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Pharmaceutical News Harvest (TM) for 5/27/15

5/27 Fast Takes
Novo Nordisk executive fuels firm's new obesity fight
Kansas man missing for 23 years found submerged in car
Exclusive: Mylan chairman says Teva offers nothing it can't do on its own
J&J puts global media business up for review

5/27 STIOLTO: FDA Approves Spiriva + Long Acting Beta Agonist Fixed Dose Combo Spray
- Tiotropium bromide and olodaterol
FDA Approves Boehringer Ingelheim's STIOLTO RESPIMAT Inhalation Spray as Once-Daily Maintenance Treatment for COPD … the only COPD treatment that includes two proven agents: tiotropium, the active ingredient in SPIRIVA®, and olodaterol … COPD maintenance treatment proven to be more effective than either SPIRIVA or olodaterol alone …[Boehringer ]

Back Story: Amgen / AZN Psoriasis Psoriasis Drug Had Suicide Issues,
Hence Plug Pulled & Partnership Dissolved
Amgen Down After Suicides Kill AstraZeneca Deal … "suicidal ideation and behavior" in some patients in the clinical trials of brodalumab, which is being tested for psoriasis, psoriatic arthritis and axial spondyloarthritis, would lead to such a restricted label …[Investor's Business Daily]
Editor's Note:  2 suicides, 4 suicidal ideation in 2 phase III trials.

Cholesterol Jab Differentiating Factors Will Be Price, Dosing Regimen
Fight over hot new cholesterol drugs may be won in milligrams … Amgen  will offer its drug, Repatha, as a biweekly 140 mg injection or a monthly injection of 420 mg … Praluent, from Regeneron  and Sanofi, will be offered in biweekly injections of 75 mg or 150 mg … [Reuters]
Editor's Note: Adds pricing predictions; Amgen product will be $10K per year, Sanofi product will be between $5k & $10K depending on how much you use.
See AlsoRepatha (Amgen) Google News Search  | Praluent (Sanofi) Google News Search

5/27 5
Heavy Hitters To Be Approved Between Now & Labor Day (Umm Hopefully)
5 Drugs That Could Be Summer Blockbusters … Between now and Labor Day, five companies are looking at FDA decisions that could launch blockbuster drugs, and make a big impact … [Investor's Business Daily]
Editor's note: explains 2 IBS drugs from Valeant and Actavis, cystic fibrosis drug from Vertex, and 2 PCSK9 inhibitor's.  Gives background info, projected sales, anticipated approval dates,  likliehood of approval.; 1,047 words; quick read; recommended.

Vertex: Company Loses Money, CEO Rides $45.8 Mln Gravy Train
Vertex CEO's $45.8 Million Pay Last Year Excessive, ISS Says … company's shares have gained 226 percent … Vertex hasn't been profitable since 2012 … isn't projected to make money on that basis until 2016 … [Bloomberg]

Pharma: Highest Net Profit Margins, Highest Paid Execs
- What's not to like?
Pharma Trumps All Healthcare Sectors In Executive Compensation … highest net profit margins (NPMs) of any healthcare sector and it could well be the highest NPMs for any industry including those outside of healthcare … how does executive compensation in the pharmaceutical sector compare to executive compensation in the hospital sector or the healthcare IT sector? … [Forbes]
Editor's Note: The 2nd highest paid healthcare execs are for-profit hospitals;  #3 are the Hmo's.  The lowest paid HMO CEO gets $15 Mln; the highest paid hosp CEO got $26 Mln; 935 words - fascinating article.  Jealous, Angry or inspired- you'll l feel something after reading this.

Top Prescribing Docs Biggest Beneficiary Of Pharma Financial Largesse
Drugmakers funnel payments to high-prescribing doctors … Nearly one-quarter of Medicare's top-prescribing physicians received consulting fees or other financial perks from manufacturers of the drugs they prescribed in 2013 …[Modern Healthcare]
Editor's Note: The highest paid  doc got $70.8K; Cancer and MS drugs dominate the top 20.

Cancer Drugs; Express Sets Pricing Based On Efficacy
- Reimbursement for particular drug varies depending on  type of cancer; 
New Push Ties Cost of Drugs to How Well They Work … seeking deals with pharmaceutical companies that would set pricing for some cancer drugs based on how well they work … "indication-specific pricing" model, the per-pill cost of Tarceva would be lower for pancreatic-cancer patients than for lung-cancer patients …[WSJ]
Editor's Note: This is a game changer.  This is the beginning of the end of the blank check mentality regarding cancer drug reimbursement - as long as there is more than one drug for a particular cancer.  If you are first in class or indication you are still in good shape.  Once the 2nd drug comes out, it's a race to the bottom.

Nurse Practitioners Gain Power Whether Docs Like It Or Not
- N.P. = 21st century replacement for MD, DO
Doctoring, Without the Doctor … Nebraska became the 20th state to adopt a law that makes it possible for nurses in a variety of medical fields with most advanced degrees to practice without a doctor's oversight …[NY Times]

Fast Takes
You May Have Missed: Eye Drug Fails, Ear Drug Flops, and Herpes Drug Succeeds
Officials: $1M spent on medical care for jailed Chicago teen who ate thumbtacks, screws, medical device
AstraZeneca, Amgen End Psoriasis Drug Brodalumab Deal

Court Torpedos Actavis Scheme To Force Namenda XR Patient Switches
Actavis Confirms Appeals Court Ruling Requiring Continued Distribution of NAMENDA Immediate Release …  we are disappointed by the Court's decision to uphold this ruling, we intend to continue our strong efforts to convey the significant benefits of NAMENDA XR …[Actavis Press Release]
US appeals court upholds delay in Alzheimer's drug swap … [AP]

California Hands Insurance Companies Huge Defeat, Cherry Pie For Pharma
- Price control on copays for CA health exchange
Covered California First to Cap Monthly Specialty Drug Copays … majority of Covered California's beneficiaries will have monthly payments for specialty drugs capped at $250 per month … Before the changes, consumers had to reach an out-of-pocket maximum before their insurance coverage kicked in, meaning that with some expensive specialty drugs, customers had to pay for the first few months by themselves …[Bloomberg]

At Last: $1 Million Per Injection; Gene therapy is Hot
World's Most Expensive Medicine: Is it Worth the Price? … Gene therapies aim to fix or knock out defective genes, or add those that are missing, to cure diseases … price tag reflects the fact that it's given just once and targets a disease that afflicts about 200 people … spread out over several years and could cease if a patient dies …[Bloomberg]
Editor's Note: A 2012 WSJ report claimed the drug was $1.6 million.  Hundred thou$and here, hundred thou$and there, pretty soon your talking about real money.

Saxenda (Liraglutide) Not For Diabetes But May Help You Manage Diabetes
- Patients lost 6.1% of their weight
Novo Nordisk's Saxenda Delays Onset of Type II Diabetes … time-to-onset of type II diabetes was 2.6 times longer in patients undergoing treatment with Saxenda compared to those receiving placebo. Moreover, the risk of developing the disease was cut down by approximately 80% in the Saxenda arm …[Zacks]

5/22 21st Century Cures Act Set to Shake Up FDA
House committee approves bill to speed new drugs to market .... The bill, known as the 21st Century Cures Act, requires the Food and Drug Administration to incorporate patient experience into its decision-making, streamline its review of drugs for additional uses, and consider more flexible forms of clinical trials .... Reuters

5/22 Who Is on Pfizer's Wish List?
All Eyes on Pfizer as Shareholders Await the Mega-Deal .... In addition to the tax benefits, a deal would give Pfizer more lucrative products and a way to cut costs. And now may be the time to do it before borrowing rates climb and the best targets get picked off .... Bloomberg

5/22 It's Official: CVS Buys OmniCare
CVS Buys Nursing Home Pharmacy Chain, Drug Provider OmniCare For $12.7B .... Omnicare, currently the largest provider of pharmaceutical services in nursing homes, operates 160 locations in assisted living and long-term care facilities in 47 states .... Consumerist
See also: CVS Chief Bets Big on Health Care Thrust With Omnicare Deal [Bloomberg] (autoplay video)

5/22 Jumping to Defend 340B
Hospitals Urge Congress not to Change a Drug Discount Program .... The program has become contentious as the number of institutions was expanded to about 2,000 from roughly 800 thanks to the Affordable Care Act. In doing so, this widened the number of hospitals eligible for discounts .... WSJ/Pharmalot

5/22 Rapaflo Website Draws FDA Nastygram
OPDP finds fault with Rapaflo website .... A website indicating that Actavis's alpha-blocker Rapaflo capsules can improve sleep and daytime productivity prompted an untitled letter from the FDA's Office of Prescription Drug Promotion. .... MM&M

5/22 Afinitor Also Effective in Neuroendocrine Tumors from Lung or GI Tract
Novartis' Afinitor extends progression-free survival in NET .... A Phase III trial of the drug — called RADIANT-4 — met its primary endpoint by demonstrating significant extension of progression-free survival (PFS) compared to placebo plus best supportive care .... Pharma Times

5/22 New RA Drug to be Submitted for Approval by End of 2015
Sanofi says sarilumab filing for arthritis on track .... After 12 weeks' treatment on top of non-biologic disease modifying anti-rheumatic drugs therapy, sarilumab given every two weeks by subcutaneous injection achieved a 20% improvement in symptoms in 56% of a low-dose (150mg) group and 61% of a high-dose (200mg) group. In contrast, just 31% of placebo-treated patients achieved that level of benefit. .... PM LiVE

5/22 Feds Flag Confusing Zerbaxa Label
FDA: Watch for Dosing Errors With Zerbaxa .... The presentation of the drug strength on the Zerbaxa vial and carton labeling, displayed as 1 g/0.5 g, was cited as the reason for the medication errors .... Pharmacy Practice News

5/22 Where the Grim Reaper Hangs Out in Your Neighborhood
Map Reveals The Distinctive Cause Of Death In Each State .... An analysis of mortality records uncovered the most distinctive cause of death in each state. In Texas, it's tuberculosis. In Maine, the flu. And in Nevada, it's "legal intervention." .... NPR

5/22 Sovaldi is a Huge Bargain According to this Study
Investing in hepatitis C drugs could save the economy billions, researchers suggest .... The higher cure rate and reduced side effects of treating hepatitis C patients with an all-oral combination of ledipasvir and sofosbuvir (LDV/SOF) led to substantially less absenteeism and better work productivity that could save economies of the US and five European countries more than $3.2 billion a year .... Medical News Today

5/22 Internet Drug News Fast Takes:
Otonomy's ear drug fails mid-stage trial
Memory loss may not always be first sign of Alzheimer's
Caffeine Intake Linked to Lower Risk of Erectile Dysfunction
HealthDay News
Olympic Gold Medalist Jackie Joyner-Kersee Teams up with AstraZeneca to Raise Awareness about Opioid-Induced Constipation
Business Wire
Common gene variant that affects cholesterol may raise heart risk
Medical News Today

5/21 Fast Takes
Amgen cholesterol drug could get EU green light this week
SWOT Analysis of Gilead Sciences Inc. Stock
Motley Fool
Gilead patents on costly hepatitis C drug challenged in 5 countries
Vaccine injury fund tops $3.5 billion as patients fight for payment

5/21 JNJ: 10 New Blockbuster Drugs By 2019
- Remicade biosimilar will be a punch in the stomach
J&J Invests in Alzheimer's, Cancer as Competitive Threats Emerge … investing in a collection of experimental drugs with blockbuster potential, treating widespread illnesses like blood cancer and Alzheimer's disease, to help rise above looming competitive threats to its pharmaceutical business …[Bloomberg]

CVS To Buy 800 Lb Gorilla Of Nursing Home Pharmacies
CVS Said in Advanced Talks to Buy Omnicare to Expand Pharma … Omnicare delivers drugs and helps senior-living facilities manage residents' medications … CVS and Omnicare are big in Medicare Part D … [Bloomberg]

Will Pfizer Actually Take Over Glaxo?  Citibank Analyst Pooh Poohs Idea
- Nice way to get around rules banning reflagging US corporations
Pfizer Would Benefit From Glaxo Takeover, Deutsche Bank Says …  government resistance to preserve GSK as an independent listed company is materially higher than it was with AstraZeneca, given the much larger U.K. infrastructure and GSK's status as the largest U.K. pharmaceutical entity …[Bloomberg]

Finally: Dose Of Optimism For Inhaled Insulin Afrezza
- Finding niche for Type 1 diabetics; DTC campaign planned
MannKind stock jumps on positive report about inhaled insulin … demand for the drug is likely to rise …  planned advertising campaign should also improve results, … aware of the drug were prescribing it "more frequently than we had expected, especially among Type 1 diabetics …[LA Timnes]
Related: Toujeo and Afrezza: New and Improved Insulins, Limited by FDA Labeling Constraints … Afrezza's medical importance will likely hinge on something that no trial can measure: how the change from injection to inhalation affects patient behavior. If the delivery method inspires patients to medicate themselves more consistently …[AJMC]

Flonase: GSK Biggest Spender In OTC Hay Fever Segment
GSK pumps out big bucks for Flonase OTC launch … spent an estimated $71 million in TV advertising alone for its newly OTC nasal spray Flonase … three-month spend would put Flonase at No. 5 on iSpot's 2014 annual list of top spending brands … "outperforms a leading allergy pill …[Fierce Pharma Marketing]

Muckraker Paints Advair As Dangerous Drug, 2nd Guesses Glaxo Marketing, Label
Overuse, Safety Questions Cloud Advair's Ascent to Asthma Blockbuster … scores of lawsuits and claims brought

5/20 First Four-Dose-a-Year Schizophrenia Drug Approved
FDA approves J&J's schizophrenia drug Invega Trinza .... At phase III, 93% of patients treated with the drug did not experience a significant return of schizophrenic symptoms .... PM Live

5/20 New Government Scheme to Put a Lid on the Cost of Cancer Care
Should Doctors Get Paid More If Their Cancer Patients Live? .... The Oncology Care Model would set a target price for the total cost of care over a six-month period, which would start when the patient is prescribed chemotherapy drugs. Practices will start by receiving a $160 payment per month for the patient to help cover the cost of managing their care .... National Journal

5/20 Repatha Green Light Coming Soon?
Amgen cholesterol drug could get EU green light this week .... According to an agenda posted on the European Medicines Agency's (EMA) website on Tuesday, a committee of experts will consider whether to recommend the medicine at a four-day meeting concluding on May 21 .... Yahoo

5/20 New England Compounding Center, Responsible for 64 Deaths, to Pay $200 million
Pharmacy in 2012 U.S. meningitis outbreak to pay victims $200 million .... The now-defunct Massachusetts pharmacy behind a deadly 2012 meningitis outbreak that killed at least 64 people will pay out $200 million to its victims and creditors under a bankruptcy reorganization plan .... Reuters

5/20 The Case of Promising Anti-Smoking Drug Shows How and Expensive it is to Bring a New Drug to Market
Entrepreneur Touts Cheap, Safe Smoking Cessation Drug -- But Is It? .... The drug is cytisine and it is isolated from laburnum trees in Bulgaria. In fact, it is already sold as Tabex by Sopharma in Eastern Europe, where it's been on the market since 1964. .... Forbes/John LaMattina
Original article: Pill that quashes tobacco urge found in plain sight [Washington Post]

5/20 Who's Really Being Helped by Patient Assistance Programs?
Drug Assistance Programs: All They're Cracked Up to Be? .... Except for difficulty getting into assistance programs, they're largely considered a blessing to desperate patients, but who pays for it all? It seems like the pharmaceutical companies that make the drugs are paying, but all that money winds up back in their own accounts .... US News

5/20 New Management Puts Eteplirsen on Right Track with FDA
Sarepta Soars on Start of FDA Submission for Duchenne Drug .... Sarepta has received priority review from the FDA and eteplirsen could be approved by the beginning of 2016 .... Bloomberg

5/20 Pazdur Comes Out Against Long Side Effects Warnings on DTC TV Ads
Detailed Drug Risks in TV Ads 'Waste of Time,' FDA Official Says .... Pazdur didn't endorse a specific change to drug ads on television but said he "would encourage the agency to look at this whole advertising issue in a much more innovative approach." .... Bloomberg

5/20 New Orphan Status for Humira for Hidradenitis Suppurativa
AbbVie's Humira Wins FDA Orphan Status For HS Skin Disease .... Hidradenitis suppurativa is a very painful form of inflammatory skin disease that affects body parts such as the armpits and groin. There is no approved treatment for the disease in the market yet .... Bidness

5/20 Congress to Set a Deadline for FDA's Off Label Revamp
FDA's Deadline To Update "Off Label" Policy .... A new provision in the "21st Century Cures" bill would set a deadline for FDA to issue update its policy on off-label information dissemination. That deadline is likely to come in late 2017 .... RPM Report

5/20 Has Your Teen Gotten the Second Meningitis Shot? SNY Tries Pop Star/Singing Contest
Sanofi seeks the next Teenage Idol in meningitis vaccine campaign .... As part of its ongoing Voices of Meningitis Campaign, Sanofi recently brought aboard actress and singer Lucy Hale, the star of ABC Family's "Pretty Little Liars." .... Fierce Pharma Marketing

5/20 Internet Drug News Fast Takes:
Achillion partners with J&J to develop hep C drugs
Cholesterol drugs may curb strokes among low-risk older adults
UCLA researchers identify a potentially effective treatment for methamphetamine addiction
University of California-Los Angeles
Metabolic Syndrome Rate Stabilizing Nationally
Medpage Today
Lucentis biosimilar could offer safer option than compounded Avastin
Biopharma Reporter

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