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Pharmaceutical News Harvest ™

12/18 Blincyto Price: $178,000 for Course of Treatment
Amgen Leukemia Therapy Costs $178,000, Among Priciest Drugs .... The price includes two $89,000 cycles of therapy, the median duration of treatment for patients who responded in clinical studies.... Each cycle consists of four weeks of treatment .... Bloomberg

12/18 CME Providers Hit Roof Over CMS Policy on CME Reporting
A Flip Flop? CME Payments to Doc Must be Reported to Sunshine Database .... CME payments are made by drug and device makers, as well as group purchasing organizations, to CME providers, which are either commercial firms or non-profits that organize courses for physicians. From there, payments may be made to physicians who speak at or attend CME events .... WSJ/Pharmalot

12/18 Somatuline Depot (lanreotide) Injection Approved for Gastroenteropancreatic NETs
FDA OKs Ipsen's gastroenteropancreatic tumours drug .... Approval came on the back of data from the CLARINET clinical study, which showed Somatuline cut the risk of disease progression or death by 53% versus placebo .... Pharma Times

12/18 Xtoro Approved
Swimmer's Ear Gets New Drug .... When ear infections were confirmed to be caused by P. aeruginosa or S. aureus, clinical cure rates of 70% were seen with Xtoro across both trials versus 37% of the placebo groups. .... Medpage Today

12/18 Murder Charges in New England Compounding Case
Massachusetts Pharmacy Owners Arrested in Meningitis Deaths .... 14 people were charged in a 131-count indictment, many of them pharmacists and technicians at the company... Only Mr. Cadden (head pharmacist) and Mr. Chin (supervisory pharmacist) were charged with murder .... NY Times

12/18 Spotlight on High Risk Prescribers
Prolific Prescribers Of Controlled Substances Face Medicare Scrutiny .... Medicare's drug program, known as Part D, now covers about 38 million seniors and disabled people and pays for more than one of every four prescriptions dispensed in this country.... Medicare's Part D data draws a roadmap to the doctors who prescribe controlled substances most frequently .... NPR
Direct link: Prescriber Checkup Database — Look up Any Doctor's Part D Prescribing Record

12/18 New York Has 105,000 People on Medicaid with Hep C. Only 7,000 Get Sovaldi, But It's Already the Leading Drug Cost in the Budget
Cost of Hepatitis C drug means major state Medicaid spend .... The New York Medicaid program's spending on Sovaldi outstripped its next-highest drug expenditure by more than $90 million. The second highest expenditure was for Abilify, a drug used to treat depression, schizophrenia and autism .... Bloomberg

12/18 Strike Two for Pozen Aspirin Formula
FDA rejects Pozen's aspirin drug for second time .... Regulators at the U.S. Food and Drug Administration raised concerns about a foreign manufacturing facility of an active ingredient supplier .... Triangle Business Journal

12/18 Teva Loses Place at Front of Line to Make Generic Celebrex
Mylan, Actavis prevail in Celebrex exclusivity fight, pushing Teva aside .... A Richmond, VA-based court reversed an FDA decision that had bestowed 180-day exclusivity on the Israeli drugmaker .... Fierce Pharma

12/18 Internet Drug News Fast Takes:
UCB Cancels Sale of Generic-Drug Unit to Buyout Firms
Study: 49 percent of patients withhold clinically sensitive information in their EMRs
Clemson University
Estimates of Benefits and Harms of Annual Mammography Screeing Over 10 Years of 10,000 50-Year-Old Women
Work Steals Valuable Sleep Time, Study Finds
HealthDay News
Oxy suspect allegedly spent thousands on drug-sniffing dog
Ellsworth (Maine) American

12/17 Your Wellness Data is All Over Town
Sexually Active? How Much Do You Drink? Your Workplace Health Records May Not Be as Private as You Think .... Corporate wellness programs have become one of the biggest areas where health data is being collected, with hundreds of vendors amassing millions of pieces of intimate and potentially embarrassing health information on American workers .... Bloomberg

12/17 Printed PIs Going the Way of the Dodo
FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically .... What the rule does require is a product's "immediate container label and outside package to bear a statement directing health care professionals to FDA's labeling repository to view the electronic version of prescribing information." .... Regulatory Focus

12/17 Salix Cleaning Up Channel-Stuffing Mess
Salix Limits Sales of Drugs to Let Wholesalers Cut Inventory .... Salix said it will sell minimal amounts of Apriso and Uceris, which treat inflammation of the colon, and Xifaxan 550, an antibiotic given to people with a complication of liver disease. Together, the drugs made up 56 percent of Salix's $382 million in second-quarter sales .... Bloomberg

12/17 Big Insurer and Cancer Center Test Bundled Payment
UHC, MD Anderson strike bundled pay deal for cancer care .... Under the deal, UnitedHealthcare will give MD Anderson fixed-rate payments to care for up to 150 patients with specific kinds of head and neck cancers. The deal would only affect patients who are enrolled in health plans through their employers .... Advisory Board

12/17 Inflammation Marker Predicts Coronary Risk; Available as Blood Test
FDA Approves Blood Test to Gauge Heart Attack Risk .... The test is designed for people with no history of heart disease, and it appears to be especially useful for women, and black women in particular .... WebMD

12/17 Long-Acting Signifor Gets Ok
Fresh off Afinitor failure, Novartis turns tide with Signifor LAR approval .... The Swiss drugmaker has won FDA approval for a long-acting version of Signifor, to treat acromegaly, a rare endocrine disorder .... Fierce Pharma

12/17 Got a 45 Minute Wait in a Doctor's Office? How About a Blast of Ads!
Point-of-care marketing could shoot past DTC as pharma's latest trend .... As aging baby boomers visit doctors more often and grow more receptive to health-based information, POC could become even more effective than other advertising mediums .... Fierce Pharma Marketing

12/17 Employers Getting Aggressive and Personal on Weight Loss
Memo to Staff: Time to Lose a Few Pounds .... Getting obese employees to normal weight, or even overweight, would save employers an average of 9% of the money they spend on health care or lose in productivity due to employee sick time, says one economist .... Wall Street Journal

12/17 Cholesterol Hype Begins Even Before Drug is Filed for Approval
Sanofi, Regeneron lay groundwork for PCSK9 rollout with Cholesterol Counts campaign .... The specialty cholesterol drugs--injectable antibody treatments--will be pricey, and drugmakers face a job persuading doctors and payers that they're worth adding to statin therapy. .... Fierce Pharma Marketing

12/17 Device Cleans Blood Plasma Before Transfusion
FDA approves Cerus system to cut blood transfusion infections .... The Intercept Blood System for plasma uses ultraviolet light and a chemical called amotosalen that inactivates viral pathogens in the blood. The plasma is then purified to remove the chemical and its byproducts .... Reuters

12/17 Internet Drug News Fast Takes:
Activis to Replace Most Allergan Executives After Deal
For blood pressure, sugar may be worse than salt
Ratings Agencies: Grim outlook for healthcare, hospital sector in 2015
Pfizer Ponies Up to Develop Long-acting Growth Hormone
The Street
Auspex Pharma drug curbs movement disorder in Huntington's patients

Fast Takes
Cancer's Next Big Thing -- Immunotherapy
CEO Candidate Bernard Poussot Turns His Back On Sanofi, Chooses Roche-Genentech

12/16 Court Body-Slams Forest Evergreening Tactic
The End of the Hard Switch? What the Judge Says About an Actavis Tactic … tactic known as "hard switching " or "product hopping". This is when a drug maker launches a newer drug and then removes the older drug from the market before a generic arrives, which forces patients to switch to its newer medicine …[Pharmalot]
Judge halts Alzheimer's drug swap until July … District Judge Robert Sweet tells Dublin-based Actavis PLC to continue making the drug Namenda available through July, when generic alternatives become available …[AP]

New Teva CEO Ready To Buy His Way Out Of Pipeline Drought PRN
-  Practically guarantees profit of $5 per share from 2016 onward*
For Teva Pharmaceuticals, stagnation is the new growth … returning Teva to the mergers and acquisitions game, where it has been missing in action for the past three years - the best period in the history of the pharmaceutical industry … [HARRETZ]
Editor's Note: if he doesn't deliver on the $5, Wall Street is likely pummel this stock.

Sophiris Goes China Syndrome: Sole Drug Disappoints, Shares Tank 80%
Interim data indicates Sophiris drug may not be effective … PRX302, designed to be injected directly into the prostate … interim data showed that its only compound was not effective in treating lower urinary tract symptoms of enlarged prostate …[Reuters]

India Gov Throws Wet Blanket On Cipla Hopes For Generic License
To 5 Novartis Patented Meds
Government may not act on Cipla's patent plea …  compulsory license for the medicines [the 5 Novartis drugs it intends to copycat despite patent protection] under section 92 of the Patents Act -- a rarest of rare provision to be used in case of national emergency or in extreme urgency … non-commercial use -- may not be "fit" to pass legal scrutiny …[Times Of India]

India Price Control Causing Drug Shortages
After price control, several key drugs in short supply …  Among the drugs facing shortage are Zyloric (allopurinol), Ocid (omeprazole), CCM (calcium supplement) and Etroxin (Levothyroxine Sodium) among others. Albumin, a lifesaving protein, has been in short supply for nearly four months now … Ten capsules of Zyloric used to cost Rs 37.40 ($0.59) . But after price control measures announced by the government, it now costs Rs 23.30 ($0.37).
Editor's Note:  If you marry the devil's daughter don't be surprised when your father-in-law pays a visit.

FDA 2014 approvals outpace those of 2013
FDA 2014 approvals outpace those of 2013 … 35 novel drugs in 2014 compared to 27 in 2013 … 5 of this year's approved new molecular entities were for orphan drugs …[MM&M]
Editor's Note: Lots of other granular stats; recommended.

Fast Takes
India:  price controls  52 more so-called "essential" drugs - pricing authority
Drug-resistant infections could cost the global economy $100 trillion by 2050
Obesity Pill Upstart Orexigen Therapeutics Gaining on Rivals
Adam Feuerstein

Geodon: 15 Years Post-Approval,  FDA Issues Deadly Skin Disease Warning
Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions … rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). See the FDA Drug Safety Communication for a Data Summary and additional information … [FDA]
See Also: Really gross pic of woman with this  reactionAnother one 

India Supreme Court: Sorry Bayer, Generic Nexavar Stays
Nationalize patent hands it over to Natco
Bayer Loses Battle to Block Generic Version of a Cancer Drug in India … Indian Supreme Court rejected its bid to block the Indian government from allowing a lower-cost version of its Nexavar kidney cancer medication from being sold. …[Blogs WSJ]

Novartis Experimental Cream Tops Stelara In Tests
Novartis psoriasis drug tops J&J's Stelara in late-stage study … Cosentyx is expected to be the first in a clutch of new treatments for plaque psoriasis which target the inflammation-causing protein interleukin-17 (IL-17) to gain market approval ,,,[Zurich]

Judge Nukes Actavis Namenda Evergreening Tactic (For Now)
Judge Rules Drug Maker Can't Shelve Old Pill …
victory for New York's attorney general, who had filed an antitrust lawsuit against Actavis in September, accusing the company of forcing patients to switch to the newer version of the widely used medicine to thwart competition from generic manufacturers …[NY Times]

New Indicatiuon: FDA Approves Eli Lilly's Cyramza for Lung Cancer
- Eli Lilly Gained Cyramza When It Acquired ImClone in 2008
FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer … to treat non-small cell lung cancer, the most common type of lung cancer … Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has grown (progressed) despite treatment with scertain other drugs …[FDA]

New Version Of Gardisil Covers 5 Additional HPV Bugs
Newest HPV Vaccine Protects Against 9 Strains … Gardasil and Gardasil 9 are both approved by the FDA for use in boys and girls, but Cervarix is not approved for use in boys … In addition to the four covered by the current Gardasil vaccine, Gardasil 9 covers types 31, 33, 45, 52 and 58, …[Forbes]

Investigative Report Claims Yahoo, AZN, Sanofi, Others
Track Your Websites You Visit, Compare It To Your Pharmacy Records
- Known as matchback ads
How Marketers Know If You're Buying Viagra … Drugmakers and Internet companies are quietly joining forces to link U.S. pharmacy records with online accounts to target ads to people based on their health conditions and the prescription drugs they buy … Bloomberg]

Sugar Worse Than Salt For Blood Pressure?
- New study says dump sugar not salt
Study Suggests Sugar Is Worse For Blood Pressure Than Salt: Really? … increases insulin levels which activates the sympathetic nervous system, leading to increases in heart rate and blood pressure … reduces the sensitivity of the receptors that regulate our blood pressure … constricts blood vessels, and increases blood pressure …[Forbes]

12/12 Blood Tests Will Help Find Alzheimer's Treatment
Tests May Soon Predict Alzheimer's. Do You Want to Know? .... This year, research teams announced blood tests under development to diagnose Alzheimer's before symptoms arise, including one that predicted the disease's onset with 100 percent accuracy a decade in advance .... Bloomberg

12/12 "Forced Switch" Blocked
U.S. judge says Actavis must keep selling Alzheimer drug .... The company planned to withdraw Namenda IR from the market in August to focus sales on its new drug, called Namenda XR, which is taken once instead of twice daily.... The move, also called a "forced switch," asks doctors to transition patients to Namenda XR, which will not face generic competition for years .... Reuters

12/12 Pharma and Insurers Careful with Venture Deals
How Can Digital Health Startups Work With Health Insurers And Big Pharma? .... Deliotte's research shows that few patients would trust apps controlled by either pharma or health insurers .... Forbes

12/12 Geodon Gets New Warning
FDA warns Pfizer's antipsychotic could cause fatal skin reaction .... A new warning has been added to the drug's label to describe the condition - known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) - which may start as a rash and spread all over .... Yahoo

12/12 Flush Twice, and Get Your Results Next Day
How DNA Sequencing In Sewers Could Detect Disease Outbreaks .... Public health officials would no longer have to wait for someone to spike a fever to know that Ebola virus was in Manhattan—they would be alerted by the sequences coming from the sewers, and they would know within a few blocks where it was .... Forbes/Matthew Herper

12/12 Tamoxifen Reduces Breast Cancer Rates by 30%; Five Years of Treatment Shows Effect for 15+ Years
Breast cancer drug tamoxifen has long-term effect .... The estimated risk of developing breast cancer was 8% in the tamoxifen group, compared to 12% in the placebo group, equating to 22 women being treated with the drug for every one breast cancer case prevented after 20 years .... Guardian

12/12 Copaxone Competitors Will Hit Teva's Bottom Line
Teva sets 2015 sales forecast up to $1B lower than analysts expected .... The company anticipates four specialty product approvals and 5 submissions next year .... Fierce Pharma

12/12 80% of Exchange Silver Plans Use Coinsurance for Specialty
Exchange Plans Increase Costs of Specialty Drugs for Patients in 2015 .... The incidence of plans charging coinsurance greater than 30 percent for specialty medications has increased from 27 percent of Silver plans in 2014 to 41 percent in 2015 .... Avalere

12/12 Capital Accord on Biosimilars
Biotechs and Generic Drug Makers Compromise on Biosimilar Lobbying .... Going forward, the companies have agreed to approach state legislatures with the same blueprint for substituting interchangeable biosimilars .... WSJ/Pharmalot/Ed Silverman

12/12 Recommended: Data Dump on Drug Spending from CMS
Medicare and Medicaid Account for Almost $100 Billion of 2013 Prescription Drug Spend .... Spending on Part D drugs accelerated to a 10.5 percent growth rate in 2013 – notably faster than the 2012 growth rate, pegged at 5.3% in the report .... RPM Report/First Take

12/12 Internet Drug News Fast Takes:
Aetna says demand surging for individual Obamacare plans
Human trial of experimental Merck Ebola vaccine Is suspended
Market Watch
Americans think that most physicians have it made. They're wrong.
IUD Gaining in Popularity for Contraception Choice in U.S.
HealthDay News
Statins not tied to male gonadal, sexual dysfunction
Medical Xpress

12/11 "Matchbacks" Tell Sites Your Prescription History as You Browse the Web
They Know You Buy Viagra and They Want to Sell You More .... Drugmakers and Internet companies are quietly joining forces to link U.S. pharmacy records with online accounts to target ads to people based on their health conditions and the prescription drugs they buy. .... Bloomberg

12/11 Billions Spent on Lyrica for Lower Back Pain; Study Says It Doesn't Work
Pfizer's Lyrica Doesn't Help Most Common Back Pain .... In a trial of 29 people over the age of 50 with severe lumbar spinal stenosis, those given Lyrica saw no more improvement than with a placebo, according to research published today in the journal Neurology .... Bloomberg

12/11 Shire Hypes $3 Billion Pipeline
Shire Sees Experimental Drugs Adding $3 Billion to Sales .... AbbVie walked away from buying Shire in October, paying a $1.64 billion breakup fee, after changes in U.S. tax rules made the transaction less appealing for the North Chicago, Illinois-based company. AbbVie had planned to move from the U.S. in a so-called tax inversion .... Bloomberg

12/11 Major Patent Expirations Coming Up: Abilify, Crestor, Lyrica, Symbicort
Drug makers face another $65 billion patent cliff .... Perhaps the biggest hit will be absorbed by Otsuka which sells the anti-psychotic drug Abilify. Bristol-Myers Squibb also markets the drug with Otsuka .... Marketwatch

12/11 Don't Like the Price for a Drug? Sue!
Gilead Faces Suit Over Hepatitis Drug's Price .... The Septa lawsuit accuses Gilead of discriminatory pricing for Sovaldi because some customers have received discounts and others haven't. Gilead has taken steps to provide the drug at steep discounts in developing countries .... WSJ

12/11 Keytruda Studied Against 30 Different Cancer Types; Show Results Against Breast Cancer
Merck Advancing Breast Cancer Drug to Mid-Stage .... Keytruda shrank tumors to some extent in one-third of 27 patients evaluated in a study called KEYNOTE-012. All had what's called triple-negative breast cancer that had spread outside the breast, and about 85 percent had worsened after multiple rounds of chemotherapy .... ABC News

12/11 Gardasil 9, Effective vs 5 Additional HPV Types
Merck wins FDA approval for Gardasil follow-up .... In a study of approximately 14,000 females ages 16 through 26, Gardasil 9 proved as effective as Gardasil at blocking the four shared HPV types, and researchers determined it was 97% effective in preventing cancers caused by the 5 additional types. .... Fierce Vaccines

12/11 Jan 7 — Advisory Committee Takes Up First Biosimilar for US Market
FDA plans review of Sandoz's Neupogen biosimilar .... FDA's Oncologic Drugs Advisory Committee will meet January 7 to discuss Sandoz's biologics license application for EP2006, a biosimilar version of Amgen's top-selling Neupogen (filgrastim) and the first ever biosimilar application in the US .... MM&M Online

12/11 People 65–79 Average 27 Prescriptions Per Year
Many Senior Citizens Take Too Many Medicines -- Here's How To Fix It .... Every senior should have someone who is watching over his or her intake of prescription drugs. Seniors need a care manager — someone at the center of their care who knows everything that is being prescribed, what is working, and, most importantly, knows when it's time to discontinue what doesn't work .... Forbes/Guest Post by Roy Beveridge, MD of Humana

12/11 Tobacco Costs Us Each Over $500 Per Year, Even if We Have Never Smoked
Cigarette smoking accounts for 8.7% of total healthcare spend .... Taxpayers bear 60% of the cost of smoking-attributable diseases through such publicly funded programs as Medicare and Medicaid. Despite declines in the rates of smoking in recent years, the costs on society due to smoking have increased .... Drug Store News

12/11 Internet Drug News Fast Takes:
Walgreen CEO Is Out as Top Shareholder Pessina Takes Over
Half of listed Medicaid doctors are actually unavailable
Advisory Board
Special K, a Hallucinogen, Raises Hopes and Concerns as a Treatment for Depression
NY Times
Men with poor semen have poorer health, too
NBC News
Mood Ring—Cell Phones Can Hear Depression in People's Voices

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