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7/29 Revlimid Cost Hits $162,000 a Year; Accounts for 63% of Celgene's Revenue
Celgene Raises Guidance as Sales of Top Drug Revlimid Grow .... Revlimid is one of the most expensive cancer drugs in the world.... Its average wholesale price was about $644 per pill in the second quarter, up from $393 in the second quarter of 2008 .... Bloomberg

7/29 "Pump Your Own Stomach" Obesity Treatment Draws Fire
Critics of weight-loss device urge U.S. regulator to reverse approval .... Critics are urging the Food and Drug Administration to reverse its AspireAssist decision, saying the device mimics, promotes and could lead to potentially life-threatening disorders such as bulimia and binge-eating .... Reuters

7/29 Post Crestor, AZN Finds New Sales
AstraZeneca's Earnings Meet Estimates as New Drug Sales Rose .... Sales of newer drugs rose, with heart drug Brilinta gaining 49 percent to $211 million and the latest cancer treatments bringing in $251 million. Farxiga, a diabetes treatment, generated $214 million, beating analyst estimates of $192 million .... Bloomberg

7/29 Sanofi's Adlyxin Approved
FDA Approves New GLP-1 Receptor Agonist Adlyxin for Diabetes .... Adlyxin will be available in a disposable prefilled injectable pen in a single dose of 20 µg. Patients will also receive a disposable prefilled pen in a single dose of 10 µg that they should initiate once daily for 14 days. On day 15, patients will increase the dosage to 20 µg once daily .... Bloomberg

7/29 Financial Maneuvers Create Sky-High Drug Pricing and Profits
Financial cycles of acquisition and 'buybacks' threaten public access to breakthrough drugs .... The researchers, from Cambridge University's Department of Sociology, say pharmaceutical company development practices effectively leave the public "paying twice": firstly for the initial research, and then for patent-protected high priced medications .... Medical Xpress

7/29 ICER Under Fire
Critics target institute that evaluates price, value of drugs .... The drug makers and other groups targeted ICER when the Centers for Medicare and Medicaid Services proposed in March to consider its reports for coverage in a Medicare project.... ICER's reports often find drugs are priced up to three times higher than their actual value .... USA Today (autoplay video)

7/29 Orkambi Catches Up to Expectations
Hefty Orkambi commercial spend helps Vertex pick up the growth pace .... While an FDA go ahead on a new indication could help Vertex reach about 2,400 children in the U.S., there are even more young patients eligible for the therapy in Europe... perhaps the tally at about 3,400 .... Fierce Pharma

7/29 All Laws, No Action
Amid opioid epidemic, rules for drug companies are loosened .... The law allows companies accused of failing to report suspicious orders of dangerous drugs to submit a "corrective action plan" to persuade the Drug Enforcement Administration to postpone or abandon proceedings against them. The law also raises the bar for the DEA to temporarily suspend their licenses .... LA Times

7/29 FDA Not Interested in Your FitBit
FDA Declares 'General Wellness' Devices Exempt From Regulations .... The FDA does not plan to review low-risk "general wellness products," such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements .... Regulatory Focus

7/29 Opdivo, Eliquis, Daklinza Drive Higher Sales for BMS
Bristol-Myers revenues climb on strong Opdivo performance .... Sales of Opdivo increased nearly six-fold compared to last year, totaling $840 million in the second quarter.... Although Bristol-Myers faces stiff competition from Merck's Keytruda, Opdivo has quickly locked up significant market share early on .... BioPharma Dive

7/29 Internet Drug News Fast Takes:
New York pharmacy owner, husband plead guilty to large opioid pill scheme
Pfizer Announces Positive Top-Line Results from Pivotal Phase 3 Maintenance Trial of Oral XELJANZ® (Tofacitinib Citrate) in Ulcerative Colitis
Company news release
Judge rules against some 1,300 lawsuits over Bayer's Mirena IUD
Walgreens to shut down
Chain Drug Review
Lack of Fitness Second Only to Smoking as Predictor of Early Death:
Olympic Drug Cops Will Scan for Genetically Modified Athletes

7/28 FTC Forces Teva Garage Sale
Teva Wins U.S. Nod for Actavis After Divestiture of 79 Drugs .... The companies agreed to sell 79 existing and future drugs including anesthetics, antibiotics, weight-loss drugs and oral contraceptives to 11 rival firms to win approval.... The divestitures must be completed 10 days after Teva's acquisition of Allergan's generics unit .... Bloomberg

7/28 Lechleiter Retiring, David Ricks New CEO at Lilly
Incoming Lilly CEO says dealmaking will be a focus .... Eli Lilly & Co will likely step up the pace of making deals with other drugmakers while aggressively developing new drugs on its own, the company's newly appointed chief executive David Ricks has announced .... Reuters

7/28 Shop Until the Doctor is Ready to See You
Retail revolution 2.0? More hospital outpatient departments, medical groups are moving into malls .... Hans Nordby, a managing director at real estate firm CoStar, predicted that it will become less and less rare to see a medical center next to the food court in the coming years. "Ten years from now we aren't going to think anything about it," he said .... Advisory Board Daily Briefing

7/28 Abbott Deal Shaky as Feds Look at Alere
Alere Faces Criminal Probe Over Medicare, Medicaid Billing .... Federal law bars health-care companies from covering copayments for patients insured by government programs like Medicare and Medicaid. The Justice Department also is investigating whether Alere made payments or delivered items of value to doctors who order the tests .... WSJ

7/28 Plans Wary of ICER, Abacus
New tools for assessing drug value haven't caught on with payers — yet .... None of the 11 plans queried actively rely on these new methods and a majority do not expect to do so next year either .... Stat/Pharmalot

7/28 Want to Be in a Clinical Trial? That'll Be $14,000 Please
Warning: Government Listing Of Clinical Trials Doesn't Disclose Costs To Patients .... Advocates argue that's failure to disclose charges by trial sponsors misleads consumers and allows the site to become a marketing tool for pay-to-play research .... Kaiser Health News

7/28 Reference Pricing Saved 33% on Diagnostic Tests; How About on Drugs?
With reference pricing, patients spend less on diagnostic testing .... In the year after implementing reference pricing, the average price paid per test by Safeway decreased from $27.72 to $18.90, while the price stayed the same over time for Anthem enrollees not subject to reference pricing. .... Reuters

7/28 Long-Term Benefits Found for ADHD Meds
ADHD medication reduces risky behavior in children, teens .... Compared with children who were diagnosed with ADHD but did not receive medication, those who took medication were 3.6 percentage points less likely to contract a sexually transmitted disease, 7.3 percentage points less likely to have a substance-abuse disorder and 2.3 percentage points less likely to be injured .... Medical Xpress

7/28 Viewpoint: We Aren't Paying Enough for Vaccines
A Force More Powerful Than Anti-Vaxxers? Economics! .... Health economist David Ridley found that a 10% increase in the price of a vaccine was associated with a 1% reduction in the chance that this vaccine would experience a shortage the following year. .... Forbes/Peter Ubel

7/28 Pfizer Avoids Securities Trial
Pfizer Reaches Initial Deal Settling Celebrex, Bextra Suits .... Pfizer is settling a securities class-action lawsuit accusing it of keeping investors in the dark about the cardiovascular risks of the arthritis drugs Celebrex and Bextra .... Bloomberg

7/28 Internet Drug News Fast Takes:
Many Well-Known Hospitals Fail To Score High In Medicare Rankings
Kaiser Health News/NPR
Study: Digital revolution transforming shopper marketing
Drug Store News
Alzheimer's biotech Alzheon to move once-failed drug into new PhIII
Fierce Biotech
Florida identifies two more Zika cases not related to travel
TauRx misses primary endpoints in Alzheimer's combo PhIII trial
Fierce Biotech

7/27 Lily Projects 5% Revenue Growth per Year Through End of Decade
Lilly Posts Higher Drug Sales, Plans to Increase Dividend .... Sales of Jardiance totaled $40.1 million, falling short of analysts’ projections of $51.9 million. Hopes are high for the diabetes treatment....if claims for cardiovascular and kidney benefits are allowed .... Bloomberg

7/27 Fluoroquinolones Black Box Made Scarier
FDA enhances warnings on group of strong antibiotics .... The antibiotics known as fluoroquinolones include Johnson & Johnson's Levaquin, Bayer's Cipro extended-release tablets and Merck Inc's Avelox .... Reuters

7/27 ESRX Maintains Profits on Less Volume
Express Scripts Prescriptions Fall, Earnings Match Estimates .... The average profit on each prescription processed rose from a year earlier, with Ebitda per adjusted claim rising 2 percent to $5.70 from a year earlier .... Bloomberg

7/27 Prescription Misuse Highest in Mountain States, Lowest in Southeast
More than half of adults misuse medications in Quest study .... The study identified the drugs most often misused by patients depending on their age: amphetamines for youth 17 and under, but benzodiazepines and anti-anxiety medications for adults 25 and older, followed by opioid painkillers .... Washington Post

7/27 Reorg and Pivot at GSK Consumer Healthcare
GSK Consumer Healthcare to prioritize digital after agency review .... The nine agencies will work on GSK Consumer Healthcare's seven top-tier brands and twelve core brands, which the company expects will deliver 90% of its future growth. The seven top-tier brands include painkiller Voltaren, toothpaste brand Sensodyne, and over-the-counter cold and flu treatment Theraflu. The twelve core brands include the pain reliever Excedrin and allergy spray Flonase .... MM&M

7/27 Meloxicam Effective for Pain After Bunionectomy
Recro Pharma's intravenous painkiller succeeds in trial .... Meloxicam met its primary goal of a statistically significant difference in the intensity of pain, over the first 48 hours, between patients given the drug and those given a placebo .... Reuters

7/27 PhRMA Adds Jazz and Horizon
Pharma trade group says price gougers are outliers, but then accepts two more .... Among five companies that were just added to its roster, two of them -- Jazz Pharmaceuticals and Horizon Pharmaceuticals -- have also relied on excessive pricing to fuel their growth, while investing much less than other drug makers in research and development .... Stat/Pharmalot

7/27 Progress on Generic Applications
FDA Continues Steady Reduction of Generic Drug Application Backlog .... The new data (up to July 1, 2016) reveals that FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016. The agency has also approved 315 more ANDAs over that same time period and sent 66 more complete responses (or rejections) for industry action .... Regulatory Focus

7/27 Untreated Children with Hep C Infection
Children Exposed To Hepatitis C May Be Missing Out On Treatment .... Jessica Wen, a Philadelphia pediatrician specializing in liver diseases estimates that about 1 or 2 of every 1,000 young children have chronic hepatitis C. .... NPR

7/27 Internet Drug News Fast Takes:
Diabetes Linked To Risk Of Mental Health Hospitalization In Young Adults
Kaiser Health News
How LSD and shrooms could help treat anxiety, addiction, and depression
How your morning mood may influence your work quality
Advisory Board Daily Briefing
BMS' Opdivo, Amgen's Repatha first on Japan's list for new price restrictions
Fierce Pharma
Teva and Mylan Are Looking to Buy Pfizer's Overseas Generic Business
Tokai pharmaceuticals ends prostate cancer drug trial
Boston Globe

7/26 Revlimid Delays Progression in Lymphoma Type But Does Not Improve Survival
Celgene drug fails to extend survival in lymphoma study .... Revlimid, a multiple myeloma treatment with annual sales of about $6 billion, was being tested versus a placebo in patients whose diffuse large B-cell lymphoma had responded to initial treatment with Roche's Rituxan and chemotherapy .... Reuters

7/26 J&J Tries Incubator to Seed New Discoveries
The Radical Experiment That's Changing the Way Big Pharma Innovates .... What's odd, though, is that these researchers toiling away within J&J's walls--and making use of J&J's abundant resources--do not work for the company. Nor do the findings or the discoveries they produce there belong to J&J .... Fortune

7/26 Employers Says PBMs Part of the Problem on High Drug Prices
Pharmacy-Benefit Managers Under Pressure .... The Health Transformation Alliance, a coalition of 30 of the country's biggest employers, wants to rewrite their pharmacy-benefit contracts to eliminate the undisclosed drug-price markups that supply much of the PBM industry's profits. Instead, the PBMs would mainly receive administrative fees .... Barrons

7/26 Gilead: HIV Drugs Beat Expectations, But Hep C Sales Slowing
Gilead Lowers Product Sales Guidance on Weak Hepatitis C Sales .... Sales of Gilead's hepatitis C drugs continue to retrench due to increased competition and pricing pressures. The company lowered its 2016 forecast for net product sales .... The Street

7/26 You Need Four or More Generics for a Particular Drug Use to Get Real Savings
Generic drug alternatives crucial to competition, cost control, JAMA says .... The likelihood of having four or more generic drug approvals varied significantly by the type of therapy, with neurological and psychiatric drugs having the highest rates, at 100 and 88 percent respectively. Oncological drugs had the lowest rate, at 27 percent .... Healthcare Finance

7/26 Measure Drug Levels in the Body Without Repeated Needle Sticks
Microneedle Patch for Painless Monitoring of Drug Intake .... The device is in a form of a patch that's stuck onto the skin, painlessly pushing microneedles through to sample the interstitial fluid .... Medgadget

7/26 Next Step in CMS Volume to Value Pathway
CMS proposes mandatory cardiac bundled-payment pilot .... In 2014, hospitalizations for heart attacks for more than 200,000 beneficiaries cost Medicare over $6 billion, the CMS said. Yet for every treatment, the cost could vary by as much as 50% .... Modern Healthcare

7/26 "Dream Team" Lung Cancer Combos
Bristol-Myers to combo Opdivo, Yervoy with AbbVie's Rova-T in next-gen cancer cocktail trials .... The new trials will explore the two- and three-drug combos as treatments for non-small cell lung cancer, where Opdivo is already approved. The two companies are hoping that Opdivo, as a PD-1 checkpoint inhibitor, will complement Rova-T's ability to target and kill cancer-initiating cells .... Fierce Pharma

7/26 Answer: No
Is 'Generic Viagra' Legitimate? .... While a generic form of Viagra, known as sildenafil, is made in some countries, bargain hunters may be buying sugar pills, or inadvertently getting a low dose of the drug .... Fierce Pharma

7/26 Wall to Wall Coverage
Republican convention viewers sure saw a lot of drug ads .... Nearly 40 percent of the spots that ran during ABC, CBS, and NBC's broadcasts of the convention touted pharmaceutical companies, prescription medications, or over-the-counter drugs .... Stat

7/26 Internet Drug News Fast Takes:
U.S. Says Florida Network Defrauded Medicare and Medicaid of Over $1 Billion
NY Times
These drugs could cut American health costs by $250 billion (if only we could take them)
In a Hospital, Health Care Until the Clock Runs Out
NY Times
Tobira crushed after NASH drug flunks a PhIIb, but slice of data drives PhIII plans
Patients With Severe Schizophrenia Aren't Getting The Help They Need
Health Affairs Blog

7/25 Catastrophic Coverage Now 37% of Part D
Medicare safeguard overwhelmed by pricey drugs .... The cost of Medicare's "catastrophic" prescription coverage jumped by 85 percent in three years, from $27.7 billion in 2013 to $51.3 billion in 2015, according to the program's number-crunching Office of the Actuary .... AP

7/25 Zika is Here
Doctors devise care plan for babies as Zika threat looms in U.S. .... Florida said it is investigating two possible cases of Zika not related to travel to an area where Zika is active, raising the possibility of the first incidence of local transmission of the mosquito-borne virus .... Reuters

7/25 FDA Cracks Down on Eyebrow and Eyelash Tinting
Eyebrow- & Lash-Tinting Might Become Illegal In The U.S. .... It is already illegal in California for any licensed professional to have eyebrow or lash tint in their possession or in a salon, and to administer tint on or anywhere near the eyes .... Motley Fool

7/25 80% of APIs are Imported from China and India
Facing Cancer Drug Shortage, U.S. Relies on Banned Chinese Plant .... The agency issued an indefinite ban on the factory in September, a first for Hisun, one of China's leading exporters of pharmaceuticals products. Yet to avoid possible shortages of drugs, the FDA allowed the plant continue exporting about 15 ingredients for use in finished drugs in the U.S., including nine key cancer medicine components .... Bloomberg (autoplay audio)

7/25 Diabetes CGM Breakthrough
FDA greenlights Dexcom G5 CGM as replacement to fingerstick treatment decisions .... San Diego, California-based Dexcom can market the G5 as a continuous glucose monitor that patients can actually base treatment decisions on rather than a complement to the blood glucose meters .... MobiHealth News

7/25 Educational Materials Shouldn't Be Reported Under Sunshine Laws, Say Docs
Medical groups push to water down requirements for disclosing industry ties .... Nearly 100 national and state medical societies from around the United States are backing a Senate bill that would exempt drug and device makers from reporting payments made to doctors for receiving continuing medical education, or CME, sessions, medical journals, or textbooks .... Stat

7/25 Viewpoint: Value-Based Drug Pricing Will Lead to Higher Prices Not Savings
Value-Based Drug Pricing: Watch Out for Side Effects .... Medicine depends on many cheap generic drugs like penicillin to treat conditions as diverse as acne, gout, hypertension, heart disease, and cancer. Pricing these drugs according to their value would make them unaffordable to uninsured and underinsured patients and dramatically increase the aggregate costs of pharmaceuticals. .... David Blumenthal, M.D./Commonwealth Fund

7/25 Rundown of New Lung Cancer Drugs
5 New Lung Cancer Drugs Have Been Approved Since October .... The new therapies generally fall into one of two categories: immunotherapy or gene-specific .... Motley Fool

7/25 Manufacturing Issues Trip Up Latanoprostene Solution
FDA raises concerns over Valeant's eye drop .... The U.S. FDA, in a complete response letter (CRL) regarding the eye drop for a type of glaucoma, raised concerns over Current Good Manufacturing Practice at the unit .... Reuters

7/25 Upcoming Approvals, Guidelines, Trial Results Will Shake Up Diabetes Market
Eli Lilly, J&J, Novo Battle Diabetes -- And Each Other .... The U.S. FDA, in a complete response letter (CRL) regarding the eye drop for a type of glaucoma, raised concerns over Current Good Manufacturing Practice at the unit .... Investors Business Daily

7/25 Internet Drug News Fast Takes:
Humana is pulling out of at least eight states' ACA exchange markets
Advisory Board Daily Briefing
Takeda Said to Explore Sale of Chemicals Unit to Raise Cash
Updated Brain Map Identifies Nearly 100 New Regions
NY Times
Tinnitus Experienced By 10% Of Americans
Huffington Post
Personality Change May Be Early Sign of Dementia
NY Times

7/22 Novo Takes Coverage Push to the Conventions
At the Republican convention, drug maker lobbies for more coverage of obesity drugs .... Pharma giant Novo Nordisk co-sponsored the "Rethink Obesity" panel here, and plans to co-host a similar event during the Democratic convention next week in Philadelphia. The goal: To push lawmakers to enact a bill, pending in Congress, that would lift a longstanding ban on Medicare paying for obesity medication .... Stat

7/22 Slo-Mo on FDA Generics Label Regulation
New warning rule for users of generic drugs left in limbo .... Five years after the Supreme Court blocked most personal-injury lawsuits against makers of generic drugs, a rule designed to strengthen patient protections have stalled, leaving what consumer groups warn is a safety gap for millions of users .... LA Times

7/22 Indian Manufacturers Provide 31% of New Generics Approvals
India's Drug Approvals Near Record Despite FDA Inspection Blitz .... The FDA approved a record 83 new generic drug applications out of India's publicly listed firms in the last six months of 2015, just as sanctions against the biggest of those firms were making headlines .... Bloomberg

7/22 Cancer Combos a Winning Strategy for Roche
Roche Profit Rises 7% as New and Old Cancer Drugs Get Paired .... The world's biggest maker of cancer drugs is breathing new life into some of its aging tumor fighters with novel medicines that doctors combine with older ones for extra potency .... Bloomberg

7/22 Scangos Out at Biogen
Biogen CEO Resigns After Six Years of Boom-and-Bust Leadership .... Under his watch, Biogen secured approval of Tecfidera, the blockbuster multiple sclerosis pill which sparked a new era of growth at the company.... But the good times did not last. Tecfidera's sales waned, forcing Biogen to rely on regular drug-price hikes more than finding new customers .... The Street/Adam Feuerstein

7/22 Only One in Three Drug Addicts in US is Diagnosed and Receiving Treatment
Opioid Abusers Missing Out on Addiction-Fighting Drug .... Pain management physicians rarely prescribed Suboxone, even though they are the most prolific at prescribing opioid painkillers. They handed out fewer than five Suboxone prescriptions per doctor in 2013, the findings showed .... HealthDay

7/22 Election Year Drama Aside, Pharma Should be Able to Maintain Price Power
Why the Price Is Right for Drug Companies .... The Bureau of Labor Statistics' Producer Price Index showed a nearly 6% rise in pharmaceuticals prices from June 2015 through June 2016, well above broader inflation rates .... WSJ$$

7/22 Herceptin Biosimilar Successful in Phase 3
Amgen, Allergan biosimilar found as effective as Roche cancer drug .... There were no "clinically meaningful" differences in data gathered from patients given Herceptin and the copycat version, ABP 980, to treat a type of early breast cancer (Sean Harper, Amgen's executive vice president of R&D) .... Reuters

7/22 Feds Bust Up Merger Party
Justice Department Moves To Block 2 Big Health Insurance Mergers .... The lawsuits filed this morning challenged a $37 billion merger between Humana and Aetna, which the Justice Department alleges "would lead to higher health-insurance prices, reduced benefits, less innovation, and worse service for over a million Americans," and a $54 billion acquisition of Cigna by Anthem, which the court filing states would be the largest merger in the history of the health insurance industry .... NPR

7/22 Swiss Company Strengthens US Presence
Galenica to Buy Relypsa for $1.53 Billion to Beef Up in U.S. .... The transaction gives Galenica's business unit Vifor Pharma a U.S. commercial network and global rights to Relypsa's drug Veltassa, which was the first new medicine in 50 years to be approved in the U.S. for hyperkalemia .... Bloomberg

7/22 Internet Drug News Fast Takes:
Rehab Hospitals May Harm A Third Of Patients
NPR Health Blog
Galderma licenses PhII atopic dermatitis drug from Roche's Chugai
Fierce Biotech
Tracking Cancer In Real Time
Kaiser Health News
EU clears AZ's FDA-rejected diabetes combination
Frustrated You Can't Find A Therapist? They're Frustrated, Too
Kaiser Health News

7/21 Mighty Crestor Falls
AstraZeneca Fails to Keep Generic Crestor Rivals Off Market .... Sales of the name-brand drug are likely to plunge 30 percent to $3.5 billion this year as cheaper alternatives become available .... Bloomberg
See also: Indian Firms Get Approval for Generics of AstraZeneca Drug

7/21 Prescriptions for the Eldest Need Careful Management
Over 80? Too few medications might be dangerous .... More than half of the study participants were taking five or more medications, but still, two-thirds were not receiving medications they should have, and 56 percent were misusing medications. Four out of 10 patients were both underusing and misusing medications .... Reuters

7/21 Keep an Ear Out for Hints of Policy from Cleveland
5 health and medicine issues to watch for at the GOP convention .... To mainstream Republicans, Clinton's plan — which includes letting Medicare negotiate drug prices and importing cheaper medications from other countries — is a big-government nightmare.... There's just one problem: Trump wants to do the same things .... Stat

7/21 Compounding Explosion Draws Feds' Scrutiny
Medicare fraud investigators wary of soaring compounded drug prices .... In Medicare's drug program, known as Part D, the number of Medicare beneficiaries getting compounded drugs has grown 281 percent since 2006 to nearly 280,000 in 2015. Spending on such drugs in Medicare's Part D grew 625 percent between 2006 and 2015, to $509 million .... Kaiser Health News

7/21 'It's the prices, stupid!'
America's health care prices are out of control. These 11 charts prove it. .... The International Federation of Health Plans report undercut a common misconception about American health care: that it's more expensive because we use more of it. Americans actually tend to use slightly less health care than people living elsewhere. We go to the doctor less, for example, and have fewer hospitals per capita than most European countries .... Vox

7/21 AZN Layoffs and Moves
AstraZeneca culls its neuroscience team, exits Kendall Square office .... A spokesperson for AstraZeneca tells me that they're exiting an office in Kendall Square -- which is mainly occupied by the neuroscience team for iMed -- and relocating any of the staffers who will be staying on at their operation in Waltham .... Endpoints

7/21 Kaiser Commission Breakdown of Medicaid Drug Spending
Medicaid spends a lot on outpatient drugs, but which cost the most? .... Between January 2014 and June 2015, the costliest medications were the Abilify antipsychotic pill; the Sovaldi and Harvoni hepatitis C treatments; the Vyvanse attention deficit medicine; and the Truvada HIV drug .... Stat/Pharmalot

7/21 Jimenez Sees Squeeze
Novartis CEO predicts drug pricing overhaul in U.S. after the election, whoever wins .... Pricing pressure is already taking a bite out of Novartis sales, the company said in its second-quarter earnings release. Price erosion at its generics unit, Sandoz, dragged sales down by 5 percentage points, while volume grew by 8 percentage points .... Fierce Pharma

7/21 Opdivo Filed for Advanced Head and Neck Cancer
US, EU regulators to review Opdivo for new cancer indication .... Head and neck cancer is a hard-to-treat disease with a 4% five-year survival rate in stage 4 patients. Findings from the Checkmate-141 trial have demonstrated an overall survival benefit in head and neck cancer patients after treatment with Opdivo .... BioPharma Dive

7/21 High-Tech Inhalers Will Measure Flow and Doses; Scan for Allergens
Your inhaler's watching you: drugmakers race for smart devices .... Linked wirelessly to the cloud, the gadgets are part of a medical "Internet of Things" that promises improved adherence, or correct use of the medication, and better health outcomes .... Reuters/Yahoo

7/21 Internet Drug News Fast Takes:
Aetna ready to fight for $37 billion Humana deal in court
St. Louis Post-Dispatch
Only extreme sitting linked to increased heart disease risk
Differin Gel approved for over-the-counter sales
American Pharmacy News
DNA pioneer James Watson: The cancer moonshot is 'crap' but there is still hope
J&J unit's former executives convicted of unapproved marketing

7/20 Brodalumab Gets Panel OK; REMS Requested
FDA panel backs Valeant psoriasis drug with risk program .... Panelists said there was a need for new drugs for psoriasis and they would like to have brodalumab available as an option. They offered various suggestions about how to mitigate the suicide risk, including a boxed warning and a patient registry to collect patient data and more clearly assess suicide risk .... Reuters

7/20 Study: Diabetes Drugs Lower Blood Sugar But Don't Extend Life or Prevent Heart Disease
No Clear Survival Benefit Seen Among Diabetes Drugs .... Researchers analyzed 301 randomized clinical trials of patients with type 2 diabetes, and found that while metformin outperformed some other drug classes for its effect on hemoglobin A1c levels, there were no significant differences in mortality -- including when placebo was included as a drug class .... Medpage Today

7/20 Entresto Sales Force to Triple in Size
Novartis Ramps Up Heart Drug Spending as Top Seller Goes Generic .... The Swiss drugmaker will spend an additional $200 million to hire sales representatives and educate physicians after new treatment guidelines were issued in May backing the use of Entresto for heart failure. .... Bloomberg

7/20 Behavioral Health Specialist Pharmacy Chain Integrates with Clinics
Fast-growing Genoa plans more pharmacies .... Genoa is the only large-scale pharmacy chain dedicated to meeting the needs of patients with such serious mental health issues as schizophrenia and bipolar disorder. .... Chain Drug Review

7/20 Neulasta Biosimilar Got Complete Response Letter
FDA knocks back Novartis copy of Amgen's drug Neulasta .... U.S. regulators have declined to approve Novartis' so-called biosimilar copy of Amgen's Neulasta drug that fights infections in cancer patients, the Swiss drugmaker has announced .... Reuters

7/20 Legal Deep Dive into the Amarin Case and What It Means for Drug Marketing
FDA Sanctions Off-Label Drug Promotion .... The optional preclearance procedure for off-label promotion introduced by the FDA in the settlement could have important implications for the regulation of other promotional activities, such as direct-to-consumer advertising .... Health Affairs

7/20 FDA Backs ECT; Eases Class Designation of Equipment
FDA: Electroshock has risks but is useful to combat severe depression .... Citing evidence from 60 randomized trials of ECT, once known as electroshock therapy, the FDA acknowledged the risk of memory loss but said that there is now enough evidence to ease access to the therapy for certain people .... Washington Post

7/20 Uncle Sam Fixing to Bust Up Big Health Insurer Mergers
U.S. Said Readying Suits Against Anthem, Aetna Insurer Deals .... Aetna and Humana will probably fight any lawsuit in court, while Anthem and Cigna are less likely to litigate against the government, said Ana Gupte, an analyst at Leerink Partners .... Bloomberg (autoplay video)

7/20 J&J Sales Up 9%
J&J hikes forecast as standouts Imbruvica, Xarelto crank up pharma growth .... Imbruvica, the blood cancer drug, racked up global gains and now leads the market in second-line leukemia treatment.... Xarelto, a reliable growth driver, delivered $594 million in sales, up more than 25% .... Fierce Pharma

7/20 Not Easy to Find Subjects for Clinical Trials
Companies Try New Ways to Attract Patients to Drug Trials .... Pharmaceutical makers monitor online forums to develop effective recruitment approaches and send cars to pick up patient volunteers .... WSJ

7/20 Internet Drug News Fast Takes:
New rankings: The highest-paid physician specialties
Advisory Board Daily Briefing
GSK Launches First ResearchKit Study by a Major Pharmaceutical Company
Number of advanced prostate cancers skyrocket in U.S.
CBS News
Implant Effective at Combating Opioid Dependence
Health Day
Consistent Use of Monthly Vaginal Ring Protects Against HIV
Health Day

Fast Takes
Latest gimmick to promote IBD drug - Marvel Comics
Fierce Pharma
Roche Blood Cancer Medicine Fails to Show Major Improvement

7/19 Experts Pooh Pooh Notion Of Pfizer Breaking Up
To split or not to split? One Wall Street wag thinks Pfizer may remain intact … splitting up the company could disrupt cash flow and weaken the strength of its balance sheet … Pfizer executives may reject a split, since the stock is inexpensive relative to similar drug makers and offers total annual shareholder return of about 9 percent …[Pharmalot]

PhRMA Opens Doors To Teva; Other PhRMA Companies Not Happy
- Claim they are generic knockoff artists, not research oriented
Teva wins controversial bid to join PhRMA bid despite protests from branded rivals … AbbVie argued against letting the copycat giant in; it claimed that doing so would dilute the association's "emphasis on innovation"--and spur "internal conflicts" between  …[Fierce Pharma]

7/19 Addyi: Dismal Sales Get Worse After  Sales Force Cutback
- Valeant exec remains upbeat despite horrible sales
Scripts sink for Valeant's troubled female libido drug in wake of rep cuts … Since the cutbacks, prescriptions have dropped to about 1,000 in May from more than 1,300 in April,  … the way the company sees it, the drug is still on the right track …[Fierce Pharma]

Reefer Madness! Medical Marijuana Is Already Saving $165M Per Year For Medicare
Reefer Madness! Medical Marijuana Is Already Saving $165M Per Year For Medicare … if all states legalize marijuana, annual savings could be triple that amount, $500 million … patients choosing marijuana instead of prescription drugs for conditions that marijuana might treat … [Forbes]

Fast Takes
Opioid Bill Overwhelmingly Approved by Senate
FDA rejects Santhera's request for accelerated approval of Duchenne muscular dystrophy treatment Raxone
First Word
Two for two: FDA panel gives green light to Novartis' Enbrel biosim
Biopharma Dive
FDA rejects oxycodone + naltrexone combo fixed combo tabs
Elite Press Release
Ex-Drug Executive Shkreli to Face U.S. Fraud Trial in June 2017
NY Times

Afrezza Re-Launch Unimpressive
MannKind - Afrezza Scripts Starting Off Modestly On Relaunch … sales team of 60 to 70 reps is pounding the pavement in a regionalized physician marketing campaign …  200 total scripts with new scripts dipping down to the lowest level since two weeks into the first launch back in February of 2015 …[ Seeking Alpha]

Suicide Link Means Valeant Psoriasis Med Prospects Iffy
- Amgen pulled plug on med last year on suicide issues -  upon which Valeant bought it
Suicide link has FDA staffers iffy on Valeant's brodalumab … 6 suicides that cropped up in clinical trials prompted Amgen ($AMGN) to bail on its long-running brodalumab collaboration with AstraZeneca, and the British pharma giant sold rights to Valeant a few months later …[Fierce Pharma]
Editor's Note: In May 2015, Amgen announced that it was ending its participation in co-development of the compound because of reports of patients having "events of suicidal ideation and behavior.

Submarine Patents Mean Enbrel May Be Bulletproof Till 2029 Despite FDA Panel Decision
Makers of Humira and Enbrel Using New Drug Patents to Delay Generic Versions … Enbrel's main patent has already expired. But the drug is now protected by two "submarine patents … If those patents hold, by 2029, Enbrel will have been on the market without generic competition for 31 years …[NY Times]
Related: Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz's Enbrel Biosimilar … [Regulatory Affairs Professionals Society |Online]

Physician Assistants Becoming More Important Targets
- Majority now work in non-primary care setting
Physician Assistants Moving Into Specialties Amid Doctor Shortage … more than 108,000 PAs across the country … 70% of physician assistants now work in "non-primary care specialties … median salary of PAs in primary care is about $95,000, though some specialties are making between $100,000 and $120,000 …[Forbes]

7/15 Here Comes the Russian Money
Russian Oil Billionaires' Next Big Investment - American Health Care .... With two Washington insiders in tow to help navigate the terrain, the Russians are preparing to invest as much as $3 billion in the industry over three years, starting in the U.S., where it accounts for almost a fifth of the economy .... Bloomberg

7/15 New App for RA Patients Will Gather Data, Alert Providers
Can population management improve healthcare apps? Pfizer aims to find out .... The app is being used by rheumatoid arthritis patients to track activity between doctor visits--which is nothing new--but adds in a population manager who will monitor the app data from patients and alert a patient's healthcare provider to increases in disease activity .... Fierce Pharma

7/15 Certain 'Patient-Protecting' Policies Shelter High Drug Prices
Insurers Can Reduce Drug Prices, If Policymakers Let Them .... Insurers' negotiating power—and thus their ability to lower drug prices—hinges on their ability to restrict access. Yet in many ways, policymakers have stripped that ability away from insurers .... Health Affairs Blog

7/15 Drug Cost Complaints Not Changing Manufacturer Behavior
Drugmakers' Pricing Power Remains Strong .... More than two-thirds of the 20 largest pharmaceutical companies said price increases boosted sales of some or most of their biggest products in the first quarter .... WSJ

7/15 Backed Up at the Goal Line on Crestor
Judge sets late-breaking rules for AstraZeneca's last stand on Crestor .... Trend lines show the generic quickly gaining market share--and Crestor losing it--but those changes leveled off early this month, with Crestor's brand scripts at just over 200,000 and the generic's at just over 150,000 .... Fierce Pharma

7/15 Why Did Juno Get the Quick Restart?
A cancer-drug trial is so important that the FDA has let it continue despite three patients dying .... Juno proposed dropping the chemotherapy drug implicated in the deaths. The FDA agreed, and within three days of the suspension, it allowed the trial to start again. Re-evaluations of this kind can often take more than 30 days .... Quartz
See also: And then there were 4: Juno adds another victim in CAR-T death tally [Endpoints]

7/15 Fewer Pills Prescribed in Medical Pot States
One striking chart shows why pharma companies are fighting legal marijuana .... In medical-marijuana states, the average doctor prescribed 265 fewer doses of antidepressants each year, 486 fewer doses of seizure medication, 541 fewer anti-nausea doses and 562 fewer doses of anti-anxiety medication. But most strikingly, the typical physician in a medical-marijuana state prescribed 1,826 fewer doses of painkillers in a given year. .... Washington Post

7/15 Teva Expects $2 Billion in New Income from Acquisition
Teva, Allergan generics deal to close 'at any time now' .... Teva anticipates its revenues will rise 41% in three years, from 2015's $19.7 billion to a high-end estimate of $27.8 billion by 2019 .... Washington Post

7/15 ICER Says 'Check Our Math'
ICER to Re-Evaluate How to Assess Value and Comparative Clinical Effectiveness .... The Institute for Clinical and Economic Review (ICER), an independent nonprofit research institute, has opened a national call for suggestions on how to improve its value assessment framework, which assesses the comparative clinical effectiveness and value of health care tests, treatments and delivery systems .... Regulatory Focus

7/15 Death in Clinical Trial; Company Does Not Believe Treatment-Related
Brain Tumor Patient Dies After Ziopharm Gene Therapy Injection .... The Ziopharm patient, diagnosed with a recurrent brain tumor, was treated with the company's experimental gene therapy, known as Ad-RTS-hIL-12. The gene therapy, which is supposed to stimulate a tumor-killing immune response -- is injected directly into the patient's tumor .... The Street

7/15 Internet Drug News Fast Takes:
E-cigarettes could cut smoking-related deaths by 21 percent
Slavitt: CMS is considering MACRA delay
Advisory Board
Moderately reducing calories in non-obese people reduces inflammation
Tufts University, Health Sciences Campus
Health care has improved, study finds, but the changes are small
Washington Post
Metamizole Could Be Alternative to Classical NSAIDs
Health Day News

7/14 Gilead's Formula: Prices Up, Profits Up, Taxes Down
The drug company that shocked the world with its prices dodged $10 billion in taxes .... The California-based pharmaceutical giant moved some of its assets to Ireland, apparently allowing income from some U.S. drug sales to be shifted abroad and taxed at a lower rate.... It has also avoided nearly $10 billion in taxes by not bringing some of its foreign profits back to the United States .... Washington Post

7/14 Abilify and Seroquel Come Out Even in Head to Head Study
A comparison between quetiapine and aripiprazole for treatment of schizophrenia .... Based on the outcomes of the current study, no significant difference was evident between aripiprazole and quetiapine regarding improvement of positive and negative symptoms of schizophrenia .... Medical Xpress

7/14 Health to Hit 20% of GDP by 2025
Health spending in U.S. to rise 5.8 percent a year through 2025: CMS .... The annual growth of health expenditures between 2015 and 2025 will be 1.3 percentage points faster than growth in gross domestic product.... The spending will represent 20.1 percent of the country's total economy by 2025, up from 17.5 percent in 2014 .... Reuters

7/14 Fast Lane Sought for Compassionate Use
Republicans embrace the 'Right to Try' to get experimental medicines .... The move embraces so-called Right to Try laws that have been passed by 31 states and allow terminally ill patients to leapfrog the drug development process, which typically takes years before new treatments become available. .... Stat News/Pharmalot

7/14 Antiretroviral Therapy Drastically Cuts HIV Spread
Small HIV Infection Risk in Condomless Sex With Use of ART .... HIV transmission is highly unlikely among heterosexual couples who have sex without condoms when one partner carries the virus but takes antiretroviral therapy .... HealthDay News

7/14 Another Biosimilar Coming Down the Pike, This Time for Enbrel
Sandoz Enbrel biosim cruises at FDA panel, endangering key Amgen sales .... With the 20-0 vote, Novartis' generics unit advances in its crusade toward a potential big sales boost and a second biosim on the U.S. market that's just getting acquainted with the biosimilar concept .... Fierce Pharma

7/14 Generic for Faslodex Coming in 2019
AstraZeneca settles Sandoz patent fight over its top-selling cancer med .... Faslodex is currently AstraZeneca's top-selling oncology product, bringing in $704 million last year and $190 million in the first quarter of 2016, up 24% on higher demand .... Fierce Pharma

7/14 Pharmaceutical Care at Hospital Discharge Pays Off
CVS: Rx reconciliation can cut hospital readmissions .... The researchers found that risk of hospital readmission at 30 days was reduced by half, lowering the overall risk of hospital readmission from 22% to 11% for those in the medication reconciliation program. The health plan also saved $2 for each $1 spent on the program, for a total savings of more than $1,300 per member. .... Chain Drug Review

7/14 Diabetes Complications Account for 61% to 80% of Disease Costs
Diabetes treatment 'inextricably' linked to patient education .... Between 4% and 15% of diabetes-related costs in an international sample of countries (US, UK, Germany, Brazil, Mexico and Saudi Arabia) are linked to patients simply not adhering to therapies or not persisting with them .... PMLiVE

7/14 When Immunotherapy Fails
UCLA study finds why some cancers stop responding to immunotherapy .... Dr Ribas estimated that about 40 percent of patients with advanced melanoma, the deadliest form of skin cancer, will initially respond to an immunotherapy, but about a quarter of those 40 percent will relapse within three years of treatment .... Reuters

7/14 Internet Drug News Fast Takes:
First baby born in Texas with Zika-related birth defect
No one knows why more adults are getting Type 1 Diabetes
Fox News
Merck's Former Chief Medical Officer to Join Flagship Ventures
A Medical Mystery of the Best Kind: Major Diseases Are in Decline
NY Times/Upshot
Nilotinib Shows Early Promise for Parkinson's Disease
HealthDay News
Antipsychotic drug also relieves nausea from cancer chemotherapy

7/13 Xiidra Will Take On Restasis for Dry-Eye
Shire Surges After FDA Approves Xiidra for Dry-Eye Disease .... Xiidra could become a blockbuster by 2022, with sales of just over $1 billion, according to the average of seven analysts' estimates.... The FDA approved the eye-drop for both early signs of dry eye detectable by doctors and symptoms such as stinging and burning .... Bloomberg

7/13 One Step Closer to Biosimilar for Humira: FDA Panel 26-0 Yes
FDA panel backs Amgen copy of AbbVie arthritis drug Humira .... The panel voted 26-0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in safety and effectiveness to the original. The panel concluded that the study results could be extrapolated to other conditions for which Humira is approved, including Crohn's disease and ulcerative colitis and should be approved for those conditions as well. .... Reuters

7/13 Effective Treatment for Postpartum Depression
Sage's drug for postpartum depression succeeds in mid-stage study .... Data on 21 patients showed that the drug, SAGE-547, achieved a statistically significant reduction in symptoms at 60 hours, compared to a placebo, on a standard depression scale used in clinical research .... Reuters

7/13 Research Gets the Axe at Merck
Merck Cuts Back — Again .... The North Wales, PA site is being closed (the screening operations there are moving to Kenilworth). New Jersey discovery chemistry (Kenilworth and Rahway) is being cut by 20%, and Rahway's med-chem is entirely moving to Kenilworth over the next few months .... In the Pipeline

7/13 Astroturfing Part B
Pharma trade group helps fund patient fight against Medicare project .... Groups that advocate for patients' and doctors' interests are working in near lockstep with the big pharmaceutical companies that fund the groups to fight a proposed Medicare rule that could affect the companies' bottom lines .... USA Today

7/13 Cures Bill Running Out of Steam
Senate delays Cures bill, as window for major legislation narrows .... The package would include funding for President Obama's precision medicine initiative and Vice President Joe Biden's cancer research program .... Stat

7/13 Sutent Strategy
Here's How Pfizer's Protecting Its Kidney Cancer Drug From New Competitors .... Pfizer hopes to outmaneuver its competitors by expanding the use of Sutent to all kidney cancer patients who have undergone surgery. Doing so would open up Sutent to far more patients than it can address today .... Motley Fool

7/13 $30 Million in DTC TV Ads for Humira in June
AbbVie continues heavy spend on Humira TV ads as biosimilar competition looms .... In June, AbbVie's Humira once again topped the monthly chart of pharma TV drug ad spending.... Pfizer's Lyrica and Sunovion's Latuda repeated in the second and third spender spots .... Fierce Pharma

7/13 Prevnar Gets Indication for Adults
FDA expands use of Pfizer's best-selling pneumonia vaccine .... The U.S. FDA has expanded the use of Pfizer's best-selling pneumonia vaccine, Prevnar, to adults aged 18 through 49. The vaccine is already approved for use in adults aged 50 and above, and children aged 6 weeks to 17 years .... Reuters

7/13 Internet Drug News Fast Takes:
Best Places to Work in Healthcare - 2016 (alphabetical list)
Modern Healthcare
25% Of Physicians Are Born Outside The U.S. Can Immigration Reform Fix The Shortage?
Forbes/Nicole Fisher
CytRx plunges after announcing Phase 3 trial results
Juno Therapeutics to Resume JCAR015 Phase II ROCKET Trial
Company news release
Heart Failure Patients Warned About The Dangers Of Mixing Prescriptions
Kaiser Health News
Surgery found to increase risk of chronic opioid use
Medical Xpress

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