Drug Prices Are Hardly Going Up at All …  inflation among generic drugs dropping from 4 percent two years ago to zero … lowing inflation doesn't roll back earlier price increases … for the moment at least, the acceleration of prices in the generic drug market seems to have paused …[Bloomberg]

Fast Takes
Turing Blinks - Issues 50% Price Cut On  Controversial Toxoplasmosis Pill Daraprim
Allergan CEO: $187 Mln PaydayPoss After Pfizer Merger Goes Off
Teva: COPD Campaign Is LOL
Fierce Pharma Marketing
Woman Has Operation, Lives With a Pair of Surgical Scissors in Her Body for Five Years
Yahoo Health
Bristol-Myers Lets Low-Income Countries Copy Hepatitis C Pills
Teva Climbs On Goldman Sachs Upgrade: 2016 'Very Attractive'
FDA approves Bristol's Opdivo for kidney cancer
FDA approves 3rd multiple myeloma med of 2015, Takeda's Ninlaro
Biopharma Dive

Novo's Oral GLP1 Pill Hits Phase III Next Year
- Launch anticipated for 2020
Novo Nordisk's PIONEER Trial Will Establish A New Frontier In Oral Anti-Diabetics … Novo Nordisk's first diabetes pill is entering Phase 3 in next year's PIONEER trial … Solid-form oral biologics are expected to become a major part of Novo's repertoire … working to modify peptides with special properties that help it survive passage through the digestive system …[Seeking Alpha]

Pfizer + Allergan Inversion Deal: Pharma Leviathan Is Born
- Deal thumbs nose at US Treasury; Incorporate In Ireland
Pfizer and Allergan to Combine With Joint Value of $160 Billion … Read to be CEO, Saunders to be president of new Pfizer Plc …  structured so that Dublin-based Allergan is technically buying its much larger partner, a move that makes it easier for the company to locate its tax address in Ireland … largest ever in the pharmaceutical world …[Bloomberg]
Clinton Says Pfizer-Allergan Leaves Taxpayers 'Holding the Bag' …[Bloomberg]

Pfizer Allergan: More Than $2 Bln In Adverting Last Year
Pfizer and Allergan Deal Creates Advertising Behemoth … Pfizer is the seventh largest U.S. advertiser … Pfizer spent about $1.4 billion on measured media in the U.S. last year … Allergan spent $267 million and Actavis, which in March completed its acquisition of Allergan and assumed its name, spent about $387 million in 2014 …[WSJ]

Experts Expect Allergan + Pfizer Tieup Will Result In Big Layoff
With veteran job-choppers Pfizer and Allergan joining hands, how many layoffs are in the cards? …  history of wielding the ax in the wake of large tie-ups. Take Wyeth, a 2009 Pfizer buy ... pharma giant announced 20,000 job cuts … when it was Actavis, it announced it would let go 30% of its U.S. sales force after closing its Warner Chilcott transaction …[Fierce Pharma]
Editor's Note: Happy Holidays; Santa's sled will soon take off, if you work in pharma, tis the season for layoff. 

Pharmacists in California and Oregon to Prescribe Birth Control
Pharmacists in California and Oregon to Prescribe Birth Control … women will be able to get hormonal contraceptives, like pills and rings from a pharmacist. To get birth control at the pharmacy, women will undergo a brief screening with pharmacists and fill out a questionnaire   …[Time]

Pricey Sanofi Cholesterol Jab Locked Out Of CVS/Caremark
- Amgen scores formulary monopoly for 70 Mln life PBM
- FYI, Express covers both
CVS Makes Exclusive Deal to Cover Amgen's Cholesterol Drug …  concluded that the drugs were clinically equivalent … decision is effective on Dec. 1 … discount CVS obtained from Amgen was "substantial," Brennan said he would not reveal the amount …[Bloomberg]
CVS' Amgen Pick 'Raises The Bar' For Regeneron, Sanofi … gave CVS a "substantial" discount … Repatha will be the only PCSK9 inhibitor on the CVS/Caremark commercial formularies … Choosing one cholesterol drug allows the company to "get the best price possible … [Investor's Business Daily]

Very Much Worth A Click***********
FDA Drug Approvals and Changes: November Edition
Medscape (really really cool Slide Show)

Cystic Fibrosis Drug Is Budget Buster; $260K Per Patient Per Year Till Forever
New $710-A-Day Drug Saves Lives But Strains State Budgets … Vermont will be on the hook next year for $3.6 million for a drug expected to treat only 40 people … Orkambi - taken as two pills, twice daily - is a combination of two cystic fibrosis drugs that won approval from the Food and Drug Administration on July 2 … [DDD]

Sanofi Whistleblower Alleges Company Attorneys Destroyed Documents
Sanofi Whistleblower Alleges Company Attorneys Destroyed Documents …  accused Sanofi, among other things, of shifting $34 million in kickbacks and "incentive payments" to doctors and pharmacies to influence them to prescribe its diabetes drugs … [Biospace]

11/23 Fast Takes
Experts foresee big premium increases for Medicare drug plan
AbbVie's Humira repeats, joined by BMS' Opdivo in leading TV spending for October
Fierce Pharma Marketing
14 Top Urgent Care Center Chains in the U.S.
Health Data Management
Robber Barron Of Pharma CEOs Martin Skreli Buys Majority Stake In Failing Drug Company
Chicago Tribune
Tailspinning Afrezza Maker MannKind Starts CEO Search as Edstrom Steps Down
Big Pharma Learns to Share; AZN, Sanofi In 1st Of Kind Deal
EU Green Lights Biosim Enbrel
Janssen Submits Once Daily INVOKAMET® XR (Canagliflozin / Metformin Release)
JNJ Press Release

Novartis: Sales Manager Blows Whistle On Alleged Kickbacks, NVS Must Pay $390 Mln Fine
- Potential $100 Mln reward for whistle blower
- Exjade, Gleevec, Tasigna, Myfortic, TOBI
Novartis To Pay $390 Million to Settle False Claims …  leveraged its control over patient referrals to pressure BioScrip, Accredo, and US Bioservices to hire or assign nurses to call Exjade patients and, under the guise of education or clinical counseling, encourage patients to order more refills …[Corp Crime Reporter]

11/23 Pfizer Dismisses US Government Scare Tactics On Road To Become Irish Entity
- Quick deal could make Treasury Department threats moot
- So sure deal will go through, gambles up to $4.5 Bln on break up fee
Pfizer negotiating 2-3 percent Allergan break-up fee - sources … break-up fee, to be paid by Pfizer if it were to walk away from Allergan, would come out to $3 billion to $4.5 billion based on a $150 billion deal value …[Reuters]
Pfizer, Allergan reportedly prepping record $150B merger ahead of new inversion rules … Treasury Department sent a letter to lawmakers saying that it would be releasing new rules to further tighten conditions on tax-inversion mergers on top of an initial set of changes issued last year …[Biopharma Dive]
Pfizer, Allergan Could Merge By Monday; Street Dismisses Treasury Scare … analysts do not believe the Treasury's notice can derail a merger between the two companies …  [Bidness]

11/23 Nexium: AZN Versus Dr Reddy: Color Purple Fight Drrag On
- Reddy cries foul, claims AZN settled with it years ago, knew it would make pills purple, seeks redress
Dr Reddy's sues AstraZeneca over purple colour of Nexium generic … AZ had asserted its purple coloured pill is protected by three federal trademarks … In addition to Dr Reddy's, generic versions of Nexium is sold by companies such as Mylan and Teva in colours like blue and white …[Economic Times]

11/23 FDA Staff Excoriates BioMarin Duchenne Dug Ahead Of Meeting
FDA review casts doubt on first drug for combating Duchenne …  "life-threatening" side effects, such as a low blood platelet count and severe kidney damage … lack of "substantial evidence" of effectiveness … [Pharmalot]
Editor's Note:  You rarely seen pre-meeting review documents as negative as this.  In our opinion, approval of this drug is rather unlikely .

11/23 Ousted Sanofi Chief Viebacher To Launch Drug Company
- Focus on cultivating, selling off Phase III assets
Former Sanofi chief to launch Boston Pharmaceuticals with $600m … plans to acquire multiple drug compounds from other companies or academic labs, take them through the first rounds of clinical studies to "proof of concept," and then sell them off … We want to be a high-quality source of Phase 3-ready assets …[Boston Globe]

11/23 Inhaled Insulin; CEO Resigns Abruptly, 90 Year Old Founder Takes Over
- Will Sanofi Pull out of marketing agreement
Is This One Giant Lurch for MannKind? …  Sanofi has the right to exit the Afrezza partnership as early as January.  Management thinks that's unlikely, and given Sanofi's focus on diabetes  … management blamed Afrezza's lack of quick uptake on insurance companies' …[The Street]
MannKind Founder Returns to Helm, for Now, as CEO Resigns … [Genetic Engineering & Biotechnology News]

FDA : 37 New Drugs With 6 Weeks To Go, On Track To Top Last Year's 41
Bumper haul of expensive new drugs heads to U.S. and Europe … Drug research focused on medicines for rich countries … generics will account for between 91 and 92 percent of all U.S. dispensed prescriptions by 2020, up from 88 percent at present …[Reuters]
Editor's Note: Contains nice rundown of this years top new drugs with explanation and retail prices.

11/20 After Pfizer Pulls Out, Puerto Rico Struggles for Good Jobs
The Town Viagra Built Tries to Move On .... Barceloneta and other Puerto Rican towns were the beneficiaries of Section 936 of the Internal Revenue Code, which provided a tax exemption for mainland U.S. companies, mostly manufacturers with operations in Puerto Rico and other U.S. territories. At the peak, 14 pharmaceutical and other plants operated in Barceloneta .... Bloomberg

11/20 Medically Possible to Wipe Out Hep C, But Can We Afford It?
Price looms as major hurdle in hepatitis C eradication .... Treatment costs $83,000 to $153,000 for an illness that infects as many as 3.5 million people in the U.S. and up to 150 million worldwide. The numbers are growing as intravenous drug use is increasing. .... Reuters

11/20 Big Blow to ObamaCare; UNH Likely to Drop Out
UnitedHealth considers ditching ACA's exchanges due to giant losses .... Many of UnitedHealth's 550,000 exchange enrollees were sicker than expected and "strong users of services." In addition, many people have been signing up outside of the open-enrollment period, and those typically are the people using the most services .... Modern Healthcare

11/20 Coinsurance and High Tiers Placing Impossible Burden on Cancer Patients
American Cancer Society Calls for Limits on Out-of-Pocket Costs for Cancer Drugs .... Most insurance plans in the six states that were examined placed all or nearly all of the 22 medications studied into payment "tiers" that require the biggest out-of-pocket costs by patients .... Kaiser Health News

11/20 Comparative Low Break-Up Fee Shows Pfizer Confidence in Inversion Deal
Pfizer negotiating 2–3 percent Allergan break-up fee — sources .... A break-up fee of that amount, to be paid by Pfizer if it were to walk away from the Allergan deal, would show confidence that the regulatory risk to the merger does not pose an existential threat, despite the U.S. Treasury planning this week to tighten the rules on corporate tax inversions .... Reuters

11/20 Big Payday at the Top After Merger
Pfizer Deal Could Be Worth $187 Million for Allergan's Saunders .... Saunders's performance-based shares are based on Allergan's stock. If total shareholder return compound annual growth rate surpasses 10 percent in the period between July 1, 2014, to Sept. 1, 2017, the equity award pays out at its target value .... Bloomberg

11/20 Drugmakers Work to Strangle California Proposition in the Crib
Big Pharma spending millions to defeat effort to slash drug prices .... The measure would require drug makers to give big discounts to state agencies serving HIV patients, retirees, inmates, and low-income people.... Its backers submitted more than 540,000 signatures earlier this month .... Stat News

11/20 Viagra vs. Cialis vs. Levitra: Which Has Highest Satisfaction Score?
Brand-Name Drugs Increase Cost But Not Patient Satisfaction .... When it comes to patient satisfaction, however, there isn't much difference between brands and generics, according to data collected by the website Iodine, which is building a repository of user reviews on drugs .... ProPublica
Direct link: More than 100,000 people sharing their medication experience and advice

11/20 Just Keep Them Coming
CVS ReadyFill program improves medication adherence .... Members who received a 30-day supply of chronic medications and were enrolled in CVS' ReadyFill, an automatic prescription refill program launched in 2009, had a MPR of three points higher than members who filled medications the traditional way. Enrollees also had 2.5 fewer days of excess medication on hand .... American Pharmacy

11/20 Future Landscape of Primary Care: Projections and Personas
Meet tomorrow's primary care consumers .... To understand how age, geography, income and care preferences impact where consumers will go for primary care in the future, use Health Research Institute's interactive tool to explore the stories of seven different consumers. .... PwC

11/20 Syrian Fighters Tanked Up on Amphetamines
This Is the Powerful Drug Syrian Militants Take to Fight Harder and Longer .... Syria is now one of the world's leading producers of a powerful amphetamine called Captagon. Some experts suspect that millions of dollars in profits from the export of the drug, primarily to other Arab countries, are being used to beef up arsenals on all sides of the fight .... Maxim

11/20 Internet Drug News Fast Takes:

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