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Fast Takes
Citrus fruit linked with melanoma in preliminary study
FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data
Ed Silverman; Pharmalot
Pharma may cut off Greece if they don't start paying their bills
TriCalm® Launches Two Non steroid Anti Itch Products
Company Press Release
China: The Future Of Pharmaceutical Industry Innovation?

6/30 Nurse Pleads Guilty; Narcotic Prescription Payola; Subsys (Fentanyl)
- They bribed her with speaker fees and fancy dinners
APRN Admits Receiving Kickbacks from Drug Company for Prescribing Pain Medication … majority of these dinner programs, ALFONSO did not give any kind of presentation about the drug at all …  paid ALFONSO as a speaker for more than 70 dinner programs at a rate of approximately $1,000 per event.  In many instances, the dinner programs were only attended by ALFONSO and a sales representative … programs were attended by individuals, including office staff and friends, who did not have licenses to prescribe controlled substances … [U.S. DEPARTMENT OF JUSTICE]
Related: Doubts Raised About Off-Label Use of Subsys, a Strong Painkiller … Subsys, is a form of fentanyl, a narcotic that is often used when painkillers like morphine fail to provide relief. The product was approved in 2012 for a relatively small number of people -- cancer patients -- but has since become an outsize moneymaker for the obscure company that makes it …[NY Times]

6/30 German Merck Grapples: To Pharma Or Not To Pharma
- 70% privately owned company; could jettison pharmaceuticals althoether
A Makeover at the 'Other' Merck …   70% is owned by the Merck family through the partnership E. Merck KG …  U.S. connection could also give Merck a final shot at saving its beleaguered pharmaceuticals division. The company is teaming up with Pfizer Inc. to develop and commercialize a new tumor treatment …[WSJ]

6/30 Novartis Hypes Efficacy Of Its New Monoclonal Antibody For Plaque Psoriasis In Other Ailments
-COSENTYXTM (secukinumab);  $4,700 per two pen pack
New data fuel hopes for broad use of Novartis psoriasis drug … approved by the U.S. Food and Drug Administration in January for treating the painful skin condition plaque psoriasis …  showed the drug acting rapidly on psoriatic arthritis and, significantly, that its efficacy was sustained over one year … psoriasis and one-year effects in ankylosing spondylitis …[Reuters]

6/30 Supremes: Midazolam Kosher For Killing People
Supreme Court Says Use Of Lethal Injection Drug Is Legal …  death penalty states have turned to midazolam, which hasn't been approved by the FDA, to put people into a deep, coma-like stat … while the second and third drugs were painful, the first drug, rendering the prisoner deeply unconscious, would prevent any great risk of pain …[NPR]
Editor's Dose: Why not use halothane? Or chloroform? Or ether?  Why not use fentanyl?  You give them a 60 ml IV push of fentanyl 0.5mg/ml and they ain't waking up.  If you really want to send them off softly, add 200mg of heroin.  OR why not cyanide like the Nazis used to commit suicide.  Cheap, effective and works in seconds. 

6/29 Fast Takes
7 Diseases You'll Probably Have By Age 50
Yahoo Science
Middle Age Memory Failures Can Predict Alzheimer's 18 Years Before Diagnosis
Supreme Court Saves Obamacare a Third Time, But Big Challenges Remain
Motley Fool

Lilly Alzheimer's Drug Had Questionable Beginning
- Read about the cave of solitude where statisticians decide if a drug works
Deep in 'the Cave,' Lilly's CEO Decided Alzheimer's Drug's Fate … glimmer of efficacy seen in three years ago will either strengthen, or vanish like so many that had gone before it. … One group of patients -- those who started taking the drug when their disease was only mild or moderate -- was deteriorating slower than expected …[Bloomberg]

California Bans Most Vaccine Exemptions
California Passes Bill to End Vaccination Exemptions …  unvaccinated children without a medical exemption would have to study at home or in organized, private home-schooling groups. … would make California the third state to eliminate religious and other personal vaccine exemptions … [NBC]

Afrezza 5 Months Post-Launch Not too impressive but it could be worse
- Social media tsunami, most of it positive but dosing could be issue
MannKind's Afrezza: Another Look At The Early Adopters' …  majority of Afrezza users who have posted details at Tu about their use of the inhaled insulin have written of very positive results. However, not all of the early adopters have had success with Afrezza … investors believe that the Sanofi DTC will prove that the diabetic community will embrace Afrezza …[Seeking Alp-ha]

Drugs From Human Feces Bacteria & The Biotech Bubble
Investors Think This Company's Gut Bacteria Are Worth $1.9 Billion … Shares of Seres Therapeutics, a company trying to create new medicines from the bacteria in the human gut, nearly tripled in their first day of trading on Friday, giving the company a first-day market cap of $1.9 billion …[Bloomberg]

Payors' Hair On Fire Over New Cholesterol Jabs
- PCSK9 will burn through money faster than Hepatitis C Pills
Merck cancer drugs and Sanofi, Amgen cardio meds have formularies on high alert … According to Formulary Journal, payers think that even if PCSK9 inhibitors are prescribed only for a narrow patient population, that costs for the drugs could surpass the astronomical amounts of money that Sovaldi generated in its initial launch …[Fierce Pharma]

Veggies & Proteins 1st, Then Carbs:  Recommended Diabetics Chow Down
Order of food during a meal may influence blood sugar … Overweight and obese people with type 2 diabetes may feel better after a meal if they start it off with vegetables or proteins and end with the carbs, suggests a new study of 11 people.

Blood Pressure Drugs Good Alzheimer's Bad
Why Higher BP May Protect Against Alzheimer's Risk … link may be due to the antihypertensive medications more than the high blood pressure itself. John Kauwe, a co-author of the study, concluded "we need to take a serious look at them for Alzheimer's prevention."…[Monthly Prescribing Reference]

Horizon Pharma In Play
- It's getting a bit frothyi in here n'est-ce pas?
Horizon Pharma Seen In Deal-Making Mode … With a market cap just over $5 billion, however, Horizon is at least $9 billion smaller than other acquisitive specialty pharma companies … turned down nearly 30 deals this year as it continues on the hunt for drug acquisitions …[Investor's Business Daily]

Watch Valeant Become The Berkshire Hathaway Of Drugs
Valeant Pharmaceuticals And Zoetis: A True Mega Deal Is On The Horizon … At their current pace of acquisitions, drugmakers like Allergan and Valeant are poised to soon eclipse industry giants such as GlaxoSmithKline, Lilly and Bristol Meyers in market cap … once an industry afterthought mired in operational problems, are nipping on the heels of large drug-makers …[Forbes]

Fast Takes
5 drug categories having the biggest impact on pharma spending
Formulary Watch
Bristol-Myers to stop new antiviral drug research
Half of US Hispanics unaware they have high cholesterol
Egalet's Abuse-Deterrent, Extended-Release Morphine Demonstrates Bioequivalence
Company Press Release

Cymbalta Lawsuit: Lilly Jury Trials Regarding Discontinuation Syndrome Called "Brain Zap"
Lilly Facing First Trials Over Cymbalta Withdrawal Symptoms … downplayed Cymbalta's withdrawal side effects, which allegedly include electrical-shock sensations described in court filings as "brain zaps." Other withdrawal effects are said to include nausea, vomiting and insomnia …  bid to have former Cymbalta users' lawsuits thrown out was rebuffed by a federal judge …[Bloomberg]

Daiichi Sankyo's bloodthinner Lixiana gets EU OK
Daiichi Sankyo's bloodthinner Lixiana gets EU OK … Lixiana (edoxaban) is a once-daily selective factor Xa-inhibitor which, in clinical trials, was shown to have comparable efficacy to veteran anticoagulant warfarin but with a superior safety profile …[Pharma Times]

Wall Street Punishes Pfizer Over Viagra Cancer Link
Pfizer Stock Falling on Study Possibly Linking Viagra to Melanoma … study found that men who took these drugs had a 21% higher chance of developing melanoma compared with men who did not take these drugs … While there is an association, a cause-and-effect relationship remains unclear, the Journal noted …[The Street]

Valeant Looks To Gobble Up Another Drug Company - This Time Veterinary
- 800 pound gorilla of animal meds was spun off from Pfizer in 2013
Valeant makes takeover approach to Zoetis … preliminary approach to buy animal-health giant Zoetis …  isn't clear what the company's reaction to the approach was, if any, or whether it is open to a sale …[Market Watch]
Editor's Note: Zoetis is estimated to be worth $24.85 billion.  Zoetis is the world's largest  producer of medicine and vaccinations for pets and livestock.

Off Label: Free Speech Or Criminal Act?
FDA sued by drug manufacturer over constitutional right to discuss off-label uses … In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent … [Lexology]

Fast Takes
Connecticut man gets eight years for breaking baby daughter's limbs
FDA Expands indications for Eisai's Fycompa (severe epileptic seizures)
Pharma Times
For Vitiligo Patient, Arthritis Drug XELJANZ® (tofacitinib citrate) Restores Skin Color
The top 10 patent losses of 2015
Fierce Pharma

FDA: Daytrana Can Cause Permanent Loss Of Skin Color
Calling all ambulance chasers!
- Not necessarily in area where patch was applied
FDA Drug Safety Communication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD … patients also reported skin color changes on parts of the body where the patch was never applied. In all cases, the decreased skin color was permanent …[FDA]

Abbott Hypes Stunning Efficacy Data For Its Hep C Treatment
- 1B Hep C patients get 100 percent (n=60/60) sustained virologic response at 12 weeks
AbbVie Announces New Phase 3b Results In Genotype 1b Chronic Hepatitis C Patients With Compensated Liver Cirrhosis … Genotype 1 is the most common type of HCV genotype, accounting for 60 percent of cases worldwide 3 and in Europe, the most prevalent genotype is 1b (47 percent) …[AbbVie Press Release]

Sickle Cell Drug: Pfizer Launches Phase III Trial
Pfizer kicks off PhIII sickle cell trial … orphan drug rivipansel as a treatment for sickle cell disease patients hospitalised with vaso-occlusive crisis, a common and very painful complication of the condition …[Pharma Times]

Pre-Diabetes?  What Does That Mean?
You Have Prediabetes -- Now What? … People without diabetes have a normal HbA1c reading of 5.7 percent; those with prediabetes often have a range of 5.7 to 6.4 percent. Beyond that is full-blown diabetes … 30 percent of people with prediabetes will develop full-blown Type 2 diabetes within five years …[US News & World Reports]

New Antidepressant Announcement? Press Releases Ain't Science
Hope And Hype For New Type Of Antidepressant … D-cycloserine, was originally developed as a treatment for tuberculosis. Now, the brothers, Jonathan (CEO) and Daniel (scientist) Javitt, have founded a new company, NeuroRx, to develop it as an antidepressant …All findings could be due to placebo effect … [Forbes]
Related: Study shows drug combination can treat bipolar depression …[Reuters]

Obamacare 5 Years Old -- Docs Warming Up
- Approval ratings rise steadily
In ACA's Fifth Year, Doctors Warm To Obamacare … 83% of doctors in the Medicus survey now say health reform is working, giving the ACA a passing grade of A, B, C or D…[Forbes]

Study: Part D Fraud Rampant
- Pharmacists bill Medicare $2.3 Bln; too many questionable claims
Fraud Still Plagues Medicare's Prescription Drug Program …More than 1,400 pharmacies had questionable billing practices last year in the drug program. Some billed for extremely high numbers of prescriptions per patient and others billed for a high proportion of narcotic controlled substances. Collectively, they billed Part D $2.3 billion in 2014 …[NPR]
Editor's Note: Above report cites patterns of questionable prescriptions for  Solaraze, Vascepa and Lovaza; which seem to be high in certain locations such as New York and Los Angeles.

Fast Takes
More Than Two-Thirds of Americans Are Overweight or Obese
Live Science
Cancer drugs get a new consumer's guide
LA Times
BMS melanoma cocktail would gain heft in melanoma space, say analysts
A Bill Would Prevent Drug Makers From Frustrating Generic Rivals

Sanofi: Former CEO Gets New Job As Venture Capitalist Kingpin
- Fired? Perhaps but laughing all the way to the banco
Former Sanofi CEO Reinvents Himself With Bertarelli Fund … Sometimes when you're CEO, you are not sure whether you are running the company or the company's running you … wanted to do something more entrepreneurial, … declined to comment on whether he was approached about leading other drugmakers  …[Bloomberg]

JAMA Meta Analysis: Sorry Ambulance Chasers; Viagra Probably Doesn't Cause Melanoma
- All about the life style, bout the life style, bout the life style
Report: Viagra Doesn't Cause Melanoma But The Viagra Lifestyle Might … It's not Viagra and other ED drugs that cause melanoma, but rather the lifestyle and socioeconomic characteristics of the typical patient--the tendency to vacation in sunny climes, for example …[Forbes]
Use of Phosphodiesterase Type 5 Inhibitors for Erectile Dysfunction and Risk of Malignant Melanoma … pattern of association (eg, the lack of association with multiple filled prescriptions) raises questions about whether this association is causal … [JAMA. 2015;313(24):2449-2455. doi:10.1001/jama.2015.6604]

JAMA: Medical Weed: Pain, Spasticity Yes; Everything Else, Probably Not
Most uses of medical marijuana wouldn't pass FDA review, study finds … very little reliable evidence to support the drug's use. The review .. Patients who use medical marijuana to treat chronic neuropathic pain or cancer pain would probably have the least to fear from FDA …[LA Times]
Cannabinoids for Medical Use A Systematic Review and Meta-analysis … low-quality evidence suggesting that cannabinoids were associated with improvements in nausea and vomiting due to chemotherapy, weight gain in HIV infection, sleep disorders, and Tourette syndrome …[JAMA. 2015;313(24):2456-2473. doi:10.1001/jama.2015.6358]

CNBC Commenmtary Skewers Generic Substitution
- Inert ingredients different, FDA cool with not enough or too much active ingredient
Two big problems with generic-drug substitution … Generic drugs only have to meet the standard of 80 percent to 125 percent of the bioavailability of the referenced drug … not required to have the same inactive ingredients posing problems for people with sensitivities, and creating more variance in quality control  …[CNBC]

Fast Takes
Pradaxa antidote works: Bayer
Vical's Herpes Vaccine Fails company's shares down 47%
Gardasil 9 Effectively Stops 90% Of Cancers Caused By HPV In Girls and Boys
FDA sued by drug manufacturer over constitutional right to discuss off-label uses

Illegal drugs (Spice, Bath Salts), Precursors Online: Chinese Gov Looks The Other Way
- Policy of salutary neglect; Mexican cartels good customers
In China, Illegal Drugs Are Sold Online in an Unbridled Market … open online drug market is just the most blatant example of what international law enforcement officials say is China's reluctance to take action as it has emerged as a major player in the global supply chain for synthetic drugs …  leading producer and exporter of synthetic drugs, including methamphetamine, as well as the compounds used to manufacture them …[NY Times]

Survey: Shire Most Reputable Drug Company
- Sanofi Boehringer close behind
Shire tops US reputation survey … report used over 50,000 consumer rankings to measure the public's perception of pharma firms based on seven dimensions … Sanofi, Bayer and Boerhinger Ingelheim were close behind …[Pharma Times]

Medical Marketing & Media Healthcare Marketing Finalists Next Month
The MM&M Award 2015 Are Here … prestigious MM&M Platinum Award for Outstanding Contribution to Healthcare, this year's enhancements include two more--Best New Product Launch and MM&M Titanium Award for Best in Show. … no greater accolade in healthcare marketing than winning an MM&M Award …[MM&M]

Breaking Bad IN REAL LIFE -  Merck Scientist Busted For Cooking GHB
Scientist charged with making drugs in his Springfield home faces drug charges after receiving a large delivery of a chemical commonly used to synthesize GHB …  being held on $200,000, charged with manufacturing the recreational with intent to distribute …[]

Asco: Alimta Worthless For Lung Cancer
Avastin (bevacizumab), Jevtana (cabazitaxel)  Not Much Better

Drug Costing $9,200 Scores Zero on Cancer Doctor Value Scale … leading group of U.S. cancer doctors created a scoring system for oncology drugs, awarding a zero for overall benefit to the $9,200-a-month regimen featuring Eli Lilly & Co.'s Alimta.

More Adults Are on ADHD Drugs Than Kids
More Adults Are on ADHD Drugs Than Kids …  Adults in the U.S. have overtaken children in taking medication for the condition and accounted for 53 percent of the industrywide 63 million prescriptions for ADHD drugs last year, according to data compiled by Shire …[Bloomberg]

Glaxo Sells 2 Older Meningitis Vaccines To Pfizer for $131 Mln
GSK sells two vaccines to Pfizer to ease competition concerns …  GlaxoSmithKline has agreed to sell two meningitis vaccines to Pfizer to satisfy antitrust concerns after its recent acquisition of vaccines business of Novartis … Nimenrix and Mencevax …[Reuters]

Prophylactic Blood Thinner For Angioplasty Approved After 10 Years
FDA approves Medicines Co's blood clot drug after a decade … Cangrelor, also known as Kengreal, is an intravenous therapy aimed at preventing blood clots in patients who need percutaneous coronary intervention (PCI) or angioplasty, ...hit the market as early as July …[Reuters]

Fast Takes
These are the Fortune 500's fastest-growing pharma companies
Gilead Sciences: New Harvoni Prescriptions Decelerate
8 accused of selling millions of counterfeit 5-Hour Energy drinks
LA Times

AZN Wins Medal For Talking Fish Head Commercials
AstraZeneca wins Pharma Grand Prix at Cannes … AstraZeneca's "Take it from a Fish" integrated digital campaign, whose elements included a series of videos in which two talking fish carry on a conversation about triglycerides, won the category's top prize …[MM&M]
Editor's Note: They so recycled a scene from the Sopranos Season 2 finale where Tony has a conversation with a talking fish in a dream sequence.  Click here to watch the 2007 Sopranos talking fish episode.  (AZN used striped bass and the Sopranos used red snapper).

Gilead: China Refuses To Grant Solvaldi Patent
Gilead Patent for its Sovaldi Hep C Drug is Rejected by Chinese Authorities … rejection could, eventually, lead to lower-cost generics in China and elsewhere, since China is a large provider of pharmaceutical ingredients to companies around the world …[Pharmalot]
China Rejects Gilead's Sovaldi Patent Application … ruled that this prodrug was developed using previously published techniques and didn't meet the "new and non-obvious" requirement for a patent … second patent on sofosbuvir in China may also be subject to legal challenges …[Benzinga]

FDA: Generic Drugs Should Look Similar to the Drugs They Knock Off
Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says … recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference … [Regulatory Affairs Professionals Society]
See AlsoSize, Shape, and Other Physical Attributes of Generic Tablets and Capsules Guidance for Industry …[FDA]

Teva Buys Chunk Of Mylan As Part Of Hostile Takeover Strategy
Teva takes 4.6 percent stake in Mylan as part of bid … action gives Teva standing in the Dutch Courts, specifically the Dutch Enterprise Chamber that oversees acquisitions, if a legal challenge related to its efforts to buy Mylan becomes necessary.… [AP]

AZN: Diabetes Is Our Future
AstraZeneca and its diabetes plans … A year after Pfizer tried and failed in its takeover bid for AstraZeneca, the Anglo-Swedish firm says that diabetes will help it maintain its independence … diabetes portfolio includes several big drugs for type 2 diabetes …[PM Live]
Editor's Note: Mentions Sanofi, Afrezza, Exubera, Novo, Forxiga, Onglyza, Byetta, Bydureon.  If you work in the diabetes market you need to read above article.

Pharma Is  An Amateur When It Comes To Mobile Internet
Mobile's role in healthcare is still experimental … outside players such Apple, Google and Samsung moving into the industry at a speed healthcare and pharma have not been used to …  the start of the new digital and mobile health economy …[MM&M]

LOL: North Korea Claims It Has Cure for MERS, Ebola and AIDS
North Korea Claims It Has Cure for MERS, Ebola and AIDS … official Korean Central News Agency said scientists developed Kumdang-2 from ginseng grown from fertilizer mixed with rare-earth elements …  According to the pro-North Korea website Minjok Tongshin, the drug was originally produced in 1996 …[NY Times]

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