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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
Reuters
Self management may reduce blood pressure
Reuters
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
Hello, May I Help You Plan Your Final Months?
WHYY

8/27 Fast Takes
Alkermes Gains on Aripiprazole Lauroxil NDA Submission
Zacks
Insys Therapeutics' Cannabidiol Gets Orphan Drug Status
Zacks
New type 2 diabetes pill Jardiance® (empagliflozin) now available in U.S. pharmacies
Lilly Press Release



8/27
Do The Ebola Drugs Actually Work?
- 2nd drug recipient dies; if the drug is so great - why did this happen?
How Will We Know If The Ebola Drugs Worked … another ZMapp recipient had passed away, … impossible to know if the treatment helped the patients, did nothing, or delayed their course of recovery. … To truly determine the effectiveness of ZMapp, not statistically possible with an n of 6 in even the best of circumstances, the inclusion criteria and site conditions would have needed to be as standardized as possible …[Forbes]

8/27
Medical Pot Appears To Ameliorate Hunger For Pain Pills
- 25% fewer OD deaths seen
Could Medical Marijuana Laws Cut Painkiller Deaths? … States that have legalized medical marijuana may be reaping an unintended benefit from easing up on restrictions: They appear to have nearly 25 percent fewer deaths from overdoses involving prescription painkillers … effect increased in the years after the laws were enacted, suggesting the laws themselves may cause the difference. … [ABC]
Duh: Its cheaper, easier to get, you don't have to look over your shoulder for cops.  As long as you stick to smoking it, it's nearly impossible to acutely overdose.  What's not to like?

8/27
Novo Nordisk Says: We Go It Alone; No Need For Major Acquisitions
Novo Nordisk CEO Has No Plans for Big Acquisitions … no plans whatsoever in buying anything larger than things that we can finance through our own cash … insulin market is big enough and growing fast enough that Novo Nordisk doesn't need to …[WSJ]
Related: Novo Nordisk aims for 2016 Tresiba launch in U.S. … [Reuters]

8/27
Pills, Schmills, Treat My Arthur-ituis With An Injection
Biologics have higher psoriatic arthritis adherence … A study of psoriatic arthritis patients found greater adherence among patients whose initial treatment was a biologic, compared to those who started with a non-biologic treatment …[MM&M]

8/27
PhRMA Urges: Off Label Promo Is Corporate Freedom Of Speech; Urges Dismissal Of Intergrilin Whistleblower
PhRMA Urges Court to Reject Off-Label Promotion Case … unapproved but fully legal uses of many FDA-approved prescription medicines to treat patients makes it critical that healthcare professionals have access to accurate, comprehensive, and current information about such uses …[MM&M]

8/27
Pfizer/AstraZeneca: Ready for round 2?
Pfizer/AstraZeneca: Ready for round 2? … With the expiration of a three-month period during which Pfizer must stay away from AstraZeneca, under U.K. takeover law, on Tuesday, speculation that the maker of Viagra may eventually seal this deal has risen …[ MSNBC]


8/26
Fast Takes
Unvaccinated Kids  Shouldnt Be Allowed in Public Schools; say  79% of SERMO Doctors Polled
Sermo Press Release
J&J Paid Over $150K to Doctor Who Sat on FDA Safety Panels
New Brunswick Today
Zorvolex (diclofenac) Gains New Pain Indication
MPR
Fera to Launch Generic Moxatag
MPR
Mylan Launches Generic Precedex
MPR

8/26
Roche Buys Intermune For $8.3 Bln To Beef Up Specialty Med Portfolio
Roche to buy U.S. biotech firm InterMune for $8.3 billion …  world's leading maker of cancer drugs expand into the treatment of rare or incurable diseases … deal brings it a promising new drug, pirfenidone, for treating a progressive and ultimately fatal scarring condition of the lungs. Pirfenidone is approved for so-called idiopathic pulmonary …[FOX]

8/26
Roche Flip-Flops On Decision To Buy Out Chugai
Roche Said to Have Decided Against Bid for Rest of Chugai … owned 62 percent of Chugai as of June 30, was in talks to acquire the rest of the shares for about $10 billion, … dropped those plans after the Japanese drugmaker's management signaled opposition … Roche bought 50 percent of Tokyo-based Chugai in 2002 and boosted the holding to 59.9 percent in 2008.  … [Bloomberg]

8/26
Black Box For Antidepressants Turned Out To Be Good Thing
- Antidepressant lawsuits have dried up
'Black box' warning on antidepressants vastly reduced lawsuits against Eli Lilly, others … A once-fertile field of litigation for trial lawyers -- Lilly and other drugmakers once faced hundreds of lawsuits over their antidepressants -- has pretty much dried up. Only a few wrongful-death or injury cases tied to antidepressants remain in U.S. courts …[IndyStar]
Editor's Note: Only two of the hundreds of Prozac lawsuits ever made it before juries -- and Lilly won both.

8/26
JNJ Settles With Vivus Regarding Topirimate, Walks Away From Lawsuit
- JNJ's patent for using topiramate as weight loss, blood pressure, diabetes pill now officially belongs to Vivis
VIVUS Announces Acquisition of Topiramate-Related Patents From Janssen Pharmaceuticals … VIVUS, announced the acquisition of a group of patents from Janssen covering uses of topiramate as monotherapy and in combination with other pharmaceutical agents to treat a variety of medical conditions … [Vivus Press Release]

8/26
Merck Novel Cancer Drug Looks Like Shoe In
- "
Programmed Death Receptor" modulating agent
U.S. approval of Merck cancer immunotherapy expected soon …  pembrolizumab would become the first treatment for cancer that blocks a protein called Programmed Death receptor, or PD-1 … Bristol-Myers Squibb and Roche Holding AG, are also racing to bring drugs in the same class to market, which analysts say could reach $30 billion in annual sales by 2025 …[Reuters]

8/25
Fast Takes
Cardiologist Pay Drops For The First Time  As Interventions Scrutinized
Forbes
Ranbaxy Faces $40 Mln (Rs 240 Crore) Fine From State Of Texas
Economic Times
Mylan Launches First Generic Klor-Con® Extended-Release Tabs
Mylan Press Release

8/25
Factoid: Hydrocodone Is The Most Prescribed Drug In The USA
Q:
What will happens in October when All hydrocodone goes Schedule II?
A: No Refills, many addicts expected to migrate to heroin
New Rules For Hydrocodone: What You Should Know … Since 2007, more U.S. prescriptions were written for hydrocodone + acetaminophen than any other drug. In 2012, that was over 135 million prescriptions … #2 most prescribed drug is thyroid hormone (levothyroxine sodium), the only other drug to pass 100 million prescriptions in a year…[Forbes]

8/25
Ixekizumab: Eli Lilly's Answer To Enbrel Looks Like a Winner
- Experimental data says it's more effective
Lilly psoriasis drug impresses; battle nears with Amgen, Novartis … 31 to 41 percent achieved clear skin compared with 5 to 7 percent of those treated with Enbrel … would seek marketing approval in the first half of 2015 for its drug ixekizumab for patients with moderate-to-severe plaque psoriasis … [Reuters]

8/25 New Triple Combo Pill For HIV Gets Nod
- "Triumeq" marketed by 3 company joint venture (Glaxo, Pfizer, Shionogi )
Glaxo, Pfizer's ViiV Wins Approval for HIV Combo Drug … combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine … (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) … [Pharma Letter]

8/25
Wal-Mart Goes After CVS MinuteClinic
Wal-Mart Takes Aim at CVS … Wal-Mart's clinics could tempt away CVS patients with low-cost (an office visit costs $40 at a Wal-Mart clinic) …  rural markets where there's a shortage of physicians. If that model succeeds, however, Wal-Mart could conceivably move into urban areas and muscle in on CVS' turf everywhere …[Motley Fool]

8/25
Glaxo Gets Nod For Another Elipta Delivered Product; Flutasone; AKA "Arnuity™ Ellipta"
-
Insurers not expected to embrace it
GSK Ellipta franchise expands …  doses are Arnuity Ellipta 100mcg and 200mcg … Payers and patients have not strongly taken to the new Ellipta drugs … respiratory unit has been ailing--US respiratory sales fell 14% during the second quarter compared to the same period last year, and by 17% for the first six months of this year …[MM&M]


8/22 Broad New Indications for Eliquis
FDA approves use of Eliquis to treat leg, lung clots .... The FDA has also approved use of the pill to reduce risk of recurrent blood clots in the deep veins of the leg, called deep vein thrombosis, and in the lung, called pulmonary embolism, following initial therapy .... [Reuters]

8/22 Hydrocodone Crackdown Could Boost Heroin Use
D.E.A. Increases Restrictions on Prescription Painkillers Like Vicodin .... Doctors will no longer be able to call in prescriptions by telephone, and patients will not be allowed to get refills on the same prescription, but will have to return to a health care professional to get a new one. The drug will have to be kept in special vaults in pharmacies. .... [NY Times]

8/22 Ixekizumab Tops Enbrel in Phase III; Lilly will File in Early 2015
Lilly psoriasis drug impresses; battle nears with Amgen, Novartis .... analysts have forecast that ixekizumab, if approved, could generate annual sales for Lilly of $600 million by 2020 .... [Reuters/Yahoo]

8/22 Xiaflex Shows New Cosmetic Use
Auxilium drug effective against cellulite in mid-stage study .... 68 percent of the patients given a mid and high dose of the drug — which is already marketed as Xiaflex, an injectable drug for other conditions — reported being "satisfied" or "very satisfied" with the results. That compared with only 34 percent of patients given a placebo .... [Chicago Tribune]

8/22 One Stop Genetic Testing
Illumina Partners With Big Pharma To Create New Genetic Tests For Cancer .... The idea is that companies would tell Illumina what cancer genes they are developing drugs targeted against. Then, using this information from all of these companies, it could create a genetic test that runs on its DNA sequencing machines that all companies could use in clinical trials, so that instead of developing tests one by one there would be a single test .... [Forbes/Matthew Herper]

8/22 Spurned Pfizer May Propose to Irish Lass
Pfizer eyes Actavis in backup plan to another AstraZeneca bid .... An Actavis buy would build up Pfizer's established products unit, widely seen as the first prospect for another sale or spin-off. It would add some new products to Pfizer's branded stable, which is in need of help. And because of Actavis' recent buying spree, it's worth some $59 billion .... [Fierce Pharma]

8/22 Big Name Endorsements a Waste of Money
Celebrity-endorsed drug ads don't work, says research "....even if consumers deem the celebrity as more credible and pay significantly greater attention to the ad, it does not change the desire to act and search for more information, discuss the disease with their doctor or ask for a prescription." (Study co-author Professor Brent Rollins, of the Philadelphia College of Osteopathic Medicine) .... [Pharmafile]

8/22 Opdivo + Abraxane Combo to be Tested on Multiple Tumor Types
BMS hooks up with Celgene to test cancer combo .... The companies are hoping that combining the immunotherapy Opdivo, which targets distinct regulatory components of the immune system, with the chemotherapy Abraxane, which works by interfering with the ability of cancer cells to divide, will lead to a greater anti-tumour response than either agent alone .... [Pharma Times]

8/22 Hep C Campaign to Launch at Truck Meet
AbbVie aims to truck ahead with hep C testing promo campaign .... Together, AbbVie and OraSure--parties to a copromotion agreement focused on testing individuals with the latter's OraQuick HCV Test--have teamed with the Healthy Trucking Association of America to educate drivers about HCV and encourage them to get tested .... [Fierce Pharma Marketing]

8/22 Internet Drug News Fast Takes:
Aspirin not only prevents pain and inflammation, it also helps end inflammation
Drug Store News
Type 1 Diabetes Antibody Test Gains FDA Nod
MedPage Today
Pfizer Launches Expanded Access Program for Breast Cancer Drug
Regulatory Focus
Baxter's long-acting haemophilia A therapy BAX 855 meets main goal of Phase III study
First Word Pharma
Brains of Children With Autism Fail to Trim Synapses
NY Times
Orgasm rates for single women less predictable than men's, vary by sexual orientation
Journal of Sexual Medicine


8/21 Arnuity Ellipta Approved
FDA approves GSK's Arnuity Ellipta for treating asthma .... FDA has approved fluticasone furoate inhalation powder as a once-daily corticosteroid for maintenance treatment of asthma in patients aged 12 and older .... [Healio]

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8/21 Which Drugs Had Biggest Sales Gains?
Hardest-charging drugs this year? They're not just Sovaldi and Olysio .... Older drugs that pulled out the stops include one eyebrow-raiser: Sanofi's diabetes treatment Lantus, which saw a $511 million leap over the first half of 2013. It's been on the market since 2000. Humira, always a big growth product for AbbVie, jumped by even more, $1.1 billion .... [Fierce Pharma Marketing]

8/21 OpenFDA Makes Data-mining Easier
New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes .... Open APIs would, the White House hoped, allow people to access the raw data FDA puts out through its various databases—approvals, adverse event reports, recall notices, etc—and repurpose them, potentially making them easier to use or more enjoyable to read .... [Regulatory Focus]

8/21 Think Competition Will Drive Down Hep C Med Prices? Think Again
Don't worry about a hep C pricing war, analysts tell Gilead-watchers .... Even if AbbVie's regimen is cheaper, payers have "limited tools" to use to restrict access to Gilead's therapy, which will probably include a new combo pill by year's end. AbbVie has said—and recently—that it's not interested in a price war .... [Fierce Pharma]

8/21 Tech Upgrade Pays Off
Meaningful Use Measures Reduce Adverse Drug Events .... Florida hospitals that in 2010 adopted all five core measures for medication management under the meaningful use program reported the lowest rates of adverse drug events in the state .... [ihealthbeat]

8/21 Clarithromycin and Cardiac Risk
Common Antibiotic Linked to Heart Deaths .... After adjusting for factors such as age, sex, baseline cardiac risk, and the use of other medications, ongoing use of clarithromycin was associated with a 76% higher risk of cardiac death compared with the use of penicillin V .... [PTCommunity]

8/21 Many Schizophrenics Can Achieve State Not Thought Possible
Many With Schizophrenia Say They're Happy .... 37 percent of surveyed schizophrenia patients said they were happy all or most of the time....by way of comparison, about 83 percent of people without schizophrenia said they were happy most or all of the time .... [HealthDay News]

8/21 Amicus Has Successful Oral for Fabry Disease in Phase III
Amicus seeks to upset Fabry market .... The company's oral medication migalastat HCI worked as well as Sanofi's Fabrazyme and Shire's Replagal (both are approved injectables) among patients with what the drugmaker called "amenable mutations." .... [MM&M]

8/21 More Pfizer Takeover Talk
AstraZeneca Is Tougher Target for Possible New Pfizer Bid .... After three months, the target can invite the bidder to re-enter talks -- an unlikely scenario in this case given AstraZeneca’s earlier rejections. The bidder can also make its own approach with a single knockout offer it feels sure the target would be able to recommend to shareholders .... [Bloomberg]

8/21 $1000 Genome Transforming Care
Flatley's Law: How One Company Is Creating Medicine's Genetic Revolution .... The only thing more extraordinary than the growth rate of the sequencing revolution is that the beneficiary is a single company, Illumina of San Diego, and most of the credit for the rate of change can be laid at the feet of one entrepreneur, Chief Executive Jay Flatley .... [Forbes/Matthew Herper]

8/21 Internet Drug News Fast Takes:
First Wellness Program Firing Suit Filed by U.S. Agency
Bloomberg
Could health systems pull out of non-expansion states? Why some are worried
Advisory Board
Giant Rats Trained to Sniff Out Tuberculosis in Africa
National Geographic
Possible antibiotics side effects include later obesity, via gut microbiome
Bioworld
Aetna to shut down CarePass by the end of the year
MobiHealthNews

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