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4/18
Fast Takes
FDA Grants Fast Track Status To Amgen Heart Failure Drug
Forbes
Teva, Pfizer settle patent lawsuit over painkiller Celebrex
Reuters
Penn & Teller Bitchslap Anti-Vaccine Activists
Youtube (warning: adult language)

4/18 China Flip Flops On Drug Price Control (Kinda Sorta)
- Drugmakers stopped making certain drugs when they couldn't make money off them
- Poster child was Tapazole; nationwide shortage when Commies set prices too low
China backs away from price controls on basic drugs … will loosen price controls on a list of "commonly used low-cost medicines", allowing pharmaceutical companies to set prices as long as the daily cost of taking the drug "remains in a certain range" … pharmaceutical companies had told Reuters they were unwilling to continue supplying loss-making products … "We stopped producing in June 2012 because the price was too low …[Reuters]

4/18
FDA Cracks Down On Opiate Labeling; No More Moderate Pain
- Black box reminds docs when, when not ; admits it's only a recommendation, docs have final say
FDA wants stronger warning labels for long-acting opioids … requiring labels of all long-acting opioids to say they should be used strictly for patients in severe pain … Currently, the labels indicate they are appropriate for patients with moderate and severe pain … DA has acknowledged the agency really has no ability to ensure that doctors actually restrict their prescriptions to patients with severe pain …[Reuters]

4/18
Study: Derms Are Suckers For Drug Samples
- Claims sample docs patients spend  $465 versus $200 for no-sample docs
Free samples of prescription drugs are costly to patients, study says … $6.3 billion worth of free samples  in 2011 … 25% of their [dermotologist] prescriptions came with a free sample … 79% of acne prescriptions in private practices were for name-brand or branded generic drugs, compared with 17% of prescriptions written by the academic dermatologists …[LA Times]
Editor's Note: Flawed methodology; authors fail to make the case that samples were the causative effect.  Academic docs in general write more generics than private practice docs; was it the really samples that made the difference?  Maybe it was another factor. Is it realistic to compare the prescribing habits of a Veterans Admin dermatologist to a 5th avenue dermatologist?   Read the article for yourself.  Article talks about the "harms of samples".  Really? Really? JAMA is anti-pharma.  In general, JAMA publishes negative articles regarding samples, sales reps, branded drugs, coupons, etc, yet they cheerfully accept millions of dollars from drug companies for advertising.  They never misses a chance to malign the industry; this is no exception. 

4/18
Diovan Quirk: Patent Expired, Price Increased,
Branded Product Still Going Strong
- Legal loophole empowers Novartis to charge 37% more than before patent expired
The Law of Gravity Isn't Working for This Off-Patent Drug …  safety concerns over Ranbaxy's factories in India have kept the company from selling its Diovan version. Since other drugmakers can't market their own generics until Ranbaxy's pill has been on sale for 180 days, Novartis continues to be the only seller of the heart pill in the U.S.--at a price that's 37 percent higher than what the company charged when the medicine was under patent …[Bloomberg]

4/18
Glaxo: 5 Bribery Scandals Later, Hypes Strategy To Take Incentives Away From Salesmen, Docs
GSK, facing bribery claims, battles to build new sales model … aims to become the first in the industry to stop paying outside doctors to promote its products, end payments for medics to attend conferences and delink incentives for sales representatives from individual sales targets …  insiders - say GSK's unilateral move risks putting it at a marketing disadvantage, particularly in emerging markets …intends to make much greater use of digital technologies, such as webcasts and webinars …[Reuters]


4/17
Fast Takes
Mylan Launches First Generic ORTHO EVRA® Patch
Mylan Press Release
Reckitt leans towards pharmaceuticals spin-off
Reuters
Antidepressant Use in Pregnancy Tied to Autism Risk
WebMD
IMPAX Launches Authorized Generic RENVELA®
BioSpace
Can Once Daily GLP-1 Lyxumia Be The Next Major Growth Driver For Sanofi?
Seeking Alpha
Ex-Sanofi Executive Gets 16 Months for Insider Trading
Bloomberg




4/17
Stolen Herceptin, Fake Herceptin Turns Up On Open Market
- Thought to be stolen from hospitals in Italy
Stolen Vials of Cancer Drug Reintroduced as Counterfeits… Vials of the cancer drug Herceptin probably stolen in Italy have been tampered with and reintroduced into the medicine supply chain, the European Medicines Agency said. … didn't say how much of the drug was stolen, or where and when it was taken.  … [Bloomberg]

4/17
Primary Care Docs:  16 Mins Per Patient, Other Interesting Stats
Survey finds pay doesn't make doctors happy …   55% said they spent 16 minutes at most ...42% pushed past the 17-mark … 72% said they "regularly or occasionally discuss the cost of treatment … orthopedists are the highest paid physicians ($413,000 per year … cardiologists who reported $351,000 …[MM&M]
Related: If Being A Doctor Is So Horrible, Why Are Med School Applications At A Record High? … [Forbes]

4/17
30,000 Foot View: Side Effect Profile, Efficacy of Diabetes Drugs
- Free Report; Data mining of FDA adverse data reporting database for  branded diabetes drugs
- Goes so far as to name the safest drug in each class
The Comparative Safety of Type 2 Diabetes Medications: … SLGT2 inhibitors are, as expected, associated with elevated  urinary infection risks but may also be linked to more serious events … GLP-1 and DPP-4 inhibitors (especially sitagliptin) have elevated associations with pancreatitis and pancreatic cancer, but  neither class appears to have strong links to presumed renal and  hepatic complications …[Fierce Pharma]
Editor's Note: FREE Download; sign-up required; 23 pages; 7,500 words; many statistics; suggested reading if you market a type 2 diabetes product; has relative risk data for all drugs, A1C lowering  potential of all NIDDM meds; not copy approved, do not use for promotion. 
See Also: New report finds Bydureon safest of new class of diabetes drugs … Janumet and Januvia from Merck Tradjenta from Boehringer Ingelheim and Eli Lilly ($LLY), and Nesina from Takeda, may be linked to more serious side effects than has generally been believed. It found that Nesina raised the most concern … [Fierce Pharma]

4/17
Glaxo New Once Weekly GLP1: Not Gonna Be Easy
Newly minted GlaxoSmithKline diabetes drug faces formidable foes in GLP-1 market … data doesn't give it an efficacy edge on Victoza, so its once-weekly dosing--compared with the Novo drug's once-daily schedule--is Glaxo's best talking point. But Bydureon is a once-weekly drug, too …[Fierce Pharma]

4/17
Cancer Drugs: Beginning Of End  Of Blank Check Mentality?
Cancer Doctors Plan to Compare Value of Expensive Drugs … world's largest organization of cancer doctors plans to rate the cost effectiveness of expensive oncology drugs, and will urge physicians to use the ratings to discuss the costs with their patients. … framework for a scoring system that will give doctors and patients options to discuss in determining how to proceed with care … [Bloomberg]

4/17
Former Novo Drug Rep, Murderer To Get New Trial (His 3rd)
- Judge allowed non-kosher evidence that swayed jury
Raleigh Convicted Murderer Jason Young Granted Third Trial … Young did not have charges filed against him for years until investigators said they had gathered enough evidence against him.  He first went to trial in 2011 and after a mistrial was declared, he was put on trial again in 2012 …  judge  made an error in the second murder trial when he allowed evidence to be entered into the criminal trial that was from a previous civil lawsuit … [Raleigh Telegram]


4/16 Albiglutide, Weekly Injection for T2DM OK'd
FDA approves GSK's Tanzeum to treat type 2 diabetes .... The once-weekly injection, generically known as albiglutide, was approved last month in Europe .... [Reuters]

4/16 Patent Law and Ranbaxy Troubles Hold Up Generics
Ranbaxy's Woes Add $900 Million to U.S. Heart Drug Costs .... While the Diovan patent expired in September 2012, the only company allowed to sell copies, Ranbaxy Laboratories, hasn't been able to manufacture and market them after four factories it runs in India failed U.S. inspections .... [Bloomberg]

4/16 Feds: Massachusetts Cannot Just Ban a Drug
US court reverses Massachusetts ban on Zogenix opioid .... A U.S. District Court judge has stopped Massachusetts from implementing a ban on the sale of Zogenix's prescription painkiller Zohydro, saying federal law superceded the state's action .... [Reuters]

4/16 Roche Shares Return 13% in 2013
Roche's Breast-Cancer Drug Sales Surge, Led by Perjeta .... Sales of Perjeta reached $202 million in the quarter, beating analysts' estimates.... Kadcyla's revenue was $116 million .... [Bloomberg]

4/16 ‘Sluggish Cognitive Tempo’ — Sounds Like ‘Monday’ to Me, But It Might Be the Basis for Whole New Batch of ADHD Prescriptions
Idea of New Attention Disorder Spurs Research, and Debate .... Yet now some powerful figures in mental health are claiming to have identified a new disorder that could vastly expand the ranks of young people treated for attention problems.... the condition is said to be characterized by lethargy, daydreaming and slow mental processing .... [NY Times]

4/16 Latest from IMS: Patients Heading Back to the Doctor’s Office
U.S. healthcare usage and spending resumes rise in 2013 .... Spending on medicines rose 3.2 percent in the United States last year to $329.2 billion. While that was far less than the double-digit increases seen in previous decades, it was a rebound from a 1 percent decline in 2012 .... [Reuters]
See also: Prices Soaring for Specialty Drugs, Researchers Find [NY Times]
See also: 2013 favored specialists, specialty Rx [MM&M]
See also: IMS: Spending on medicines up slightly on greater utilization of healthcare system [Drug Store News]

4/16 Novartis Job Cuts
Novartis marks 235 admin jobs for deletion amid companywide restructuring .... The Swiss drugmaker plans to lay off 215 administrative and support staff in New Jersey by the end of June, and another 20 in similar positions elsewhere in the U.S. .... [Fierce Pharma]

4/16 1 + 1 = 4 When Mixing Benzodiazepines and Opiates
Risks Of Popular Anxiety Drugs Often Overshadowed .... When Dr. Michael Kelley, a medical director at a Maine hospital, first took the job 15 years ago, about 75 percent of the detox patients were alcoholics, and the rest were drug addicts. Now, he says, 90 percent of them are drug addicts whose drugs of choice often include the combined use of opiates and benzos; both are sedatives that can slow respiration .... [NPR]

4/16 Internet Drug News Fast Takes:
Obamacare's surprising effect on car insurance
Advisory Board
Cheaper 'Gene Panel' Screening May Reveal Cancer Risks
HealthDay News
Walgreen pressured to move headquarters to Europe
MedCity News
Johns Hopkins Bloomberg School of Public Health Researchers Find Association Between SSRI Use During Pregnancy and Autism and Developmental Delays in Boys
Johns Hopkins
FDA Formally Withdraws Approval for Second Generic Version of Popular Antidepressant
Regulatory Focus
Pre-Diabetes and Diabetes Nearly Double Over the Past Two Decades
Johns Hopkins



4/15 Another Oral Hayfever Drug OK'd
Merck's grass pollen allergy drug wins U.S. approval .... Grastek contains extracts of the timothy grass allergen. The tablet is placed under the tongue and dissolves .... [Reuters]

4/15 Romney's Old Firm to Profit from Substance Abuse
Bain Capital sees opportunity in methadone clinics .... The Boston-based private equity firm recently took over Habit OPCO Inc., the largest chain of substance treatment facilities in Massachusetts, with 13 locations from Boston to Springfield. Bain paid $58 million to acquire the for-profit centers .... [Boston Globe]

4/15 Full Court Press on Diabetes Patients
With new health law, insurers target diabetics .... Insurers have gotten savvy figuring out patients who skip appointments or aren't taking their medicine, and many have customized plans for diabetics that offer everything from pharmacy home delivery services to home health aides. .... [AP/Yahoo]

4/15 Single Daily Pill, No Ribavirin, Eliminated Hep C in 94–99% of Patients
Trials Advance Hunt for All-Oral HCV Tx .... A single-pill combination of two drugs for hepatitis C (HCV) had impressive results in two large studies, with cure rates ranging from 94% to 99% .... [Medpage Today]

4/15 New Hep C Medicines a Bargain Compared to Alternatives
Drugmaker Studies Find a Bargain in $84,000 Medicine .... Older approaches required injections of two medicines, the immune-system booster interferon and the antiviral ribavirin, for as long as a year, causing side effects including flu-like symptoms and anemia. Combined with Vertex Pharmaceuticals Inc.’s Incivek, those treatments cost almost $200,000 per cure .... [Bloomberg]

4/15 Off the Shelf and on to the Home Screen
PDR expands its services beyond the book .... 70% and 80% of doctors are using "some form of EHR technology," and end up looking at [EHR screens] "five to seven hours a day".... PDR's reach currently includes 65,000 active EHR prescribers .... [MM&M]

4/15 Reyataz + Cobicistat Combo
Bristol-Myers Squibb seeks FDA approval for combination of Reyataz, Gilead Sciences' cobicistat .... fixed-dose combination of the protease inhibitor Reyataz (atazanavir) and Gilead Sciences' pharmacokinetic enhancer cobicistat for the treatment of HIV-1 infection in combination with other therapies .... [First Word Pharma]

4/15 Spending on Cholesterol-Lowering Drugs Dropped 14% in 2013
The Cost to Treat Cholesterol Plummets, But Will It Last? .... For now, the effect on spending by a bump in prescriptions won't be great, but if PCSK9 drugs become available, their ostensibly higher prices could blunt cost savings from the shift to generic statins, especially if the American Heart Associations' projection that roughly 40% of the population will suffer from some form of cardiovascular disease by 2030 prove correct .... [Motley Fool]

4/15 23% of Pregnant Women on Medicaid Filled Opioid Script in 2007
Surge in Narcotic Prescriptions for Pregnant Women .... In the study of women enrolled in Medicaid, 41.6 percent of pregnant women in Utah were prescribed opioids, and 35.6 percent in Idaho. Oregon had the lowest, at 9.5 percent, with New York at 9.6 percent. .... [NY Times]

4/15 Whistle-Blower's Story
Drug firms have used dangerous tactics to drive sales to treat kids .... A Denver Post investigation into antipsychotic use found that foster children were prescribed the potent mood-altering drugs at a rate 12 times higher than that of other children on Medicaid in Colorado in 2012. .... [Denver Post]

4/15 National Patterns in Prescribing for Macular Degeneration
These maps tell you everything that’s wrong with our drug pricing system .... The map below shows how much Medicare spends per beneficiary on drugs that are administered in medical settings .... [Washington Post/Wonkblog]

4/15 Internet Drug News Fast Takes:
Akorn gets U.S. approval to buy Hi-Tech Pharmacal, with conditions
Reuters
Study says we’re over the hill at 24
Simon Fraser University
Prenatal SSRI Exposure May Up Odds of Autism in Boys
HealthDay News
Lexicon Pharma's diabetes drug successful in mid-stage study
Reuters

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