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3/26 Eylea Now Approved for Diabetic Retinopathy
FDA again expands usage of Regeneron eye drug Eylea .... The FDA decision marked the fourth approval for Eylea, an injectable medicine that had sales of $2.78 billion in 2014 .... Reuters

3/26 Anthrasil Approved, Being Added to U.S. Strategic Stockpile
FDA approves Emergent BioSolutions' inhaled anthrax treatment .... The treatment is a sterile solution that neutralizes toxins of Bacillus anthracis, the bacterium behind the infection .... Reuters

3/26 DeCode Can Predict Which Icelanders Will Die Of Cancer
Genome Study Predicts DNA of the Whole of Iceland .... Large genome databases are starting to reveal critical health information—even about people who have not contributed their DNA. .... MIT Technology Review

3/26 CEO's Philosophy at Novatis: "Getting Bigger or Getting Out"
From Snitch Pill to Xbox Sensors, Novartis Goes Digital .... Jimenez is barreling down untested paths at the frontier of biology and digital technology to prepare for a future in which the use of smartphones and other digital devices to monitor health will be the key to getting paid .... Bloomberg

3/26 New Crop of Psoriasis Drugs Aim to Grab Stelara's Market
Psoriasis data wars heat up at AAD with Novartis, Boehringer studies .... Novartis, which trumpeted a head-to-head win for Cosentyx over the J&J drug last December, kept the ball rolling with results showing that at 16 weeks, its med improved skin clearance in significantly more plaque psoriasis patients than Stelara did .... Fierce Pharma Marketing

3/26 Are Gut Bacteria the Link Between Diabetes and Antibiotics?
Greater Use of Antibiotics Tied to Higher Odds of Diabetes .... Two to five courses of a penicillin increased the risk of diabetes by 8 percent, while more than five courses increased the risk by 23 percent .... Health Day News

3/26 Quadracel for Tetanus, Pertussis and Polio
FDA OK for Sanofi's Quadracel vaccine .... US regulators have approved Sanofi's Quadracel vaccine for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in children aged between four and six years old .... Pharma Times

3/26 Congress Starts Asking Questions About 340B
New Rules Seen for Drug Discount Program .... Hospitals are not required to divulge how they use the savings from the program, which was created in 1992 to aid medical facilities that serve as “safety nets” in less affluent communities. Some hospitals may use savings instead for general purposes .... Roll Call

3/26 After August Inspection, FDA Stops Aarti Imports
FDA Bans Shipments From Indian Drug Maker Aarti .... In a 2012 inspection, the FDA found that a quality-control analyst had recorded completion times for lab analyses that had not yet occurred, and there were failures to account for unexplained discrepancies in test-result data .... WSJ

3/26 Printed PI Advocates Have Their Say
FDA's Electronic Drug Labeling Proposal Comes Under Fire .... In 2013, US patients filled 3.9 billion prescriptions for prescription drugs at retail pharmacies. The number of package inserts that must be printed has given rise to a multimillion-dollar industry, complete with its own advocacy organization .... Regulatory Focus

3/26 Internet Drug News Fast Takes:
Obama ready to sign bipartisan fix for Medicare doctor payments
Rueters
Adequate sleep tied to women's sexual function
Rueters
Study finds why drug for type II diabetes makes people fat
Georgia State University
Celladon Heart-Failure Study Looms Large as Next Big Test for Gene Therapy
The Street
Otezla Disappoints in RA
MedPage Today


3/25 Study Demonstrates Survival Benefit for First-Line Use of Keytruda
Merck says melanoma drug meets goal; study halted .... Patients taking Keytruda showed meaningful improvement in overall survival and in delayed progression of disease, compared with those taking Yervoy .... Reuters

3/25 Grab a Bag of Popcorn and Watch the Best TV Drug Commercials
Ten Best DTC Ads of 2014 .... The great, the good and everything in between .... MM&M

3/25 With More Access to Doctors, More Diabetes Found
More diabetes cases diagnosed after Medicaid expansion .... The findings suggest that expanding Medicaid, the government-run health insurance for the poor, allows people with diabetes to be diagnosed earlier than before, which may improve outcomes later on .... Reuters

3/25 37 New Cancer Drugs in Past 5 Years; Compared to 19 in Previous 5 Years
Faster FDA Spurs Cancer Breakthroughs .... Drug development for cancer and rare diseases have benefited from both the new FDA policies and advances in gene scanning that allow researchers to target drugs to patients most likely to benefit. Much of the foundational research was sponsored by the government, which tripled funding of the National Institutes of Health to $30 billion in the 15 years through 2008, and has kept it at about that level since .... Bloomberg/Yahoo

3/25 More Jobs Gone at GSK
GlaxoSmithKline tags 180 sales-and-admin jobs for cutting in NC .... The British pharma giant plans to cut 180 sales, managerial, operations, marketing and support staff roles--some in the field and some in-house .... Fierce Pharma

3/25 Many CVS, Walgreens, RiteAid Employees Earn < $9.00/hour
After Target wage hike, labor groups turn to drugstore chains .... Labor activists said the wage hikes by big retailers will give them greater leverage with drugstore operators, who make up one of the fastest-growing and most profitable areas in retail .... Reuters

3/25 States Debate Broader Access to Naloxone
Amid crisis, states expand access to opioid rescue drug .... Government figures show opioid overdoses now claim the lives of about 120 people each day in the United States. Overdoses were the leading cause of injury death in 2012, killing more 25- to 64-year-olds than motor vehicle crashes .... USA Today

3/25 Geriatrics Journal Article Blasts "Low-T" Prescribing
Why All Those Testosterone Ads Constitute Disease Mongering .... Prescriptions for testosterone nearly doubled in the three years ending in 2013, to 2.3 million.... That drove sales of topical testosterone drugs like AndroGel and Axiron $2 billion a year, with AbbVie taking more than 65% of the market.... the FDA reports that a quarter of the men who received testosterone prescriptions never even had their hormone levels tested .... Forbes

3/25 New Thinking on Diabetes: Goals Should Differ for Different Patients
2015 Diabetes Standards Focus on Individualized Tx Approach .... Therapeutic decisions for diabetes should be individualized, considering factors such as ethnicity and cardiovascular risk, according to a new ideas and opinions piece in Annals of Internal Medicine .... HealthDay News

3/25 New Theory of Alzheimer's Tosses Years of Research Out the Window
Study Reveals Tau as Driver of Alzheimer's Disease .... Researchers at the Mayo Clinic's campuses in Jacksonville, Florida, and Rochester, Minnesota, have found that the progression of dysfunctional tau protein drives the cognitive decline and memory loss seen in Alzheimer's disease (AD). Amyloid, the other toxic protein that characterizes AD, builds up as dementia progresses but is not the primary culprit .... PTCommunity

3/25 Internet Drug News Fast Takes:
Merck increases share buyback program by $10 bln
Rueters
New study shows non-invasive imaging tests can detect coronary artery disease long before it strikes
Mount Sinai School of Medicine
FDA grants orphan drug status to Treeway's ALS treatment
PMLiVE
Many Doctors Who Diagnose Alzheimer's Fail To Tell The Patient
NPR
Get Your Priority Review Voucher, While They Last
RPM Report/First Take


3/24 Which Are the Next Blockbuster Drugs?
11 Promising New Drugs Expected to Make Billions in Sales .... The number of potential drug blockbusters is a significant jump from 2014, in which three drugs were predicted to have more than $1 billion in annual sales eventually .... The Street

3/24 DTC TV Spending Hit $4.5 Billion in 2014
It's true: drug companies are bombarding your TV with more ads than ever .... Other highly advertised drugs included Humira, a rheumatoid arthritis treatment; Lyrica, a treatment for pain caused by nerve damage; and Eliquis, an anticlotting drug approved in December 2012 .... Washington Post

3/24 Argument for "Deprescribing"
Statins can be stopped toward the end of life .... Among people without active heart disease who were expected to live no more than a year, stopping the drugs didn't increase the number of deaths within 60 days, but did improve quality of life .... Reuters

3/24 VX-661 Not as Effective as Hoped
Vertex Falls as Cystic Fibrosis Drug Disappoints in Trial .... After four weeks of treatment, patients who took Vertex's VX-661 with Kalydeco saw a 4.4 percentage point increase in the amount of air they could exhale in 1 second, a measure of pulmonary function. At 12 weeks the improvement fell to 3 percentage points .... Bloomberg

3/24 Cuts at Daiichi Sankyo Hit Sales Force
Daiichi Sankyo starts layoff drive with 16% cuts at HQ .... Sales reps in the field are set to find out their fate in mid-April, with cuts of 30% or more expected .... Fierce Pharma

3/24 Tanezumab Back in Testing
FDA removes the brakes on Pfizer and Lilly's pain drug .... A once-halted pain candidate from partners Pfizer and Eli Lilly now has the green light to resume late-stage testing, as the FDA has lifted a clinical hold tied to some serious safety concerns for the whole class of drugs .... Fierce Biotech

3/24 Dropping 'Idec', Biogen Goes for Short and Sweet
Biogen shortens name as it prepares to focus on Alzheimer's drug .... With a new website as of today, the state's largest drugmaker is shortening its name to simply Biogen and adopting a new logo. .... Boston Business Journal

3/24 FDA Looks Into Deaths After Zyprexa Relprevv Injections
Results of FDA review of injectable Zyprexa, two deaths inconclusive .... "The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv" .... Healio

3/24 New Combo From BI and Lilly — Jardiance + Trajenta
US launch for BI/Lilly diabetes combo Glyxambi .... Glyxambi is the first treatment in the US to marry the dual mechanisms of action of a sodium glucose co-transporter-2 inhibitor and a dipeptidyl peptidase-4 inhibitor in a once-daily pill. .... Pharma Times

3/24 Marketing and Popular Appeal Count More for Sales than Rigorous Testing
10 popular products not endorsed by the FDA .... Despite none of these products being FDA-approved, they're hugely popular online. There are all kinds of products, homeopathic and otherwise, that continue to be sold on Amazon and other websites .... SF Gate

3/24 Internet Drug News Fast Takes:
FDA approves Abiomed's blood pump device
Rueters
Obamacare subsidies likely expanded insurance coverage
Rueters
This Is The Drug In The Rolling Stones' Song "Mother's Little Helper"
io9
Gene-Altered Apples and Potatoes Are Safe, F.D.A. Says
NY Times
Everyday Health buys rare-disease agency Cambridge BioMarketing
MM&M
Is Google working on a cure for cancer?
Telegraph


3/23 Aducanumab: First Drug to Significantly Slow Cognitive Decline
Biogen's Alzheimer's drug slows mental decline in early study .... It marks the first time an experimental drug demonstrated a statistically significant reduction in amyloid plaque as well as a slowing of clinical impairment in patients with mild disease .... Reuters
See also: Biogen Reports Its Alzheimer's Drug Sharply Slowed Cognitive Decline NY TImes

3/23 Another Hedge Fund Challenging Pharma Patents
Hedge Funds Found a New Way to Attack Drug Companies and Short Their Stock .... Taking advantage of new rules created by Congress three years ago, hedge funds have increasingly been filing challenges to pharmaceutical patents. Some may be angling for payouts to drop their claims, while others are shorting the stock .... Bloomberg

3/23 Amiodarone–Sovaldi Warning
Gilead Warns After Hepatitis Patient on Heart Drug Dies .... Gilead Sciences Inc. said nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest .... Bloomberg

3/23 No 'Rush to the Exits' for Employers
Employers Warm To Obamacare, Stick With Coverage .... Just three percent of employers are now likely to terminate health plans for active employees, according to Mercer, one of the largest employee benefits consultancies .... Forbes/Bruce Japsen

3/23 Can Soriot Deliver the Growth He Promised?
AstraZeneca Lags in Cancer Race Where Losing May Spur Buyout .... If AstraZeneca can't show revenue progress, its shares, carrying a high relative valuation, could slump to the point where the company becomes vulnerable to another takeover bid .... Bloomberg

3/23 Lack of BCG Threatens Bladder Cancer Patients
Cancer drug shortage sends patients on grim search .... BCG is currently sold by just one company, Merck, which doesn't expect to churn out enough of the life-saving drug until next year .... NY Post

3/23 New Cholesterol Injectables Could Top $2 Billion in Sales in 2016
New Type of Cholesterol Drug Could Prove Costly .... [Analyst Richard Evans] estimates 11.6 million people with heart risks need more than a statin to lower their cholesterol, but argues it is unrealistic to assume all would switch to PCSK9 inhibitors. Using a 25% discount, he sees annual patient costs of $3,000 to $4,000 .... WSJ/Pharmalot

3/23 Data Slideshow: Top 10 Biotechs
The Top 10 Biotech Companies In The U.S. .... Market value, sales, and 5-year average sales growth .... Forbes

3/23 "Evergreening" Protects Lucrative Insulin Market
Why People with Diabetes Can't Buy Generic Insulin .... A generic version of insulin, the lifesaving diabetes drug used by 6 million people in the United States, has never been available in this country because drug companies have made incremental improvements that kept insulin under patent from 1923 to 2014 .... Johns Hopkins Medicine

3/23 "Too Much of a Bother — I'll Just Skip It"
More than 25 percent of acne patients fail to get prescribed medications .... Those who were prescribed two medications had the highest rate of primary non-adherence — not getting a medication or not using it — at 40 percent, followed by those prescribed three or more medications (31 percent) and those prescribed just one (9 percent) .... Wake Forest Baptist Medical Center

3/23 Internet Drug News Fast Takes:
Why drug names are so increasingly weird
Chicago Tribune
Before Judges, the Godfathers Become Sick Old Grandfathers
NY Times
Esperion grooms cholesterol-cutting drug with new data ahead of phase III
Bio World
Japanese filing for Amgen's PCSK9 inhibitor Repatha
Pharma Times
Blue Shield Of California Loses Exemption From State Taxes
NPR


3/20 Zarxio Survives First Amgen Attack, More Coming
U.S. judge rejects Amgen bid to block biosimilar Neupogen .... U.S. District Judge Richard Seeborg denied Amgen's request for a preliminary injunction to prevent Novartis' Sandoz unit from launching its copycat .... Reuters

3/20 Movantik Coming to Market Under Joint AstraZeneca, Daiichi Sankyo Deal
AstraZeneca, Daiichi Sankyo to Sell Constipation Drug in U.S. .... The drug is used to treat opioid-induced constipation in adults with chronic noncancer pain .... $$WSJ

3/20 Amicus Sees Light at the End of the Tunnel for Fabry Disease Pill
With Data in Hand, Amicus Preps For Drug Filings in U.S., Europe .... The company will file papers for approval of its Fabry pill, migalastat, in Europe, in the second quarter. Based on feedback from the FDA at a meeting earlier this week, Amicus intends to file an application for U.S. approval in the second half of the year. .... xconomy

3/20 Compounded Drug Costs for Tricare Rise from $5 Million to $514 Million in Past Decade
Tricare to tighten compound drug rules .... Pharmacy contractor Express Scripts will begin screening every ingredient used in compounded medications to ensure that all substances in these custom prescriptions are approved by the Food and Drug Administrationnds to file an application for U.S. approval in the second half of the year. .... Military Times

3/20 Beyond Hep C, What's Blowing a Hole in Your Budget?
The diseases that are driving up American drug spending .... The increase in projected costs for hereditary angioedema, a rare genetic blood disorder affecting less than one in 10,000 Americans, is due to one drug approval (Ruconest) last year and the anticipation of a few more in the next couple of years. High-priced drugs for rare conditions have been a big driver of spending in general .... Quartz

3/20 Breo Ellipta Gets Panel Recommendation for Adults
FDA panel backs Glaxo asthma drug for adults, not adolescents .... The panel voted 16 to 4 that the product, Breo Ellipta, should be approved for once daily treatment of asthma in adults 18 years and older. It voted 19 to 1 that the data did not support approval for use in children aged 12 to 17 .... Reuters/Yahoo

3/20 Insomnia, Migraines, Pain? Pernix Has Got You Covered
Pernix looks for a sales trifecta from 100 new Zohydro reps .... With about two-thirds of chronic pain patients also reporting poor or unrefreshing sleep, the New Jersey company sees some serious value in promoting all-hydrocodone pain med Zohydro--which it agreed last week to purchase from Zogenix for up to $383 million--alongside its prescription sleep aid Silenor .... Fierce Pharma Marketing

3/20 Medical Tourism Growing 25% Per Year
The Patient Abroad: An Exploration of the Motivations and Impact of Medical Tourism .... Approximately 11 million people were medical tourists in 2013, generating a market worth over $50 billion .... MM&M

3/20 HIV and Hep C Drive Higher Drug Spend for Exchange Patients
Enrollees on the Exchanges Fill More and Costlier Prescriptions .... Prime's members who enrolled in plans on the health exchanges filled an average of 11.7 prescriptions, which was 13.6% more than their counterparts in commercial plans. Spending for members on the public exchanges was almost 200% higher because these individuals were 2.5 times more likely to hepatitis C or HIV .... AJMC

3/20 Asklepion's Cholbam Approved
FDA Approves Cholbam for Rare Bile Acid Synthesis Disorders .... People with these rare disorders lack enzymes needed to process cholic acid, normally made by the liver from cholesterol. This leads to reduced bile flow, potentially poisonous build-up of bile acid products in the liver, and less absorption of fats and vitamins .... HealthDay News

3/20 Internet Drug News Fast Takes:
New Hope for Stroke Boosts Demand for Device to Nab Clots
Bloomberg
Sobriety tests in all new cars might prevent most drunk driving deaths
Reuters
Industry makes $7,000 for each tobacco death
Reuters
Biologists Call for Halt to Gene Editing Technique in Humans
NY Times
One-third of heart attack patients don't remember they had a heart attack
Vox


3/19
Fast Takes
DEA Approves Study Of Ecstasy In Treatment Of Seriously Ill Patients
Huff Post
Gilead Sciences: How Big a Threat is Merck?
Barron's

3/19 Antipsychotics Deadlier Than Thought for Dementia Patients - WebMD
Antipsychotics: Deadlier Than Thought for Some? … took antipsychotics were more likely to die early … risk of death among patients taking antidepressants was lower than among those taking antipsychotics or valproic acid … [Web MD]

3/19
COPD: AZN Hypes Experimental Replacement For Advair
AstraZeneca Says New Lung Drug Combination Improves Breathing …  competing product to GlaxoSmithKline Plc's Anoro and Novartis's Ultibro drugs for treating COPD … long-acting muscarinic antagonist together with a long-acting beta agonist … [Bloomberg]

3/19
Revealed: Novo Rebates Diabetes Drugs 50%, Poss Refile For Tresiba Earlier Than Expected
- Lantus replacement faces uphill battle
Novo Sees U.S. Price Gains Even With New Sanofi Insulin  … preparing for discussions with the FDA on refiling its Tresiba insulin for approval. The agency rejected it in 2013 because of heart safety concerns … continue to be list-price increases in the product categories where we operate and that there will be increased discounting …[Bloomberg]

3/19
Actavis: Buy The Company Fire The Workers?
- 11,500 Allergan workers neck on chopping block: who's next?
Actavis job-cutting drive hits 400-plus on Long Island … announced the layoffs back in September, and since then it's gotten to work trimming Forest's ranks in other states … hasn't yet said, though, is whether, which and when employees will face the ax as a result of its Allergan tie-up …[Fierce Pharma]
Related: Actavis Plans Job Cuts, China Expansion for Allergan …[Bloomberg]

3/19
Sadness In Drug Addictville
- Pssst: wanna buy some pain pills that don't get ya high?
Holy Grail: Pain Pills Without the High … attempting to trigger different opioid receptors, known as kappa- and delta-opioid receptors, that they hope will have similar painkilling properties without the euphoric …Pfizer and Biogen are developing drugs that avoid opioid receptors entirely …[WSJ]

3/19
Envelope Please;
- My company can kick your company's ass
The top 15 pharma companies by 2014 revenue … For the first time, a biotech company has nudged aside one of the biggest Big Pharma names. Eli Lilly … rest of the top 10 are the usual suspects--Sanofi, Merck, GlaxoSmithKline, AstraZeneca nd Bayer HealthCare. They're in slightly different slots for 2014, but all present and accounted for …[Fierce Pharma]
Editor's Note: Tracy Stanton does it again; another Fierce Pharma must read article.

3/19
US pharma market value projected to be $550 billion in five years
- Remember the 2010 patent cliff?  It's officially over
US pharma market value projected to be $550 billion in five years …  Every few years you have a wave of new drugs," … uptick in prescriptions will reflect the investments Big Pharma and smaller biotechs have been making to create drugs that go beyond new-and-improved versions of old drugs to creating therapies that are new and novel. … [MMM]

3/18 Sanofi Upgraded On FX, Cholesterol Drug Promise
Investor's Business Daily

3/18
CVS: Gilead Hep C Pills Are Cost Effective
- Express' Kvetching* unfounded
Gilead's hepatitis C drugs largely cost-effective in U.S. -study … shorten treatment times are largely cost-effective despite their hefty U.S. price tags … funded by CVS Health, one of the largest U.S. pharmacy benefits managers, $12,825 for every healthy year of life. …[Reuters]
*
Editor's Note: Translated into English, Kvetching is a Yiddish word (verb) that means whining and complaining in an irritating manner.

3/18
Mirror Mirror On The Wall: Who Will Be The Next To Fall
The Hottest Question in Pharma: Which Company Will Be Next To Sell? … most small and midsize drug makers are targets … possible targets because of their size and their product mix: Jazz Pharmaceuticals, Impax Laboratories, Anacor Pharmaceuticals, Kythera Biopharmaceuticals, Akorn and Perrigo …[Pharmalot]

3/18
FDA; Breo For Kids: Questions Regarding Asthma Exacerbation, Safety
GSK, Theravance's Breo Faces Scrutiny Over Safety for Asthma … memo included in an agency staff report for the advisory meeting that says Breo doesn't appear to work much better than steroids alone for patients ages 12 to 17, and individuals in that group had more hospitalizations than older ones …[Bloomberg]

3/18
A Look At Afrezza Prescriptions Through Week 6 And Predictions Through Week 10
A Look At Afrezza Prescriptions Through Week 6 And Predictions Through Week 10 … 5 had a total of 154 nRx with cumulative prescriptions filled reaching 444. Week 5 saw a growth in prescriptions of 36% …. in week 10 we could see total revenue from Afrezza equal to about $943,850 …[Seeking Alpha]

3/18
Slimming Meds: Sounds Good In Theory But Sales Always Disappoint; Why?
- Millions of fat people them not buying them in large numbers
Weight-Loss Drugs Seek Acceptance From Patients and Physicians … Concerns about cardiovascular-related side effects still linger … reluctance among patients because of safety issues with past diet drugs …  barrier to adoption is spotty insurance coverage: Some patients shell out $200 a month or more for the drugs …[WSJ]
Editor's Note: 1,220 words report; insightful; must-read for the army of chubbby chasing drug reps and marketers.
Editor's Note: Think about it; 88 million obese people in the USA.  I doubt the the entire prescription slimming med class does $75 million per year.  There is a huge disconnect here between the people marketing these pills and  their target population.  Concerns regarding cost, formulary, and safety apparently outweigh the health risk reduction message.

3/16 Fast Takes
4 Drugs That Work Differently In Women Than Men
Yahoo Health
Pfizer's Lyrica fails post-marketing study
Pharma Times
Pfizer Plans To Expand Vaccine Portfolio; Strategic Acquisitions May Be In The Cards
BidnessEtc
Actavis Receives FDA Approval of SAPHRIS® for Kids (age 10-17)
Actavis Press Released
Getting Ready For The Next Flu Pandemic, With Ebola On The Side: New Antiviral Drugs
Seeking Alpha

3/16
Early Data Points To Large Cardio Event Reduction With PCSK9 Cholesterol Jab
- Still too early to say benefit is for sure
Tests of Cholesterol Drugs Offer Hope of Reducing Heart Attacks and Strokes … early results suggest that there might be such a benefit, maybe even a big one …  0.95 percent of those in the group that received the drug had suffered a heart attack, stroke or other cardiovascular problem, compared with 2.18 percent in the group that did not take the drug …[NY Times]
Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events … Over a period of 78 weeks, alirocumab, when added to statin therapy at the maximum tolerated dose …[NEJM

3/16
Insurers Brace For Much Hyped PCSK9 Cholesterol Jab
- Very effective, very expensive, 10 million potential patients
Experimental cholesterol drugs cut heart risk, but questions remain …  cutting LDL by 61 percent … experimental drugs are antibodies, given by injection, designed to target the PCSK9 protein that maintains LDL cholesterol in the bloodstream … annual cost as high as $10,000 …[Reuters]
Experimental anti-cholesterol drug shows promise …  human monoclonal antibody that blocks a harmful protein in the liver, freeing the organ up to remove LDL cholesterol from the blood …  FDA may decide to make the treatment available after an expected review of the data later this year …[AFP]

3/16
Merck Surgical Anesthesia Wake-Up Drug Dealt Yet Another Setback
Merck surgery drug sugammadex dealt another setback … FDA has canceled a March 18 meeting to review sugammadex, which is designed to help patients "wake up" after surgical anesthesia … [AP]
Merck can't get the sugammadex curse lifted, faces 3rd FDA rejection … [Fierce Biotech]

3/16
IMS (Mother Of All Pharma Data) CEO Has $25 Mln Payday In 2014
- Small salary big stock grant made difference despite massive loss
IMS CEO's $25.9 Million Pay Tops Biggest Health Companies … IMS reported a net loss of $189 million for 2014, down from a profit of $82 million the year prior … IMS sold $2.64 billion last year -- 3.6 percent of

3/12 Fast Takes
Multiple Undeclared Drugs Found in Sex Enhancement Pills
MPR
Antiepileptic Drug LevetiracetamMay Delay Alzheimer's Dementia in Elderly
MPR
Mylan Launches First & Only Available Fentanyl Patches 37.5, 62.5 and 87.5 mcg/hr
Mylan Press Release
Johnson & Johnson CEO's pay rises 48%
Market Watch

3/12
Colorado Passes Law Allowing Biosimilar Substitution
Biosimilars bill approved by Colorado Legislature … pharmacist will also have to notify the patient and the prescribing physician of the switch … chains opposed the notification requirement because it could be difficult to get word to doctors, and some opponents worried that the extra step could discourage biosimilar substitution …[Denver Business Journal]
Editor's Note: This is today's most important story; the PBM industrial complex's assault on FDA's regulatory powers. The doctor notification clause means the doctor still has the final say.  I predict that Express and CVS will fight harder next time to remove the doctor notification clause.

3/12 Statins Linked To 46% Increase In Diabetes
- Linked to decrease in insulin sensitivity & reduction in insulin output
Statins increase risk of type 2 diabetes, study suggests … 24% decrease in insulin sensitivity and a 12% decrease in insulin secretion … results were adjusted for a number of factors, including body mass index, waist circumference, physical activity, family history of diabetes and beta-blocker and diuretic treatment … [Royal Pharmaceutical Society 2015; The Pharmaceutical Journal, PJ March 2015 online, online | URI: 20068064]

3/12
Evidence Suggests Homeopathy Is Mostly Is Hogwash
- People biased to believe whatthey want to believe
Americans spend billions on homeopathy. The best evidence says they're wasting their money. … high-quality studies did not find that homeopathy performed better than a placebo  … not only did homeopathy treatments perform no better than other medicines, but they also failed to outdo sugar pills …[Vox]

3/12
FDA Proposal: Allow Drug Reps To Dispute Package Insert Safety Data
- Consumer groups outraged
FDA proposal to allow drug reps to circulate data draws protests … FDA said it would allow distribution of new information in medical journals showing that the severity or frequency of a side effect is lower than described on the product label. …  could even "call into question a causal relationship between a drug and an event in the approved labeling …[Reuters]

3/12
Salix Bidding Underway: Endo Makes Offer
Endo Bids for Salix, Seeking to Upend Valeant Deal … Endo's cash-and-stock proposal values Salix at $175 per share … Valeant agreed last month to pay $158 a share in cash for Salix, whose Xifaxan for travelers' diarrhea is poised to receive additional approvals …[Bloomberg]
Endo Raises Buyout Offer for Salix Pharmaceuticals in This Letter to Salix Chairman …[The Street]

3/12
Open Payment Database: Website Snafus Prevent Pharma From Doing Their Job
Open Payments glitches limit submissions … two problems: the final submit button that allows manufacturers to enter a record doesn't always work, and the system has rejected the submissions of some records based on certain physicians' National Provider Identifiers …[MMM]

3/12
Rumor Mill: Teva To Buy Mylan
- Don't get too excited; it's still just a rumor
Sale Rumor, Drugs Launch Boost High-Rated Mylan Stock … after speaking with Teva, the rumor that it might acquire Mylan appeared to be "untrue and baseless… Analysts were divided about the logic …[ Investor's Business Daily]


3/11
Express: Drug Spending Surges; Specialty Drugs, Hep C Pills Blamed
- Hasn't grown this fast in more than 10 years
Drug Spending Accelerated In 2014: Express Scripts … prescription-drug spending rose more last year than it had since 2003 … spending on hepatitis C drugs accounted for more than half of the increase … [Investor's Business Daily]
Hepatitis C drugs drive 13% jump in medicine spending ...spread of hepatitis C and other specialty drugs helped to double the spending increase, which would have been 6.4% without them. Spending on specialty drugs soared by nearly 31%, the highest increase ever recorded … [Market Watch]

3/11 Zogenix Cashes In Its Chips; Sells Rights To Controversial Pain Pill Zohydro
- Pain business was too much of a pain
Zogenix sells painkiller Zohydro …  Zohydro ER sales force will be transferred to Pernix … agreed to sell its Zohydro ER opioid painkiller business for $100 million plus a potential of up to $283.5 million in regulatory and sales milestones …[UTSaqnDiego]
Pernix to Acquire Zohydro® ER Franchise from Zogenix, Inc. … igned a definitive agreement to acquire the Zohydro ER franchise from Zogenix, Inc. (ZGNX). The acquisition includes three extended release hydrocodone products, including an abuse-deterrent pipeline and all related intellectual property …[Pernix Press Release]

3/11
Nurse Practitioners Get Full Practice Privileges In 19 States
- Basically no different from a primary care doctor
States Lift Nurse Practitioner Hurdles Amid Doctor Shortage …  full practice authority allows nurse practitioners to evaluate patients, make diagnoses, "order and interpret diagnostic tests" and prescribe without maintaining a collaborative agreement with doctors … doubling in number to more than 205,000 in the last decade …[Forbes]

3/11 FDA Panel Green Lights  Drug To Treat Double Chin
FDA Panel Backs Kythera Double-Chin Treatment … anticipates launching the treatment, ATX-101, in the second half of the year. Advisory-panel recommendations aren't binding but are considered by the FDA and often foreshadow the final decision … [WSJ]

3/11
AbbVie Rolls Dice On Sustainability Of $100K Leukemia Drug
- Smart money:  blank check mentality for cancer drugs isnt going away any time soon
Investors Bet $100,000 Cancer Drug Prices Are Here to Stay …  pharmaceutical industry and Wall Street are signaling they don't expect the brakes on pricing any time soon in the oncology field. Companies that are developing cancer drugs rose in reaction to both the deal and regulatory approval of a $12,500 …[Bloomberg]

3/11
JNJ Pleads Guilty, Pays Small Fine To Settle Contaminated Medicine Probe
Tylenol maker to pay $25 mln for selling metal-contaminated drugs … troubles began in May 2009 when a consumer complained after noticing "black specks" in the bottom of a bottle of Infants' Tylenol. The specks were found to be nickel and chromium particles …[Reuters]

3/11
New Bristol-Myers CEO on tap for $8.7M-plus pay package
New Bristol-Myers CEO on tap for $8.7M-plus pay package …  base salary will stand at $1.4 million … set to collect $8.735 million, all told. But if all goes well, he could rack up $11.35 million or more. That's a big raise for Caforio: In 2013, as EVP, he collected $3.3 million …[Fierce Pharma]

3/11
Rumor Mill Hints Novo Nordisk Readies For Saxenda Launch?
Novo Nordisk Readies For Saxenda Launch - Investors Need To Keep Expectations Realistic … will join Qsymia, Belviq, and Contrave in the anti-obesity space … Sales reps rumors swirling that an announcement will happen this week. … This week we are seeing the first hints that announcements are imminent …[Seeking Alkpha]
See Also: Novo Press Release (hints at market positioning of Saxenda) | Cafι Pharma's Novo Nordisk Message Board


3/11 Fast Takes
USA Charge for a lipid panel blood test range from $10 to $10,169
VOX
Amgen to cut about 300 jobs
Pharmalot

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