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8/26 Mylan in FTC Hot Water; Used Exclusionary Contract to Keep Competitors Out of Schools
Mylan may have violated antitrust law in its EpiPen sales to schools, legal experts say .... In order to qualify for a reduced price of $112.10, schools had to agree they would "not in the next twelve (12) months purchase any products that are competitive to EpiPen(R) Auto-Injectors" the agreement stipulates .... Stat

8/26 Mylan Budges; Is It Enough?
Mylan offers discounts on EpiPen amid wave of criticism .... The list price of the drug will remain the same, but the company said it would increase the maximum copay assistance program to $300 from $100 for patients who pay for the 2-pak in cash or who are covered by a commercial health insurer .... Reuters

8/26 EpiPen Sh*tstorm Building for Months
How Parents Harnessed the Power of Social Media to Challenge EpiPen Prices .... Ms. Kantayya's petition “Stop the EpiPen Price Gouging,” grew from a few dozen signatures to more than 70,000 people who sent more than 100,000 letters to Congress .... NY TImes

8/26 High Deductible Plans Hit Many EpiPen Families Hard, Fueling the Outrage
How Payers Contributed to the EpiPen Pricing Controversy .... The payors got mad and raised the pain level on patients -- raising copays and toughening medical policies (this is important, Mylan does not determine price to consumers, payors do). As Epipen is broadly purchased ahead of the new school year, the pain became acute for many families over the past month .... Drug Channels/Adam Fein

8/26 Pharma Companies Who Are Raking it in, Hand Over Fist
Mylan isn't alone: 11 drugmakers with off-the-charts pricing power .... Each of these drug companies' operating profit margins hit 25% or more over the past 12 months excluding interest and taxes.... That blows away the 15.8% profit margin of companies in the Standard & Poor's 500 index and the 20% profit margin at Mylan. .... USA Today (autoplay video)

8/26 Strategy Overview for Merck KGaA
Germany's Merck Builds Up Non-Drug Businesses .... Most global pharmaceutical companies are streamlining in the face of tougher competition from generic drugs, but Germany's Merck KGaA is bucking the trend by expanding outside of health care .... WSJ

8/26 Amgen Close-Mouthed on Parsabiv CRL
Amgen's Shameful Silence Covers Up Reasons for FDA Drug Rejection .... An Amgen drug to treat secondary hyperparathyroidism was rejected by U.S. regulators Wednesday but the biotech company offered no public explanation for why the drug's marketing application was denied .... The Street/Adam Feuerstein

8/26 Show Me the Data!
Payers say they'll cover pharma's beyond-the-pill offerings. They just want proof first .... Lung cancer patients who used a particular app improved overall survival by seven months compared to average standard follow up care. The app triggered a call to the patient's doctor when anomalies were noted in the data stream .... Fierce Pharma

8/26 Jennifer Aniston to Pitch for Xiidra
Shire taps Jennifer Aniston for awareness campaign as it enters the eye care market .... The drugmaker expects the multi-channel initiative to lay its foundation in the ophthalmology market, following the approval in July of its chronic dry eye drug, Xiidra. The campaign will also set the stage for Shire to compete with the current market leader, Allergan's Restasis .... MM&M

8/26 Siponimod Helpful for Secondary Progressive Multiple Sclerosis
Novartis announces positive phase III results for MS drug siponimod .... The Phase III EXPAND study, the largest randomized, controlled study in secondary progressive multiple sclerosis (SPMS) to date, met its primary endpoint, compared with placebo .... Reuters

8/26 AG Says Subsys Maker Pushed Drug to 'Pill-Mill'-Type Docs
Illinois attorney general sues Insys over fentanyl drug marketing .... Subsys, which Insys launched in 2012, is a spray approved for managing pain in cancer patients that contains fentanyl, a highly-addictive and regulated synthetic opioid.... The lawsuit alleges that rather than marketing the drug to oncologists treating cancer patients, Insys instead illegally marketed it to doctors who prescribed high volumes of opioid drugs .... Reuters

8/26 Internet Drug News Fast Takes:
Obesity Is Linked to at Least 13 Types of Cancer
NY Times
FDA approves first cognitive tests for head injury
Fox News
Obamacare accountable care programs had $466 million in Medicare savings last year
AZ-Lilly start second pivotal trial of fast-tracked Alzheimer's drug
Review: Stem Cell Tx for Heart Failure Not Ready Yet
Medpage Today

8/25 Copaxone Patent Defenses Breaking Down
Teva Plunges After Two U.S. Copaxone Patents Invalidated .... Novartis AG and Momenta Pharmaceuticals Inc. jointly sell a cheaper version of the daily shot. Even with the generic-drug competition, Teva has been able to maintain sales by switching about 80 percent of patients to the 40-mg injection .... Bloomberg

8/25 Another PARP Inhibitor Goes Before FDA; Decision on Ovarian Cancer Drug in February 2017
Clovis Jumps as Cancer Drug Gets Priority for FDA Review .... Rucaparib inhibits a protein called PARP, which is involved in DNA repair. In theory, by disrupting cancer cells' ability to repair themselves, the drug can slow their uncontrolled growth and replication .... Bloomberg

8/25 Mylan CEO is Daughter of Democratic Senator Joe Manchin of West Virginia
The Senator's Daughter Who Raised Prices on the EpiPen .... Bresch could get called up to Capitol Hill next month to explain her company's justification for raising the price on the life-saving allergy shot. But that could be awkward, since she's the daughter of Democratic Senator Joe Manchin of West Virginia .... Bloomberg
See also: Clinton calls for lower price on allergy drug EpiPen [Reuters]
See also: Top US medical group blasts EpiPen's 'exorbitant' costs [Medical Xpress]
See also: How Congress, the FDA, and Sarah Jessica Parker Helped EpiPen Become a $1 Billion Business [Gizmodo]

8/25 AZN Deals Away Antibiotics Line
Pfizer to buy antibiotics business from AstraZeneca .... The two established medicines in the deal --- Merrem, used to treat serious infections in hospitalized patients, and Zinforo, an intravenous antibiotic used for skin and soft tissue infections and pneumonia -- generated sales of $250 million in 2015 .... Reuters

8/25 Lundbeck Sales Up 5% on Abilify Maintena and Brintellix
Lundbeck keeps the turnaround coming in H1 with big leap in U.S. sales .... The brand new antipsychotic Rexulti, approved in the U.S. last July, grew to $47 million, a nice jump for an early launch. It's approved to treat schizophrenia and as an add-on antidepressant, and Lundbeck and partner Otsuka have been running DTC ads in the U.S. since February .... Fierce Pharma

8/25 Fexapotide Successful in Phase 3 Against BPH
Fexapotide placebo crossover study reveals lower incidence of surgery .... The fexapotide patients required 82 percent to 95 percent fewer surgeries compared to patients who received conventional BPH treatments. The patients also saw a reduced rate of prostate cancer development .... American Pharmacy News

8/25 Estimates: 395 People with Zika in Florida by Mid-September; 8 Pregnant Women; Outbreaks Very Possible in Texas and Louisiana
How Big, Really, Is The Zika Outbreak In Florida? .... "Zika is one of those diseases that is always like an iceberg -- you just see the tip," says Alessandro Vespignani, a computer scientist at Northeastern University in Boston, who has been tasked with modeling the spread of the virus .... NPR Shots blog

8/25 PharMerica Wants to Sell
Pharmacy manager PharMerica explores possible sale .... PharMerica was created in 2007 by a merger of businesses spun off from AmerisourceBergen Corp and Kindred Healthcare. It provides pharmacy services, ranging from dispensing prescriptions to trying to control drug costs, to about 15 percent of U.S. nursing homes .... Reuters

8/25 Debate Over MammaPrint Study: Is It Safe to Skip Chemo If Your Genes Say So?
When DNA and medical tests disagree about breast cancer risk, which to believe? .... 5.2 percent of the no-chemo group saw their cancer advance within five years, while 3.3 percent of women who had chemo did .... Stat

8/25 Internet Drug News Fast Takes:
Stoned Vs. Drunk: Small Study Finds Sex On Pot Brings More Wariness, Less Regret Than Alcohol
WBUR Commonhealth
After much delay, Pennsylvania to launch prescription drug-monitoring database
Here's how a President Clinton could force down drug prices by executive action
LA Times
FDA tentatively approves generic version of Suprep
American Pharmacy News
Industry, patient groups respond to FDA draft guidance on patient data access
MobiHealth News
Regular nibbling on nuts linked to low inflammation

8/24 She Lost Her Opportunity to be CEO After She Testified Against an Executive Who Tried to Rape Her
Turing Pharmaceuticals Accused of Retaliating for Sex Assault Complaint .... The executive who testified before Congress with Martin Shkreli has filed a federal complaint against Turing, accusing one of Mr. Shkreli's friends, a fellow founder of the company, of sexually assaulting her in a hotel room in March .... NY Times

8/24 40,000-Woman Study Establishes HRT–Breast Cancer Link
The Final Word Is Out: Menopausal HRT Triples the Risk of Breast Cancer .... The authors found that the hazard ratio (HR) for invasive and in situ breast cancer was 1.95 (95% CI, 1.55-2.46; P<.001) for current users of menopausal hormonal therapy compared with never users, and this ratio grew with increasing number of years of usage. For women who used MHT for more than 15 years, the HR was 2.02 .... AJMC

8/24 Whistleblower Suit Airs Celgene Internal Marketing and Safety Conversations
From Nightmare Drug to Celgene Blockbuster, Thalidomide Is Back .... From the beginning, off-label prescriptions drove Thalomid's sales. In the first 12 months after its U.S. debut for leprosy, about 70 percent of the prescriptions were for oncology patients .... Bloomberg

8/24 Almost a Third of Formulary Exclusions Have Negative Effect on Patients
AJMC review: Formulary exclusions tend toward neutral, positive patient impacts .... The 20 studies looked at 21 exclusions, six of which showed positive effects on patients (meaning the patients's condition improved as a result), six of which had a negative effect (meaning more frequent or severe symptoms or lapses in disease control) and 9 of which had a neutral impact .... Drug Store News

8/24 Drug Prices Are High to Pay for the Billion Dollar Acquisitions
With $14 Billion Purchase, Pfizer Signals That Cancer Drug Prices Will Remain High .... By paying that extra $5 billion (beyond what Sanofi was willing to pay), Pfizer is saying that it expects Xtandi to be able to compete with generic versions of Johnson & Johnson's similar drug, Zytiga, and that talozaparib will succeed .... Forbes/Matthew Herper

8/24 Finally, A Social Media Thing Pharma Can Use
Instagram Stories' appeal for pharma? Familiar platform and no pesky user comments to deal with .... Pharma "can start engaging with consumers and then gradually, as they engage with that community more and more, they can turn it from a push to a two-way dialog." (Andrew Grojean, Intouch Solutions) .... Fierce Pharma

8/24 Hospira Closures
Pfizer to shed four Hospira sites .... Pfizer will lay off 104 staffers as part of a plan to shed four distribution sites it took over when it acquired Hospira, including 40 staffers in Atlanta, 19 in Dallas, 23 in Los Angeles, and 22 from King of Prussia .... BioPharma Dive

8/24 A Review: ADHD Nation
Overselling A.D.H.D.: A New Book Exposes Big Pharma's Role .... Disorders of attention were once thought to be relatively rare by experts, affecting only an estimated 3 percent of preadolescent children. But kids and teenagers are now diagnosed so routinely that getting a prescription for Ritalin or Adderall has practically become a standard rite of passage, particularly in the United States .... NY Times

8/24 JAMA Study: Drug Patents Too Easy to Game
Tighter Patent Rules Could Help Lower Drug Prices, Study Shows .... The study found that new drugs have a median 12.5 years of exclusive market access, and it's even longer for completely new medications. Lead author Aaron Kesselheim says drugmakers often use "life-cycle management" tactics to extend their exclusive market access .... NPR Shots blog

8/24 Bad Docs Still Speak
Doctors Get Disciplined For Misconduct; Drug Firms Keep Paying Them .... The analysis identified at least 2,300 doctors who received industry payments between August 2013 and December 2015 despite histories of misconduct .... NPR Shot blog

8/24 Internet Drug News Fast Takes:
Penn medicine researchers predict sudden cardiac death risk
University of Pennsylvania School of Medicine
6 Teaspoons a Day: U.S. heart group sets limit on sugar for kids and teens
Got a Thyroid Tumor? Most Should Be Left Alone.
NY Times
Expect healthcare agencies to make more digital acquisitions
Disease-Guided Approach Ups Specificity of Statin Treatment
HealthDay News

8/22 Fast Takes
No Meaningful Risk of Birth Defects Seen With Antipsychotic Drugs
Medpage Today
Pfizer spent $14 billion on a company with just one approved drug -- here's why that's a game changer
Yahoo Finance
Retail Pharmacist Salary Growth Stalls, while Hospital Pharmacists' Salaries Rise
Drug Channels
Too many treatment guidelines are written by experts with financial conflicts, study finds

8/23 EipPen: Mylan Called On Carpet Over Astronomical Price Increases
Senators press Mylan Labs over 'outrageous' EpiPen pricing … A pack of two EpiPens cost about $100 in today's dollars in 2004, but the list price now tops $600 … only explanation for Mylan raising the price by six times since 2009 is that the company values profits more than the lives of millions of Americans …[Pharmalot]
Why Did Mylan Hike EpiPen Prices 400%? Because They Could … [Forbes]

Egg On Sanofi Face From Unsuccessful Hostile Grab At Medivation
Sanofi's Hostility Backfires … paying a high price for its early tactical blunders in the pursuit of oncology specialist Medivation …cost Sanofi dearly in lost credibility and management time … highlighted its strategic weakness … [Bloomberg]

FDA Rejects Antidote To Eliquis, Xarelto; Manufacturing Issues Concern FDA
- Pradaxa shines because it's only drug in class with an antidote
Portola 'surprised' with CMC concerns in FDA rejection of anticoagulant candidate … "caught off guard" after the US FDA raised manufacturing concerns in a complete response letter for its Factor Xa inhibitor, AndexXa … [Biopharma Reporter]
Boehringer's Pradaxa keeps its antidote edge as FDA swats down Portola contender … [Fierce Pharma]

Pfizer Gets Nod For Abuse Resistant Oral Oxycodone
- Only P.O. oxycodone with abuse resistant label
FDA Approves TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) Extended-Release Capsules CII with Abuse-Deterrent Properties for the Management of Pain … only oxycodone with oral abuse-deterrent features described in the labeling … when the pellets are crushed the sequestered naltrexone is released and is available to counteract the effects of oxycodone …[Pfizer Press Release]
Editor's Note: We expect TROXYCA® ER  will have an easy time getting on formularies because it's unique.  Other abuse resistant pain pills are coming down the pike but until the are FDA approved, Pfizer's got a gold mine.

Fast Takes
Pfizer nears $14 billion deal for Medivation-source
Think Your Obamacare Plan Will Be Like Employer Coverage? Think Again

NY Timesd
ACLU threatens to sue Colorado over hepatitis C drug  rationing
Alli: A popular weight-loss pill:  buoyed by studies that understated its harms
Big Sell-Off of Pfizer Amid Merger Collapse (PFE, AGN)
Allergan CEO Brent Saunders Has $140 Million Golden parachute
Second breakthrough badge for Janssen's antidepressive
Pharma Times

FDA: Questions Soliqua Pen (Insulin Glargine + GLP1 Fixed Combo),
Faces 90-day Delay
Novo's similar product to have first to market advantage
FDA delays decision on Sanofi, Zealand's diabetes drug, handing lead to Novo Nordisk … proposed delivery system is "complicated," "not intuitive" and could "lead to use and dosing errors." … demanding more information on the drug delivery device, pushing back the PDUFA date and nearly wiping out the time Sanofi saved by redeeming a $245 million (€216 million) priority review voucher …[Fierce Biotech]

Worth The Click *************
Webinar:  FDA CDER Summit on Adherence Packaging: The Role of Innovation

Drug Pricing Think Tank: PCSK9 Meds Priced 300% Overpriced
JAMA: PCSK9s should cost $4536, but don't … treating the entire eligible population with PCSK9 inhibitors is not a cost-effective … in order to be cost-effective, the PCSK9 inhibitors would have to have an annual cost of $4,536 …[Biopharma Dive]

Bristol: Launch Success Considered Tops In Pharma Industry
Read the Label on Pharma's New Drug Sales …  Bristol-Myers gets substantially more sales from recently approved medicines than any other company … Newer drugs accounted for 42 percent of Bristol-Myers' revenue in …  runner-up Novo Nordisk managed just 24% …[Bloomberg]

8/22 Sanofi's 6th To Market GLP1 Has Good Safety Profile
Unlike Victoza, not associated with thyroid cancer in animals
- Victoza said to be cardioprotective, more effective,
Sanofi's Adlyxin holds a slight safety edge over Novo's Victoza, report finds
… But there's a trade-off: Advera deemed Adlyxin less efficacious than Victoza and Byetta at reducing Hb1Ac, a standard blood sugar benchmark, and fasting glucose, in those head-to-head trials … [Fierce Pharma]
See Also: Evidence Review: Adlyxin (lixisenatide) for Type 2 Diabetes … [Advera]

Legal Battle Over Biosim Remicade Are Far From Over
- Analysts expect October launch
Pfizer plans for October Remicade biosimilar launch, boosted by IP ruling … legal battles with J&J are far from over says an IP lawyer … launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch … [Biopharma Reporther]

Obamacare Boon To Drugsellers
Patient Prescriptions Jump 80% After Obamacare's Medicaid Coverage Kicked In … coverage for poor Americans filled nearly 80% more prescriptions and paid nearly 60% less out-of-pocket in 2014 compared to 2013 …[Forbes]

8/19 More Valeant Dirty Tricks
Valeant Accused in Suit of Secretly Refilling Prescriptions .... One pharmacy worker in Phoenix said Philidor had a group of 10 employees "devoted to calling patients to enroll them in the automatic refill program without their permission" .... Secrecy was so important to the Valeant-Philidor relationship that the employees had to sign confidentiality agreements "empowering the pharmacy to sue workers who divulged information about its activities" .... Bloomberg (autoplay video)

8/19 Pharmacist Salary and Job Growth Outlook
Retail Pharmacist Salary Growth Stalls, while Hospital Pharmacists' Salaries Rise .... In 2015, the average gross base salary for a pharmacist at a retail, mail, and specialty pharmacy was $119,517--up a paltry 0.1% from 2014. Retail employment grew slowly, with slightly fewer pharmacists working at drugstores and mass merchants .... Drug Channels (Adam Fein)

8/19 Big Pharma Nervous About Trump Tearing Up Trade Deals
Donald Trump's trade talk is making the drug industry uneasy .... The Republican presidential nominee has promised to aggressively renegotiate America's trade deals -- and to tear them up if need be. Those pledges are now rankling a biopharmaceutical sector that depends heavily on the deals to protect their intellectual property .... Stat

8/19 GSK Recognized for Activities Strengthening Health Care in Lesser-Developed Countries
How GlaxoSmithKline Is Changing the World .... GSK has made a calculated bet on intellectual property leniency in poor nations, releasing drugs from patent protection and thus lowering their prices .... Fortune

8/19 Otezla Expected to Hit Blockbuster Status in 2016
CELG's Otezla Continues Dominating US Inflammation and Immunology .... In the US market, total weekly prescriptions for Otezla have surpassed those written for competitor drugs such as Johnson & Johnson's Stelara (through its subsidiary Janssen Biotech), Novartis' Cosentyx, and Eli Lily's Taltz. .... Market Realist

8/19 Lyrica's Patent Payday for University
The Pill That Made Northwestern Rich .... Total royalties amounted to about $1.4 billion, including annual payments plus the value of the rights the university sold. With compounded growth over a decade, Lyrica is now responsible for as much as 18 percent of the $10 billion Northwestern endowment .... Bloomberg

8/19 Andexxa Gets CRL Despite Breakthrough and Orphan Status
FDA rejects Portola's lead candidate .... The agency asked for Portola to offer additional information, primarily related to manufacturing. It also asked for more data to support the inclusion of edoxaban and enoxaparin in the label .... Fierce Biotech

8/19 Exchange Plan Members Previously Insured Need $341 PY for New Prescriptions
Study Finds Obamacare Increased Prescription Drug Use, Reduced Spending .... Uninsured people who gained private coverage between 2013 and 2014 also filled 28 percent more prescriptions and paid 29 percent less out-of-pocket per prescription in 2014 compared to the prior year .... Morning Consult

8/19 "Special K" Getting a Close Look
FDA Fast-Tracks Ketamine for Depression Treatment .... Ketamine -- perhaps best known as a street drug -- is listed by the World Health Organization as an important anesthetic and has been used off-label for pain, anxiety, depression and post-traumatic stress disorder .... Health Day

8/19 Manufacturers Hope to Pin Down FDA on Patch Policies
Drug Companies Reveal Shortcomings in FDA Draft Guidance on Generic Topical Patches .... Mylan, Perrigo, AstraZeneca and Apotex are seeking more clarity and raising questions with the shortcomings of FDA draft guidance aiming to improve the way adhesion data is used for abbreviated new drug application submissions of transdermal delivery systems and topical patches .... Regulatory Focus

8/19 Internet Drug News Fast Takes:
Adding Ages: The fight to cheat death is hotting up
Turkey's investigation into drugmaker Novartis 'ongoing': official
How Big A Risk Is Acetaminophen During Pregnancy?
NPR Shots Blog
CMS examines inappropriate steering of people eligible for Medicare or Medicaid into Marketplace plans
EpiPen corporation drastically jacks the price of their life-saving product by 400%, sending patients scrambling
NY Daily News

8/18 FDA Warns Chinese Drugmaker on Quality Data
Chinese Drugmaker Hid Data That May Show Contamination .... Zhejiang Medicine has a contract that ends next year to supply Pfizer Inc.'s Hospira unit with the main ingredient for vancomycin, a widely used antibiotic.... The FDA letter didn't say which drugs were affected by flaws in testing records .... Bloomberg

8/18 Merck One of Five Bidders for Medivation
Merck enters race for cancer drugmaker Medivation .... Merck & Co Inc is one of at least five pharmaceutical companies that submitted indications of interest in buying U.S. cancer drug company Medivation Inc earlier this month .... Reuters

8/18 FDA Has No Power to Order Recalls of Dangerous Cosmetic Products
Their Hair Fell Out. Should the F.D.A. Have the Power to Act? .... Unlike pharmaceutical companies, cosmetic companies are not required to notify the government of "adverse reaction" reports -- even if someone dies. The F.D.A. instead has had to depend on consumers stepping forward .... NY TImes

8/18 FDA Application Fee for a New Drug: $2,038,100
The government agency in charge of approving drugs gets a surprising amount of money from the companies that make them .... The Avalere Health report found that since PDUFA was passed in 1992, pharma companies have contributed $7.67 billion to the federal agency .... Business Insider

8/18 Remicade Biosimilar Expected on Oct. 3
J&J braces for biosim attack after losing last-ditch Remicade patent fight .... A U.S. District Judge has struck down a key patent on the drug, clearing the way for Celltrion and Pfizer's Hospira unit to launch their copy of the $4.5 billion drug .... Fierce Pharma

8/18 Dysport Strategy
Ipsen hopes to be David to Allergan's Goliath .... Roughly 77% of all patients with cerebral palsy have some type of spasticity and require treatment for it. In the case of lower limb spasticity, botulinum toxin treatments are used to reduce muscle tone (which is exaggerated in patients with cerebral palsy), and improve function and gait .... BioPharma Dive

8/18 FDA Panel Discusses OTC Infectious Disease Diagnostics
FDA Advisors: Over-the-Counter Tests for STIs Offer Benefits .... An FDA panel agreed that benefits would most likely outweigh the risks for over-the-counter (OTC) tests to detect sexually transmitted infections, but panel members were less sure about the benefits of OTC influenza testing .... Medpage Today

8/18 Handy Table of Top Ten Consumer Health Sites, as Measured by Comscore
Healthline's traffic rises, putting it closer to WebMD and Everyday Health .... Healthline had nearly 32.5 million unique visitors in July 2016, a 44% increase from the same month a year ago, according to ComScore. Healthline reported the second-biggest growth among the top 10 health sites during that time. CNN Health had an 89% jump in unique visitors, from 8,651 in July 2015 to 16,363 in July 2016 .... MM&M

8/18 Antipsychotics Appear Mostly Safe for Gravidas — But Look Out for Risperidone
Most antipsychotic drugs not tied to birth defects .... About 33 of 1,000 children not exposed to antipychotics in the womb were diagnosed with birth defects. That compared to about 38 per 1,000 children exposed to typical antipsychotics and about 45 children per 1,000 who were exposed to atypical antipsychotics .... Reuters Health

8/18 Explainer: Patents vs. Market Exclusivity
Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market? .... The length of US market exclusivity is one of the reasons why so many companies want to introduce their treatments in the US first (and why new drugs generally reach the market in the US more quickly than elsewhere) .... Regulatory Focus

8/18 Internet Drug News Fast Takes:
Wealthy Czechs Pour Funds in Quest for Cancer-Fighting Drugs
A Self-Serve Dialysis Machine May Be Coming Home With You
Healthcare's struggle with social media continues, but help may be forthcoming
MedCity News
A CIO problem: 50% of doctors don't know what MACRA is
Advisory Board Daily Briefing
45 million reasons you should have invested in Apple instead of having children

8/17 Three-Quarters of Praluent Prescriptions Turned Down by Health Plans
Amgen, Sanofi Cholesterol Drugs Not Cost-Effective, Study Says .... Amgen Inc., Sanofi and Regeneron Pharmaceuticals Inc. would need to cut prices on their new cholesterol-lowering drugs by more than two-thirds to make them cost-effective to use in the U.S. .... Bloomberg

8/17 Pfizer Bets on Immuno-oncology and Cocktails
Pfizer's Bold Bid to Conquer Cancer .... A scant decade ago, Pfizer wasn't even a player in cancer therapy. But with Lipitor and Viagra headed for the patent cliff, the company switched gears and made a bold decision to tackle cancer with a two-pronged attack .... Motley Fool

8/17 Jersey Beats Out PA for Combined Allergan Headquarters
Allergan to consolidate operations in NJ .... Allergan (formerly Actavis) will consolidate its U.S. corporate headquarters at a new location in Madison, New Jersey. The move will bring together all of the business operations from Parsippany, Bridgewater, Jersey City and Rockaway .... BioPharma Dive

8/17 BIO and PhRMA Propose Guidelines for Off-Label Communications
Lobbyists create off-label principles following FDA lawsuits .... BIO and PhRMA set out three key concepts that govern its new information-sharing principles for drugmakers communicating with payers and healthcare providers: communications must be based on scientific- and statistically-sound data; communications should disclose limitations of the data; and those disclosures should be related to data accuracy .... MM&M

8/17 47% of "Orphan" Drug Uses for Were for Non-Orphan Purposes
Report Finds Orphan Drug Pricing Increased More With Higher Off-Label Use .... The average price increase for a sample of orphan drugs available between 2012 and 2014 was 26 percent. Yet the greatest price increases, an average of 37 percent, were for orphan drugs prescribed primarily for non-orphan uses. Orphan drugs used almost exclusively for their original purposes saw an average price increase of 12 percent between 2012 and 2014. .... Morning Consult

8/17 IBM's Watson at Work Developing Cancer Treatment Regimens
Why Doctors Want A Computerized Assistant For Cancer Care .... A computer may soon be able to offer highly personalized treatment suggestions for cancer patients based on the specifics of their cases and the full sweep of the most relevant scientific research .... NPR Shots Blog

8/17 Smart Inhaler Trial Planned
AstraZeneca plans new connected inhaler trial to improve medication adherence in COPD patients .... Both trial groups will use Symbicort inhalers connected to patient support tool BreatheMate, which automatically detects and logs maintenance medication uses and sends the data to their phone via Bluetooth, but one group will also get daily reminders in the form of beeps and flashes on the inhaler while the other will not .... MobiHealth News

8/17 Daily Injectable Abaloparatide, for Osteoporosis, Filed with FDA
Osteoporosis, a Disease With Few Treatment Options, May Soon Have One More .... After 18 months, four women of the 824 taking the Radius drug had a new spine fracture, compared with six of the 818 taking Lilly's drug Forteo and 30 of the 821 taking a placebo .... NY Times

8/17 Trial Subjects Can Log in with Facebook; Report Their Status on Smartphone or Tablet
Entrepreneur seeks to change clinical trial paradigm .... The company has developed a nimble interface for executing trials that more closely resembles social media than traditional clinical research documents but still conforms to regulatory requirements .... Med CIty News

8/17 Orlistat Approval Studies Reported Only a Small Fraction of AEs
A popular weight-loss pill was buoyed by studies that understated its harms .... Researchers who reviewed data summaries and published journal articles found that seven drug trials funded by the drug maker Roche in the 1990s downplayed the frequency of apparent side effects like diarrhea or incontinence .... Stat

8/17 Internet Drug News Fast Takes:
A surging trend: Uber, Lyft have hospitals rethinking patient access
Advisory Board Daily Briefing
Retirees Need $130,000 Just to Cover Health Care (Per Person)
Athletes are keeping their distance from a genetic test for concussion risks
Stat News
Study Says FluMist Vaccine Does Indeed Work, Contradicting CDC
NPR Shots blog
Aetna to Quit Most Obamacare Markets, Joining Major Insurers

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Corey Nahman Licensed Pharmacist (State Of NY; Lic #035512)

We subscribe to The HONcode of  online conduct:

1.  Qualification of author(s)
This site is published and webmastered by Corey Nahman, Registered pharmacist in the Sate of New York.
2.  Complementarity
Let it be known that the information provided on this site is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her existing physician.
3.  Privacy.
We respect the privacy of the users of this site.  Please see our plain English privacy policy.
4. Attribution
At all times, the information on this site shall be footnoted with the source(s) of published information, date and medical and health pages provided.
5.  Justifiability
This site shall at all times back up claims relating to benefits and performance.
6  Transparency
This site shall at all times use accessible presentation, you can e-mail the publisher of this site at his personal e-mail address at any time.
7.  Financial disclosure
This site is supported by click advertisements, banner advertisements and affiliate arrangements.  All ads are properly labeled as such.  If you have any questions regarding how we make money please e-mail the webmaster with your questions.  All advertisements shall be clearly distinguished from content.

Badea, Badea, Badea,
That's All Folks!