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Pharmaceutical News Harvest (TM)
8/28 Fast Takes
PCSK-9 Inhibitors Could Raise U.S. Healthcare Costs by $119 Billion a Year
Motley Fool
Vanda Pharmaceuticals fends off patent challenge to schizophrenia med Fanapt (iloperidone)
Washington Business Journal
Drug and Device Makers Pay Thousands of Docs with Disciplinary Records
Amid layoff fears, AstraZeneca stakes a 'For Sale' sign on US campus
Generics creep in as Teva loses two Copaxone patents
Biopharma Dive

8/28 Mylan Coupon Olive Branch Fails To Deflect 480% Price Hike
- Is Mylan is the new Valeant? CEO to be subpoenaed by congress
Mylan's EpiPen Price 'Cut' An Outdated Drug Industry PR Move  … trying to re-frame a pricing problem into a coverage problem … members of Congress are promising to bring Mylan's CEO before lawmakers to answer questions on the EpiPen price increase …[Forbes]
Related: Sarah Jessica Parker cuts ties with EpiPen … [USA today]
Related: How Parents Harnessed the Power of Social Media to Challenge EpiPen Prices … [NY Times]

8/28 Amgen Fights Back; Refutes JAMA's Anti-PCSK-9 Article
Amgen refutes 'flawed' cholesterol study …  study also used list price rather than the price patients actually pay after rebates and discounts, resulting in estimates that "are around 400 times higher than the 2016 analyst consensus estimates for PCSK9 inhibitors … [Biopharma Dive]

Adam Feuerstein Blasts Amgen
Amgen's Shameful Silence Covers Up Reasons for FDA Drug RejectionAn 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]
Who is Adam Feuerstein? If you are in biotech you already know and you know better than to piss him off.

Novartis Hypes Positive Data For Severe Multiple Sclerosis Pill
Novartis touts positive data from PhIII multiple sclerosis trial … the oral, once-daily BAF312 (siponimod) met the primary endpoint of a … reduced the risk of disability progression in a severe form of multiple sclerosis …[ Fierce Pharma]
Related: Novartis is Favoured to Win the Race for a New MS Drug … []

PBM's Hate Co-Pay Cards; Here's Why
The co-pay card debate simmers, as payers push back … "Instead of reducing the actual price of the medicine, co-pay cards simply drop the cost of the consumer's portion, leaving the insurer to pay the same high price and pass on the effects to its future customers …[ MMM Online]

Lilly CEO Set To Retire; 49 Year Old Successor  Takes Spotlight
- Has a lot riding on Alzheimer's treatment
Eli Lilly's next CEO could carry first Alzheimer's treatment across the finish line … joined Lilly in 1996 as a business development associate and has been pharmaceutical marketing director and national sales director  … fter 25 years of research, Lilly is aiming at the devastating disease on multiple fronts. …[Indy Star]

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

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