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10/6 Fast Takes
Amicus Therapeutics Plunges on Delay in NDA SubmissionFor Fabry's Pill
Premiums for Medicare prescription drug coverage are set to go through the roof
Motley Fool
Bristol-Myers Cancer Drug Combination to Cost $256K a Year
CVS/pharmacy Opening Eyeglass and Hearing Aid Centers in Select Locations
CVS Press Release

10/6 BMS paying $14M to settle SEC charges Sales Reps Paid Bribes To China Hosp Staffers
- Lilly, Pfizer paid similar fines in recent years
Bristol-Myers pays $14M to settle charges of paying bribes in China … sales personnel at the company's joint venture plied staff at hospitals owned or controlled by the Chinese government with cash, jewelry, meals, travel and entertainment … low salaries and strained budgets have driven doctors, nurses and hospital administrators to make ends meet by accepting money from patients, drug suppliers …[Pharmalot]

Insurers  Scheme To Avoid Putting Jardiance On Formulary
- They're afraid that they will not be able to demand juicy rebates if the admit it's unique among the class
US insurers hold back Lilly's death-defying diabetes drug … Aetna Inc, CVS Health Corp and Molina Healthcare Inc said they would need further clinical data and a change in medical society guidelines on Lilly's Jardiance before agreeing to make it easier for patients to receive the $4,800-a-year treatment. That's a process that could take anywhere from 18 months to several years … [Reuters]

Nobel Prize Winning Drugs Have Roots In Dirt From Golf Course, Ancient Chinese Medicine
- Antibiotic from dirt, malaria med from wormwood
2015 Nobel Prize In Medicine Awarded For Discovery Of Malaria, River Blindness Drugs From Nature … searching soil samples for microbes that made chemicals that could kill roundworms, the cause of river blindness and elephantiasis. According to the Nobel lecture, a sample was collected next to a golf course … [Forbes]
Related: Beating parasites wins three scientists Nobel prize for medicine …[NY Times]

FDA Green Lights Ultra Long Acting Version Of Active Ingredient Found In  Abilify
- Injection every 6 weeks or once per month
FDA Approves ARISTADA™ for Treatment of Schizophrenia … first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection …[Alkermes Press Release]

Activist Group Promotes Truvada By Urging Unprotected Sex
Just what the pundits feared
Campaign encourages gay men to have unprotected sex in attempt to boost sales of anti-HIV drug … guerrilla advertising campaign is encouraging gay men to have unprotected sex to promote a non-approved drug that combats HIV infection … "You don't just get HIV when you have unprotected sex, you could also get syphilis, gonorrhea, a number of other STIs." …[The Age]

Behind The Scenes: Dirty Trick Shkreli Uses to Prevent Generic Competition For $750 Pill
- Games loophole in FDA process
How Martin Shkreli prevents generic versions of his pricey pill … distribution system that prevents generic drug makers from purchasing Daraprim. And without sufficient supplies, a generic drug maker is unlikely to have enough medicine to run clinical tests needed for FDA approval … I'm certainly not going to make it easier for them. We're spending millions and millions in research to find a better Daraprim, if you will." …[Pharmalot]
Editor's Note: They could easily torpedo Turing's scheme - mandate a special license be issued to FDA-approved generic manufacturers to bypass closed distribution.  OR outlaw closed distribution systems altogether.

10/5  Fast Takes
5 Big FDA Decisions Expected in October
247 Wall Street
Gilead: FDA Approves Letairis® + Tadalafil Combo Pillk for Pulmonary Arterial Hypertension
Gilead Press Release
Why is FDA guidance on biosim interchangeability taking so long?

Decision On Shire Dry Eye Drug Due Later This Month
Shire's lifitegrast: The Most Important PDUFA Date in October? … FDA is set to issue its decision on Shire's dry-eye disease drug later this month and its decision could have a big impact on Shire …[Motley Fool; VIDEO]

Diabetic Investor Says Afrezza Will Always Be Dud
Diabetic Investor On MannKind: 'There's A Reason Why So Many People Are Short This Stock' … turnaround is like believing the Chicago Bears are going to the Superbowl this year … diligence team said, 'don't do this deal.' But he pushed it through …[Benzinga]
RelatedMannKind Cuts Its Headcount, But Will It Matter? … Mannkind's losses on Afrezza are running at about $12 million per quarter …[Motley Fool]

Get Ready For Biosim Enbrel
FDA accepts Sandoz submission for copycat Enbrel … sales of $4.7 billion last year … Sandoz is seeking approval for all indications included in the label for Enbrel … Novartis last month launched the first biosimilar drug in the United States, company's copycat version of Amgen's blockbuster cancer drug Neupogen …[Reuters]

Megan Fox Becomes A Drug Rep
'New Girl' season 5 spoilers: Megan Fox to fill in for Zooey Deschanel …  Fox will be playing Reagan, a pharmaceutical sales representative who comes in and rents Jess's room while the other has been sequestered for jury duty. She will be in for multiple episodes … [Christian Today]

Turing CEO Skrelli Is Just Tip Of Iceberg: Report
- Valeant in Congress' crosshairs: blood pressure drugs up 550%, Glumetza 800%
Massive, unexpected drug price increases are happening all the time … average price increase for products made by specialty pharmaceutical companies, which concentrate on pricier drugs, was 16% in 2012, 29% in 2013, 22% in 2014, and 19% so far in 2015 … Valeant is the biggest standout  …[Quartz]
Valeant's Drug Price Strategy Enriches It, but Infuriates Patients and Lawmakers … Valeant's habit of buying up existing drugs and raising prices aggressively, rather than trying to develop new drugs, has also drawn the ire of lawmakers … [Cuprimine had] more than quadrupled its price overnight … $35,000 for the 120 capsules

10/2 Sticker Shock at Price for New Melanoma Combo
Bristol-Myers Cancer Drug Combination to Cost $256,000 a Year .... The price is for a patient that takes four doses of the combination -- which includes a standard dose of the drug Yervoy and a lower dose of Opdivo -- every three weeks, followed by a higher dose of Opdivo alone every two weeks .... Bloomberg
See also: FDA approves costly Bristol-Myers drug combo for melanoma [Reuters]

10/2 FTC Blasts 'Product-Hopping'
Drugmaker Tactic to Block Generics May Violate Law, FTC Says .... Brand-name drugmakers sometimes make insignificant formulation changes to their products just before patents are about to run out and as generics are about to come to the market. Those formulation tweaks let the drugmaker switch patients to the new brand-name drug, or to make improved product claims .... Bloomberg

10/2 Which Pharma Companies Are Jacking Up Prices the Most?
Massive, unexpected drug price increases are happening all the time .... The average price increase for products made by specialty pharmaceutical companies, which concentrate on pricier drugs, was 16% in 2012, 29% in 2013, 22% in 2014, and 19% so far in 2015 .... Quartz

10/2 Eteplirsen Maker Borrows Patients from Other Studies to Support Benefit
Sarepta gets creative in bolstering its case for quick eteplirsen approval .... Pulling together a control arm by selecting patients who had been enrolled in other studies--a rare maneuver--the biotech sought to reassure doubters that its drug provided a significant, long-lasting benefit with clear biomarker evidence that the drug usually worked as expected .... Fierce Biotech
See also: Sarepta Unveils New Data to Make Stronger Case for Duchenne Drug Approval [The Street]

10/2 Afrezza Manufacturer Says Goodbye to More Workers
MannKind engages in third round of layoffs in Danbury .... Sales of Afrezza--which was approved by the U.S. Food and Drug Administration last year and hit the market in February--so far have been lackluster, with marketing partner Sanofi reporting total sales of about $5.5 million as of June 30. .... NewsTimes

10/2 When All Studies Are Published, Not Just Ones with Positive Results, A New Picture Emerges
Effectiveness of Talk Therapy Is Overstated, a Study Says .... Treatments like cognitive behavior therapy and interpersonal therapy are indeed effective, the analysis found, but about 25 percent less so than previously thought. .... NY Times

10/2 Less than Half of Those with HIV Getting Any Treatment
UN: HIV Patients Should Start Treatment Immediately .... The new guidance means that all 37 million people with HIV globally should be offered immediate treatment, a prospect that may be unrealistic in poor countries, where many patients are still unable to get medicines. Last year, only about 15 million people with HIV were being treated. .... NY Times

10/2 Jazz's Defibrotide to Get Early Decision
FDA grants priority review to defibrotide for hepatic veno-occlusive disease .... The FDA granted priority review to defibrotide, an investigational agent in development for treatment of patients with hepatic veno-occlusive disease who have evidence of multiorgan dysfunction after hematopoietic stem cell transplantation. .... Healio

10/2 Wanna Pair of Beestungs? Allergan Has Got You Covered
FDA Approves Lip Filler That Lasts A Year — Will Kylie Jenner Do It? .... A study found that within 3 months, 79% of subjects showed a "meaningful improvement in lip fullness after treatment [using Juvederm Ultra XC] — results can still be seen up to one year." .... Hollywood Life

10/2 Remember Willie Horton? Campaign Will Make Shkreli the Face of Pharma
Not done yet, Hillary Clinton airs pharma-focused ad starring Turing CEO .... In a new campaign ad airing this week, Clinton makes Shkreli the "star," interspersing an image of his face from a Today Show interview with newscast snippets about his outrageous Daraprim price hike .... Fierce Pharma

10/2 Internet Drug News Fast Takes:
For seniors, hearing trouble linked to greater risk of death
Teva to Buy Rimsa for About $2.3 Billion
Merck sells Kuvan rights back to BioMarin
Pharma Times
Two-Day FDA Advisory Committee Meeting to Address Drug Compounding Questions
Regulatory Focus
Geisinger to close on AtlantiCare acquisition, beefs up New Jersey presence
Health Care Finance News

10/1 FDA Taking Hard Look at Chinese Pharma Manufacturing
Trashed Tests Put FDA on Notice as China Pushes Drug Exports .... China has a growing drug industry, and one that increasingly wants to make not just raw ingredients but finished drugs for export. Yet there are currently only two FDA drug inspectors in the country, overseeing about 700 facilities involved in drugmaking. .... Bloomberg

10/1 Remember the PBMs Throwing Hissy Fits About PCSK9 Inhibitors? Never Mind, They Turned Down All the PreAuths
New cholesterol drugs won't be budget busters: Express Scripts .... Everett Neville, a vice president of Express Scripts, said Express Scripts and insurers had rejected a surprisingly high number of prescriptions for the two injectable drugs, Praluent from Regeneron Pharmaceuticals and Sanofi, and Amgen Inc's Repatha. .... Reuters

10/1 MacArthur Genius Finds the Patent System Drives Investment in the Wrong Sorts of Drugs
What Cures Are We Missing Out On? .... The study found that drug-company investment increased with the stage of cancer targeted. In essence, pharma R&D labs work much harder trying to get the sickest patients a few more months of life than trying to treat tumors at an earlier stage, which could add years to patients' lives .... Bloomberg

10/1 More Buck, Less Bang
Cancer Drugs Aren't As Cost-Effective As They Used To Be .... In the mid-nineties, cancer drugs generally provided an extra year of life for less than $100,000, most new treatments typically provide a year of life for as much as $150,000 or even $200,000 .... Forbes/Peter Ubel

10/1 What the FDA Means by 'Breakthrough' Isn't What Regular Folks Expect
Word 'breakthrough' dramatically affects perceptions of a new drug's effectiveness .... Some 42% of the women who took compounded hormones thought that "natural" or "bioidentical" hormones are safer than other types of hormones, even though there are more than 30 tested and FDA-approved hormones for menopause, including many that are similar to human hormones. .... Medical Xpress

10/1 Industry-Financed Docs Pooh-Pooh Low-T Cardio 'Signal'
What risk? Physician group questions FDA view on Testosterone drugs .... A leading physicians group is questioning claims that testosterone replacement therapy increases the risk of heart disease — contradicting concerns expressed by the Food and Drug Administration .... Pharmalot

10/1 Ocrelizumab, for MS, Forecast at $656 Million Sales in 2019
Roche poised for MS coup with success in hard-to-treat progressive form .... The company has announced positive Phase III data for the drug in primary progressive multiple sclerosis, a less common form of the disease--affecting about 10% to 20% of sufferers--that right now remains untreated .... Fierce Pharma Marketing

10/1 Many Women Prefer 'Natural' Hormones to FDA-Approved Therapies
One-third of hormone users at menopause take unapproved, untested compounded drugs .... Some 42% of the women who took compounded hormones thought that "natural" or "bioidentical" hormones are safer than other types of hormones, even though there are more than 30 tested and FDA-approved hormones for menopause, including many that are similar to human hormones. .... The North American Menopause Society

10/1 'Trajectory Modeling' Gives Early Warning of Nonadherence
CVS study: Early medication-fill patterns can predict future adherence .... A patient's future medication-adherence behavior can be predicted by examining the patient's patterns of medication fills in the first few months after beginning chronic therapy .... American Pharmacy News

10/1 What Gets You in Hot Water with the FDA?
Omitting risk info in ads is top reason for FDA warning .... About 60% of FDA warning letters and untitled letters issued to pharmaceutical companies over the past two years cited omitted risk information in promotional materials .... MM&M

10/1 Internet Drug News Fast Takes:
Bayer restructures its operations, drops Bayer Healthcare group
Increasing calcium intake 'does not improve bone health of seniors'
Medical News Today
Study Links Asthma to Low Levels of Gut Bacteria in Newborns
Wall Street Journal
Placebo power: Depressed people who respond to fake drugs get the most help from real ones
University of Michigan Health System
Pfizer Boosts Its Guidance, Suggesting Better Times May Be Coming
Motley Fool

9/30 Average Part D Monthly Premiums Will Break $40 Barrier
Medicare drug plan prices set to rise in 2016, some by a lot .... More than 15 million people enrolled in the top 10 Medicare "Part D" prescription drug plans will face average premium hikes of 8 percent next year .... CNBC

9/30 Billions at Stake on Immunotherapy — Who Do You Bet On?
Which Big Pharma Will Grab the Lion's Share of the Cancer Immunotherapy Market? .... Cancer immunotherapy is one of the hottest areas of cancer research these days, and the market looks to be worth billions. .... Motley Fool

9/30 Pain Pills Walking Out the Door at MGH
Mass. General to pay $2.3 million over drug thefts .... According to the settlement agreement, one nurse identified as J.S. stole 14,492 pills, and a second nurse, identified as J.Z. 1, pilfered 1,429 tablets.... most of the pills were the prescription painkiller oxycodone .... Boston Globe

9/30 Leading Cancer Doc Calls for Paying for Value
The drug price conundrum: a Q&A with Memorial Sloan Kettering's Dr. Peter B. Bach .... "Pharma is walking a line where they want total pricing control and they want to be opaque like any other for-profit company, but they want to use rationales that are in the public interest." .... Fortune

9/30 Lixisenatide (Lyxumia) Filed
FDA will review Sanofi's diabetes drug lixisenatide .... In the 5,000-patient-plus GetGoal clinical programme, the once-daily shot worked as well as twice-daily exentide (Lilly's Byetta) in lowering blood sugar levels with a similar safety profile .... Pharma Times

9/30 No Good Answers on Warnings for DTCA
NEJM: FDA's proposed risk-disclosure guidelines still aren't enough .... "After 30 years of DTCA, it's not clear that advertising is the best medium for communicating risk information, but marketers should at least be required to try to communicate risk information as effectively as they do their promotional messages." (Jeremy A. Greene, M.D., Ph.D., and Elizabeth S. Watkins, Ph.D.) .... Fierce Pharma Marketing

9/30 Alexion vs. Canada
Canada is trying to cut the price of a $525,000-a-year drug, and is getting sued for it .... Alexion's suit fundamentally challenges Canada's right to compel companies to lower the prices on patented drugs. If it succeeds, prices could rise dramatically in the country. .... Quartz

9/30 Medication Therapy Management Model Will Pay Insurers for Better Adherence
CMS tests model to increase drug adherence on Part D plans .... Participating plans will be able to offer different medication therapy management services based on enrollees' level of medication-related risk, with interventions tailored to those enrollees' specific barriers to improvement. .... Modern Healthcare

9/30 Kardashians Tested at Pathway Genomics, the Company in Hot Water with the FDA
Kardashian trio tested for genetic cancerous gene in San Diego .... Kim Kardashian, sister Khloe and their mother Kris Jenner — joined by celebrity doc Paul Nassif and a camera crew — journeyed to San Diego to get tested for a rare, genetic and often fatal cancer mutation .... NY Daily News

9/30 Oncotype DX Validated in NEJM Study
Breast Cancer Gene Test Helps Predict Who Can Skip Chemo .... For patients who fell into the test's low-risk category, 99 percent didn't develop metastatic breast cancer five years after surgery, even though they didn't have chemotherapy. The overall survival rate among this group was 98 percent .... NPR

9/30 Internet Drug News Fast Takes:
U.S. states urge FDA to ensure warnings on liquid nicotine products
Lilly/Incyte unveil more PhIII success for RA drug baricitinib
Pharma Times
Aspirin may double survival for cancer patients
Medical News Today
Arsenic found in many US red wines, but health risks depend on total diet
University of Washington
A Health-Care Model in Coal Country
Wall Street Journal

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