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5/22
Sanofi, Regeron Asthma Med Has Magic Bullet Potential
- 87% response rate
Regeneron, Sanofi asthma drug seen as potential game changer … dupilumab, an injectable treatment being developed by Regeneron  … slashed episodes by 87 percent in a mid-stage trial … meant to attack the underlying causes of the respiratory disease  … works by simultaneously blocking proteins that have been linked to inflammation, interleukin-4 (IL-4) and interleukin-13 (IL-13)….[Reuters]
New Drug May Help Some Asthmatics, Study Finds … number of asthma attacks or other outbreaks of symptoms decreased by 87 percent in those getting the drug, dupilumab, compared with those getting a placebo …  three of the patients taking dupilumab experienced a worsening of asthma compared with 23 on the placebo …[NY Times]

5/22
Activis Saves 20% Per Year By Incorporating In Ireland
Actavis Lowers Tax Rate to 17% After Warner Chilcott Deal …  major tax advantage that will lower the company's tax rate to 17 percent from about 37 percent over the course of a year … unfortunately for the U.S. taxpayer and the job seeker, that we're forced to move more jobs overseas so we can get a lower tax rate and be competitive …[Bloomberg]

5/22
2013 FDA Drug Approval Calendar
2013 FDA Drug Approval Calendar … [ 10 interesting products including:] Merck Drug/indication: Suvorexant for insomnia, FDA advisory panel: May 22, Approval decision date: June-July … Valeant, Drug/indication: Efinaconazole, toe-nail fungus, Approval decision date: May 23… Zogenix, Drug/indication: Zohydro, chronic pain , Approval decision date: Summer …[The Street]

5/22
Novartis Seeks To Beef Up Alzheimer Portfolio
Novartis Ramping Up Alzheimer's Pursuit as Rivals' Drugs Fail …  remains high on our radar, with high unmet medical need …  95 percent of Alzheimer's research has been focused on amyloid … sells Exelon, a drug that lessens symptoms of the disease by preventing the breakdown of a substance linked to learning and memory … about $930 million in sales …[Bloomberg]

Value Based Pricing:  Important  NEW Word For Pharma Marketers:
- VBP = Iceberg that Pharma is on course to collide with
Can Pharma handle pricing for value in this country? … VBR means that the large public and private payers have decided the price they're prepared to pay for any health care product or service will depend upon how much it improves outcomes and reduces overall costs … diabetes pill with an average price of $1.50 in Europe costs $8.20 here …[Philly.com]

5/22
Analyst Questions Forest Pipeline
Is There a Pill For That? Forest Labs' Iffy Pipeline … overpaid when it spent $1.2 billion in 2011 to secure the rights to Vibyrd … heavy generic competition. "The days of the blockbuster antidepressant are largely behind us … Namenda, which owns more than a 35% share of total Alzheimer prescriptions, could face generic challenges as early as 2015 … Can a new generation of products turn the tide and float the drug maker back to profitability? …[Ycharts]

5/22
Internet Drug News Fast Takes
Pain Relievers Do Not Cause Asthma, Study Finds
NY Times
Teva Bets on Reformulating Old Drugs as Investors Say 'Show Me'
Bloomberg
Vitamins That Cost Pennies a Day Seen Delaying Dementia
Bloomberg
WellPoint Reaches New 52-Week High
The Street
Warner Chilcott Reaches New 52-Week High
The Street 


5/21
Actavis (Formerly Watson) Buys Warner Chilcott For $8.6 Bln
Actavis buying Warner Chilcott in all-stock transaction valued at about $8.5 billion … would create the third-biggest specialty pharmaceutical company in the U.S…  announcement follows reports that Actavis had rebuffed takeover bids from generic drugmaker Mylan …[Wash Post]
Related: Actavis 'Moves' To Ireland For A Lower Tax Rate … Actavis is going to declare its new headquarters will be in Ireland, where the drugmaker can pay significantly less corporate tax … clear example of how the U.S. tax rate hurts business …[Pharmalot]

5/21
Merck Sleeping Pill: FDA Staffers Have Dose Related Safety Questions
FDA Staff: Merck Sleep Drug Effective but Some Dosage Concerns … effective but not safe at the higher doses ... concerns about next-day driving impairment and daytime sleepiness that "can be severe and worsen suddenly …[NASDAQ]
Editor's Note:  Adds information regarding starting dose and dose for elderly.

5/21
Pharma Walks Away From Ads On Paper, Reprints, Detail Pieces
- iPad is t he paper killer
Pharmas dial back reprints spend, floor it on digital to reach HCPs … Print professional spend plummeted 40% from 2009-2010, and then another 20% between 2010 and 2012, when it clocked in at 41% of HCP promotional budgets … [MM&M]

5/21
XenoPort Pulls Plug On Experimental Spastic MS Pill, Shares Tumble
XenoPort to drop multiple sclerosis drug, shares fall …  The drug, arbaclofen placarbil, was XenoPort's only product in late-stage trial … late-stage trial failed to show significant improvement over a placebo. …[Reuters]

5/21
Inotuzumab: Pfizer Pulls Plug On Experimental Lymphoma Drug
Pfizer halts study of lymphoma drug unlikely to help survival … compared with patients who got either Rituxan and Teva's Treanda or Rituxan and the chemotherapy drug, gemcitabine. …  independent monitors found it was not likely to improve survival …[Reuters]

5/21
Study: Beta Agonists, Muscarinic Antagonists Equally Cardio-Risky
-Both bronchodilators both gave 28% cardio event risk
Similar Cardiovascular Risk Observed With COPD Drugs … no difference in the increased risk for cardiovascular disease between the two main classes of drugs used in the first-line treatment of chronic obstructive pulmonary disease … long-acting inhaled beta-agonists) and LAMAs (long-acting muscarinic antagonists) …[Forbes]

5/21 Cut Out The Middlemen: Drug Companies Sell Directly To Patient
- Recurring payments, auto-refills, No PBM's mean more sales
A New Drug Sales Model … recurring credit card payment plans … people don't pay close attention to their credit card statements or get accustomed to seeing a recurring bill and start to overlook it, …  don't have a middle man to inform them that a generic version of a drug is available, they might not know to switch …[Motley Fool]

5/21
Internet Drug News Fast Takes
9 Most Obese Countries In The World (Mexico = #2)
Motley Fool
Bayer says pulmonary hypertension drug shows promise in prolonged trial
Reuters
Health Canada Recalls quietapine; contaminated with clindamycin
CTV

5/20
EU Backs Cyproterone + Ethinyl Estradiol Diane Despite
Questionable Safety Profile
EU watchdog backs Bayer acne drug for certain patients …  benefits outweighed the risks - provided measures were taken to minimize the chance of blood clots forming in veins and arteries …[Reuters]
Acne Pill Diane-35 Linked to 100 Cases of Blood Clots? …  authorized for acne treatment in France and for some European countries as a dual contraception-acne treatment solution … used by millions of women worldwide as a contraceptive … [Guardian Express]

5/20
Study: Animal Tranquilizer Ketamine Effective For Depression
Club-Drug Ketamine Relieves Depression in Largest Patient Study … used to anesthetize horses … patients taking ketamine were twice as likely to report improvement than those on a placebo … 45.7 percent still reported a response to ketamine, versus 18.2 percent in the placebo … [Bloomberg]

5/20
Big EU Pharma Rack Up Impressive YTD Share Price Gains
- Roche leads pack: 23% up since January
European drug stocks are on a tear … dividend-hungry investors return to a sector previously blighted by a lack of new blockbusters … patent cliff now is in the rear-view mirror for most companies … Roche  is up by roughly 19% and GSK shares have posted a 23% jump …[Money.Cnn.com]

5/20
Indian Government Fixes Prices On 652 Drugs
- Up from the 74 currently under price control
Govt to regulate rates of 652 medicines; prices set to fall … adversely impact GlaxoSmithKline and Sanofi Aventis the most … companies incurring significant losses would be forced to take a relook at their business models and many would look at redeploying their sales force  …[Economic Times]

5/20
Cell-Death Cancer Drugs: Bristol Myers Leads Pack
With 'Cell Death' Drugs, Bristol-Myers May Win No Matter What … new class of drugs that allow the immune system to attack cancer cells is generating excitement. Bristol-Myers Squibb may have an unmatchable advantage in the field over competitors …[Forbes]

5/20
California Senate Wants  Jumbo Printing On Rx Bottles
- Problem is standard labels are too small
California Senate requires larger print for drug labels … state Senate has approved legislation requiring pharmacists to print specific, important information on prescription labels in at least 12-point type. … Pharmacists may be forced to dispense medicine in oversized containers so that the label can be large enough to meet the requirements … [LA Times]

5/20
Oral Insulin To Begin Phase 2 Trials
Oramed: First Trial Of Orally Delivered Insulin … oral insulin capsule ORMD-0801, to begin shipping to clinical sites for human Phase II testing … resists inactivation during digestion and delivers a full therapeutic dose across the intestinal wall with all its components intact …[Seeking Alpha]

5/20
Can Mannkind Inhaled Insulin Succeed Where Pfizer's Exubera failed?
- Afrezza inhaler tiny, dosing simpler
Why MannKind's Afrezza Will Succeed Where Pfizer Failed … patients that used Exubera, quickly went back to injections because administering the proper dosage was horribly complicated … Afrezza insulin cartridges contain a uniform amount of insulin -- unlike Exubera -- adjusting the dosage is simple arithmetic …[Seeking Alpha]

5/20
Internet Drug News Fast Takes
Obamacare: no-cost help for depression, weight loss, smoking, and STDs
TakeApart.com
Impax Labs launches authorized generic version of Zomig tablets, nasal spray
Impax Press Release
J&J Wins Expanded Approval of Simponi for Bowel Disease
Bloomberg
Transition to Propellant-Free Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray Nears Completion
Boehringer Ingelheim Press Release
Mylan Launches Generic Tricor(R) Tablets
Mylan Press Release
Multiple Sclerosis and Hemophilia: Biogen'sJust Getting Started
Motley Fool



5/17 Just a Fancy, Expensive Way to Identify Key Opinion Leaders
Pills Tracked From Doctor to Patient to Aid Drug Marketing .... One company, Activate Networks, assigned physicians a ranking based on how connected they were, which helped companies decide where to send a representative, or whom to invite to a talk about a drug .... [NY Times]
See also: Drug Marketers Use Social Network Diagrams to Help Locate Influential Doctors [NY Times graphic]

5/17 Moveable Starting Line Helps FDA Finish Early
Xofigo Approval: Three Months Early--Or Two Months Late? .... The new terms of the Prescription Drug User Fee Act performance goals that took effect in October give FDA an extra two months after an NDA is submitted before it is "officially" filed .... [The RPM Report/First Take ]

5/17 Drugmakers Rather Not Wade Into Social Media Fray
Pharmas are cool with YouTube but fear Twitter .... Respondents were most comfortable with YouTube (68% called it acceptable, update or no), followed by LinkedIn (62%) and Facebook (60%, even though many abandoned their brand pages on the site after comments were mandated). Respondents were twitchy about text messaging (49%), Twitter (42%) and Flickr (32%) .... [The RPM Report/First Take]

5/17 The Kids Are Not Alright
One in five U.S. kids has a mental health disorder, CDC reports .... "Boys are more likely than girls to have most of the disorders overall," said Ruth Perou, the team leader for child development studies at the CDC. .... [HealthDay]

5/17 After Just Five Weeks, Tecfidera Has Reached Half of Gilenya's Sales Level
Multiple sclerosis prescription data confirm warehousing effect for Biogen Idec's Tecfidera .... Although Biogen Idec's multiple sclerosis therapy Tecfidera has delivered an impressive performance since launching five weeks ago, total and new prescriptions for competing therapies have yet to decline. .... [First Word Pharma]

5/17 Worth a Click for the Declining Revenue Chart
Cheerleaders: Look Beyond Pharma For Jobs .... Widespread job cuts in the pharmaceutical industry result in part from loss of patent protection for formerly blockbuster drugs. That saps revenue growth and, as genrics displace a brand name drug, the need for a large sales force drops off sharply .... [First Word Pharma]

5/17 Roche May Have Found its Rituxan Replacement
Data show new Roche leukemia drug may improve on Rituxan .... The combination of obinutuzumab plus chemotherapy led to an 86 percent reduction in risk of disease progression, according to data from an ASCO abstract .... [Yahoo]

5/17 Forteo + Prolia = Strongest Bones
Combo Drug Therapy May Work Best to Strengthen Bones .... Bone density measured at the lumbar spine increased 6.2 percent with teriparatide alone and 5.5 percent with denosumab alone, but combination treatment resulted in a 9.1 percent increase .... [HealthDay]

5/17 A Look Down the Tracks at Drugs in Development for Alzheimers
Any Light at the End of the Tunnel for Alzheimer's Disease? .... While many researchers still think the amyloid hypothesis holds the most potential for treating Alzheimer's, a few companies are also now focusing on reducing tau tangles .... [Motley Fool]

5/17 Internet Drug News Fast Takes:
AstraZeneca Advances Three Cancer Drugs Into Late-Stage Trials
Bloomberg
Feces Contaminate More Than Half of U.S. Public Pools
Bloomberg
Novartis says has no intention of buying Actavis
Reuters
Sanofi recruits patients for arthritis trials
MedCity News
Through the Eyes of a Burglar: Study Provides Insights on Habits and Motivations
University of North Carolina at Charlotte
Pharmacist-Directed Anticoagulation Service Can Impact Patient Satisfaction
Henry Ford Health System




5/16 "Every single FDA inspector that went to India said they would never take a Ranbaxy drug…"
Dirty medicine .... The epic inside story of long-term criminal fraud at Ranbaxy, the Indian drug company that makes generic Lipitor for millions of Americans. .... [Fortune]

5/16 Xofigo OK'd for Advanced Prostate Cancer
Bayer, Algeta Win U.S. Approval for Prostate Cancer Drug .... The Food and Drug Administration cleared the medicine more than three months early for patients whose disease has spread to their bones .... [Bloomberg]

5/16 Simponi Now Approved for Ulcerative Colitis
FDA expands indication for Johnson & Johnson's Simponi for ulcerative colitis .... The expanded approval of the drug was based on two clinical studies demonstrating that the tumour necrosis factor-alpha inhibitor was associated with a higher clinical response rate than placebo .... [First Word Pharma]

5/16 A Physician/Behavioral Econ Expert Discusses if Women Will Take Breast Cancer Prevention Pills
Who Wants to Take a Pill to Prevent Breast Cancer? .... With this report on breast cancer prevention pills, the United States Preventive Services Taskforce has switched from rejecting something patients believed in to endorsing something most patients will reject .... [Forbes]

5/16 Another Try at at Cancer Vaccine Shows Promising Early Results
Gradalis's Fang Bares Its Teeth in Fighting Ovarian Cancer .... The mean time between starting treatment and cancer recurring for patients receiving the vaccine was 470 days, versus 193 days for patients receiving standard treatment .... [xconomy]

5/16 6% Headcount Cut at Astellas
Astellas shutters OSI and Perseid, lets 200 US staff go in R&D reorg .... As part of the shakeup, the company is shuttering two of its US subsidiaries — OSI, the Farmingdale, NY-based oncology firm (of Tarceva fame) it acquired for $4 billion in 2010, and Redwood, CA-based DNA shuffling specialist Perseid, on which Astellas exercised a buy-out option for $76 million in 2011 .... [MM&M]

5/16 Back Pain Pills Killing Function Up Front
Meds for Back Pain Tied to Higher Erectile Dysfunction Risk .... Long-term use of opioids was associated with greater use of medications for erectile dysfunction or testosterone replacement compared with no opioid use (odds ratio, 1.45). .... [HealthDay]

5/16 One Step Closer to Cloning People
Scientists Clone Human Embryos To Make Stem Cells .... The accomplishment is a long-sought step toward harnessing the potential power of embryonic stem cells to treat many human diseases. But the work also raises a host of ethical concerns .... [NPR]

5/16 Drug Research and Development Should Be Delinked from Manufacturing and Marketing
How Drug Companies Keep Medicine Out of Reach .... For almost a decade, the United States has been standing in the way of an idea that could lead to cures for some of the world's most devastating illnesses .... [The Atlantic]

5/16 Combination Therapies Latest Trend in Melanoma
Bristol-Myers Drug Cocktail Stymies Melanoma Tumors .... Tumors shrank in 40 percent of patients, and in 53 percent of those who got the most effective dose combination of Yervoy and experimental therapy nivolumab .... [Bloomberg]

5/16 Internet Drug News Fast Takes:
US Senate confirms Tavenner as Medicare/Medicaid chief
Reuters
Drug shortages persist despite federal efforts to stop them
Advisory Board
Warning didn't change for-profit dialysis drug use
Reuters Health
FDA approves genetic test for lung cancer drug
USA Today
Estimated Health Costs in Retirement Drop
NY Times

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