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Pharmaceutical News Harvest ™

9/2 Fast Takes
Rivaroxaban and Liver Injury: Case Studies Add to Safety Questions
Latest Ebola Outbreak Traced to Single Animal Source, Spread at Funeral
Twenty-seven percent of rheumatoid arthritis patients are not taking their medication as prescribed.

The Clot Thickens: Lawyers Boost Spending to Solicit Xarelto Lawsuits
- Lawyers invest $1.2 million in ads looking for Xarelto victims who wanna sue
The Clot Thickens: Lawyers Boost Spending to Solicit Xarelto Lawsuits … Spending [on advertisements seeking patients who want to sue over Xarelto] jumped to $1.2 million in July from just $8,000 in June … 90% of the spending was for national television spots, but more than three quarters of the ads ran on local television stations.

Website That Tracks Which Docs Got Food, Money Down Again
CMS Open Payments System Broken Again … American Medical Association says that CMS again shutting down the Open Payments System "adds to the growing concerns that the site is simply not ready to go public" and "further underscores the need for physicians to have more time to register, review and correct inaccurate data that may be housed on the government website …[Health Data Management]

Pioglitazone, Bladder Cancer Risk: No Link in 10-Year Study
Pioglitazone, Bladder Cancer Risk: No Link in 10-Year Study …  initial 5-year interim analysis had demonstrated a statistically significant increased risk among patients who used pioglitazone for >2 years. However, the 10-year analysis did not show any statistically significant findings of this increased risk …  [MPR]

Takeda, Lilly Lose Bid to Overturn $9 Billion Actos Award
Takeda, Lilly Lose Bid to Overturn $9 Billion Actos Award … verdict, which is likely to be reduced on appeal, is the second-largest in the U.S. … urors deliberated for little more than an hour March 8 before finding that Takeda and Lilly acted with "wanton and reckless disregard" in marketing Actos and that the drugmakers should pay a combined $9 billion in punitive damages. …[Bloomberg]

Much Excitement About Novartis Experimental CHF Drug
-  Combines Diovan +  another class of drug called a neprilysin inhibitor.
'Most exciting ever' Novartis drug points to huge sales …  data for LCZ696 released at the weekend beat expectations, showing the medicine slashed deaths and hospitalizations, worked across all groups of patients, and had no serious side effects…. analysts predict peak sales of $5 billion or more …[Reuters]
Novel heart failure drug shows big promise …  32 people would need to be treated with the new drug to prevent one death from heart-related causes. … twice-a-day pill combination of two medicines that block the effects of substances that harm the heart while also preserving ones that help protect it. One of the medicines also dilates blood vessels and allows the heart to pump more effectively …[AP]

Anti-Cholesterol Jab Halves Heart Attack and Stroke in Early Test
Early data suggest Sanofi, Regeneron drug may halve heart risk … first evidence that targeting a protein known as PCSK9 could slash cardiovascular risks for millions of patients…. 1.4 percent of patients suffered a major cardiovascular event against 3.0 percent of those on placebo …[Reuters]
Early Hint At Cardiovascular Outcomes With Sanofi's and Regeneron's Rapidly Advancing Cholesterol Drug … Sanofi and Regeneron planned to file for approval of alirocumab in the US and elsewhere in the fourth quarter of 2014 …24 and 52 weeks LDL was reduced by 61% and 57%, respectively, … [Forbes]

Cipla: Generic Advair, HIV Meds Will Make It A  USA Powerhouse
Cipla Targets U.S. With Glaxo's Advair, Anti-AIDS Drugs … planning its first-ever manufacturing plant in the U.S… Generic Advair -- if Cipla gets it through -- it will change the face of Cipla … Cipla has approvals for copies in 10 countries in Europe, including Germany and Sweden … [Bloomberg]

8/29 Ebola Accelerating, Will Cost $500 Million Plus
West Africa Ebola outbreak could infect 20,000 people, WHO says .... The estimate is based on a projection that the virus could spread to 10 further countries beyond the four now affected — Guinea, Liberia, Sierra Leone and Nigeria .... [Reuters]

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8/29 Kabiven and Perikabiven Approved
FDA approves Fresenius Kabi's Kabiven and Perikabiven for parenteral nutrition .... FDA has granted approval for Fresenius Kabi's Kabiven and Perikabiven, which are intravenously infused solutions of lipids, dextrose, amino acids and electrolytes in three-chamber parenteral nutrition (PN) bags. The three-chamber PN bags help in delivering these nutrients in volumes and concentrations that meet the nutritional needs of most patients. .... [Pharmaceutical Business Review]

8/29 A Look at CVS-Caremark's PBM Business
The $76 Billion CVS Business You've Probably Never Heard Of .... The purchase of Caremark catapulted CVS forward; revenue jumped from $43 billion in 2006 to more than $132 billion over the trailing-12 months. CVS' operating profit has similarly climbed following the acquisition, growing from $2.4 billion in 2006 to $8 billion in 2013. .... [Motley Fool]

8/29 Review of Acne Treatments
Oral Contraceptive Equal to Antibiotics for Acne Care .... Review shows antibiotics superior at three months; equivalent reduction in acne lesions at six months .... [HealthDay News]

8/29 Amgen Wins Race to File PCSK9 First
Amgen seeks US approval of PCSK9 inhibitor evolocumab .... The application, which Amgen said is the first made to the FDA for a PCSK9 inhibitor, is supported by data from approximately 6800 patients, including more than 4500 subjects with high cholesterol in 10 Phase III trials .... [First Word Pharma]

8/29 More Big Pharma Mergers Expected
Consultants expect M&A tempo to continue .... PwC anticipates that the year's second half will also see some notable deals, but the firm's first-half analysis shows that the numbers behind the recent noise can be a little misleading .... [MM&M]

8/29 27% of RA Patients Not Taking Prescribed Treatment
Arthritis patients failing to take expensive medication .... Twenty seven per cent of rheumatoid arthritis patients in the study who were on a class of drugs known as anti-TNF therapies did not take them as prescribed in the first six months .... [University of Manchester]

8/29 Apps Dominate Mobile, But Big Pharma Having Trouble Getting on Board
Who's doing the mobile app dance right? Only a few in pharma .... 29% of drug and device executives view mobile as the most important digital technology for their companies over the next 3 to 5 years .... [Fierce Pharma Marketing]

8/29 C Diff Vaccine on Fast Track
Pfizer's candidate C. difficile vaccine PF-06425090 gains FDA fast track status .... A senior Pfizer executive estimated that 250,000 cases of C. difficile-associated disease, including 14,000 fatal cases, occur in the US annually .... [First Word Pharma]

8/29 Schedule of Major Announcements, FDA Decisions, and Meetings for the Fall
Your September Biotech Back-to-School Calendar .... Here's a list of noteworthy and stock-moving September events .... [The Street/Adam Feuerstein]

8/29 Internet Drug News Fast Takes:
U.S. officials approve Pennsylvania Medicaid waiver program
CBO: Health care spending will be much lower than we thought
Advisory Board
Cancer Patients With Depression Often Untreated
HealthDay News
Eating Clay Is Touted by Celebrities
NY Times
Health Law Spurs Focus On Faster Drug Development
Kaiser Health News

8/28 New Indication for Promacta
FDA approves GSK's Promacta for treatment of Severe Aplastic Anaemia .... SAA is a blood disorder where bone marrow doesn't produce enough red blook cells, white cells and platelets. The drug helps by helping to induce proliferation and differentiation of bone marrow stem cells to increase production of blood cells .... [Drug Store News]

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8/28 Q&A with Regeneron's Leonard Schleifer
Drug Maker in High-Stakes Race With Rivals .... Regeneron, the Tarrytown, N.Y., drug maker, led by Chief Executive Leonard Schleifer, is racing to bring a new type of cholesterol-lowering treatment, thought to be worth billions in annual sales, onto the market before its competitors. .... [WSJ]

8/28 If You're Going to an FDA Meeting in September, Double Check the Address
FDA Internal Meeting Means Public Meetings Off Campus .... In September, however, FDA has a slew of meetings — and a lot of them are off-site. Scheduled so far in September are four advisory committees over five days at White Oak, four advisory committees off-site, two non-advisory committee meetings at White Oak and six non-advisory committee meetings over eight days off-site .... [RPM Report/First Take]

8/28 Pharmacists Talk Up Chats with Customers
Medication reviews help ensure proper medication management .... 83% of surveyed customers said that a medication review with a Shoppers Drug Mart pharmacist made remembering to take their medication properly easier, and 82% were more confident in managing meds. Some 85% said they were interested medication reviews becoming a routine part of their medication management .... [Drug Store News]

8/28 Therapist's Help Boosts Pill Power
Adding cognitive therapy to meds may speed depression recovery for some .... Overall, 73 percent of the combined treatment group achieved recovery, versus 63 percent of the medication-only group .... [Reuters]

8/28 Ivabradine Filed for Heart Failure; Already Sold in Europe
FDA grants Amgen's ivabradine filing for chronic heart failure priority review .... Results from the Phase III SHIFT trial showed that ivabradine was associated with about a 25-percent reduction in the risk of death and hospitalization due to heart failure. .... [First Word Pharma]

8/28 Why Roche Bought Intermune
Roche CEO On Intermune Deal: 'This Is A Growth Story' .... Perfinidone is expected to receive FDA approval by November 23. Roche Chief Operating Officer Dan O'Day says that the doctors who are visited by Xolair sales representatives are likely to overlap significantly with those who would prescribe ppirfenidone. .... [Forbes/Matthew Herper]

8/28 Lack of Diversity in Study Group Left a Population Unprotected
Dosage of HIV drug may be ineffective for half of African-Americans .... A simple genetic test for the gene that makes the CYP3A5 protein could be used to determine what doses would achieve effective levels in individuals .... [Johns Hopkins Medicine ]

8/28 Six New Competitors Angling for Psoriasis Market
Big Pharma, Big Biotech prepare for showdown in next-gen psoriasis market .... Not only will the new generation of treatments be competing with one another, but with Enbrel biosimilars that could join the party in the not-too-distant future. Cipla, Novartis and others have a target on the $8.78-billion-a-year seller .... [Fierce Pharma Marketing]

8/28 Nice Work if You Can Get It — Top Specialty Pharma Execs Average $20 Million a Year
Worth the Money? Assessing Executive Pay at Specialty Drug Makers .... Compensation for top management averaged $20 million compared with $39 million among large cap drug makers .... [Pharmalot]

8/28 Internet Drug News Fast Takes:
Ebola vaccine from GSK to begin U.S. clinical trials within weeks
Self management may reduce blood pressure
Why blood banks are shrinking
Advisory Board
Recent growth in health care spending for commercially insured individuals is due primarily to increases in prices for medical services, rather than increased use
The Dartmouth Institute for Health Policy & Clinical Practice
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