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Pharmaceutical News Harvest ™

Fast Takes
Glaxo Says Dividend Is Secure as Analysts Question Payout
You Should Be Scared: Antibiotics May Have Just Stopped Working in India
Take Apart
AstraZeneca's Lynparza Approved in EU for Ovarian Cancer
257,000 Doctors Will Get 1% Medicare Pay Cut For Using Paper Records

12/22 Glaxo Shingles Vaccine: Stunning Efficacy Could Challenge Merck
New GSK shingles vaccine may challenge Merck after strong test data … reduced the risk of shingles by 97.2 percent in adults aged 50 years and older compared to placebo …  result looks compelling compared to Zostavax, which has showed 69.8 percent efficacy in patients aged 50 to 59 years, and lower efficacy in older people …[Reuters]

Viekira Pak: AbbVie Answer To Solvaldi, Harvoni Approved By FDA
12 week Viekira 12% less than 12 week Harvoni
FDA approves AbbVie all-oral hepatitis C treatment … AbbVie regimen consists of four different anti-viral drugs to be taken as three pills in the morning and one in the evening. …[Reuters]
FDA Approves AbbVie's VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C Virus … VIEKIRA PAK consists of the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an approved HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal …[AbbVie Press Release]
AbbVie Prices Hepatitis C Drug 12% Below Gilead Rival … Viekira Pak could generate $2.9 billion in sales next year … revenue will help North Chicago, Illinois-based AbbVie expand its sources of revenue beyond best-seller Humira, the rheumatoid arthritis treatment that is projected by analysts to bring in $12.6 billion this year …[Bloomberg]

Viekira Pak Versus Harvoni, Solvaldi: Tale Of The Tape
Abbvie's Hep C Regimen Approved, Marketing Battle With Gilead Up Next … patients treated with Viekira Pak will swallow three pills in the morning and one pill at night at a price of $83,000 for a 12-week course of treatment. Gliead's Harvoni costs $94,500 [for 12 weeks although some patients only take it for 8 weeks at a cost of $63K ] …[The Street]

Diabetes Linked To Cancer Again
A New Study on Diabetes Reveals Potentially Frightening News …  patients with either type 1 or 2 diabetes have a higher incidence rate of cancer, and a higher death rate from cancer, than non-diabetics. … 29.1 million people in the U.S. now have diabetes, of which more than one in four is unaware they have the chronic disease. This is up from 26 million in the CDC's last update. Further, the number of people with prediabetes has ballooned to 86 million from 79 million. … [Motley Fool]

Express Scripts Eagerly Waits AZN, Lilly Patent Cliff
Patent Cliff Means Pharmaceutical Companies Will Lose $65 Billion by 2019, says GlobalData … hardest will include Otsuka, Eli Lilly, and AstraZeneca (AZ), with a significant proportion of losses coming in the Central Nervous System (CNS) treatment sector. … "AZN's CNS segment has been bleeding sales as a result of the company losing its patent on Seroquel (quetiapine fumarate) … [Global Data]
Drug Giants Face $65 Billion in Lost Sales as Insurers Attack Patents …  "In this environment, more than ever, we anticipate that payers will rely on Express Scripts' formulary and step management programs to maximize the savings potential of new generics …[Motley Fool]

FDA approves Cubists' drug for antibiotic-resistant bacteria
- Novel antipseudomonal cephalosporin with an established beta-lactamase inhibitor.
FDA approves Cubists' drug for antibiotic-resistant bacteria … to treat complicated urinary tract and intra-abdominal infections won U.S. approval on Friday, highlighting the regulator's interest in tackling the growing threat of the so-called superbugs … faces competition from several other companies, including AstraZeneca Plc and Actavis Plc. The companies' rival drug is being reviewed by the FDA, which is expected to reach a decision in the first quarter of 2015. …[Reuters]
Cubist Announces Approval of  ZERBAXA™ (Ceftolozane/Tazobactam) for Complicated Urinary Tract and Complicated Intra-abdominal Infections … first new antibiotic approved in the U.S. under the Generating Antibiotic Incentives Now (GAIN) Act to treat Gram-negative bacteria. … intravenous (I.V.) formulation at a 1.5 g q8h dose for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections  …[Cubist Press Release]

Nobody Wants Those Garage Sale Drugs
Record Pharma-Deal Year Not Enough to Sell Mature Drugs … some of the largest pharmaceutical companies tried to sell their portfolios of older drugs -- and failed … "Private-equity firms and trade buyers are still very interested  … Glaxo said it ended the sale of its North American and European established products, with annual sales of about 1 billion pounds ($1.6 billion), because the offers weren't high enough. …[Bloomberg]

12/18 Blincyto Price: $178,000 for Course of Treatment
Amgen Leukemia Therapy Costs $178,000, Among Priciest Drugs .... The price includes two $89,000 cycles of therapy, the median duration of treatment for patients who responded in clinical studies.... Each cycle consists of four weeks of treatment .... Bloomberg

12/18 CME Providers Hit Roof Over CMS Policy on CME Reporting
A Flip Flop? CME Payments to Doc Must be Reported to Sunshine Database .... CME payments are made by drug and device makers, as well as group purchasing organizations, to CME providers, which are either commercial firms or non-profits that organize courses for physicians. From there, payments may be made to physicians who speak at or attend CME events .... WSJ/Pharmalot

12/18 Somatuline Depot (lanreotide) Injection Approved for Gastroenteropancreatic NETs
FDA OKs Ipsen's gastroenteropancreatic tumours drug .... Approval came on the back of data from the CLARINET clinical study, which showed Somatuline cut the risk of disease progression or death by 53% versus placebo .... Pharma Times

12/18 Xtoro Approved
Swimmer's Ear Gets New Drug .... When ear infections were confirmed to be caused by P. aeruginosa or S. aureus, clinical cure rates of 70% were seen with Xtoro across both trials versus 37% of the placebo groups. .... Medpage Today

12/18 Murder Charges in New England Compounding Case
Massachusetts Pharmacy Owners Arrested in Meningitis Deaths .... 14 people were charged in a 131-count indictment, many of them pharmacists and technicians at the company... Only Mr. Cadden (head pharmacist) and Mr. Chin (supervisory pharmacist) were charged with murder .... NY Times

12/18 Spotlight on High Risk Prescribers
Prolific Prescribers Of Controlled Substances Face Medicare Scrutiny .... Medicare's drug program, known as Part D, now covers about 38 million seniors and disabled people and pays for more than one of every four prescriptions dispensed in this country.... Medicare's Part D data draws a roadmap to the doctors who prescribe controlled substances most frequently .... NPR
Direct link: Prescriber Checkup Database — Look up Any Doctor's Part D Prescribing Record

12/18 New York Has 105,000 People on Medicaid with Hep C. Only 7,000 Get Sovaldi, But It's Already the Leading Drug Cost in the Budget
Cost of Hepatitis C drug means major state Medicaid spend .... The New York Medicaid program's spending on Sovaldi outstripped its next-highest drug expenditure by more than $90 million. The second highest expenditure was for Abilify, a drug used to treat depression, schizophrenia and autism .... Bloomberg

12/18 Strike Two for Pozen Aspirin Formula
FDA rejects Pozen's aspirin drug for second time .... Regulators at the U.S. Food and Drug Administration raised concerns about a foreign manufacturing facility of an active ingredient supplier .... Triangle Business Journal

12/18 Teva Loses Place at Front of Line to Make Generic Celebrex
Mylan, Actavis prevail in Celebrex exclusivity fight, pushing Teva aside .... A Richmond, VA-based court reversed an FDA decision that had bestowed 180-day exclusivity on the Israeli drugmaker .... Fierce Pharma

12/18 Internet Drug News Fast Takes:
UCB Cancels Sale of Generic-Drug Unit to Buyout Firms
Study: 49 percent of patients withhold clinically sensitive information in their EMRs
Clemson University
Estimates of Benefits and Harms of Annual Mammography Screeing Over 10 Years of 10,000 50-Year-Old Women
Work Steals Valuable Sleep Time, Study Finds
HealthDay News
Oxy suspect allegedly spent thousands on drug-sniffing dog
Ellsworth (Maine) American

12/17 Your Wellness Data is All Over Town
Sexually Active? How Much Do You Drink? Your Workplace Health Records May Not Be as Private as You Think .... Corporate wellness programs have become one of the biggest areas where health data is being collected, with hundreds of vendors amassing millions of pieces of intimate and potentially embarrassing health information on American workers .... Bloomberg

12/17 Printed PIs Going the Way of the Dodo
FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically .... What the rule does require is a product's "immediate container label and outside package to bear a statement directing health care professionals to FDA's labeling repository to view the electronic version of prescribing information." .... Regulatory Focus

12/17 Salix Cleaning Up Channel-Stuffing Mess
Salix Limits Sales of Drugs to Let Wholesalers Cut Inventory .... Salix said it will sell minimal amounts of Apriso and Uceris, which treat inflammation of the colon, and Xifaxan 550, an antibiotic given to people with a complication of liver disease. Together, the drugs made up 56 percent of Salix's $382 million in second-quarter sales .... Bloomberg

12/17 Big Insurer and Cancer Center Test Bundled Payment
UHC, MD Anderson strike bundled pay deal for cancer care .... Under the deal, UnitedHealthcare will give MD Anderson fixed-rate payments to care for up to 150 patients with specific kinds of head and neck cancers. The deal would only affect patients who are enrolled in health plans through their employers .... Advisory Board

12/17 Inflammation Marker Predicts Coronary Risk; Available as Blood Test
FDA Approves Blood Test to Gauge Heart Attack Risk .... The test is designed for people with no history of heart disease, and it appears to be especially useful for women, and black women in particular .... WebMD

12/17 Long-Acting Signifor Gets Ok
Fresh off Afinitor failure, Novartis turns tide with Signifor LAR approval .... The Swiss drugmaker has won FDA approval for a long-acting version of Signifor, to treat acromegaly, a rare endocrine disorder .... Fierce Pharma

12/17 Got a 45 Minute Wait in a Doctor's Office? How About a Blast of Ads!
Point-of-care marketing could shoot past DTC as pharma's latest trend .... As aging baby boomers visit doctors more often and grow more receptive to health-based information, POC could become even more effective than other advertising mediums .... Fierce Pharma Marketing

12/17 Employers Getting Aggressive and Personal on Weight Loss
Memo to Staff: Time to Lose a Few Pounds .... Getting obese employees to normal weight, or even overweight, would save employers an average of 9% of the money they spend on health care or lose in productivity due to employee sick time, says one economist .... Wall Street Journal

12/17 Cholesterol Hype Begins Even Before Drug is Filed for Approval
Sanofi, Regeneron lay groundwork for PCSK9 rollout with Cholesterol Counts campaign .... The specialty cholesterol drugs--injectable antibody treatments--will be pricey, and drugmakers face a job persuading doctors and payers that they're worth adding to statin therapy. .... Fierce Pharma Marketing

12/17 Device Cleans Blood Plasma Before Transfusion
FDA approves Cerus system to cut blood transfusion infections .... The Intercept Blood System for plasma uses ultraviolet light and a chemical called amotosalen that inactivates viral pathogens in the blood. The plasma is then purified to remove the chemical and its byproducts .... Reuters

12/17 Internet Drug News Fast Takes:
Activis to Replace Most Allergan Executives After Deal
For blood pressure, sugar may be worse than salt
Ratings Agencies: Grim outlook for healthcare, hospital sector in 2015
Pfizer Ponies Up to Develop Long-acting Growth Hormone
The Street
Auspex Pharma drug curbs movement disorder in Huntington's patients

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