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Pharmaceutical News Harvest ™

10/1 Fast Takes
Sanofi posts positive results for injectable drug in chronic sinusitis
Company Press Release
JNJ beefs up hepatitis, anti-viral pipeline with $1.7 Bln buy of Alios
Investor's Business Daily
Walgreen Says Sales Reach Record as Drug Business Grows
Bloomberg


10/1
Ebola Strikes USA; First Confirmed Case That we Know Of
- Visitor from Liberia falls ill in Texas
Ebola Update: 1st Case Diagnosed in the US …  The man flew out of Liberia on Sept. 19 and arrived in the United States on Sept. 20. He did not have symptoms during his flight or when he landed, but began showing symptoms around Sept. 24 … Ebola patients are only contagious when they show symptoms, and so this patient was not infectious during his flight … [Live Science]
Editor's Note: CDC is downplaying the possibility that he infected anyone.

10/1
According to CMS, 546K Docs Received $3.4 Bln In Drug Company Largess From Aug To Dec 2013
Drug and device firms paid $3.5B to care providers … value of industry payments and other financial benefits totaled nearly $3.5 billion in the five-month period from August through December 2013 … 546,000 clinicians and 1,360 teaching hospitals received benefits … Manufacturers must report payments and gifts unless they are valued at under $10 …[AP]
Editor's Note: Above article repeats falsehood that doctors get free pens, golf outings at fancy resorts.   These practices have been outlawed since  2009 but reporters keep propagating this B.S. for some reason.   I am surprised that 2 talented journalists from AP (Ricardo Alonso-Zaldivar & Jack Gillum) didn't check their facts before this article was published.  Maybe someone from the industry will set the record straight.  I would do it myself but I have no credibility

10/1
Internet Drug News Test Drives OpenPaymentsData.gov
- Site Impossible To Use; Guaranteed To Frustrate Anyone Familiar With The Internet
The people who brought you the IRS, armored personnel carriers for campus police and Congress do it again … We visited the site and tried to get information regarding how much largess a particular doctor received.  After 15 minutes we gave up.  As far as intuitive navigation, ease of use or usefulness, on a scale of 1 - 10, we give it a -15.  Even the directions are impossible to decipher …[Internet Drug News]
Editor's Note: Doctors have nothing to worry about.

10/1
Sucampo, Takeda Launch Amitiza DTC
- Ads employ visual metaphor of twisted balloon creatures
Sucampo goes all-in on Amitiza with new DTC effort … on the market for the better part of a decade and holds the broadest indication in the category … [ads use] balloons--which are tied and twisted in various ways to show an upset stomach, a doctor, and even a toilet …[MM&M]

10/1
Pfizer Campaign: Selling Viagra To Women For Their Men
Viagra ads target women for 1st time … Ads for rival Cialis have featured couples getting frisky during everyday activities  … [ad copy:] it's just you and your honey. The setting is perfect. But then erectile dysfunction happens again … not just getting an erection, but keeping it …[AP]
Editor's Note: Features long legged sexy model clad in negligιe, lying seductively on an outdoor four posted bed.
See Also: Viagra spoof commercial; YouTube; > 45 million views - ha ha he he

10/1
Sovaldi: French Punish Gilead With Special Tax
France uses tax to put pressure on hepatitis C drug prices … Socialist government said it had designed a "progressive contribution scheme … selectively tax drugmakers when the total cost to the state from their hepatitis C drugs exceeds a certain amount each year …[Reuters]

10/1
India Prime Minister: 'Tough Nuggies: We Ain't Changing Our Drug Patent Laws'
- Claims that voiding patents is god for humanity silent on lining India pharma pockets
India's Modi must resist U.S. pressure on drug patents: MSF … The world can't afford to see India's pharmacy shut down by U.S. commercial interests." … India's patent laws and policies have fostered robust generic competition … [Reuters]

9/30
Fast Takes
BMJ: Women With Large Waistlines More Likely To Get Breast Cancer
Huff Post
Salix constipation drug gets nod for expanded use; opioids for chronic pain unrelated to cancer
Reuters
3 Likely Biotech Buyout Candidates
24/7 Wall Street
Daily Dose of Aspirin May Cut Prostate Cancer Risk: Study
Bloomberg

9/30
Orphan Drugs: Insurers Unfazed By Six-Figure Per Price Tags
- Tab can reach $440K per year per patient for certain products
High Prices for Orphan Drug can be Sustained, a Payer Survey Shows … despite the tumult, the cost for orphan drugs - medicines that are designated by the FDA to treat a rare disease and may cost as much as $400,000 annually - is apparently not fazing some insurers. … coverage or access policies are unlikely to change to a large degree over the next several years …[Pharmalot]
See Also: How A $440,000 Drug Is Turning Alexion Into Biotech's New Innovation Powerhouse … [Forbes]
Editor's Note: Forbes article is from 2012; at that time, Cinryze, a drug for hereditary angioedema was priced at $417K per year.  Soliris, a drug for a rare anemia went for $440k.  Want to see the entire list?  Click HERE

9/30
Sunshine Act Data About To Go Live
-
But, only 5 month's worth of data from last year
Get Ready to Learn About the Money Doctors Take From Drugmakers … financial relationships between doctors and the makers of drugs and medical devices have long been hidden. That's poised to change on Tuesday … information will only cover payments made from August to December 2013 …[Bloomberg]

9/30
Oct 6th Is Date All Hydrocodone Products Go From CIII to CII
DEA: Vicodin, Some Other Pain Meds Will Be Harder to Get … inal regulation, which takes effect Oct. 6, will mean that patients generally must present a written prescription to receive the drug, and doctors will no longer be able to call in a prescription to the pharmacy in most instances …[Kaiser Health News]

9/30
International Biosimilar Goldrush Is On:
245 Companies Take Biosimilar Plunge
Hundreds of firms join global hunt for copycat biotech drugs … copycat [small molecule] medicines are typically offered at a 20 to 30 percent discount to innovator brands - rather than the 90 percent or so seen with conventional generics … South Korea and Brazil stand out as pioneers of biosimilar drug development, with India's …[Reuters]

9/30
FDA: Ad For Hemorrhoid Pain Drug Pacira Gets FDA Spanking
Pacira gets OPDP opioid promotion Warning Letter … The problem: Exparel is indicated for surgical pain related to bunion or hemorrhoid removal surgery, but the promotional items the FDA does directly address in this letter seem to indicate other, non-approved uses for the drug. …[MM&M]

9/30
Early, Frequent Antibiotic Use Linked To Childhood Obeastity
- Fattens up hogs, cattle, chickens; add people to the list?
Early, frequent antibiotic use linked to childhood obesity … Wide spectrum antibiotics appear to change the mix of bacteria in a baby's gut, predisposing to obesity … who were prescribed four or more courses of antibiotics in that period, were more likely to be obese at some point between their their second and fifth birthdays than were those who had taken no antibiotics  …[LA Times]

9/29
Fast Takes
FDA OKs Spiriva Respimat for COPD
Medpage TODAY
CVS Pays $6 Mln Whistleblower fine; whistleblower pockets $1 Mln
Reuters
New FDA Program Protects Pharmacies From Rogue Wholesale Drug Distributors
Pharmacy Times
Scientists grapple with ethics in rush to release Ebola vaccines
Reuters
No benefit from continued use of AstraZeneca's Iressa drug
Reuters
The Listerine-Type Strip That Could End Migraines
Bloomberg (Video)

9/29
Roche; Breast Cancer; Perjeta Cocktail Expends Life 15.7 Months
- Rare, remarkable efficacy; many cancer drug life extension measured in weeks
Breast cancer drug Perjeta could extend patients' lives by 15 months
…  magnitude of survival benefit which we have never seen before in advanced breast cancer, let alone this particular type, previously regarded as having a poor prognosis and being difficult to treat …[Guardian]
Roche Breast Cancer Drug Perjeta Appears to Greatly Extend Patients' Lives … [NY Times]

9/29
Xolair; Bad News; Label Update; Heart Attack, Stroke, Blood Clots
- Ambulance chasers can't be far behind
FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events … problems included mini-strokes known as transient ischemic attacks or TIAs; heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins … suggestive of a serious safety signal …[FDA]
FDA says asthma drug Xolair raises risk of heart, brain problems …  higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins … marketed jointly by Roche and Novartis … greater risk of pulmonary hypertension, or high blood pressure in the arteries of the lungs …[Reuters]

9/29
Under Threat Of Lawsuit, Actavis Un-Discontinues
Non-XR Version Of Namenda
Actavis to keep selling Alzheimer's drug in U.S. for 60 days … agreement with New York's attorney general to keep selling a top Alzheimer's drug for 60 days so U.S. patients will not be forced to switch to a newer, more expensive form of the drug with additional patent protection …[Reuters]

9/29
Docs Use Fujifilm Anti-Flu Med To Treat Ebola
- Polymerase inhibitorselectiely inhibits viral RNA synthesis
Fujifilm Says French Ebola Patient Taking Its Avigan Drug … favipiravir targets polymerase, an enzyme viruses use to replicate inside the body, to stop the viruses from spreading … Favipiravir is in the final stages of human studies in the U.S. as a treatment for flu …[Bloomberg]

9/29
Novartis  Answer To Enbrel, Humira Impresses In Phase III Trials
- Novartis hopes to replace TNF inhibitors
Novartis' blockbuster hopeful scores a win in psoriatic arthritis … secukinumab, is an injected antibody that blocks interleukin-17A, a protein that plays a major role in inflammation … [achieved endpoints of] preventing joint damage and maintaining clear skin …[Fierce BioTech]

9/29
Drug Companies, Patients Critical Of FDA Social Media Guidelines
- FDA outlaws pharma use of Twitter because there is no package insert
- Fight not over; 1st Amendment issues may be raised
FDA Social Media Guides Draw Industry, User Criticism … limitations FDA recommends cannot withstand basic First Amendment scrutiny, because there are less restrictive means of ensuring that information presented on these platforms is truthful and …  perversely, is likely to result in more inaccurate information about medicines online that will go uncorrected …[MM&M]


9/29 Abbott and AbbVie Beat Racketeering Rap
- Torpedos activist union's dream to outlaw drug coupons
Abbott, AbbVie win dismissal of claims over Humira, AndroGel .... A federal judge in Chicago dismissed racketeering claims in a lawsuit accusing Abbott Laboratories and AbbVie Inc of causing health plans to pay unnecessarily for the latter's blockbuster Humira arthritis drug and AndroGel testosterone drug instead of cheaper generics .... [Reuters]

9/29 Pharma Sales Focus Shifts to Formulary Committees and Health System Execs
As Doctors Lose Clout, Drug Firms Redirect the Sales Call .... At big hospital systems, salespeople woo administrators to get on 'formulary' .... [WSJ]

9/29 Pharmalot Reveals What Actavis Tried to Hide; Another Ed Silverman Scoop
What Actavis Did Not Want You to See in That Antitrust Lawsuit .... In the un-redacted version, some Forest execs provided testimony under oath suggesting plans to discontinue the older pill were not as imminent or certain as suggested in public statements due to manufacturing problems .... [Pharmalot]

9/26 Secukinumab Succeeds in Phase 3, Sales May Hit $1 Billion if Approved
Novartis Says Psoriasis Drug Met End-Goal of Arthritis Studies .... About 30 percent of people with the skin disease psoriasis have psoriatic arthritis, a long-lasting condition that causes joint pain and stiffness, and may lead to irreversible damage. The market for drugs to treat the ailment will reach $3.7 billion in 2023 .... [Bloomberg]

9/26 New Chairman at GSK
Glaxo Names RBS's Hampton as Chairman, Replacing Gent .... Hampton, 60, oversaw changes as chairman of grocery-store company J Sainsbury Plc and at Royal Bank of Scotland, encouraging analysts that he may overhaul management at the U.K.'s biggest drugmaker .... [Bloomberg]

9/26 AZN MEDI3902, for Pneumonia Often Afflicting Hospital Patients
AstraZeneca pneumonia treatment on FDA fast-track .... The FDA has granted fast-track designation to the investigational monoclonal antibody MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa. .... [Pharma Times]

9/26 91% of Patients are on Time for Doctor Visits; Same Not True for the Doctors
How Often Do People Arrive Late To Appointments? .... On average, patients said they spent a total of 38 minutes waiting — 23 of them in the aptly titled waiting room and another 15 minutes in the exam room. .... [fivethirtyeight.com via Matthew Herper]

9/26 Pharmaceutical Care Popular with Patients
Pharmacist, patient interaction increasingly important in pharmacy customer satisfaction .... Want satisfied pharmacy customers? Ensure that they have direct interaction and collaboration with pharmacists and implement an in-store clinic or wellness center .... [Drug Store News]

9/26 Two New HIV Drugs Approved
Tybost (Cobicistat) and Vitekta (Elvitegravir) Approved as Individual HIV Drugs .... A next-generation boosting agent and an integrase inhibitor joined the growing ranks of approved HIV medications on Sept. 24, when the U.S. Food and Drug Administration (FDA) stamped its seal of approval on Tybost (known generically as cobicistat) and Vitekta (elvitegravir) .... [The Body]

9/26 Continuing Debate Over Substitutions for Biologics
Will interchangeables open a biogenerics market in U.S.? .... Drugmakers used to the generic small-molecule model see interchangeable biologics as an easier sell than biosimilars, since interchangeables can be substituted when the reference biologic is prescribed. Biosimilars, on the other hand, have to compete head-to-head with an established brand, which may match their discounted price .... [BioWorld]

9/26 Internet Drug News Fast Takes:
This Hair Growing Laser Helmet Was Just Approved By The FDA
io9
Gastric bypass bests banding for weight loss, diabetes, high blood pressure, and cholesterol control
UT Southwestern
'We're not ready': Hundreds of nurses stage Ebola 'die-in' on Las Vegas strip
Advisory Board
One in four kids on ADHD meds gets therapy too
Reuters
Desmopressin Offers Modest Benefit for Nocturia
HealthDay News

9/25 Drug Companies Do Less and Less Research Each Year
'The process by which drugs are discovered and developed will be fundamentally different in the future' .... The R&D infrastructure for drug development is shrinking, perhaps irreversibly, and our ability to discover and develop new medicines is being progressively dismantled .... [Medical Xpress]

Got Resume?

9/25 Agreement Delays Forced Switch to Namenda XR
Actavis to keep selling Alzheimer's drug in U.S. for 60 days .... Actavis has reached an agreement with New York's attorney general to keep selling a top Alzheimer's drug for 60 days so patients will not be forced to switch to a newer, more expensive form of the drug with additional patent protection .... [Reuters]

9/25 Adderall XR Marketing Settlement
Shire to pay $56.5 mln to settle improper marketing probe .... The company was also accused of promoting the drug for unapproved uses and of making other false claims not supported by data, such as that Adderall XR would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted disease .... [Reuters]

9/25 Chains Offering Cheap Generics Finding Many Takers
Generic discount drug programs getting wider use .... Nearly a quarter of those eligible for programs offering discounts on generic medications are using the benefits .... [Reuters]

9/25 How Well Does Crestor Work for You? Real-time Polling of Consumers Gives the Answer
To Gather Drug Data, a Health Start-Up Turns to Consumers .... With 100,000 surveys completed and more added daily, Iodine is building the largest survey ever taken of Americans' drug experience, intended to help consumers and perhaps guide policy. .... [NY Times]
Direct link: Iodine

9/25 Otsuka and Lundbeck Submit Brexpiprazole for Approval
FDA accepts new schizophrenia drug filing .... In the two Phase III schizophrenia trials, patients receiving brexpiprazole showed greater improvement in symptoms compared to the placebo group, measured by a change from baseline in the Positive and Negative Syndrome Scale .... [Pharmafile]

9/25 Activists: 'Fire Hamburg for Zohydro Approval'
Anti-addiction groups call for new FDA chief .... Deaths linked to the addictive medications, including OxyContin and Vicodin, have more than tripled over the last 20 years to an estimated 17,000 in 2011 .... [Medical Xpress]

9/25 Big Bet on Inhaled Levodopa
For Second Act, Acorda Drops $525 Million On Inhaled Parkinson's Drug .... Civitas' main asset is an inhaled form of levodopa, the main treatment for Parkinson's disease. The pills patients currently take can wear off, leaving them with periods in which their tremors and other symptoms return. The inhaler could be used to rescue them at those moments .... [Forbes]

9/25 Sanofi Software Brings Regular Glucose Monitor Updates to Doctors without an Office Visit
Sanofi rolls out HCP software .... MyStar Connect offers a scenario in which patients log into a site and enter the meter's information on a regular basis, and doctors read this data before and/or between appointments and reserve the nine-to-10 minute appointment talking about the data and what needs to be done .... [MM&M]

9/25 Feds Promise to Bust Anyone Honoring Copay Coupons for Medicare Recipients
Can copay coupons be kickbacks? HHS says yes .... A new Inspector General's report points out that some 7% of seniors are using coupons to help cover their prescriptions. That's something like 2 million Medicare recipients. .... [Fierce Pharma Marketing]

9/25 Internet Drug News Fast Takes:
Your medical record is worth more to hackers than your credit card
Reuters
Billing dispute leads to blocked patient data in Maine
Boston Globe
Sandoz launches Kerydin topical solution
Drug Store News
Merrimack, Baxter Ink $970M+ Deal for Pancreatic Cancer Drug
Xconomy
In First, FDA Sends Warning Letters to Companies Citing Use of Pinterest
Regulatory Focus


9/24 Pfizer Eyes Actavis
Pfizer Said to Have Approached Actavis About Takeover to Lower Tax Rate .... The U.S. drugmaker continues to explore ways to cut its tax rate and gain a new product pipeline .... [Bloomberg]

Got Resume?

9/24 Otezla Approved for Plaque Psoriasis
Celgene Wins U.S. Approval of New Psoriasis Pill .... Celgene is studying Otezla for use against other diseases as well, including rheumatoid arthritis and another form of arthritis that can lead to a new bone formation on the spine, called ankylosing spondylitis .... [Bloomberg]

9/24 PillPack Has Built a Better Mousetrap for Prescription Management
PillPack's New Dashboard Tries To Tame Pharmaceutical Insanity .... PillPack allows customers to replace their unruly pillboxes with a pre-assorted, foolproof ticker tape of medicine, shipped straight to their door every two weeks .... [Fast Company]

9/24 FDA's Janet Woodcock Wins Bipartisan Praise
Creating A New FDA/Capitol Hill Legend .... CDER Director Janet Woodcock has pulled off the Capitol Hill miracle of being the regulator embraced by both sides of the aisle .... [RPM Report/First Take]

9/24 Obesity Slowdown May Be Easing Diabetes Epidemic
Diabetes rates may be leveling off overall .... Researchers found little change in the prevalence and incidence of diabetes between 2008 and 2012, following drastic increases in both numbers between 1990 and 2008 .... [Reuters Health]

9/24 Gilead's Game Plan
Gilead Sciences: A Preview of Important HIV Drug Study Results .... Tenofovir alafenamide, if successful, will allow Gilead to continue growing its dominant HIV business even with looming patent expirations of some of its older HIV drugs .... [The Street]

9/24 Revamp REMS
FDA Wants to Make Some of the Most Dangerous Drugs Less of a Burden on Companies and Physicians .... The FDA soon plans to implement four "priority projects" meant to improve its Risk Evaluation and Mitigation Strategies (REMS) programs .... [Regulatory Focus]

9/24 Can the FTC Win a Pay-to-Delay Case?
Why the FTC Lawsuit over Pay-To-Delay Deals Matters: Rutgers Law Professor Michael Carrier Explains .... It's conceivable that private plaintiffs [suing over pay-to-delay] have a stronger case, based on available facts, than the FTC .... [Pharmalot]

9/24 Best Places for Doctors to Train
Report ranks top residency programs — see how yours stacks up .... The University of California–San Francisco placed in the top 10 lists for 16 medical specialties and was ranked No. 1 in three of those specialties. Johns Hopkins University placed in the top 10 lists for 14 specialties and was ranked No. 1 in four specialties .... [AMA Wire]
Direct link: Residency Navigator

9/24 Boehringer Ingelheim Reducing Staff
Boehringer Ingelheim to cut up to 600 jobs in Germany .... Boehringer Ingelheim plans to manage the job cuts through natural attrition, retirements and the expiry of temporary contracts .... [First Word Pharma]

9/24 Internet Drug News Fast Takes:
The living hell of a man who orgasms 100 times a day
NY Post
Now Everyone Can Know What's In Their DNA
Fast Company
Test young women for gonorrhea and Chlamydia
Reuters Health
Philips to Split Lighting, Health Tech Businesses
Re/Code
U.S. Curbs on Inversions May Deter Some Pharmaceutical Deals
NY Times DealBook

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