Internet Drug News.com



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

6/12 Fast Takes
Feds now back morning-after pills for kids
AP
ORENCIA® (abatacept) Shows Comparable Efficacy to Humira® (adalimumab) in Year Two Data from Head-to-Head Study
Bristol Myers Press Release
People With Sleep Apnea At Increased Risk For Sudden Cardiac Death
Forbes
Inflated Figures: Novartis Probes Galvus Sales Practices In India
Pharmalot


6/12
NEJM: Generic Cocktail Noninferior To Enbrel
-
A.K.A. - Amgen's OMG moment
Generic Drugs as Effective as Amgen's Enbrel for Arthritis … no more effective than a cocktail of cheaper generic therapies in treating a severe joint disease affecting … could prompt changes in the way physicians treat patients, potentially saving significant amounts of money…[NASDAQ]
Therapies for Active Rheumatoid Arthritis after Methotrexate Failure … triple therapy, with sulfasalazine and hydroxychloroquine added to methotrexate, was noninferior to etanercept plus methotrexate in patients with rheumatoid arthritis who had active disease …[Full Text; NEJM; June 11, 2013DOI: 10.1056/NEJMoa1303006]
Editor's Note: Not copy approved; not for distribution; not for use in front of customers.

6/12
Inhaled Insulin: Why Are Mannkind Shares Up 212% Since January?
- Trial results due August, NDA poss by October
Can MannKind Deliver A Summer Blockbuster? … When trial data is released in August, this is obviously a huge binary event for MannKind shares … Positive trial results mean that MannKind will be ready to submit a New Drug Application for Afrezza by October …[Seeking Alpha]

6/12
Walgreens: $80 Mln Fine Because
Pharmacists Should Have, Could Have
Walgreen Pays $80 Million to Settle DEA Painkiller Probe … pharmacists blatantly ignored red flags and filled prescriptions they knew or should have known would be illegally diverted [such as oxycodone] …  six Walgreen pharmacies in Florida are barred from distributing controlled substances for two years …[Reuters]

6/12
Old People Don't Trust Generics; Medicare Peeps Much
More Likely To Get Brand Name Meds Than Vets
Medicare prescribes more brand name drugs than VA … two to three times more likely than those covered by the U.S. Department of Veterans Affairs to be prescribed brand name diabetes drugs  … 51 percent of Medicare statin users nationally took a brand name version, compared to 18 percent of VA statin users …[Reuters]

6/12
Who Is Catamaran?  Why Did Cigna Hire Them
To Be Rx Claim Adjudicators

- Inks 10 year pact with Canadian back office PBM manager
Catamaran Gains Cigna's Prescription Drug Business … middleman among employers, drugmakers and pharmacies by negotiating prices and managing medicine use by workers, defeated larger competitors CVS Caremark and Express Scripts to win Cigna's business …[Bloomberg]
Editor's Note: Catamaran is the company behind RxClaim.  Catamaran is an Illinois based PBM company that deals with formulary administration, benefit plan design and management, pharmacy network management, drug utilization review, clinical services and consulting, reporting and information analysis, mail services and specialty pharmacy, and consumer web services.

6/12
Topical Prostaglandin Impotence Drug Now Approved In 10 countries
Apricus impotence drug approved in 10 countries … working with several partners to prepare for the next step to launch the drug … active ingredient in Vitaros, alprostadil …[AP]
Apricus gets European OK for ED drug Vitaros … topically cream that stimulates blood flow, as distinguished from orally active drugs …  advantage of acting rapidly and safely, including for diabetics or patients who don't respond to Viagra after removal of the prostate …[UTSanDiego]

6/11
Fast Takes:
FDA panel ejects Dynavax's hepatitis B vaccine; more data needed
Reuters
JAMA: Hypoglycemia In Diabetics Linked To Dementia
JAMA
FDA Sends Janssen Biotech Letter Over Doxil Website
PharmaLive
Did You Know The Glaxo US HQ Is Really A Sublet 10-By-10 Foot Office?
Pharmalot
RoActemra (tocilizumab) gets EU nod to treat arthritis in children
Reuters

6/11
Testosterone Replacement Therapy Officially Part Of Landscape
- Effective marketing campaign(s) raises awaremess, drove demand
After Years of 'Low-T' Ads, Testosterone Use Is Up … promising improved energy, mood and sex life …  lack of rigorous evidence showing the drugs are beneficial … concerns the drugs may increase the risk of cardiovascular problems as well as prostate cancer …[PharmaLive.com]

6/11
Shire: New CEO Restores Ups Headcount On
Anticipated Vyvanse Indications, EU Growth
Shire's New CEO Adds Sales Staff, Damps Takeover Talk … Vyvanse to more than $2 billion from $1.03 billion last year … expects to restore a "significant" portion of those [150] jobs in anticipation of widening use for Vyvanse … trials of the drug in binge-eating disorder, which afflicts as many as 6 million Americans, and major depressive disorder … [Bloomberg]

6/11
Sanofi: New Flu Vaccine Gets Nod
Fluzone Quadrivalent, Four-Strain Flu Vaccine, Approved By FDA ...adults, adolescents and children 6 months and older … available in the upcoming 2013-2014 flu season … 226,000 people in the United States are hospitalized each year for influenza …[HuffPost]

6/11
AZN Beef Up Respiratory Pipeline With $1.5 Bln Deal
AstraZeneca Pays Up To Patch Up Another Key Area … Pearl's PT003 is a LAMA/LABA combination in Phase III studies … solid efficacy relative to Boehringer's Spiriva, and a US filing could come in 2015 … [skeptics] … have asked pointed questions about Pearl's positioning as fifth-in-class …[Investopedia]

6/11
Glaxo Fires Senior R&D VP For Fudging Data (That Got Published)
- Not the 1st time said exec acted as loose cannon
Glaxo Dismisses Exec Over Fabricated Data & Retraction Is Sought … senior vp and head of R&D in Shanghai, China … also placed three other employees on administrative leave pending a final review and a fifth has resigned … [Pharmalot]

6/11
Lemtrada: 25 Years In Development,
Sanofi MS Med Inches Toward EU Green Light
- Active ingredient, also found in Campath currently used as leukemia med; recombinant DNA-derived humanized monoclonal antibody that is directed against the 21-28 kDa cell surface glycoprotein CD52.
Sanofi MS drug nears green light after pass-the-parcel marathon … quarter-century journey from a laboratory in Cambridge, England, to a possible $1 billion-a-year seller …  Lemtrada, which works by knocking out immune system cells called lymphocytes, has ebbed and flowed and there is still no guarantee it will be approved …[Reuters]

6/11
Niaspan: Effective Ads, Favorable Guidelines Meant Huge Sales
- Disappointing trial data  threw wet blanket on trend
Abbott Doubled Niaspan U.S. Sales Before Trials Cut Use … aggressively promoted its Niaspan cholesterol treatment, almost tripling U.S. use of the medication, in the seven-year period before studies in 2011 found the drug ineffective … ads, said that the drug can help raise HDL levels, cut the risk of heart attacks and slow the build-up of arterial plaque …[Reuters]

6/10
Belviq In Launch Mode At Long Last
- Analysts not expecting big sales based on Qsymia model
Weight loss drug Belviq gets overdue US launch … available in U.S. beginning next week, nearly a year after the drug was officially approved … uphill battle in the U.S. market …  limited insurance coverage and high out-of-pocket expenses for patients with coverage …[ AP]
New Obesity Drug Hits the Market … choice between two new obesity drugs. They couldn't be more different … Qsymia, sold by VIVUS  , has been on the market since September … Getting insurers to cover the drugs is the key to sales …[Motley Fool]
Editor's Note:  In trials, Belviq patients lost 3.7% of their body weight.  Qsymia Ptiwnts lost between 6.7% and 9.4 % in separate trials.

6/10
Lantus Patent Expires 2015 - Sanofi Prepares For Scenarios
- Combo mix with GLP-1 Lyxumia, seen as way to fend off biosimilar competition
Sanofi steps up diabetes drive as rivals raise the stakes … improved version of Lantus in late-stage trials as well as a combination of the product with Lyxumia, a once-daily injection …  likely to face competition from a so-called biosimilar version of the original Lantus made by Eli Lilly [after 2015]…[Reuters]

6/10
Anatomy Of A Drug Deal
Large, small drug firms join for profitable results … Sometimes these deals work, sometimes not. Last week presented four examples, three starting and one ending (badly), involving the drugmakers GlaxoSmithKline, Johnson & Johnson, Pfizer, and AstraZeneca … generally, Big Pharma pays an amount up front to Small Pharma, then pays more if the compound reaches milestones …[Philly.com]

6/10 I
t's Time to Buy Amgen Stock. Here's Why
It's Time to Buy Amgen Stock. Here's Why … 1. Amgen is cheap  …  2. Amgen has the best record around … 3. Amgen pays you best …[Motley Fool]

6/10
Internet Drug News Fast Takes
Teva recalls wrongly packaged sleeping pill
Globes (India)
High deductibles linked to lower Rx fills and cancer screenings
MM&M
Gilead's Hepatitis C Drug to Get Priority Review by U.S. FDA
Bloomberg
FDA finds fungus in drugs from Tennessee pharmacy
Bloomberg
Sagent Pharmaceuticals Recalls of Three Lots of Vecuronium Bromide for Injection,
Sagent Press Release
Endo Health Reaches New 52-Week High
The Street
Forest Stock Hits New 52-Week High
The Street

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