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5/2 Fast Takes
Obesity Linked To Psoriasis
Morning Ticker
Sanofi Shares Tumble 7% After $9.3 Billion Bid For Mediavation
Pocono Record
FDA Approves First Drug Approved for the Treatment of Hallucinations Associated With Parkinson's Disease
Acadia Press Release
Warren Buffett Says Valeant's Business Model Proved 'Enormously Flawed'
FDA Worried Yeast Infection Drug Diflucan (Fluconazole) Causes Miscarriages
Teva enlists House M.D. actor to hype migraine (not a doctor but plays one on TV)
Fierce Pharma Marketing

5/2 Novo: Experimental Once Weekly GLP1 Cut Cardio Risk
- Plans FDA Submission Q4 2016
Now Novo Says Semaglutide Cuts CV Risk: SUSTAIN-6 Top-line Data … once-weekly product called semaglutide, which is not yet approved anywhere …  0.5-mg and 1.0-mg semaglutide, which was administered subcutaneously once weekly  … [Medscape]
Novo's semaglutide passes sixth Phase III test … [BioCentury]

Perjury Allegations Reopen Merck, Gilead Patent Battle
-  Trial awarded 10% royalty to Merck; $200 million penalty in limbo;
Gilead Judge Re-Opens Case Amid Claim Merck Scientist Lied … allegation the now-retired scientist deceived jurors with testimony that he was responsible for early breakthroughs on compounds that led to a cure for the liver disease … Merck claims Durette never intentionally misled the jury, later acknowledging that he'd been …[Bloomberg]

New Valeant CEO Could Get Half A Billion Dollars
Payout To Turn Company Around
- No wonder he left Perrigo
Valeant's New CEO Joe Papa Will Make Over $500 Million If Stock Rockets To $270 By 2020 … $100 million if its stock can return to an October 2015 level of $150 a share. If Valeant's share price hits $270, Papa will make well over $500 million …[Forbes]
RelatedValeant CEO Michael Pearson Had Chance at $2.66 Billion Payday …[Bloomberg]

Big Pharma Under Pressure to Pay For Drug Take-Back Programs
Big Pharma Under Pressure to Pay For Drug Take-Back Programs … pressure on pharma is not likely to die down. … shareholder resolutions calling on three drug makers to review their policies on take-back programs …[Fortune]

PBM Rebates Put Brakes On Gilead Profit For Hep C Pills
Forced to discount pricey hepatitis C drugs, Gilead misses sales target …  hepatitis C drugs actually reached more patients in the United States … Even so, revenue was down, in large part because of steep discounts and rebates …[Stat]

India Labeled Intellectual Property No-Goodnik By Obama Admin
- Place on so-called "watch list"
Pharma cheers, advocates jeer as US keeps India on list of bad patent players … placed India on what is known as the annual priority watch list … laws and court rulings in India that, in some cases, have made it easier for their generic rivals to sell lower-cost, copycat versions of their medicines …[Pharmalot]

Death Of Crestor Patent Means AZN Must Cut $1 Billion In Expenses
- Crestor patent expires next week; 20% of AZN sales
AstraZeneca plots cost cuts to save $1.1B as Crestor generics loom … AstraZeneca will target sales and administrative functions for cuts  … key products fell short, including Symbicort, which was "especially weak, branded Nexium, facing generics and the OTC version, also missed …[Fierce Pharma]

4/29 Industry Pundit Thinks FDA Will Overrule Panel on Eteplirsen
Sarepta Can Win Speedy FDA Drug Approval .... If Woodcock agreed with all the bad things said about eteplirsen on Monday night, if she had no plans to overrule or cast aside the recommendations against approval, why did she go out of her way to meet with DMD boys and their families immediately after the meeting ended? .... The Street (Adam Feuerstein)

4/29 ESRX Will Swat Down Price Hikes Immediately
Valeant-Style Price Hikes Targeted for Review by Drug Plan .... Express Scripts is starting a new program designed to respond rapidly to price spikes on old drugs, making it easier to steer patients to cheaper alternatives when a medicine unexpectedly soars in price .... Bloomberg

4/29 Bidding Opens for Medivation
Sanofi launches $9.3 billion fight for U.S. cancer firm Medivation .... Sanofi's non-binding proposal is to buy Medivation for $52.50 per share in cash, representing a roughly 36 percent premium over Medivation's stock price one month prior .... Reuters

4/29 Abbvie Buys Stemcentrx
AbbVie forges deeper into cancer, as clock ticks for Humira .... The suburban Chicago drugmaker will buy privately held Stemcentrx and its experimental treatment for small cell lung cancer, which accounts for about 10 percent to 15 percent of all lung cancers and is notoriously difficult to treat .... Reuters

4/29 Explosive New Technologies — Liquid Biopsies, Gene Tests — Draw Regulators
There's a new sheriff in town in Silicon Valley — the FDA .... As a tidal wave of new health-related gadgets, apps and tests hits the market, the Food and Drug Administration, the Federal Trade Commission and other enforcement agencies are showing up in Silicon Valley like they've never done before. .... Washington Post

4/29 Sovaldi and Harvoni Sales Flat; But Gilead Has $26 Billion in the Bank for New Pipeline
Gilead's Profit, Hepatitis C Drugs Sales Miss Estimates .... While the drugs have been among the fastest-selling medications of all time, AbbVie and Merck & Co. now offer similar products. Gilead has said it expects U.S. sales of its hepatitis pills to be flat this year .... Bloomberg

4/29 Public Citizen Mad About How FDA Redacts Public Resumes of Advisors
FDA sued for hiding too much info about its expert panel members .... A consumer advocacy group has gone to court to force the agency to disclose more information about the people whose opinions help determine the fate of numerous drugs and devices .... Pharmalot

4/29 SGLT2s Overtaking DPP4s
Following positive outcomes data, a new diabetes class is on the rise .... New patient growth for drugs in the category is in the single digits year-to-date — but total prescriptions are up over 30% .... MM&M

4/29 Xtampza, Abuse-Resistant Form of Oxycodone
FDA Approves New Version of Oxycodone .... Xtampza is made by Massachusetts-based Collegium Pharmaceutical with proprietary technology that combines oxycodone with fatty acid and waxes to form small spherical beads that are placed inside the capsule. The beads are designed to resist breaking, crushing, chewing, dissolving and melting .... Pain News Network

4/29 Takeover in Heart Devices Market
Abbott to Acquire St. Jude Medical for $25 Billion .... Abbott and St. Jude Medical will capture a larger position across the market for cardiovascular devices .... NY Times

4/29 Average Monthly Cost of Oral Cancer Drugs Launched in 2000: $1,869. In 2014: $11,325
Spike in Cost of Certain Oral Cancer Drugs Puts Squeeze on Patients .... These kinds of medications have become more popular since 2000, with 32 therapies introduced between 2000 to 2014. .... ABC News

4/29 Internet Drug News Fast Takes:
Patients' top complaint? It isn't doctors or nurses, study finds
Advisory Board Daily Briefing
Drug Overdose Deaths Leading to More Organ Donors
US News
Acadia drug approval could clear way for Axovant dementia therapy
What Pharma's Are Doing on Periscope — Update on the Landscape
Eye on FDA
Aurobindo to move U.S. HQ, manufacturing to North Carolina
Fierce Pharma

4/28 Whistleblowers (One a Repeat) Win $98 Million in Protonix Settlement
Pfizer to Pay $784.6 Million to Resolve Drug Discount Case .... Pfizer agreed to pay $784.6 million to resolve a 14-year-old lawsuit claiming its Wyeth unit overcharged the government by hiding the discounts it was giving hospitals for drugs used to treat acid-related damage to the esophagus .... Bloomberg

4/28 GSK Turns a Corner
Glaxo Profit Rises for First Time Since 2013, Tops Estimates .... GlaxoSmithKline reported its first increase in quarterly profit since 2013, as demand for its vaccines and new drugs helped offset declines in the sales of its blockbuster Advair. .... Bloomberg (includes video with CEO Andrew Witty)

4/28 "The price is never the price, unless you're a cash-paying customer" (Adam Fein) — The New York Times Explains High Drug Costs
The Complex Math Behind Spiraling Prescription Drug Prices .... Although list prices for drugs rose about 12 percent in 2015, net prices — what insurers and employers actually paid — grew only about 2.8 percent, the lowest rate in years, according to IMS Health .... NY Times

4/28 Addyi Creator's Latest Project: Date Rape Drug-Detecting Fingernail Polish
The Woman Behind the 'Female Viagra' Has a New Venture .... Called The Pink Ceiling — a fitting name, given Whitehead's signature hot pink lipstick and clothing — the new company is something of a cross between a VC fund, an incubator, and a consulting firm. Whitehead says that the company will partner with startups that provide products or services to women, helping the fledgling businesses come to market and scale .... Fortune

4/28 $3 Billion in Mobile Pharma Ads in 2015
Mobile ad spending up, but pharma's share remains small .... Retail, finance and cars are still the biggest overall spenders in digital media, the IAB report found, accounting for 22%, 13% and 13% of the total spend respectively. The pharma and healthcare category was eighth on the list of IAB industry spenders, contributing 5% of the total digital spend .... Fierce Pharma

4/28 Canadian Company Offers a Deal on Xtandi
Small company offers Medicare cheap version of pricey cancer drug .... Biolyse Pharma maintains that it can supply a version of Xtandi for $3 per 40-milligram tablet, compared with the $69.41 that Medicare paid in 2014 .... Pharmalot

4/28 Second US Biosimilar Faces Acceptance Hurdles
Why Inflectra may face greater challenges than Zarxio in winning over US docs .... Anti-TNG drugs like Remicade are generally used to treat chronic diseases over the course of a lifetime. Neupogen, and by extension Zarxio, is used only for a limited period of time .... BioPharmaDive

4/28 Valeant Officials Blasted at Senate
Ackman, Valeant Offers Apologies, Concessions at Drug Hearing .... Valeant Pharmaceuticals's outgoing chief executive, Mike Pearson, and billionaire investor Bill Ackman offered apologies and concessions to U.S. lawmakers at a Senate hearing on the price of drugs .... Bloomberg

4/28 FDA Pushes PDUFA Date Back for Hep B Vaccine
Dynavax further delayed as FDA says wait until Christmas for hep B vax decision .... Dynavax hopes to have an edge with over the marketed treatments as its vaccine as it is injected in two doses over one-month--whereas its rivals are administered in three doses over a six-month schedule .... Fierce Biotech

4/28 New Designations for Ilaris
Novartis' Ilaris awarded three breakthrough badges in the US .... The three conditions for which Ilaris is being reviewed are Tumor Necrosis Factor-Receptor Associated Periodic Syndrome (TRAPS) and Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD), and Familial Mediterranean Fever (FMF) not adequately controlled with colchicine .... Pharma Times

4/28 Internet Drug News Fast Takes:
FDA Says "No" to Single-Tablet Combination of Aripiprazole and Ingestible Sensor
PT Community
With more cash, we can eliminate malaria within our lifetime: ex-WHO official
Advocates hold NYC protest over price of pneumonia vaccine
The 7 Deadliest Emergency General Surgeries
HealthDay News
That Surgery Might Cost You A Lot Less In Another Town
Working longer may lead to a longer life, new research shows
Oregon State University

4/27 Steep Price Hikes Continue in 2016
Drug Prices Keep Rising Despite Intense Criticism .... Drug makers have raised prices on brand-name drugs by double-digit percentages since the start of the year, according to interviews with executives at Express Scripts and CVS Caremark, two major drug-benefit managers .... NY Times

4/27 Cabometyx Approved for Kidney Cancer
Exelixis, Inc.'s Cabometyx Approved: Let the Kidney Cancer Battle Begin! .... Cabometyx produced a hazard ratio of 0.66 compared to Afinitor, which corresponds to a 34% reduction in the rate of death. Opdivo produced a hazard ratio of 0.73 compared to Afinitor, a 27% reduction in the rate of death .... Motley Fool

4/27 AZN Bails on Zurampic
AstraZeneca sells U.S. gout drug rights to Ironwood for up to $265 million .... AstraZeneca has a strategy of selling certain rights to non-core medicines to help pay the bills as it invests in new drugs and copes with the loss of patent protection on a raft of former blockbusters .... Reuters

4/27 Bayer Up on Strong-Selling Xarelto and Eylea
Bayer Profit Beats Estimates as Newest Drugs Buoy Demand .... Earnings before interest, taxes, depreciation and amortization, and excluding some costs, climbed 16 percent to 3.40 billion euros ($3.83 billion) .... Bloomberg

4/27 FDA Looks at Diflucan
FDA Investigates Study Showing Yeast Infection Drug Increases Risk of Miscarriage .... The FDA is evaluating the results of a Danish study that found a possible increased risk of miscarriage with the use of Diflucan (fluconazole), a treatment for yeast infections .... Regulatory Focus

4/27 Review: Pharmacists Better Than Doctors in Managing Chronic Diseases
Pharmacists Can Manage Some Chronic Conditions Effectively .... Pharmacists may do a better job than doctors helping chronically ill patients manage their blood pressure, cholesterol and blood sugar levels if they're allowed to direct people's health care .... HealthDay

4/27 NY AG Forces Coverage for Hep C Drugs for All
New York Insurers to Change Coverage of Hepatitis C Drugs .... Deal requires seven insurers to cover the drugs for most patients with commercial insurance plans .... WSJ

4/27 Isotretinoin Warnings Often Ignored
Women using popular acne drug aren't following advice to avoid pregnancy .... Of the nearly 60,000 women who received isotretinoin, as many as 55 percent had not tried other, less dangerous acne drugs first .... Reuters

4/27 Inter Partes Review Decision May Disappoint Pharma
Supreme Court skeptical in case backed by drug makers .... The case in question focused on the Obama administration's rules for a new process to review patents. Drug makers, supporting the plaintiffs, are urging the court to change that process, which right now makes it easier to invalidate the patents that are crucial to their business. .... Stat

4/27 Pundits Give Eteplirsen 10% Chance of Approval this Go-Round
Slim Sarepta Hopes Rest With Top FDA Official .... Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, was the most senior FDA official who attended the advisory committee meeting in Hyattsville, Md., outside Washington D.C., and she made the most supportive comments among her colleagues about the drug, eteplirsen .... Barrons

4/27 New Drug Combo for COPD
FDA Approves Bevespi Aerosphere for Patients With COPD .... Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol is the only long-acting dual bronchodilator delivered through a pressurized metered-dose inhaler. .... PTCommunity

4/27 Internet Drug News Fast Takes:
'A' to 'F': Leapfrog grades 2,571 hospitals on safety
Advisory Board Daily Briefing
Weight loss may limit diabetes-related brain changes
FDA to Massachusetts Group Home: Stop Shocking Disabled Residents
Researchers find four supplements that boost efficacy of antidepressants
Drug Store News

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