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7/24 Brands Using REMS to Deny Supplies to Generics Makers
Abuse of U.S. generic-drug rules costs billions .... The report from the Generic Pharmaceutical Association said REMS have been used to prevent generic drugmakers from getting branded medicine to test their own versions, which is required to win FDA approval .... [Reuters]

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7/24 Sovaldi Blows Through Another Record
Gilead hepatitis C drug Sovaldi racks up $3.5 bln in quarter .... In its first two industry record shattering full quarters on the market, Sovaldi has racked up about $5.8 billion in sales despite reports that thousands of patients are still waiting in the wings for Gilead's two drugs in one pill, once a day combination treatment expected to gain U.S. approval this year .... [Reuters]
See also: Health insurer group asks Gilead to cut hepatitis C drug price [Reuters]

7/24 Payers Cutting Access to New Hep C Treatment
Who Gets Saved? Hepatitis Cure at $84,000 Makes Doctors Choose .... Constrained by limited budgets, health insurers and government programs are forced to make hard choices about which patients will get the cure. Many are opting to treat only the sickest. .... [Bloomberg]

7/24 Idealisib Approved; Gets Black Box and REMS
FDA approves Gilead blood cancer drug Zydelig .... FDA approved the use of Zydelig in combination with Roche AG's Rituxan for patients with relapsed chronic lymphocytic leukemia (CLL) .... [Reuters]

7/24 BI Hid Benefits of Dose Control for Dabigatran
Monitoring, Dose Adjustment for Pradaxa? .... Blood level monitoring and dose adjustment for dabigatran (Pradaxa) could reduce major bleeding risk by 40% compared with well-controlled warfarin, according to company documents allegedly hidden from physicians and regulators .... [MedPage Today]

7/24 Rep: Celgene Pushed Thalidomide Derivative for Off-Label Use
A Legal Test for a Drugmaker's Off-Label Cancer Treatment .... Former saleswoman Beverly Brown alleged that "Celgene's initial marketing efforts for Thalomid were tantamount to ongoing human experimentation." She claimed that her ex-employer marketed Thalomid and Revlimid for purposes unapproved by the FDA, leading to unlawful claims for reimbursement .... [Businessweek via Pharmalot]

7/24 From the People Who Brought You, Now Here's the Open Payments Website
Error: You Have No Payments from Pharma .... Doctors checking a soon-to-be-unveiled federal website that will publicly list drug company payments are encountering error messages if they have not accepted industry money .... [ProPublica]

7/24 Glaxo Still Tumbling Down Patent Cliff
Another major drop in sales for GSK .... GSK's investors are worried that the firm is relying too heavily on its inhaled lung drug Advair, which makes up nearly a fifth of sales. It brought in £1.1 billion for the quarter, down 12 per cent. .... [Pharmafile]

7/24 Novartis in a Nutshell
5 Novartis Drugs You Need To Know About .... Novartis' most important drugs and the threats and opportunities that lie ahead for them .... [Motley Fool]

7/24 Lab Report Saves Owner's Life
Daisy, the dog who's sniffed out over 500 cases of cancer: She even saved the woman whose research revealed her uncanny skill .... 'The dogs can detect cancer in the urine of patients with prostate cancer more reliably than the PSA test', says Professor David Billington, referring to the blood test typically used to detect levels of prostate specific antigen, a protein linked to the disease. 'A positive PSA test is followed up by a multi-needle biopsy, which is unpleasant and invasive. .... [Daily Mail]

7/24 Internet Drug News Fast Takes:
Sanofi Pasteur starts shipping 2014 flu vaccine
Drug Store News
FDA Clears Way for Generic Invokana, Xalkori, Tecfidera and Dozens of Other Drugs
Regulatory Focus
FDA Warns of Compounded Drug Recall by Texas Firm
ABC News
Merck taps music industry for US HIV campaign
Life expectancy gains threatened as more older Americans suffer from multiple conditions
Johns Hopkins University Bloomberg School of Public Health

7/23 Sovaldi Sales in 2nd Quarter Could Hit $4 Billion
Gilead Expected to Post Sky-High Hep C Sales in June Quarter .... Gilead's second quarter performance seems largely irrelevant ahead of the FDA approval decision in October (or sooner) for the single-pill, fixed-dose combination of Sovaldi and ledipasvir. This is the hepatitis C therapy (no interferon or ribavirin required) everyone has been waiting for .... [The Street/Adam Feuerstein]

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7/23 What Works for Weight Loss? Jenny Craig, Weight Watchers, and Qsymia
Study compares cost-effectiveness of weight-loss programs and drugs .... Average weight loss at one year ranged from 2.4 kg (about 5 pounds) for Weight Watchers to 7.4 kg (16 pounds) for Jenny Craig. Those on Orlistat lost 2.8 kg (a little more than 6 pounds) whereas those on Vtrim and Lorcaserin both lost an average of 3.2 kg (about 7 pounds). Weight loss for those on Qsymia averaged 6.7kg (a little less than 15 pounds). Based on the cost and weight-loss data, the average cost per kilogram lost ranged from $155 per kg for Weight Watchers to $338 or more for Jenny Craig. Qsymia came in at $232 per kg. .... [Duke University Medical Center]

7/23 Harder to Get Your Foot in the Door
Rep access continues to shrink .... Last year 84% of dermatologists and 63% of gastroenterologists were rep-accessible. This year, these percentages have dropped to 67% of dermatologists and 47% of gastroenterologists .... [MM&M]

7/23 Therapy Guide for Patients with ER-positive Breast Cancer
Gene Marker May Predict Breast Cancer Response to Tamoxifen .... A gene signature defined by differential expression after USP9X attenuation in the presence of tamoxifen was used to identify patients with ERα-positive breast cancer experiencing a poor outcome after adjuvant therapy with tamoxifen .... [HealthDay News]

7/23 Old Age Ain't No Place for Sissies
An 'Emotional Burden' Rarely Discussed .... Bowel incontinence is also surprisingly prevalent, affecting more than one out of every six seniors who live in their own homes or apartments. Men and women are equally affected .... [New York Times]

7/23 Good Enough for Europe is Good Enough for Us
House bill would speed approval once EU OKs same product .... The bill would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union .... [MM&M]

7/23 Zuplenz Can't Get No Respect
Galena Gives Sales Team Another Useless Product to Promote .... Zuplenz competes against a host of low-priced generic formulations of ondansetron, including an easily dissolving tablet. Galena sales reps will now add Zuplenz to their bag along with the cancer pain drug Abstral, another under-performing product the company acquired last year. .... [The Street/Adam Feuerstein]

7/23 128 Genes Involved in Schizophrenia; No Hope for a One-Drug Cure
Schizophrenia Roots Tied to Complex Web of Gene Switches .... A decade-long effort by hundreds of scientists worldwide has uncovered 128 genes involved in the brain disorder schizophrenia, findings that point to new research avenues while suggesting a cure may not be achievable with a single treatment. .... [Bloomberg]

7/23 Grumble, Grumble, Grumble
News flash for biopharma bosses: More than half your employees want to leave .... More than one-half--51%, to be exact--of biotech and pharma workers are looking to jump ship to a new company.... That compares with just 38% of employees polled across different industry sectors .... [Fierce Pharma]

7/23 Payers Doing All They Can to Rein in Diabetes Costs
As More Therapies Flood the Market, Plans Worry About Rising Diabetes Costs .... Surveyed U.S. payers identified improvements in the drugs' ability to lower body weight and safely reduce the incidence of cardiovascular adverse events as key drivers of formulary inclusion .... [AIS Health via Fierce Pharma]

7/23 Internet Drug News Fast Takes:
Using a nicotine patch during pregnancy tied to higher ADHD risk
Reuters Health
When Cancer Is More Common Than Experts Thought
WSJ (Numbers blog)
China seals off 30,000 people after bubonic plague death
The Verge
FDA gives tentative approval to Teva's abacavir sulfate, lamivudine tabs
Drug Store News
Aduro pancreatic cancer treatment gets FDA breakthrough
Pharma Times

7/22 FDA Data-Mining Large Claims Databases for Safety Signals
Big Data Peeps At Your Medical Records To Find Drug Problems .... Mini-Sentinel is able to mine huge databases of medical records for signs that drugs may be linked to problems .... [NPR Health Blog]

7/22 We Will All Pay $300/Year for the New Hep C Drugs (Whether We Have the Disease or Not)
JAMA: Hep C drugs could add $300 to every American's insurance premium .... "[T]he more important issue is the number of people eligible for treatment," the commentary notes. "Sofosbuvir is not really a per-unit cost outlier but is a 'total cost' outlier because of its high cost and very large population eligible for treatment." .... [Fierce Pharma]

7/22 Allergan Fights Takeover Bid by Firing 13%
Allergan Will Cut About 1,500 Jobs in Restructuring .... The job cuts represent about 13 percent of the global workforce for the company best known for its Botox wrinkle remover .... [Bloomberg]

7/22 Touts Expect More Tax Inversions
Analysts see Perrigo, Actelion as next potential targets for US drugmakers .... Other industry observers see Pfizer returning with a bid for AstraZeneca after its failed takeover attempt earlier this year. "There's a great deal of expectation that Pfizer will try again...." .... [First Word Pharma]

7/22 4% of Patients Use Specialty Drugs, But They Account for 25% of Total Drug Spending
Specialty drugs transform lives — but at a cost .... Expensive new specialty drugs offer hope to patients with rare and chronic illnesses but also leave many worrying about paying for thems .... [Boston Globe]

7/22 Xolair Relieves the Serious Itching from Hives
Asthma Drug May Help Those With Chronic Hives .... When Xolair is taken at a high dose for a six-month period it seems to be both safe and effective at controlling the severe and often debilitating itching that characterizes long-term hives .... [Health Day]

7/22 Stem Cells for Treatment of Diabetes in Phase 1 Trial
ViaCyte asks FDA for go-ahead with human trials of cell replacement therapy for diabetes .... The trial will assess the safety and efficacy of ViaCyte's VC-01 product candidate, a stem cell-derived, encapsulated cell replacement therapy .... [Medcity News]

7/22 Science Under Glass at New AZN Headquarters
AstraZeneca reveals plans for global HQ in Cambridge .... The drugmaker says that the high technology labs on the site will be separated from other work spaces by glass walls to promote "visible science" and will feature a number of open spaces and thoroughfares .... [Pharma Times]

7/22 Internet Drug News Fast Takes:
Probiotics might help lower blood pressure
Reuters Health
The Future of Robot Caregivers
NY Times
Does a Parkinson's Drug Increase Creativity?
Daily Beast
Antipsychotics Linked to Lower Brain Volume in Schizophrenia Patients
Health Day
Lanreotide Improves Survival With Enteropancreatic Tumors
Health Day

7/21 AbbVie–Shire Deal Will Save the Company $1.3 Billion in Taxes
AbbVie finally gets Shire, its low tax base and enough new drugs to protect its future .... With a bid reaching nearly $55 billion and some goodies for the top execs, AbbVie was finally able to get Ireland-based Shire to surrender its independence, a portfolio of attention deficit hyperactivity disorder and rare disease drugs, and its low Irish tax base. .... [Fierce Pharma]

7/21 Rush for the Exits
Can Anything Stop Drug Companies From Fleeing The U.S. Tax System? .... The U.S. corporate tax rate is now one of the highest in the world, above that of Japan, France, or Germany, and it has not kept pace tax rates in the rest of the world as they have fallen .... [Forbes/Matthew Herper]

7/21 Schwan: "Let's Not Make a Deal"
Roche CEO plans to steer clear of big acquisitions .... Since acquiring the remainder of U.S. biotech company Genentech for $46.8 billion in 2009, Roche has earned a reputation as a disciplined acquirer, prepared to walk away from potential deals rather than overpay .... [Reuters]

7/21 Solvadi + Ribavirin Clears Hep C in Difficult-to-Treat Patients
Gilead Drug Combination Cures Hepatitis C in HIV Patients .... In a study of 223 HIV-infected patients, Solvadi combined with ribavirin cleared the most common U.S. strain of hepatitis C in 76 percent of newly treated patients over 24 weeks .... [Bloomberg]

7/21 FDA Will Survey Teens to See If They are Paying Attention to Drug Safety Warnings
Do Teenagers and Young Adults Understand Drug Ads? FDA Study Aims to Find Out .... The FDA is moving forward with a study of how adolescents and young adults (ages 13 to 30) understand the benefits and risks of drugs they learn about through advertising .... [Regulatory Focus]

7/21 Emergency Doc Calls 'BS' on Zofran Warning
Inside the Ondansetron Black Box .... But all this talk about whether or not ondansetron is a safe drug, it's a funny thing to talk about because when I talk to my emergency physician colleges we don't know anybody who's ever seen any kind of an adverse reaction of significance to ondansetron .... [MedPage Today]

7/21 Feds Ease Hospice Red Tape
U.S. Medicare program scales back hospice drugs restrictions .... CMS will now require prior-approval for coverage of only four categories of drugs: analgesics, anti-nauseants, laxatives and anti-anxiety drugs. .... [Reuters]

7/21 What's New in Diabetes: Glucose-Measuring Contact Lenses, the Bionic Pancreas, and 1,100 Smartphone Apps
10 Technologies Changing Diabetes Care .... "More than 30% of Medicare dollars are spent on diabetics and/or related complications. Likely diabetes, or more specifically 'insulin resistance,' will be linked to many more disease processes — i.e., Alzheimer's disease is also referred to as 'Type III diabetes,' as one of its underpinnings is insulin resistance" .... [Information Week]

7/21 Positive Results for Mekinist and Tafinlar
GSK's melanoma study stopped early on survival boost .... Patients with metastatic melanoma — carrying a BRAFV600 mutation — who took a combo of Mekinist (trametinib) and Tafinlar (dabrafenib) demonstrated an overall survival benefit compared to those taking vemarufenib .... [Pharma Times]

7/21 Trial Launched for New Indication for Eliquis
BMS, Pfizer begin patient enrollment in Phase IV EMANATE trial of Eliquis .... The companies have started patient enrollment in a Phase IV clinical trial called EMANATE evaluating the effectiveness and safety of Eliquis in patients with nonvalvular atrial fibrillation undergoing cardioversion .... [Pharmaceutical Business Review]

7/21 Internet Drug News Fast Takes:
More nurses are putting off retirement
Advisory Board
FDA approves new dosage strength of Purdue Pharma's Butrans
Drug Store News
Common gene variants account for most of the genetic risk for autism
Mount Sinai School of Medicine
HPV test better than Pap for assessing cervical cancer risk
Reuters Health
Statins drug can double breast cancer risk
Express (U.K.)

7/18 FDA Will Tackle Testosterone Products on Sept. 17
FDA committee to discuss adverse effects of testosterone products .... The FDA has called for a joint meeting of the bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee .... [Reuters]

7/18 50% of Visits to Retail Clinics from Patients Who'd Been There Before
Utilization of retail clinics for chronic, preventive care on the rise .... The percentage of visits to health care clinic locations for preventive services, screening and chronic visit utilization (combined) increased from 4% in 2007 to 17% in 2013 .... [Drug Store News]

7/18 New HAE Drug Gets OK
FDA Approves Ruconest for Hereditary Angioedema .... Hereditary angioedema affects as many as 10,000 people in the United States. Ruconest, produced from the milk of genetically-modified rabbits, is intended to restore the level of functional C1-esterase inhibitor in a patient's plasma, thus reducing swelling .... [HealthDay News]

7/18 New Melanoma Drug to Seek Approval
Roche, Exelixis Skin Cancer Drug Delays Tumor Progression .... Roche intends to seek FDA approval for the new melanoma drug, known as cobimetinib .... [TheStreet/Adam Feuerstein]

7/18 Favipiravir Rated Likely to Come to Market
Flu Drug Fighting Resistant Strains to Seek U.S. Approval .... While the Fujifilm drug is currently in human trials for seasonal flu, two studies in animals published earlier this year suggested that it is also a candidate for treating the deadly Ebola virus that is spreading in Africa .... [Bloomberg]

7/18 Watch for Updates: AbbVie, Shire Deal Nearing Completion
AbbVie, Shire set to announce merger as early as Friday .... Shire at first wasn't interested in several overtures made by AbbVie but warmed up to the idea when AbbVie upped the ante to roughly $91 a share in U.S. dollars .... [Bloomberg]

7/18 Pfizer Launches Big Campaign to Celebrate the Inevitable
Afraid of aging? Pfizer's revamped 'Get old' campaign wants you .... The company's premise is that the #FOGO campaign will spread goodwill toward Pfizer. The company's own research showed that consumers who visited went away with a 55-percentage-point improvement in their perceptions of Pfizer .... [Fierce Pharma Marketing]

7/18 Ebola Isn't Here Yet, but Chikungunya Is
It's Here! First Local Chikungunya Cases in Florida .... Chikungunya is not usually deadly, but it can cause a very bad headache, joint pain, rash and fever. Its name in the Makonde language, spoken in Tanzania and Mozambique in Africa, means "that which bends up," because patients are often contorted with pain .... [NBC News]

7/18 Sterile Injectables Maker Joins Pfizer Portfolio
Pfizer buys InnoPharma for up to $360 million .... Privately-held InnoPharma's portfolio includes 10 generic products approved by the US Food and Drug Administration, with another 19 filed with the agency .... [Pharma Times]

7/18 Health Officials Think They Can End AIDS by 2030
AIDS Epidemic May Be Subsiding .... In the last three years, new HIV infections have dropped 13 percent, and the 2.1 million new HIV infections reported last year are the fewest since the turn of the century. .... [HealthDay News]

7/18 Internet Drug News Fast Takes:
Doctors pick their favorite EHRs
Advisory Board
Eye movements reveal difference between love and lust
University of Chicago
Drug-Sniffing Dogs Ease Parents' Minds — Or Confirm Their Fears
NPR Health Blog
Amgen thyroid drug succeeds in late stage kidney patient trial
Business Insider
Donating a Kidney May Carry Hidden Insurance Costs
HealthDay News
One third of cancer patients are killed by a 'fat-burning' process termed 'cachexia'
Centro Nacional de Investigaciones Oncologicas

7/17 Inhalers Stunt Your Kid's Growth (But Not Much)
Scientific review finds asthma drugs suppress child growth .... "The evidence... suggests that children treated daily with inhaled corticosteroids may grow approximately half a centimetre less during the first year of treatment" .... [Reuters]

Got Resume?

7/17 NEJM Study Slams Niacin for Increased Death Risk, Complications
Studies see new risks for cholesterol drug niacin .... The larger study suggests that "for every 200 people that we treat with niacin, there is one excess death," plus higher rates of bleeding, infections and other problems — "a completely unacceptable level" of harm .... [AP/Yahoo]

7/17 Crenezumab Works a Little if You Give a Lot
Roche Reports Mixed Results in Trial of an Alzheimer’s Drug .... While the drug did not slow progression of the disease over all, at the highest doses it did seem to delay a decline in mental ability in patients with mild cases of Alzheimer’s .... [NY Times]
See also: Should Roche's Failed Trial Give Hope To Alzheimer's Patients? [Forbes/Matthew Herper]

7/17 Octagam 10% Approved
Hoboken company's platelet disorder drug gains receives FDA approval .... FDA has approved the intravenous drug Octagam 10%, a treatment for adults with chronic Immune Thrombocytopenic Purpura (ITP) .... [Jersey Journal]

7/17 400 Physicians Commit Suicide Every Year
Physicians have the highest suicide rate of any profession. So why haven't you heard about it? .... A recent article by internist Daniela Drake that contends being a physician has become "the most miserable profession" given pressures from insurers, employers, and declining reimbursements .... [Advisory Board]

7/17 Brand Sites Still Work for Awareness and Favorability
Online marketing increasingly effective for pharma .... Pharma online advertising has the highest viewability rates of ten industries benchmarked by the researchers, with 51 per cent of billions of advertisements assessed found to be 'viewable' .... [PMLiVE]

7/17 PocketDerm: Message a Picture of Your Zits to a Doc, Get Medicine by Mail
Acne App Takes Telemedicine to New Level .... Using the app, patients send in pictures of their acne and receive a diagnosis from a licensed dermatologist. Prescriptions come through the mail .... [Medpage Today]

7/17 If Your Dog is Being Misled by Drug Advertising, FDA is on the Case
Even Pharmaceutical Marketing for Dogs can be Improper, FDA Says in Warning Letter .... According to several promotional materials cited by FDA, the company is in effect suggesting that the drug is effective "for a broader range of indications than are described in the approved labeling" .... [Regulatory Focus]

7/17 Slim-Down Craze Sweeps Pharma
Sanofi in $8.5B sell-off talks with Mylan, Abbott, private equity .... Sanofi has talked with Mylan and Abbott about a deal for a pool of older meds.... The 200 drugs include one of the French drugmaker's most successful ever, Plavix .... [Fierce Pharma]

7/17 Health Tracking Partnership
Novartis Joins With Google to Develop Contact Lens That Monitors Blood Sugar .... Alcon will look to create products from Google’s prototype smart contact lens, which uses miniature sensors and a radio antenna thinner than a human hair to track glucose levels. The companies did not specify how the data would be transmitted .... [NY Times]

7/17 Expensive Specialty Drugs Demolishing Medicaid Budgets
Costly Vertex Drug Is Denied, and Medicaid Patients Sue .... In a lawsuit filed in Arkansas federal court last month, three people suffering from cystic fibrosis allege Medicaid officials have for two years denied them access to Kalydeco because of its $300,000 per year cost .... [$$WSJ]

7/17 Internet Drug News Fast Takes:
Gut feeling: How intestinal bacteria may influence our moods
Patients With Low-Cost Insurance Struggle To Find Specialists
NPR Health News
Medication Errors Common for Parents Measuring Liquid Meds
FDA sets out framework for rare childhood diseases

Fast Takes
Novartis Plans Alzheimer's Study in Symptomless Patients
Canada Says Lilly Offers 'Misleading' Facts in Their Patent Dispute
Dead 3 Year Girl Who Who "Woke Up" At Funeral Has Died
Huff Post
Intranasal Naloxone Product Gets Fast Track Designation
Company Press Release
Roche seeks Avastin cervical-cancer indication

7/16 World Health Organization: All Men Who Have Gay Sex Should Take Meds
WHO urges gay men to take preventive drugs for HIV … men who have sex with men [are] 19 times more likely than the general population to be infected by HIV … single daily pill combining two antiretrovirals, in addition to using condoms, has been estimated to cut HIV incidence among such men by 20-25% …[AFP]

Impax Under Investigation For Possible Digoxin Price Fix
Rising heart drug price pulls Impax into Connecticut AG investigation … Impax's Global Pharmaceuticals unit and another company, Lannett  of Philadelphia, were the last two generic manufacturers of digoxin, the Times said. But in January, Covis Pharmaceuticals of Switzerland started selling an "authorized generic …[San Francisco Business Times]

Changing Pill Shape, Color Have Big Effect On Compliance
- What do you mean it's the same thing; last time it was a round white pill
- Change in shape has higher impact than color change
Pill look different? Shape and color changes may prompt lapses … insurance companies' efforts to keep healthcare costs low - often means that when they refill a prescription, patients get a familiar medication in a new shape or color …reconfiguration of a pill's shape raised the likelihood of a patient failing to adhere … [LA Times]

Tamoxifen Skin Gel For Breast Cancer
- Works better than pill, fewer side effects
Skin gel new ammunition in fight against breast cancer …  minimized exposure to the rest of the body and concentrated the drug in the breast where it is needed … very little drug in the bloodstream, which should avoid potential blood clots as well as an elevated risk of uterine  cancer … [Wash Post]

7/16 FDA Working On Regs Regarding Publicizing Interim Cardio Data
FDA Grapples With Lesser-Known Costs of Clinical Trials Transparency  … publication of interim data can prove problematic … Sponsors and other interested parties with access to interim data may have difficulty managing the remainder of the trial in an objective manner, particularly if changes to the trial protocol are needed  … [Regulatory Affairs Professionals Society]

Fast Takes
Mylan Buys Abbott's Non US Generic Biz For $5.3 Bln
Use of Actos Linked In Alzheimer Risk Reduction
10 Mistakes Job Seekers Make...And How To Avoid Them
Novartis Layoffs Announced: More Cuts May Be Looming
Biospace Featured Article
Salix: Constipation Drug Realistor  Gets FDA Green Light For Expanded Use
Salix Press Release

LA Times Slams Drug Coupons For Specialty Meds
Who gains from those drug discount deals? (Spoiler: Drug companies) … "Manufacturers can afford to cover a lot of $25 or $50 co-payments in return for even a small increase in the sales of a $50,000 drug. …[LA Times]

Allergan Reiterates Position; Doesn't Think Valeant Is Good Match
Allergan Has Doubts About Valeant's Efforts to Improve Transparency … reiterated its opposition to a $53 billion hostile takeover bid from Valeant …  thinks Valeant's statements have been inconsistent and demonstrate a lack of ability to forecast …[WSJ]
Allergan CEO To Valeant: "All I Care About Is Creating Value For Allergan's Shareholders" …  involving his company in a "disabling conflict of interest," and that he was mainly concerned with, "losing his leadership role in the company … and likely his job."… "When I started Allergan, it was worth $2 billion … Before Pershing Square appeared,  Allergan was worth $42 billion …[Business Review]

Drug Take-Back Plan Unfair Burden On Pharma,
Is Risky To Patients & Enviornment, Pharma Groups Say
Drug makers push back in court on Alameda take-back law … unnecessary burden that actually increases the risk of unused medicines ending up in the environment or unintended hands … made oral arguments Friday in front of the U.S. Court of Appeals for the Ninth Circuit, seeking to overturn the law … [San Francisco Business  Times]

Big Money On Off-Patent Meds With Well Known Brand Names
Big pharma weigh sell-off of old drugs … Drug groups have begun discussions with private equity players about the potential sale of their off-patent medicines, but hurdles remain … portfolios of older drugs still generate billions of pounds in revenues and require very little funding for marketing or research and development …[Telegraph]

More Speculation On  Mannkind Co-Market Partner For Inhaled Insulin
- Review of  top five companies to see if they might be suitable partners for Afrezza.
MannKind: Are These Top Big Pharma Companies Potential Partners? … ideal partner would be a large, global company with a strong presence in the diabetes care niche but with no product whose sales would be threatened by a successful Afrezza … Afrezza's dosing is far more complicated than that of the pills and once-a-day injectibles it will be competing with….[Seeking Alpha]
Editor's Note: Review and analysis of  JNJ, Novartis, Roche, Pfizer, Sanofi.  Conclusin is that Sanofi is the best match. 

E-Medicine Catches On
- Cheap (less than $50) 27/7/365
The Doctor Will Click on You Now, but Can She Feel Your Pain in an E-Visit? … WellPoint this month started offering 4 million patients the ability to have e-visits with doctors, while Aetna says it will boost online access to 8 million people next year from 3 million now … costs less than $50 to visit Teladoc, American Well or MDLive …[Bloomberg]

FDA Once Again Reaches Conclusions At Odds With Its Own Staff
- Agency gave blessing to Benicar over-ruling scientists' opinion
FDA Once Again Reaches Conclusions At Odds With Its Own Staff …  Last month the FDA affirmed the safety of olmesartan  … But that reassuring view is not shared by the  FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug …[Forbes]

Fast Takes
Mylan in Late-Stage Talks to Buy Abbott Drugs in Europe
Drug Makers AbbVie and Shire Officials Meet to Discuss Merger
NY Times
India's Sun Pharma recalls over 40,000 bottles of generic Effexor
5 Most Promising Biotech Jobs By 2022
Truvada More Important to Gilead Than Sovaldi
Mothel Fool
Girl Mauled by Raccoon Gets Man-Made Ear
Motley Fool
Senators ask Gilead to explain price of Sovaldi hepatitis drug
Alarming global rise in use of antibiotics
LA Times
Ebola outbreak rages on as drug development remains slow
Fierce Biotech
Obamacare: Balm For HIV Patients, Gold Rush For HIV Meds
- HIV as a preexisting condition used to mean very high premium
Obamacare's Surprising HIV Drug Demand … [in the exchanges] HIV was the biggest category for drug claims … 55% of all specialty drug claims. For comparison, HIV drugs account for 21% of specialty drug claims in non-exchange plans …[Motley Fool]
Related: HIV Patients Accuse Health Plans of Using Drug Costs to Discriminate … HIV, certain cancers, and bipolar disorder were most often asked to pay a big chunk of the price of medication … [HIV patients] Paying 40 percent or 50 percent of the retail price could cost patients more than $1,000 a month …[BusinessWeek]

Medical Marijuana Growers: Choosing Brand Names Is Serious Work
Sound Familiar?
Why Chocolope? To sell marijuana, you need a clever name … Orenstein spent years cross-breeding marijuana plants before arriving at his proud new strain … But before releasing it to the public, he and his partners toiled over one of the most crucial steps: giving it the proper name … The more clever the name …[LA Times]

EU Nations Led By France Team Up To Fight Solvadli Price
France health minister says EU will fight price of Gilead's Sovaldi … 14 European countries are banding together to press Gilead for deep discounts … we won't be able to treat everyone and we will also be creating a risk for our social security system …[Fierce Pharma]

Salix Incorporates In Ireland: Tax Bill Drops 1/3
Salix heads to Ireland … joins the growing list of US companies seeking tax benefits by incorporating abroad … will benefit from a tax rate in the 20%-range soon after reincorporating abroad, compared to the 30%-plus tax rate it has had …[MM&M]

Inhaled Insulin: Reporter Speculates Merck A Good Partner;
Claims Lilly or Novo tie up not likely
Is This MannKind's Greatest Risk? … Merck and MannKind seem like a pretty good fit. Merck already has a sales force targeting the diabetes market with Janumet and Januvia. And the company has a global reach, something that Pfeffer indicated MannKind is looking for in a partner …[Motley Fool]

7/11 14% of Acthar Prescriptions Linked to Adverse Events
Questcor Reveals Adverse Events Data for Acthar for First Time .... The data, which was obtained under the Freedom of Information Act, showed 20 deaths and six disabilities since 2012 among patients reported to have been using Acthar and in which Acthar was recorded as "suspect," or the drug most likely to have been associated with the event .... [NY Times]

Got Resume?

7/11 Oncologists Paid at Flat Rate Actually Spent More on Cancer Drugs
Study on Cancer Care Yields Mixed Results .... A closely watched study that aimed to remove the financial incentive for doctors to prescribe expensive cancer drugs delivered a contradictory result, with lower overall treatment spending but higher chemotherapy medication costs .... [WSJ$$]
See also: Experiment cuts cancer costs, ups drug spend [MM&M]

7/11 Doc-in-the-Box Boom
Race Is On to Profit From Rise of Urgent Care .... Urgent care clinics also have a crucial business advantage over traditional hospital emergency rooms in that they can cherry-pick patients. Most of these centers do not accept Medicaid and turn away the uninsured unless they pay upfront .... [NY Times]

7/11 BMY Rushes Opdivo to FDA
Bristol-Myers Seeking Nivolumab Approval In Melanoma .... [The analyst] added that the Opdivo–Yervoy combo will probably become the standard of care and overtake Merck's anti-PD-1 pembrolizumab, which is in process for a melanoma approval perhaps eight months ahead of Opdivo's .... []

7/11 Incentives for Orphan Drugs Yielding Results
Orphan drug approvals up, but high costs pose challenges .... During the 14-year period that ended in 2013, US regulators approved 86 orphan drugs, up from 65 approvals during the 18-year period from 1983 to 2000 .... [Boston Globe]

7/11 Tramadol in Class IV as of August 18
DEA Tosses Tramadol in Class IV .... Within the first 3 years of approval of tramadol in the U.S., the steering committee quickly began to realize that patients on tramadol indeed abused the drug, and the commonly cited statistic is the monthly incidence being two to three cases per 100,000 patients in the first 2 years following its approval .... [Medpage Today]

7/11 Pay for Performance Gets a Toehold
Health Insurers Are Trying New Payment Models .... The survey estimates that $1 out of every $5 in reimbursements is being paid under an arrangement in which providers are rewarded for improving care and lowering costs .... [NY Times]

7/11 Health Plans Requiring Pre-Auth for Digoxin
Insurers balk at pricey generic version of ancient GSK heart drug .... While the average price per month for the drug is still only about $50, the website GoodRx found that some pharmacies are charging as much as $1,000 .... [Fierce Pharma]

7/11 Eteplirsen Data: Slower Decline
Sarepta Data Disappoints Wall Street As Expert Sees A Sea Change At FDA .... The best situation for the company would be if the FDA lowered the bar for approval far enough to let Sarepta's eteplirsen through without approving the similar drug from Prosensa, which was studied in a larger randomized trial that failed to meet its primary endpoint. Sarepta is also apparently blocked from selling eteplirsen in Europe by patents held by Prosensa .... [Forbes/Matthew Herper]

7/11 Psoriasis Market to Hit $9 Billion by 2023; Secukinumab Expected in 2015
Novartis' secukinumab tops Enbrel in psoriasis .... One of phase III trials published in the NEJM — called FIXTURE — compared secukinumab directly to Enbrel and found that Novartis' drug was significantly more effective in clearing the skin lesions that characterise the condition. .... [PMLiVE]

7/11 Internet Drug News Fast Takes:
Cinnamon May Be Used to Halt the Progression of Parkinson's disease
Rush University Medical Center
Shorter sleep may speed brain aging
HPV Vaccine Doesn't Raise Risk Of Blood Clots
NPR Health Blog
FDA quicker on approval trigger than EU
Are Cancer Vaccines Worth an Investment?
Motley Fool

7/10 Help is in the Way for Your Infected Toenails
Anacor's Kerydin Gets FDA Nod for Onychomycosis .... Kerydin is applied to the infected toenail once daily for 48 weeks with no debridement required during the treatment period. The drug has low systemic absorption and showed no systemic side effects .... [Yahoo/Zacks]

7/10 Mount Sinai Beth Israel Pharmacy Director Stole 1,500 Oxycodone Pills at a Clip; Tripped Up by Anonymous Letter
NYC hospital's ex-pharmacy boss accused of stealing 200,000 painkiller pills .... While serving as Mount Sinai Beth Israel's pharmacy director for 14 years before his firing this year, D'Alessando is accused of exploiting his access to the hospital's drug vault to grab oxycodone pills on nearly 220 different dates: about 100 at a time when he started in January 2009, but 1,500 at a time when the scheme came to light this spring .... [AP]

7/10 Ambien Onboard in 12% of ER Visits
Psych Drug ER Trips Approach 90,000 a Year .... The sedative zolpidem tartrate, contained in Ambien and some other sleeping pills, was involved in almost 12 percent of all ER visits and in 1 out of 5 visits for older adults .... [ABC News]

7/10 Cracks Developing in Off-Label Promotion Wall
FDA has free-speech, safety issues to weigh in review of 'off-label' drug marketing rules .... In the long-running conflict between federal regulators and drugmakers over how companies promote their drugs for unapproved uses, the landscape could be shifting, if only in subtle ways, and the outcome could affect doctors and patients alike .... [Washington Post]

7/10 Atopic Dermatitis Treatment Successful in Phase 2
Sanofi-Regeneron drug tames eczema in study .... Dupilumab was named "clinical advance of the year" in 2013 by industry publication Scrip Intelligence, and some analysts expect it to capture annual sales up to $2 billion if approved .... [Reuters]

7/10 Salix Marries an Italian, and They Will Move to Ireland
Salix Pharmaceuticals to Buy Irish Company and Reincorporate Overseas .... Salix will merge with Cosmo Technologies, the Irish unit of Cosmo Pharmaceuticals of Italy, in exchange for a stake of more than 20 percent in the combined company .... [New York Times Deal Book]

7/10 Letrozole Better than Clomiphene for PCOS-Related Infertility
Cancer drug finds new use as fertility treatment .... About 28% of women randomly assigned to take letrozole had a live birth, compared with 19% of those assigned to take clomiphene.... Women underwent up to five monthly treatment cycles with either drug .... [USA Today]

7/10 Eloctate to Cost $550,000 to $600,000 Per Year
Biogen prices new, long-acting hemophilia med with eye on patient-switching .... Eloctate at $1.98 per unit, will be priced "in-line" with Baxter's Advate at about $550,000 to $600,000 per year .... [Fierce Pharma Marketing]

7/10 FDA Needs a Clue About How Google Works
FDA Chides Gilead for Google Advertisement, but is the Company Entirely to Blame? .... Google doesn't always show the "sitelinks" below the first three lines of the advertisement, and companies don't have any assurance as to whether Google will or will not do so .... [Regulatory Focus]

7/10 Opdivo Approved in Japan for Melanoma
Cancer drug nivolumab wins PD1 inhibitor race to market .... The Japanese regulatory authorities licensed nivolumab — which has the trade name Opdivo and is being co-developed by Bristol-Myers Squibb (BMS) — as a treatment for patients with melanoma that is not treatable with surgery .... [PMLiVE]

7/10 Internet Drug News Fast Takes:
NY insurer to pay up to $31 mln for denied mental health claims
Fly Farm Built in Cape Town as Maggot Meal Replaces Soy
Alzheimer's research in 'major step' towards blood test
Lung Cancer Genomic Mapping Yields New Targets in Study
Celgene's Phase 3 Study of Arthritis Drug Misses Target

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