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Pharmaceutical News Harvest (TM)9/20 FastTakesAmgen-UCB bone drug Romosozumab cuts fractures in osteoporosis for older womenFierce BiotechSanofi Fighting a Losing Battle, Sues Merck for Alleged Patent InfrigementThe StreetGSK cuts vaccine price for refugees, bowing to pressureReutersKey Insights on Drug Prices and Manufacturer Rebates from the New 2015 IMS ReportDrug Channels
map


9/20 FDA Approves Duchenne Drug; Despite Expert Panel Rejection- Social media pressure trumps science; drug will cost $300K a yearF.D.A. Approves Muscular Dystrophy Drug That Patients Lobbied For 鈥 even as it approved the drug, the agency also required the company to conduct another clinical trial to confirm the drug's effectiveness. If the drug maker fails to prove it, the agency said it may "initiate proceedings to withdraw approval. 鈥 #91;NY Times #93;See Also: Sarepta to charge $300K for Duchenne drug. 'We tried to be reasonable,' CEO saysSee Also: Did the FDA set 'a dangerous precedent' with its latest drug approval? 鈥 #91;Stat News #93;9/20 Jimmy Kimmel Mocks Epi Pen Price During EmmysJimmy Kimmel made a hilarious jab at the skyrocketing price of EpiPens while handing out PB amp;Js at the Emmys 鈥 made 7,000 peanut butter and jelly sandwiches, which he then passed out to the audience 鈥 quot;If you #39;re allergic to peanuts, well I guess this is goodbye, because we can only afford one EpiPen 鈥 #91;Business Insider #93;9/20 Kardashians Begin Labeling Diclegis Social Media Posts As Advertisements- Posts been masquerading as plain old postingsWith FTC on alert, Kardashians back down on rule-skirting social media plugs 鈥 Kardashian first got in trouble with the FDA last summer for an Instagram paid post about Diclegis that wasn't labeled as a paid ad and also neglected to give risk and benefit information 鈥 #91;Fierce Pharma #93;9/20 Valeant: We Didn't Lie: You Will Soon Get Your RebatesValeant: rebates on heart drugs are coming 鈥 report from Bloomberg last week said many hospitals had yet to receive any relief from the sharply increased prices on the medicines 鈥 issued a statement indicating the rebates would be realized first by group purchasing organizations representing hospitals 鈥 #91;Biopharma Dive #93;9/20 Rep Access To Docs Continues To PlummetPharma #39;s access to docs declines as nonpersonal promotion increases 鈥 Only 44 #37; of physicians surveyed by ZS said they will meet with sales reps. This is down slightly from 46 #37; in 2015 -- and significantly from 80 #37; in 2008 鈥 #91;Medical Marketing amp; Media #93;9/20 Tylenol Caused My Liver Failure Trial Delayed AgainBellwether in Tylenol MDL Postponed Again 鈥 wrongful death action filed by plaintiff Rana Terry, whose sister, Denice Hayes, died of liver failure in 2010, 颅allegedly caused by consuming Tylenol 鈥 more than 50 years of use and over 150 studies to support its safety 鈥 #91;The Legal Intelligence #93;9/19 Fast TakesNew NIH Rule: Drugmakers Must Report Clinical Trial Results Once Kept SecretBloombergFDA chastises companies for touting an unapproved opioid painkiller Remoxy ER (Oxycodone)Pharmalot4 ways for marketers to differentiate their brands in the rare-disease spaceMM amp;MNovo pulls 71,000 kits of glucagon med from US marketBiopharma DiveAmgen, Novartis celebrate promising migraine data, but Teva and Alder are preparing to crash the partyEndpointsLilly takes one step closer to first-ever approval for new sarcoma drugFierce Biotech9/19 Analyst: Biosim Enbrel, Humira Won't Kill Brand Name Growth For Years- Not all analysts share optimistic view Biosimilars won #39;t stop Enbrel, Humira from growing through 2022: Analyst 鈥 Never fear, makers of anti-TNF giants: Those pesky biosimilars? They won't be halting revenue growth anytime soon, Leerink Partners analysts predict 鈥 #91;Fierce Pharma #93;9/19 Colombia Threatens Price Control On Gleevec (imatinib mesylate)- American threat to withhold monetary aid backfiresColombia plans to proceed with price cut on Novartis cancer drug 鈥 may drop the price for Gleevec by up to 45 percent 鈥 Washington might withdraw support for a free trade agreement and $450 million in backing for a peace initiative between the Colombian government and Marxist rebels 鈥 #91;Pharmalot #93;9/19 Mylan's Lawyers' Fancy Footwork Scheme To Get Epi Pen Out Of Spotlight- Seeks to add Epi Pen to list of " federal list of preventive medical service"- Legal loophole: copays are against the law for "preventative medical service" productsEpiPen Maker Lobbies to Shift High Costs to Others 鈥 If the EpiPen makes the federal preventive list, most Americans would have no insurance co-pay when getting the product 鈥 would be able to continue charging high prices for the product without patients complaining about the cost. 鈥 #91;NY Times #93;See Also: Mylan's Sneaky EpiPen Maneuvers 鈥 #91;Investopedia #93;Editor's Comment: Great way to build trust with your stakeholders Mylan. 9/19 New Mexico Sues Sanofi, Bristol Over Plavix Marketing Tactics- Claims marketers overstated efficacy, understated risksAttorney General Balderas Sues Bristol-Myers Squibb For False amp; Deceptive Marketing 鈥 knew that its drug was ineffective in a percentage of the population and may have increased a patient's risk of internal bleeding, but the company failed to disclose 鈥 #91;Los Alamos Daily Post #93;See Also: New Mexico AG sues Bristol-Myers, Sanofi over blood thinner 鈥 #91;Reuters #93;9/19 Novo: Once Per Week GLP1 Reduces Cardio Risk 26 #37;- Differentiates Novo GLP1 stable in crowded market- Downside? Increased rate of blindness, retinopathy complications Novo Nordisk #39;s diabetes drug semaglutide cuts heart risk by 26 percent 鈥 third diabetes drug to show such heart benefits, after Novo #39;s Victoza injectable and Eli Lilly and Boehringer Ingelheim #39;s Jardiance 鈥 Novo will launch a bigger and longer cardiovascular impact study for semaglutide in order to show long-term benefits 鈥 #91;Reuters #93;Editor's Note: Novo is working on an oral version of semiglutide.
9/16
More Dangerous than ISIS and Assad
The Syrian Civil War Could Spell the End of Antibiotics
....
At M eacute;decins sans fronti egrave;res's hospital in Amman, half of the patients now arrive with some sort of chronic infection; of those, 60 percent are resistant to multiple drugs. United Nations officials are so concerned they recently called for an emergency General Assembly summit on superbugs in late September
....
Newsweek
9/16
Yosprala Gets FDA Nod; Aspirin + PPI
U.S. approves Aralez pill for heart patients
....
Yosprala combines aspirin and omeprazole in a way that releases the omeprazole first to protect the stomach. The aspirin is then slowly released into what the company describes as a "gastroprotective zone," thus reducing the risk of stomach ulcers
....
Reuters
9/16
Tesaro and Clovis 'In Play' After Medivation Sale
PARP Wars: Biotech M amp;A's New Hope
....
Other losers in the Medivation sweepstakes seem likely to look for other options; Gilead, for example, has said it may be willing to take a risk on the right PARP inhibitor. Johnson amp; Johnson, always the elephant in any biopharma M amp;A room, already has the rights to develop Tesaro's drug to treat prostate cancer and may want to control the rest
....
Bloomberg Gadfly
9/16
Trying to Get Some Clarity on FDAMA Section 114
AMCP Seeks an End to 20 Years of Confusion Over FDAMA Section 114
....
The law was supposed to give drugmakers freedom to share health care economic information about their products. Efforts to get clarity from the FDA are stepping up.
....
Managed Care
9/16
(FAIR) Drug Pricing Act: Congress to Ask Pharma Companies to Show Costs and Profits for Each Drug
Senators want to force drug makers to justify big price hikes
....
A bipartisan group of Senate and House members plan to introduce a bill that would force drug makers to tell the Department of Health and Human Services why any price hike of more than 10% is justified at least a month before the increase
....
USA Today
9/16
Pharma is Serious About Beating California's Prop 61 mdash; $70 Million Serious
This Vote Could Finally Make a Difference in Crazy Drug Prices
....
If California's measure mdash; which would cap how much state health programs pay for treatments at the deeply discounted level paid by the Department of Veterans Affairs mdash; passes, it could open the floodgates in other states
....
Fortune
9/16
Insulin is the Next EpiPen
A 93-year-old drug that some children can't live without tells us everything that's wrong with American healthcare
....
But instead of driving prices down, the competitors appear to increase prices step-by-step (which is why the price charts look like a staircase), something that's referred to as "shadow pricing." It's not just the insulin market that is doing this: The same thing happened with the EpiPen market when a competitor came in around 2013 and with multiple-sclerosis drugs
....
Business Insider
9/16
South African Drugmaker Hires 700 Sales People in China
Aspen Targets Further Chinese Acquisitions After Glaxo Deal
....
Aspen, which sells products such as hormones, steroids, infant formula and antiretroviral medicines in more than 150 countries, said earlier that full-year profit increased 10 percent
....
Bloomberg
9/16
Opdivo Goes to Flat Dose
FDA Approves Modified Dosing Regimen for Bristol-Myers Squibb's Cancer Treatment Opdivo
....
The label replaces "the single dose regimen of nivolumab (3 mg/kg intravenously every two weeks) with the new recommended regimen of 240 mg IV every two weeks until disease progression or intolerable toxicity for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer"
....
Regulatory Focus
9/16
"Moneyball" Approach Predicts Drug Dangers
New Big Data Approach Predicts Drug Toxicity in Humans
....
Researchers developed a computational method that analyzes data from 48 different features of a drug -- from molecular weight to details about its target -- to determine whether it would be safe for clinical use. Using machine learning, the investigators trained PrOCTOR on hundreds of U.S. Food and Drug Administration-approved drugs and drugs that failed clinical trials due to toxicity problems
....
Weill Cornell
9/16 Internet Drug News Fast Takes:
FDA Warns Stores in Crackdown on E-Cigarette Sales to Minors
Bloomberg
How tens of thousands of patients who weren't actually dying wound up on hospice care
Washington Post Wonk Blog
Company Stops Sales Of Ovarian Cancer Screening Test After FDA Warns Women Not To Use It
Forbes
Costs of US prescription opioid epidemic estimated at $78.5 billion
Medical Xpress
Merck and Pfizer's diabetes treatment meets primary endpoint of late-stage trial
Marketwatch
9/15
Crops Will Be Lead Business After Bayer ndash;Monsanto Takeover
Heroin, Nazis, and Agent Orange: Inside the $66 Billion Merger of the Year
....
A combined Bayer-Monsanto would be the biggest player in an industry with only three megacompanies left standing.... Monsanto's dominance in seeds and Bayer's strength in crop chemicals means they'll be able to sell farmers a comprehensive suite of pesticides and genetically modified seeds
....
Bloomberg
9/15
Shingrix Beats Zostavax in Protecting Older Patients
GSK shingles vaccine remains effective after four years
....
In clinical trials, GSK's Shingrix has shown greater protection for older recipients than what has been demonstrated by Merck Co's rival Zostavax vaccine.... The company plans to file for U.S., European and Japanese approval this year, and the vaccine could reach the market in 2017
....
Reuters
9/15
Sarepta Fans Jump on Any Scrap of Possibly Favorable News
Sarepta Soars After FDA Staffer's Exit Lifts Approval Hopes
....
A U.S. Food and Drug Administration reviewer who was critical of the drugmaker's proposed treatment left the agency, potentially brightening prospects for approval of the medicine
....
Bloomberg
9/15
Panel Votes to Take Black Box Off Chantix
FDA panel recommends dropping serious warning on Pfizer's Chantix
....
A serious warning on Pfizer's drug that helps quit smoking should be removed, 10 of 19 independent panelists to the U.S. Food and Drug Administration recommended
....
Reuters/Yahoo
9/15
Witty Takes Stock
How GlaxoSmithKline Took Its Medicine
....
The maddening problem for pharmaceutical chief executives is that their tenures will be judged on the results of decisions made decades before they took command. Most of the scandals of Witty's term predated him, but so did many successes
....
Matthew Herper/Forbes
9/15
Gilead Owns 58% of HIV Market; Can GSK's Tivicay Take the Lead?
You'll Never Guess Which Pharma Could Knock Gilead Sciences Off Its HIV Throne
....
GSK is advancing a revolutionary dual HIV therapy that could give Gilead a run for its money and change the standard of care for HIV
....
Motley Fool
9/15
Adam Fein, Leading Industry Guru, Takes a Deep Dive into Rebates and Channel Economics
EpiPen, Channel Economics, and the Great PBM Rebate Debate
....
Will we look back on the EpiPen incident as the beginning of the end for manufacturers鈥 gross-to-net drug pricing models and PBMs鈥 traditional role in the flow of rebates?
....
Drug Channels
9/15
Spectrum Can't Convince Advisory Panel that Treatment Works
Spectrum bladder cancer drug not effective: U.S. FDA panel
....
Apaziquone is inserted directly into the bladder following surgery to remove tumors. In 2012, two late-stage clinical trials failed to meet their main goals
....
Reuters
9/15
Analyst: Humira Sales Will Continue to Climb; Biosimilars Slow to Get Traction
Price Increases To Help Drug Hit $15 Billion In Sales
....
Over the past three-and-a-half years, [Geoffrey Porges, of Leerink] writes, prices for Humira have increased, on average, by 6% every three months. The company has also been gaining market share, resulting in a tripling of sales since 2013. Enbrel has averaged a 3.5% price increase every three months, resulting in a 40% increase in sales without an increase in prescriptions
....
Forbes/Matthew Herper
9/15
New Immune Globulin Approval
Cuvitru Approved for Primary Immunodeficiency
....
Cuvitru is the only 20% subcutaneous immunolglobulin (IG) treatment option without proline and with the ability to infuse up to 60 mL (12 g) per site and 60 mL per hour per site as tolerated, resulting in fewer infusion sites and shorter infusion durations compared with other conventional subcutaneous IG treatments
....
Pharmacy Times
9/15 Internet Drug News Fast Takes:
Pfizer Launches New "Moodivator" App to Help Support, Encourage and Motivate People with Depression
Company news release
Simone Biles Reveals She's Been Taking Medication for ADHD After Hackers Leak Her Rio Olympics Drug Test
People
Allergan to buy US drug developer Vitae Pharmaceuticals for $639 million
CNBC
Report: Get ready for most demanding consumers in history
Drug Store News
Sex toys and the Internet of Things collide mdash;what could go wrong?
Ars Technica
9/14
Where the EpiPen Price Hikes Went: $292.1 Million for Mylan's Top Five Executives in Past Five Years
EpiPen Maker Dispenses Outsize Pay
....
Mylan, lambasted for raising prices, ranks No. 2 in U.S. drug industry in executive compensation
....
WSJ
9/14
Recommended Analysis: How the Drug Pricing/Distribution Model Got So Convoluted
How Congress Can Make Drug Pricing More Rational
....
The byzantine model for selling drugs isn't a concoction of business efficiency. It's the outcome of a two-decade old legal dispute that forced drug makers to try and conceal just how much they discounted off the medicines that they were selling to health plans
....
Forbes/Scott Gottlieb, MD
9/14
Added Months for Ca Patients Come at High Cost
New Anticancer Drugs Up Costs and Life Expectancy Considerably
....
Lifetime costs, including costs for outpatient and inpatient care increased by $72,000 for patients with breast cancer who received physician-administered drugs; for these patients, life expectancy increased by 13 months. Patients who did not receive these drugs had much smaller changes in life expectancy and costs
....
HealthDay
9/14
Subsys Maker Insys, Facing Numerous Legal Issues, Spends $500,000 to Fight Legal Marijuana
A maker of deadly painkillers is bankrolling the opposition to legal marijuana in Arizona
....
The campaign against marijuana legalization in Arizona received a major infusion of cash last week from a synthetic cannabis drugmaker that has been investigated for alleged improper marketing of a highly addictive prescription painkiller
....
Washington Post
9/14
There's a Hole in America's Arm Where All the Money Goes
Study: Health Spending Related To Opioid Treatment Rose More Than 1,300 Percent
....
From 2011 to 2015, insurers' payments to hospitals, laboratories, treatment centers and other medical providers for these patients grew from $32 million to $446 million
....
Kaiser Health News
9/14
FDA Finds Balance Lacking on Cancer Websites
Skimpy risk info on cancer drug websites may give patients false hope
....
For cancer drug websites oriented toward consumers, 38.5% included quantitative information about the drugs' full complement of benefits, but only 3.1% offered a numerical rundown on all the risks. For doctors, the split was even more dramatic: More than 86% of professional sites included quantitative data on the range of benefits, while just 6.2% offered similar information about the full list of risks
....
Fierce Pharma
9/14
Review of DTC Ad Effects Finds Limited Impact
All that pharmaceutical advertising may be a 'mixed bag,' after all
....
The analysis also found that only 1 in 10 consumers were moved by such advertising to ask a doctor for a prescription
....
Stat/Pharmalot
9/14
Only 60% of Diabetics Who Should Be Getting Statins Do
Too Few Diabetes Patients Receiving Statins
....
Those prescribed statins were more likely to have cardiovascular risk factors. They also were more likely to receive non-statin cholesterol-lowering therapy (28 percent, versus 13 percent for patients not receiving a statin) and had lower mean low-density lipoprotein cholesterol (90 versus 103 mg/dL)
....
HealthDay
9/14
Small Group of Exploding-Price Generic Drugs Puts Dent In Part D Budget
'Extraordinary' generics price hikes hit Medicare Part D amid big reduction overall
....
"Established generics"-- the 1,441 drugs that stayed on the market the entire time -- fell by just 22%. More than 300 cases of "extraordinary price increases" kept prices from falling further
....
FiercePharma
9/14
"A Trail of Misuse, Addiction And Death" -- America "Awash" with Adderall
Abuse of ADHD drugs following path of opioids
....
Among those 26 and older, recreational use of Adderall, an amphetamine, rose fourfold, from 345,000 people in 2006 to 1.4 million in 2014
....
Milwaukee Journal-Sentinel/Medpage Today
9/14 Internet Drug News Fast Takes:
Hospitals Jack Up Costs 'Strategically,' Study Finds
Huffington Post
Vaccine inventor raises alarm on Lyme disease
Philly.com
Insurers May Insist On Counseling Before Genetic Tests For Breast Cancer
Kaiser Health News
Doctors Test Drones To Speed Up Delivery Of Lab Tests
NPR Health Blog
Big Pharma Spends Millions to Keep Prices High for California Agencies
The Street
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