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Pharmaceutical News Harvest ™

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]

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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Massachusetts from implementing a ban on the sale of Zogenix's prescription painkiller Zohydro, saying federal law superceded the state's action ....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
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

4/14 Fast Takes
IMPAX Laboratories, Tries Again With Once-Rebuffed Parkinson's Drug Rytary
Impax Press Release
Laboratory-Grown Vaginas Implanted In Patients, Wake Forest University Baptist Medical Center Study
Pfizer CEO Takes On Additional Role, Becomes PhRMA Board Chairman
J&J says halting development of Botox rival
Biotech: Like Lambs to the Slaughter

France Wants To Be 1st Country To With Pharmacist Enabled Biosimilar
French plan to push copycat biotech drugs worries Big Pharma … France is going out on a limb with a plan to push the use of cheap copies of biotech drugs, triggering alarm … quietly introduced the measure allowing pharmacists to substitute prescribed brand-name biotech drugs with cheaper, similar versions in its 2014 healthcare budget … [Reuters]

Remember The Dying Kid Whose Media Savy Mom Shamed Chimerix To Get Experimental Drug
- The kid's getting better, but the CEO got fired
Chimerix CEO Out In Wake Of Josh Hardy Compassionate Use Media Frenzy … Moch and colleagues worked with FDA to get a 20-patient, open-label Phase III trial in place in a matter of a week … Josh was moved out of the ICU on to the transplant floor, which is huge!!!! Also the adenovirus blood results came back less than 100 log copies. Pretty much gone … CEO Kenneth I. Moch has been replaced and will be pursuing other interests … [Forbes]
Editor's Note: The getting better  report came from John's mom, not his doctors or Chimerix.

Resurgence In C Difficile Spurs Vaccine Gold Rush
-Sanofi, Actelion lead race for c. difficile vaccine
Deadly Bowel Infection Draws Drugmakers Seeking Cures … Clostridium difficile, linked to pain, fever, nausea and diarrhea, can add from $10,000 to $13,000 to a patient's costs … infection occurs when antibiotics disrupt the intestinal bacteria, leading to an overgrowth of C. difficile, which produce toxins that cause diarrhea and intestinal bleeding …[Bloomberg]
Editor's Note:  Fecal Transplant: According to a Mayo Clinic article, fecal transplant, a cheap alternative to expensive drug treatment is 90% effective in combating c. diff.  Fecal transplantation can be performed via nasogastric tube, nasojejunal tube, upper tract endoscopy, colonoscopy and retention enema.
See Also: Fecal Transplant Pills Effective for C difficile …[Medscape 10/3/2013]

Pharma Execs: Sunshine Law Didn't  Scared Docs Away From Us
PhRMA: Sunshine Not Driving Docs Indoors … Doctors haven't disengaged from drug companies in the months since the tracking of financial relationships … "We've seen virtually no change in the way we interact with physicians … no more hesitant to interact with pharmaceutical companies now that the law is in place …[MedPage]

India Pharma Seeks Right To Make Sovaldi Knock-Off
Natco seeks to block Gilead's hepatitis C drug patent in India - source …  the move could clear the way for the Indian company to launch a cheap generic version … Natco has opposed the patent on the  grounds that Sovaldi is not "inventive" enough … believes a 12-week course of treatment and diagnosis should cost no more than $500, saying a high cost would put the drug out of reach …[Reuters]

Drugs To Compete With Sovaldi Coming Soon
- AbbVie, Glaxo, Merck meds highlighted;
- Merck exec takes swipe at Gilead price point; Merck med taken 4 weeks longer
Merck Data Show Potent Rival to Gilead's Hepatitis C Pill … Merck's idea is that medicines don't work unless patients use them," … only major difference with Gilead's drug will be four weeks longer of treatment, … Merck's two-drug combination once-a-day pill stopped the virus in 98 percent of newly treated patients with few major side effects … [Bloomberg]
Doctors welcome hepatitis C drug rivals, Gilead still leads … Merck's product showed that 98 percent cure rate at 12 weeks  … AbbVie and Bristol-Myers Squibb are also developing all-oral hepatitis C treatments that have demonstrated cure rates ... [Reuters]
Editor's Note: PBMs whine about Sovaldi's price but remain silent about similarly priced cancer drugs, which  prolong patients' lives by a few weeks and produce horrible side effects.  Why are PBMs quiet about cancer drugs?  Does this have to do with do with the rebates PBMs force cancer med makers to cough up versus Sovaldi?  BTW, in 2012 Express CEO George Paz was the 6th highest paid CEO in the USA pocketing an astonishing  $51.5 million  paycheck.  Within the past 5 years, Paz has earned in excess of $100 Mln.  Who was the #1 paid CEO?  John H Hammergren of McKesson - $131.19 mil

In Defense Of Zohydro
- 63% of acute liver failure due to opiate + acetaminophen fixed combo
Let's Get The Zohydro Facts Straight …  Acetaminophen overdose is a leading cause of acute liver failure in the U.S. …  63 percent of unintentional acetaminophen overdoses attributed to drugs like Vicodin …  patient taking Vicodin 10 mg every four hours will have the same total daily dose of hydrocodone as a person taking Zohydro ER 30 mg every 12 hours … highest dosage unit of Zohydro is lower than the highest dosage unit of all the other available extended release products on a milligram basis …[PharmaPro]
Editor's Note: Zohydro is no stronger than oxycodone.  Oxycodone has been getting harder and harder to buy.  Zohydro is also going to be hard to buy.  Guess what's not hard to buy? HEROIN!  Pharma opiate junkies are turning to cheap easy to buy heroin in large numbers.  The thing about heroin is that it's more potent than oxycodone and hydrocodone and unlike pharma opiates, you never know how strong it is until you try it.   

4/11 Sibelius Leaving
Sebelius Said to Resign as U.S. Health Secretary .... The resignation of Sebelius, 65, is expected to be announced tomorrow..... Sylvia Mathews Burwell, 48, director of the Office of Management and Budget, will be nominated to succeed Sebelius .... [Bloomberg]

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4/11 Chain Makes Big Retail Clinic Purchase
Rite Aid acquires RediClinic .... RediClinics are staffed by board certified nurse practitioners and physician assistants, who are trained and licensed to treat common conditions and provide preventive services, in collaboration with local physicians who are affiliated with a leading healthcare system in each market.... RediClinic's clinicians are able to write prescriptions for more than 30 common medical conditions .... [Drug Store News]

4/11 New Merck Hep C Pill: 98% Virus Clearance Rate
Merck Data Show Potent Rival to Gilead's Hepatitis C Pill .... Merck's two-drug combination once-a-day pill stopped the virus in 98 percent of newly treated patients with few major side effects .... [Drug Store News]

4/11 What Drugs Cost Health Plans the Most?
Which brands grab the drug-spending title? AbbVie's Humira, AZ's Nexium lead the way .... Paying for Humira prescriptions costs $28.33 per plan member.... Enbrel, another anti-inflammatory, came in second at $22.57 per member per year .... [Fierce Pharma Marketing]

4/11 Cost of One Sovaldi Pill in U.S.: $1,000. Cost of One Sovaldi Pill in Brazil: $10.
Emerging Markets Pay 1% of U.S. Price for Gilead Sovaldi .... Developing countries such as Egypt, India and Brazil won discounts to pay 1 percent of the $84,000 price Gilead Sciences Inc. (GILD) is charging U.S. patients for its new hepatitis C drug .... [Bloomberg]

4/11 Disclosure Not Changing Doctor–Drug Company Interactions
PhRMA: Sunshine Not Driving Docs Indoors .... Interviewed drug company CEOs shook their heads "no" when asked directly if doctors seemed more hesitant to interact with pharmaceutical companies now that the law was in place. .... [Medpage Today]

4/11 Current, Chronic NSAID Users Have 76% Higher Risk of AFib
Certain Prescription Painkillers Tied to Higher Risk of Irregular Heartbeat .... A long-term study suggests that older people who use common prescription painkillers, including prescription-strength ibuprofen, may be increasing their risk for developing atrial fibrillation .... [HealthDay News]

4/11 Digital Pharma Ads Not Getting Traction
Patients are glued to iPhones and tablets, but pharma ads stick to TV .... Pharma's Internet ad spending dropped by 14.4% in 2013, to $59.8 million .... [FiercePharmaMarketing]

4/11 Tamiflu Stockpile Wasted $2 Billion
Researchers say Tamiflu a waste of money .... Published in BMJ, the researchers said that while the drugs could have an impact on flu symptoms, they were worthless in terms of containing a flu pandemic .... [MM&M]

4/11 First ACA Enrollees Are High-Needs Group
Express Scripts claims analysis: High usage of HIV/AIDS, Hep C, and pain meds among ACA enrollees .... Prescriptions for treating pain, seizures and depression are also proportionally higher in exchange plans .... [Medcity News]

4/11 Internet Drug News Fast Takes:
Scientists grow viable vaginas from girls' own cells
Lupin approved for generic Actos tablets
Drug Store News
CEO out at Chimerix soon after public outcry over experimental drug
News & Observer

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