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Internet Drug News.com online since 1998
Pharmaceutical News & Information; Updated Daily
See Also: Pharmaceutical Sales

Pharmaceutical News Harvest ™
Click Here for Last Week's Pharmaceutical News Harvest ™

6/20 25% of Women Aged 50 to 64 on an Antidepressant
Nearly 7-in-10 adults take a prescription drug .... Most of the drugs are antibiotics, antidepressants and opioid painkillers.... Drugs to control blood pressure were fourth on the list, while vaccines were fifth .... [Drug Store News]

6/20 Judge's Plan B Ruling Complicates FDA Management of OTC Shifts
Naloxone Could Go OTC .... A potential OTC switch for naloxone isn't likely to become the political lightning rod that is Plan B, but it sure does draw in a range of thorny questions for politicians and policymakers to consider .... [The RPM Report: First Take ]

6/20 HPV Vaccines Working
Cancer-Causing Sex Virus Cut in Teen Girls by Vaccines .... Cases of certain HPV strains have plunged 56 percent among females 14 years old to 19 years old since the first vaccine, Merck's Gardasil, was introduced in 2006 .... [Bloomberg]

6/20 Obese Patients Have $1400 Higher Medical Costs Per Year
AMA's Obesity-As-Disease Vote Should Boost Diet Drugs .... The AMA's policy-making House of Delegates said they wanted to see the association's backing of such a resolution as spurring more treatment options and better reimbursement for treating overweight Americans to create better health outcomes .... [Forbes]
See also: Medical group recognizes obesity as a disease [USA Today]

6/20 Xarelto Promo Rapped for Lack of Bold Type
J&J's Janssen Gets Second Untitled Letter in as Many Months as FDA Targets Xarelto Advertising Piece .... The risks section, however, failed to include this same selective bold-text strategy, making the overall presentation "misleading." .... [Regulatory Focus]

6/20 Onglyza Doesn't Get Study Results It Needs
A Bristol-Myers And AstraZeneca Diabetes Trial Is A 'Dud' .... The top-line results of a large, late-stage study of their Onglyza diabetes drug failed to show superiority in reducing cardiovascular deaths, heart attacks and strokes compared to a placebo in Type 2 diabetes patients with cardiovascular risk factors .... [Pharmalot]

6/20 Better Management Could Save 8% of Nation's Health Bill
Most wasteful healthcare spending results from poor adherence .... The six areas studied led to an estimated 10 million hospital admissions, 78 million outpatient treatments, 246 million prescriptions and 4 million emergency visits per year .... [Drug Store News]

6/20 Merck Research Shake-Up
R&D chief's spring-cleaning sweeps through Merck labs .... Perlmutter eliminated franchise-head positions: senior managers who oversaw teams working on new drugs. Management in the lab had already been dealing with a smaller R&D budget, after the company reduced it to $7.8 billion for 2012, down 1.3% year-over-year .... [MM&M]
See also: Making Changes Inside Merck's R&D [In the Pipeline blog]

6/20 Pent-Up Demand for MS Drug Overwhelms Distribution
Biogen's impressive Tecfidera launch hits reimbursement, supply snags .... Some insurers have been slow to approve reimbursement for Tecfidera.... Some patients have waited several weeks for the go-ahead. Some payers want proof that patients have failed on other drugs .... [Fierce Pharma]

6/20 Halftime Recap for 2013 FDA Drug Reviews
FDA approvals in 2013 (to date) — a commercial assessment .... Many will argue that Roche's Kadcyla — approved by the FDA in February — is the most innovative launch of 2013, to date. The product is expected to provide significant commercial momentum for antibody drug conjugates .... [First Word Pharma]

6/20 Internet Drug News Fast Takes:
FDA Backs Off On Regulation of Fecal Transplants
NPR
Deadly new coronavirus a "serious risk" in hospitals — Saudi study
Reuters
After pesky suitor Royalty goes away, sources say Forest Labs is eying Elan
MedCity News
Depression in Women Tied to Diabetes, Cardiac Risk Factors
HealthDay
Concussion Damage Looks Much Like Early Alzheimer's
HealthDay


6/19 Lundbeck Hit With $125 Million Fine For Pay To Delay
Lundbeck Fined $125.6 Million by EU Drug Delay Probe … EU's first case over pay-for-delay settlements, regulators said. The EU antitrust watchdog has also sought information from companies including GlaxoSmithKline … Johnson & Johnson and Novartis AG in January were sent EU complaints over such deals that may have hampered the sale of generic versions of pain killer fentanyl in the Netherlands …[Bloomberg]

6/19
FDA Investigates 2 Deaths Linked To Zyprexa Injection
FDA investigating long-acting Zyprexa shots after two deaths … unexplained deaths of two patients in the wake of receiving intramuscular injections …  deaths occurred well after the three-to-four-hour window following injection during which patients should be monitored in a physician's office …[L.A. Times]
FDA Investigates Two Deaths In Zyprexa Patients … could cause post-injection delirium sedation syndrome in which the drug enters the bloodstream too fast and causes heavy sedation …[Pharmalot
See Also: FDA Press Release

6/19 Biotech Reps Make $167K; Field Reps: $110K, Specialty Reps: $119K
-
Feed the green eyed mon$ter - read this article
Want a raise, pharma reps? Get into biotech sales instead … for sales folks repping biotech products, with their average $164,783 in annual compensation. … [Field Reps] collect an average of $110,965 in total compensation per year … [Fierce Pharma]
Editor's Note: Adds differential for women versus men, medical sales, average bonus, etc.  Nice read if you are only making $95K and you want to drive yourself crazy.

6/19 Medicare Cracks Down On Diabetes Products By Mail Operations
- Beginning July, only 18 designated suppliers are allowed to ship to seniors
Medicare: Cost-saving changes coming for diabetics … hundreds of mail-order companies can now bill Medicare for the test strips, lancets  … beginning July 1, Medicare patients can order from only 18 mail-order companies that won government contracts …[AP]

6/19
Glaxo May Spin Off 2 Non-Performing Cardio Meds
Glaxo Gets Offer for Heart Drugs With Declining Sales … offer for branded heart medicines Arixtra and Fraxiparine … products generated about 420 million pounds ($656 million) in global revenue in 2012 compared with 510 million pounds the previous year …[Bloomberg]
Editor's note: Arixtra (fondaparinux sodium) and  Fraxiparine (nadroparin calcium injection) are anticoagulant/antithrombotic agents.

6/19
Fewer Brand Name Drugs To Clone; Generic Makers Shift To
Their Own Proprietary Brands
Generic-Drug Firms Go Beyond Knockoffs … Ranbaxy, Teva and other generic-drug makers are coming to grips with a drop in blockbuster brand-name medicines going off patent. One strategy: selling brand-name medicines…. …[WSJ]

6/19
FDA Sitting On $1 Bln Treasure Chest Of Unspent User Fees
US lawmakers slam FDA over unused industry user fees … US House Committee has strongly criticised the Food and Drug Administration (FDA) for carrying "in excess of $1,000,000,000 in unobligated [industry] user fees" halfway through the current financial year …[Pharma Times]

6/19
Mylan Turns Up EpiPen Promo Activity With Football All-Star  Hero
- Introduces $0 co-pay coupon (as opposed to Sanofi $25 off coupon for similar product)
Mylan Specialty L.P. Joins Forces with Adrian Peterson and Jo Frost to Launch Anaphylaxis Preparedness Campaign … $0 Co-Pay Offer available to both cash-paying and commercially insured patients, including those with a high deductible … "$0 Epipen Coupon Co-Pay Offer .…[Mylan Press Release]
Editor's Note:  Sanofi has recently launched a talking epinephrine injection system known as Auvi-Q and is offering a $25 off 2 prescriptions each coupon

6/18
Fast Takes
Forest Reaches New 52-Week High
The Street
Citing Side Effects, Japan Pulls Recommendations For HPV Vaccines
Pharmalot
Merck, Pfizer Sue Mylan to Block Proposed Copy of AzaSite Eye Drops
San Diego Source

6/18
Supremes: FTC Can Challenge Pay-4- Delay On Case By Case Basis
Overturns FTC Versus Actavis regarding Androgel Deal
Pay-for-delay deals can go on, Court rules, but not without legal risk … split the baby on "pay-for-delay" settlements, allowing them to continue but opening manufacturers that make them up to lawsuits … didn't go as far as the Federal Trade Commission wanted …[MM&M]
Supreme Court Rules Drugmakers Can Be Sued For Pay-To-Delay Deals … drugmakers can face lawsuits over so-called pay-to-delay patent settlements, but that such deals should not necessarily be assumed to be illegal …  agreements should proceed by applying the 'rule of reason,' rather than under a 'quick look' approach …[Pharmalot]
See Also: Click Here to read actual Supreme Court Ruling
Editor's Note
: Since the FTC has an almost unlimited budget and hundreds of lawyers at their disposal, the ruling effectively DOES outlaw pay for delay.  Theoretically, If FTC loses a case, they will keep on elevating it all the way to the Supreme court.  We predict pay-for-delay delayed, pay-for-delay denied.

6/18
Supreme Court Ruling Ambiguous; Heyday For Lawyers
- Experts say ruling will boost lawsuits, legal costs
High  Court's 'Pay-to-Delay' Ruling Met With Criticism … "If I were a patent attorney I would be opening a bottle of Champagne …  ruling says that you have to go to court every time to prove a deal is legal under antitrust law if the Federal Trade …  files a lawsuit challenging …[CNBC]

6/18
Takeda Launches DDP-4, DDP4 + Metformin Combo, DDP4 + TZD
NESINA (alogliptin) and Fixed-Dose Combinations KAZANO (alogliptin and metformin HCl) and OSENI (alogliptin and pioglitazone), Are Now Available in Pharmacies in the United States … NESINA is a dipeptidyl peptidase-4 inhibitor (DPP-4i) … KAZANO (alogliptin and metformin HCl) and OSENI (alogliptin and pioglitazone) are now available by prescription in pharmacies in the United States (U.S.) …[Takeda Press Release]
Editor's Note: Takeda is launching the above pills with a
$100 coupon for:  Nesina | Kazano | Oseni

6/18 
Analyst: Lilly's Answer To Victoza May Be Better Choice, Shares Dive
- Sanofi Lantus + GLP1 combo product also cited
Novo Drops as New Lilly Drug Threatens Victoza …  experimental drug dulaglutide has potential to wrest market share from Victoza … data for dulaglutide suggests a profile that may be better than Victoza …[Bloomberg]
Novo Nordisk shares hit by concerns over rival diabetes drugs … Sanofi is closing in on another front … improved version of its top-selling long-acting insulin Lantus, as well as a combination of the product with its GLP-1 drug Lyxumia …[Reuters]

6/18
Red Meat Linked To Diabetes
Researchers Begin To Flesh Out The Red Meat-Type 2 Diabetes Connection … people who increased their red meat consumption by more than 0.5 servings per day over each period had a 48% greater risk of developing type 2 diabetes  …[Forbes]

6/18
Restless Legs Linked Reduced Life Span
- Pharma's not interested; generics out there mean pinched opportunities
Does Restless Legs Syndrome Really Shorten Life Span? …  affects 7% to 10% of the U.S. population … patients with RLS had a 39% increased risk of death … RLS hasn't been a high-priority target for the pharma industry given the lackluster sales of Requip and Horizant, a third competitor of UCB's Neupro, and a number of generic alternatives  …[Motley Fool]


6/17
Fast Takes
Girl's New Lungs Buy Time But Don't Cure Cystic Fibrosis
AP
EU regulator advises caution on painkiller diclofenac
Reuters
Selling Your Organs: Should it be Legal? Do You Own Yourself?
Forbes
Forest Announces U.S. Availability of New Once-Daily NAMENDA XR
Forest Press Release
Uncle Sam Taps Big Pharma to Combat Antibiotic Resistance
Motley Fool
The Top 5 Diseases Caused by Obesity
Motley Fool

6/17
Merck, Bristol, AZN: Nothing To Fear; Review Our DDP Meds
- Will cooperate on Pancreas disease study; will provide statistics
Merck Backs Call for Independent Review of Diabetes Treatments … growing evidence that some of the U.S.'s top-selling diabetes medicines could lead to pancreatic disease … We welcome opportunities to discuss the data that support the safety profile of sitagliptin  …[NASDAQ]

6/17
Novo Denies Victoza Causes Pancreas Problems
Novo Nordisk Says Safety of Victoza Drug Further Supported … conflicting results, not providing reliable evidence to refute or support a causal link between diabetes drugs such as Victoza and pancreatic problems … cancer for Victoza were similar to, or numerically lower than …[NASDAQ]

6/17
Lilly Pulls Plug On Alzheimer Pill
Another Alzheimer's Disease Failure … MK-8931 reduced the amount of beta-amyloid in cerebral spinal fluid by more than 90%, but it isn't known whether that will reduce the amyloid plaques seen in Alzheimer's patients' brains …[Motley Fool]
Lilly halts Alzheimer's drug trial due to liver problems …  beta secretase, or BACE, inhibitors … Oral drugs to block beta secretase, although still unproven, have been one of the biggest hopes for slowing progression of the disease after another class of medicines being developed by Lilly and Pfizer …[ Reuters]

6/17
Market Watch: Dr Steven Nissen Had Financial Conflict Of Interest
When He Nuked Avandia On Safety
Avandia win a Pyrrhic victory for consumers … monetary awards from Takeda troubling that Nissen received funding from Takeda Pharmaceutical, which makes Actos, the major competitor to Avandia … benefit to him regardless how he chooses to spend them. … Steve Nissen and the Cleveland Clinic …[MarketWatch]

6/17
Painful Vagina: Anticonvulsants Commonly
Prescribed Despite Weak Data
Scant data on seizure drugs for women's genital pain … up to two-thirds of doctors prescribe gabapentin for the condition …. vulvodynia, affects as many as one in 12 women … Anti-seizure medications, such as gabapentin (marketed as Neurontin), are also used to treat vulvodynia. [Reuters]

6/17
FDA Backs New Use for Xgeva (denosumab) for Rare Bone Tumor
FDA approves Xgeva to treat giant cell tumor of the bone … expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor … Xgeva was approved in 2010 to prevent fractures when cancer has spread to the bones …[FDA]

6/17
Top Ten Insurer Ends Coverage For Compounded Meds
Big Insurer Ends Coverage For Compounded Meds …  largest insurers in New England, has decided to end coverage of specialty medications due to safety and cost concerns … appeals will be considered on a case-by-case basis … will still pay for compounded medications for children younger than 18 …[Pharmalot]



6/14 Compromise Ruling on Gene Patents
U.S. top court bars patents on human genes unless synthetic .... The biotech industry saw some good in the ruling, noting that the justices left intact patent protections on forms of DNA produced by scientists in laboratories and the processes used to carry out tests such as cancer screenings .... [Reuters]

6/14 Eliquis and Xeljanz Hobble Off the Blocks
Pfizer's Two New Top Pills Selling Slower Than Expected .... While Eliquis is considered to have superior clinical data, its rivals were approved earlier and have had time to establish themselves with doctors and patients.... Some health insurers and drug benefit managers were limiting access to Xeljanz and forcing patients to try multiple other therapies before getting access to the new drug .... [Bloomberg]

6/14 New Oral for RA Progresses
Lilly says arthritis pill effective in mid-stage study .... Of the 196 patients in the study, 71 percent showed a 20 percent improvement in rheumatoid arthritis symptoms. .... [Reuters]

6/14 Grow Back Your Hair and Get Off the Sauce
Baldness Drug Curbs Men's Interest in Alcohol, Study Suggests .... Almost two-thirds of the men in the study noticed they were drinking less alcohol than before taking Propecia .... [Yahoo]

6/14 Oral Hepatitis C Cocktails to Double Number of Patients in Treatment
AbbVie Says It Can Be First With New Hepatitis C Drugs .... Multidrug regimens by AbbVie, Gilead and Bristol-Myers Squibb will offer hepatitis C patients more tolerable options that do away with weekly shots of interferon.... Gilead has estimated that 150,000 patients may seek treatment in the U.S. once the new class of all-oral drugs is on the market .... [Bloomberg]

6/14 Sneeze on Your Twitter This Fall, and Everyday Health Will Say 'Gesundheit'
Twitter-Everyday Health deal means targeted Tweets .... Twitter is partnering with the health media firm on HealthBeat, through which sponsored posts (promoted Tweets, in Twitter argot) touting contextually relevant content will be routed to Twitter users, triggered by keyword, location or other algorithmic tripwires .... [MM&M]

6/14 Xgeva Approved for Rare Cancer
FDA expands approval for Amgen's Xgeva for GCTB .... The FDA has broadened approval for Amgen's Xgeva (denosumab) to include the treatment of adults and some adolescents with giant cell tumour of the bone (GCTB), making it the first treatment cleared in the US for the rare disease .... [First Word Pharma]

6/14 Ustekinumab Helpful to Those Who Failed on Anti-TNF
Stelara Succeeds in Psoriatic Arthritis .... By 1 year, among patients receiving the 45 mg dose, 47% had ACR20 responses, while 28% and 13% had ACR50 and ACR70 responses .... [MedPage Today]

6/14 Vertex Bets the Third Drug's the Charm Against CF
These Mutated Cystic Fibrosis Cells Are Worth Billions to Vertex Pharma .... Vertex is demonstrating that triple-drug combinations can significantly improve the activity of cells with the hardest-to-treat cystic fibrosis mutations .... [The Street]

6/14 Part D Plans Could Save a Lot of Money with Generics
Brand-name drugs pushing up US Medicare costs .... Spending on Medicare's prescription drug benefit, known as Part D, would have been an estimated $1.4 billion less in 2008 if its brand-name and generic drug use had matched that of the VA for the medications studied .... [Pharma Times]

6/14 Internet Drug News Fast Takes:
Scant data on seizure drugs for women's genital pain
Reuters
Number of retail clinics to double by 2015
Advisory Board
Doctor Pay Rises To $221K For Primary Care, $396K For Specialists
Forbes
NICE knocks back Lilly's Alimta in new setting
PMLiVe
Fish on Prozac show the ill effects of waterways tainted with drug residue
Minn Post




6/13 Pre-Exposure Treatment Slows HIV Spread
Gilead's Viread Reduces HIV Risk for Drug Users in Study .... In a trial involving 2,413 HIV-negative drug users in Bangkok over five years, those who received Viread daily were 49 percent less likely to get infected with HIV than those who got a placebo .... [Bloomberg]

6/13 Teva and Sun Pay the Pfizer for Protonix
Aggressive Tactics Proved Too Risky For These Generic Drugmakers .... The $2.15 billion settlement is one of the highest tabs for damages from a so-called 'at-risk" launch of a generic drug .... [Wall Street Cheat Sheet]

6/13 New Drugs on the Way for Cardiovascular
PhRMA: 215 drugs under development for cardiovascular disease .... The drugs include 30 for heart failure, 29 for lipid disorders, 19 for stroke and 17 for high blood pressure .... [Drug Store News]

6/13 Out-of-Pocket Cap May Slide to 2015 for Some
A Delay In Relief From Copays For Costly Drugs .... The Affordable Care Act sets annual limits on the amount that people will owe out of pocket for prescription drugs starting in 2014. But sick people in some plans won't get relief until the following year because the federal government is giving some health plans extra time to comply .... [NPR]

6/13 NEJM Study Finds Biologic No Better Than Generic Combination
Study shows old-school meds as effective as Enbrel .... Researchers found they could match Enbrel's effectiveness by combining sulfasalazine and hydroxychloroquine with methotrexate, which is a common RA therapy .... [MM&M]

6/13 Trebananib Extends PFS 1.8 Months in Ovarian Ca
Amgen says drug slowed ovarian cancer in trial .... Amgen said median progression free survival (PFS) in the trial was 7.2 months for patients given trebananib and chemotherapy, compared with 5.4 months for patients treated with a placebo drug and chemotherapy .... [Reuters]

6/13 Insert Printers Fight for Their Lives
Who's fighting digital healthcare? The little guys who print paper drug inserts .... Robert Brooks, executive director of the Pharmaceutical Printed Literature Association, has toured Pharmaceutic Litho's Simi Valley facility and estimates 50 to 80 such printing businesses in the country would be wiped out if the bill were enacted .... [MedCity News]

6/13 New PBM for Cigna
Catamaran Gains Cigna's Prescription Drug Business .... Cigna will handle formulary management and customer service itself, and the pharmacy benefits will carry Cigna's brand name. Catamaran will perform the "behind the scenes, back office" work .... [Bloomberg]

6/13 Orencia Wants a Piece of the Action
BMS' Orencia matches Humira in arthritis study .... Both drugs achieved an ACR20 (American College of Rheumatology 20 per cent improvement) in around 60 per cent of patients after two year's therapy, with the onset of response also similar between the groups .... [PMLiVE]

6/13 ADA Does About-Face; Supports New Look at GLP-1 Drugs
Diabetes Drugs Under Scrutiny As FDA Considers Another Study .... The FDA is considering whether to run a study to determine whether a definitive link from GLP-1 drugs can be established to acute pancreatitis and pancreatic cancer .... [Pharmalot]

6/13 Internet Drug News Fast Takes:
Dying Girl Who Sparked Transplant Policy Change Gets Lung
Bloomberg
Music device doesn't drop diabetics' blood pressure
Reuters Health
Lab chief: Hundreds of doctors took bribes in Medicare fraud scheme
Advisory Board
Commonly-Prescribed Drugs May Influence the Onset and Progression of Alzheimer's Disease
Mount Sinai Medical Center
GSK offers discount to win UK green light for platelet drug
Reuters

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