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Pharmaceutical News Harvest ™

9/23 Fast Takes
How Should Foreign Companies Interpret GSK's China Fines And Penalties?
FDA authorizes emergency use of Tekmira Ebola treatment
Tekmire Press Release
Did Boston Scientific lose $74M mesh trial over an email? On Call
Bill Would Speed DEA Listings for Controlled Substances

Lilly GLP-1 Trulicity:  Can 4th To Market Entry
Beat Market Leader Victoza?
- Victoza has 67% Share, $2 Bln In Sales
Infographic - Can Eli Lilly turn up the competitive heat in diabetes? …  Trulicity represents a commercial threat to Victoza on two counts; it is the first rival GLP-1 agonist to demonstrate non-inferiority to Novo Nordisk's product in terms of efficacy and safety and is dosed once-weekly … [First Word]
Editor's Note: Even if Lilly loses the battle, Victoza also loses because PBM's can use Trulicity  to extract larger rebates from Novo.  Express already excludes Victoza.  Let's see how Caremark and the other big players react to this new entry.

Metformin Tied To Thyroid Probs
Hypothyroid? Treated with Metformin?  This may affect you
Diabetes Drug May Affect Thyroid in Some Patients … use of metformin was associated with an increased risk of low TSH levels in patients with treated hypothyroidism … metformin's effect on TSH levels is not clear … [also] unclear whether the low TSH levels associated with metformin in this study put patients at risk …[WebMd]

Par Pharma: Cough Up $100 Mln For Unauthorized Zegerid Knockoff
Par settles patent suit and will pay Salix and MU $100M in fight over Zegerid copy …   Santarus filed the patent infringement lawsuit against Par back in 2007 … Salix bought Santarus last year. Par said that it …[Fierce Pharma]

Lipofen: E-Mail Blast To Docs Gets Cipher Pharmaceuticals In Trouble
- OPD indicated e-mail made untrue claims
OPDP slams cholesterol drug's e-mail claims …  "All fenofibrates are not created equal," and goes on to state that "other fenofibrates are formulated with small particles, which may affect absorption," while with Lipofen, "particle size is not an issue." Lipofen is produced by Cipher, but marketed by Kowa Pharmaceuticals …[MM&M]

Botox maker Allergan rejected Actavis takeover bid
- Allergan play for Salix means Valeant has tough road to hoe
Botox maker Allergan rejected Actavis takeover bid … for months has been trying to fend off a $53 billion hostile takeover offer from Valeant Pharmaceuticals is now in advanced talks to buy Salix Pharmaceuticals some of the people said. Such a deal could make Allergan too big and complicated for Valeant to buy …[WSJ]

German Merck's Biggest Acquisition Ever:
$17 Billion For Company Nobody Ever Heard Of
Merck (MRK) Records the Largest Acquisition in Their History at $17 Billion  … Sigma is the world's largest supplier of biochemicals and organic chemicals to research laboratories and had 2013 sales of $2.7 billion …  also makes high-purity inorganic chemicals for the high-tech sector for food and beverage testing products … [Zacks]

9/22 Breast Cancer Occurs Most Often in These 5 States
Motley Fool
Lemon, Lime--and Lithium? Turns Out, 7-Up Used to Contain the Potent Drug
Take Apart
India caps prices of 36 more drugs to improve access -govt official

Glaxo: No More Paying Docs To Speak To Other Docs Starting 2016
- No more dinner programs?
GlaxoSmithKline to end promotional pay to doctors … will become the first drugmaker to stop paying physicians for promotional appearances, a move that won't take effect until 2016. Instead, GSK plans to promote its drugs online and through the company's scientists …[Boston Globe]

China Levies $489 Mln Fine On Glaxo In Bribery Scandal
- Also, Glaxo exec gets suspended prison sentence
China Fines Glaxo $489 Million, Ending Bribery Probe … and imposed a suspended prison sentence on an executive for bribing doctors, capping a 15-month investigation that curbed the U.K. drugmaker's sales … equal to 1.1 percent of Glaxo's sales last year, came as a relief to some investors. …[Bloomberg]
China fines Glaxo $492 million in bribery case … case involved 46 suspects, including its country manager … ordered to bribe hospitals, doctors and other medical institutions, thereby gaining "illegal revenue worth billions," the agency said …[LA Times]

Drugstores Become #1 Purveyor Of Vaccinations, Vaccines
- Who needs a doctor appointment to get a flu shot?
Drugstores, retailers dive deeper into vaccines … Walgreen provided enough flu shots last season to protect a population roughly twice the size of Los Angeles … CVS doled out more than 5 million, or double its total from a few years ago … push by retailers muscles into an area of health care that was once largely the domain of the family doctor …[USA Today]

Horizon Pharmaceuticals Shifts Headquarters To Ireland
- Forced into inversion by exorbitant US corporate taxes
Drugmaker Defies Democrats' Effort to Halt Inversions … shifted its corporate address to Ireland today, defying a threat by Democratic lawmakers to unwind such maneuvers retroactively … Horizon is the first company to complete an address change, known as an inversion, that risks being overturned if legislation submitted by congressional Democrats this year becomes law …[Bloomberg]

Accusation: India Dumps Substandard Pharmaceuticals On Africans
India's Poor Quality Drugs End Up in Africa, Study Finds … 17.5 percent of samples of the tuberculosis therapy rifampicin sold in Africa tested substandard, which means the drug has less than 80 percent of the active ingredient that it should. In India, 7.8 percent of the medicine sampled was substandard …[Bloomberg]

How New York State Determines If Medicaid Pts Deserve Sovaldi
- They can't be addicts, have to meet other qualifications
State health officials issue Sovaldi recommendations … advanced stages of the disease [hepatitis C] and those who have also been diagnosed with liver disease, H.I.V. and other conditions associated with hepatitis C infection would have the highest priority … "no signs of high-risk behavior such as alcoholism, drug use … Patients would have to submit to blood tests during their three- to four-month course of treatment …[Capital New York]

EU Green Lights Novo's Insulin + GLP1 Fixed Combo Diabetes Jab
Europe okays Novo Nordisk diabetes combo Xultophy … once-daily single injection combination of Tresiba (insulin degludec) and Novo's blockbuster Victoza (liraglutide). It is indicated for the treatment of adults with type 2 diabetes …[PharmaTimes]

FDA Panel Rejects Low T Pill
FDA advisers shoot down Clarus' pitch for a new low-T drug … advisers voted 18-3 against approving Clarus' treatment, Rextoro, raising serious concerns … Rextoro failed to prove itself effective, chiding Clarus for turning in incomplete data from the drug's two Phase III trials …[Fierce Pharma]

Merck Hypes Once Per Week DPP-4 Diabetes Pill
Merck's weekly DPP-IV on par with daily Januvia: study … patients did as well with 25mg of the experimental medication as they did with a daily 50mg dose of Merck's Januvia (sitagliptin) … [MM&M]

9/19 Trulicity, Once-Weekly Treatment for Type 2 Diabetes Approved; Pegged as Likely Blockbuster
FDA hands Eli Lilly a big win, OKs dulaglutide for diabetes .... Lilly's once-weekly treatment has thus far bested AstraZeneca's Byetta, Merck's Januvia and metformin in controlling blood sugar in Type 2 diabetes .... [Fierce Biotech]

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9/19 Fifteen Minute Man
Vivus' Stendra gets FDA approval for use 15 minutes before sex .... The erectile dysfunction drug Stendra, currently approved by the U.S. Food and Drug Administration for use 30 minutes before sex, has now been approved for use as little as 15 minutes before sex .... [Reuters]

9/19 Why All the Drug Chains Are Pushing Immunizations
How the Flu Shot Became the New Doorbuster Deal .... Pharmacies are trying to beat the competition to the punch by pushing flu shots long before flu season is on the radar of consumers .... [Money]

9/19 Yes, Compounded Avastin is Cheaper for Eye Injections, But is the Dose Correct?
Study Shows Inconsistent Dosages of Widely Used Eye Disease Drug .... Custom-made versions of a widely prescribed, low-cost drug used to prevent a leading cause of blindness in the elderly vary widely in their dosages, Weill Cornell Medical College scientists found in analyses of the eye injections .... [Weill Cornell Medical College]

9/19 Health Insurance Cost Squeeze Continues
Fortune 500 employees can expect to pay more for health insurance .... In a survey of chief human resource officers: 73 percent report having moved or will move employees to Consumer Directed Health Plans... 24 percent report ensuring that part-time employees work less than 30 hours weekly to avoid penalty .... [University of South Carolina]

9/19 Partners Hope to Get Opioid-Induced Constipation Market Moving
AZ faces market-making task to capitalize on Movantik's edge in OIC .... Movantik is not rival-free, but currently marketed competitors are either not approved for OIC, or, like Sucampo's Amitiza, work by another mechanism entirely .... [Fierce Pharma Marketing]

9/19 Patients on Insulin Have More Cardiovascular Events
Insulin Rx Tied to Increased Major Adverse CV Events in DM .... The overall five-year event rate of death/stroke/myocardial infarction was significantly higher in insulin-treated versus non-treated patients (28.7 versus 19.5 percent; P < 0.001). This difference remained even after adjustment for baseline factors, including angiographic complexity and revascularization treatment group .... [HealthDay News]

9/19 Where's HealthKit? Apple Holding It for More Work
Apple's HealthKit plagued by bugs and delay .... HealthKit, which has been developed with the prestigious Mayo Clinic in the US, gathers data such as blood pressure and weight from various health apps on Apple devices, and can be viewed by doctors at one place. Regulated medical devices, such as glucose monitors with accompanying iPhone apps, can also send information to HealthKit .... [Pharmafile]

9/19 Doctors Lose 48 Minutes Per Day Entering Data into Electronic Medical Records
Internists Report Considerable EMR-Linked Time Loss .... Most respondents reported that at least one data management function was slower post-EMR adoption (89.9 percent) and that note writing took longer (63.9 percent) .... [HealthDay News]

9/19 Study Supports Cannabinoid Spray for MS
Sativex Helps MS Spasticity in Objective Tests .... Mean scores on the modified Ashworth scale, which measures resistance to muscular stretching, for lower limb spasticity improved by 18.2% (SD 33.7%) in patients treated with Sativex for 4 weeks, compared with a 6.7% improvement (SD 26.6%) in patients using a placebo spray (P=0.029 for the between-group difference) .... [Medpage Today]

9/19 Internet Drug News Fast Takes:
A new kind of clinic helps 30-somethings avoid Alzheimer's
Advisory Board
Professional recommendations against routine prostate cancer screening have little effect
Henry Ford Health System
Merck KGaA Names Pharmaceutical Head Oschmann Deputy CEO
India's Poor Quality Drugs End Up in Africa
Why The Math Of The Ebola Epidemic Is So Scary

9/18 Plans Use Pharmacy Tiers to Drive Away Expensive Patients
How Insurers Are Finding Ways to Shift Costs to the Sick .... The Affordable Care Act bans insurance companies from discriminating against patients with health problems, but that hasn't stopped them from seeking new and creative ways to shift costs to consumers. In the process, the plans effectively may be rendering a variety of ailments "non-preferred"... .... [NY Times]

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9/18 Accompanying Medicines Drive Down Sovaldi Adherence
Rate of Sovaldi non-adherence points to need for patient support .... Researchers found that 8.1% of patients stopped taking the drug before finishing the regimen (prior to 12 weeks). While that number may not seem high on its own, it is quadruple what was observed in Sovaldi clinical trials .... [MM&M]

9/18 Panel Votes 20-1 to Slam the Brakes on Low-T Products
Testosterone Drugs May Need Further Study on Heart Risk .... Drugmakers should conduct new trials to assess the heart risks of testosterone therapies used by 2.3 million men last year .... [Bloomberg]

9/18 Deep Dive on How Drug Prices are Set
Drug pricing: A new prescription .... Rebates negotiated by payers (which are extremely secretive and occur when there are several drugs competing in the same category) bring down the net price of branded drugs to about 73 percent of the list price. By law, Medicaid gets further discounts from what payers get, bringing prices down to between 60 and 67 percent of the list price. .... [Boston Globe]

9/18 70,000 Children Hospitalized Each Year After Getting into Adult Meds
The 12 medications sending droves of kids to the ED .... 12 types of drugs accounted for more than 75% of the hospitalizations among all age groups. Three of the drugs were painkillers, while some of the others were for treating chronic conditions such as anxiety and diabetes .... [Advisory Board]

9/18 JAMA Study Outlines Best Practice for COPD
Combination Therapy Deemed Best for COPD .... A combination drug therapy of a long-acting beta agonist and inhaled corticosteroid appears to be the best treatment for older adults with chronic obstructive pulmonary disease (COPD), especially those with asthma .... [HealthDay News]

9/18 Bel-phen Touted as Safer Version of Fen-Phen
Doc Offers Glimpse Into Arena Pharma Weight-Loss Combination Therapy .... 12 weeks of the 800-calories-per-day diet regimen yields a similar, average 12% weight loss from baseline as the Bel-phen combination therapy in his study .... [The Feuerstein]

9/18 OK to Use Avastin, Skip Lucentis
Avastin safe in eye disease, says Cochrane .... Cochrane performed an analysis of nine clinical trials comparing the two drugs in the condition demonstrating that Avastin does not appear to increase deaths or serious side-effects compared with Lucentis, although there was a greater risk of gastrointestinal disorders in people taking Avastin .... [PMLiVE]

9/18 McKinsey Runs the Numbers on First-to-Market Advantage
First-to-market launch? Bonus--but double bonus if you're Big Pharma .... The first entrant tends to enjoy a bigger market share even 10 years later--6 percentage points higher than any rival, on average .... [Fierce Pharma Marketing]

9/18 Feds Want a Look at Ranbaxy's Pricing Data
Ranbaxy Medicaid Prices Questioned by Justice Department .... Drugmakers give Medicaid a discount on their products based on what they sell the drugs for elsewhere. It's up to drugmakers to report data that sets the discounts. .... [Bloomberg]

9/18 Internet Drug News Fast Takes:
Bad Vaccine Kills Up to 50 Children in Northern Syria
NY Times
Artificial Sweeteners May Disrupt Body's Blood Sugar Controls
NY Times
Blood Test Spots Adult Depression
HealthDay News
End-of-Life Care Needs Sweeping Overhaul, Panel Says
NY Times
Study identifies when and how much various prostate cancer treatments will impact urinary and sexual functioning
Fox Chase Cancer Center

9/17 State Sues Actavis Over 'Product-Hopping'
New York Files an Antitrust Suit Against the Maker of an Alzheimer's Drug .... New York State's attorney general filed an antitrust lawsuit on Monday seeking to stop a pharmaceutical company from forcing patients with Alzheimer's disease to switch to a new version of a widely used drug .... [NY Times]
See also: NY Attorney General Files Antitrust Suit Against Actavis Over Alzheimer's Pill [Pharmalot]

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9/17 Movantik Approved for Opioid-Induced Constipation
Nektar says FDA clears constipation drug Movantik .... Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by cancer .... [AP]

9/17 $500 Million Bet on Alzheimer's Drug
AstraZeneca, Eli Lilly to Partner on Risky New Alzheimer's Drug .... Drug could make up to $5 billion in sales but has just 9% success rate .... [WSJ]

9/17 Takeover Offer to Expand Men's Health Line
Endo offers to buy Auxilium Pharma for about $2.2 bln .... Auxilium's Xiaflex is marketed in the United States to treat men with bothersome curvature of the penis, a condition known as Peyronie's disease....Dublin-based Endo makes branded men's healthcare products including testosterone replacement therapy Aveed .... [Reuters]

9/17 In Northern Cameroon, Farmers and Their Cattle Take So Much Tramadol It Ends Up in the Tree Bark
Weirdly, Tramadol Is Not a Natural Product After All .... The farmers apparently take the drug themselves, at pretty high dosages, saying that it allows them to work without getting tired. Who decided it would be a good thing to feed to the cows, no one knows, but the farmers feel that it benefits them, too .... [In the Pipeline blog]

9/17 Home of Roche and Novartis Pushes for Cheaper Meds
Switzerland takes on its top drugmakers in price row .... Swiss per capita spending on pharmaceuticals is already significantly lower than that in other countries: at $562 it is almost half of the $1,010 spent in the United States and behind other European countries including Belgium, Germany, Ireland, France and Greece .... [Reuters]

9/17 Merck Has First PD-1 Inhibitor Approval, But BMS is Hard on its Heels
BMS striving to push Opdivo past Keytruda .... Keytruda's likelihood of receiving a first- line indication may spur BMS/Ono to more aggressively pursue its Opdivo (nivolumab)/Yervoy (ipilimumab) combo therapy .... [MM&M]

9/17 "Comb" Test May Be More Accurate Than PSA
Balding at 45 Spurs Higher Prostate Cancer Risks in Study .... Balding middle-aged men have a greater chance of getting aggressive prostate cancer later in life than those with a full head of hair, say researchers who suggest the result may one day help doctors predict the disease .... [MM&M]

9/17 Zinbryta Goes to FDA in 2015
AbbVie, Biogen to file MS drug next year .... Researchers found that 73% of Zinbryta patients were relapse-free after 96 weeks of therapy, compared to Avonex patients, of whom 59% were relapse-free within the same timeframe .... [MM&M]

9/17 Oxytocin-Blocker Could Be a Companion to Talk Therapies
Want more staying power in the bedroom? Drug that blocks the 'love hormone' could be the answer .... Treatment targets a hormone called oxytocin, which triggers ejaculation .... [Daily Mail]

9/17 Internet Drug News Fast Takes:
Urine test for cervical cancer virus offers alternative to smear
Schizophrenia not a single disease but multiple genetically distinct disorders
Washington University of St. Louis
Over a Quarter of Hospital Orders Classified As Defensive
HealthDay News
Baxter's Rixubis receives FDA nod
Drug Store News
Ebola outbreak 'out of all proportion' and severity cannot be predicated
University of Warwick

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