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Pharmaceutical News Harvest (TM) for Friday April 17th

4/17 FDA approves AB Rated Generic Copaxone 20mg
Generic Version of Copaxone, Multiple Sclerosis Drug, Is Approved …  two-thirds of patients using Copaxone have already switched to the new version, which has patent protection that lasts for many more years. … 20 mg generic version of the blockbuster drug could be labeled "substitutable," meaning prescriptions for Copaxone could be automatically switched to the generic … [NY Times]

4/17 Fast Takes
Amgen motion to delay Neupogen biosimilar denied
Teva may face disgorgement in Provigil (Modafinil) pay for delay
Walgreen, Others Sue Over Alleged Aggrenox Pay-For-Delay
Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman

FDA Approves Generic Copaxone, but When Will it Become Available?
- Lawsuits may delqay launch of generic version of $72K per year treatment for MS
FDA Approves Generic Copaxone, but When Will it Become Available? … patent lawsuit is ongoing. A federal appeals court is reviewing whether a key Teva patent, which expires in September, is valid. If the patent is upheld, Sandoz would have to decide whether to risk another lawsuit - and potentially substantial damages - by selling a generic before September …[Pharmalot]

Proton Pump Inhibitors Increased Relative Risk Of Kidney Failure by 200%
Common heartburn drugs linked to kidney failure in the elderly … patients taking proton pump inhibitors [such as Nexium] are two times more likely to be hospitalized with kidney failure … hospitalization rate of 13.49 per 1,000 persons per year …[AP]

Analysts Expect More Takeover In Generic Drug Sector
Teva, Actavis, Other Generic Drugmakers May Be on Acquisition Trail … trail of consolidation has left 11 publicly traded generics companies in its wake, versus 27 six years ago …  Teva controls over 12% of the generics market. Mylan has 8%, and Actavis has around 7%. … if Teva were to acquire Mylan, the buyer would gain pricing power as the largest generics company in the world … [The Street]

Analyst Greatly Reduces Sales Expectations For Afrezza ([Insulin Human] Inhalation Powder)
- Predicted $46 Mln this tear, doubtful it will break $5 Mln
What's Afrezza's Ultimate Potential For MannKind? … lowered his Afrezza sales forecasts for 2015 to $5 million (from $46 million), for 2016 to $118 million (from $150 million), and for 2019 to $539 million (from $845 million) peak sales are now forecasted in the $2 billion to $3 billion range versus $4 billion  …[Benzinga]

Forbes: Media May Have Been Too Tough On Merck, Zetia
- Maybe it wasn't as bad  as they made it out to be
How Marketing And Media Muddled The Truth About The Heart Drug Vytorin … were patients harmed by aggressive news coverage? …  at least some heart patients - those who have had a heart attack and have chest pain - adding ezetimibe to an older cholesterol drug, Merck's Zocor, reduced the risk of heart attacks and strokes …[Forbes]

Pain Drug Maker Gets DOJ Subpoena And Stock Takes Nosedive
- Did they push the marketing envelope too far regarding off label?
Pacira Receives Subpoena from the U.S. Department of Justice … received a subpoena from the U.S. Department of Justice, U.S. Attorney's Office for the District of New Jersey, requiring the production of a broad range of documents pertaining to marketing and promotional practices related to the product EXPAREL® (bupivacaine liposome injectable suspension) …[Pacira Press Release]
The government is asking questions about this pharma company's painkiller and now the stock is getting crushed … [BusinessInsider]
Editor's Note: Exparel is indicated for use in bunionectomy hemorrhoidectomy only.  Last September Pacira got a warning letter regarding promotional items that may have suggested that Exparel is good to use on various other surgical procedures.

FDA Approves Amgen CHF Med Corlanor (ivabradine)
- Slows heart rate at sinoi-atrial node without blocking beta receptors
FDA approves Corlanor to treat heart failure …  indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate …[ FDA]
Editor's Note: According to the NY Times, a month supply of Corlanor will cost $375.
See Also: Amgen Press Release | Fact Sheet (MOA, Dose, Satudies) |
Related: SHIFT: Adding HR-slowing agent ivabradine to HF meds cuts mortality, hospitalization … reduction of heart rate contributes significantly to beneficial outcomes in patients with heart failure. It appears therefore likely that heart rate is not only a risk factor but may well be a mediator of the progression of heart failure … [TheMedscape Cardiology]

More Effective Than Plavix (prasugel) New Clot Preventer Gets FDA Panel Nod
FDA panel votes in favor of Medicines Co's blood clot preventer … panel voted 9-2 to support the approval of the once-rejected injection, cangrelor, for use in some patients undergoing angioplasty …  more effective in lowering the risk of death, heart attack, repeat procedures and stent thrombosis …[Reuters]

New Cystic Fibrosis Drug: $820/Day Per Patient For The Rest Of Their Life
- $300K per year; there are 8,500 cystic fibrosis patients in USA who could benefit from this drug
- Unlike Hep C pills, it's a treatment not a 12 week cure; how will PBM's react?
Will a New Vertex Drug for Cystic Fibrosis Become a Budget Buster? …  it may cost as much as $4.5 billion annually for the nation's health care system to pay for a combination medicine that includes Kalydeco - an existing and treatment sold by Vertex Pharmaceuticals VRTX +0.37% - along with another Vertex compound. …[Pharmalot]

Fast Takes
Acetaminophen may dull your emotions
Parents sue Botox maker after woman with cerebral palsy dies
Walgreens Continues Pay Hike Freeze for Senior U.S. Executives
NY Times

So Simple An Idea; Why Didn't You Think Of This and Make Millions?
- Mail-order pharmacy dispenses meds in pre-sorted customized blister packs
Pharmacy Startup PillPack Could Change The Way America Takes Its Medicine … instead of sending all the Lipitor in one bottle and the Viread in another, pills are sorted together into clear plastic wrappers printed with the date and time at which they should be taken …[Forbes]
PillPack Launches Service in California to Reinvent the Retail Pharmacy Experience … PillPack, the pharmacy that simplifies medication management, has launched its service in California. Customers can now receive a personalized roll of pre-sorted medications, including prescriptions, over-the-counter medications, and vitamins, delivered in individual packs organized with the date and time to take the pills, replacing error-prone pillboxes and manual solutions …[Company Press Release]
Editor's Note: He is either going to get bought out by Express or CVS or he will get squashed like a bug.  I hope  he gets bought out.

Feds to Probe Impact of Generic Drug Price Increases on Medicaid
- Want to know why generic drug prices are skyrocketing; generic drumakers respond with glib remarks
Feds to Probe Impact of Generic Drug Price Increases on Medicaid … prices for generics sold through retail pharmacies increased 37% from the previous quarter and that prices for certain generic drugs had risen over the past year by as much as 1,000% or more … asked 14 generic drug makers to provide pricing data, but the companies did not do so …[Pharmalot]

Onglyza, Nesina DDP4s To Get Warning Regarding CHF, Use In Renally Impaired
Related: Analysis of Post-Marketing Cardiac Safety Profiles of Nesina and Onglyza … Onglyza is the safest with the lowest score, while Nesina is the riskiest option with the highest score. Nesinas high score is driven by increased reporting of serious and costly AEs such as pancreatic carcinoma, gastric cancer and myocardial infarction. Januvia and Tradjenta have … []
FDA panel backs safety updates for AstraZeneca, Takeda drugs … panel found that neither Onglyza nor Nesina increased the risk of cardiovascular death, stroke or heart attack. But data showed a statistically significant increase in the risk of heart failure with Onglyza and an increased risk with Nesina that did not reach statistical significance …[Reuters]

$25 Mln - Merck CEO Frazier Was Joins Super Rich Exec Club
- Salary was paltry $1.5 Mln; stock options, incentive comp put him over the edge
Merck's Frazier joins top-paid pharma CEOs with a $25M package … beat out Pfizer's Ian Read and Johnson & Johnson's ($JNJ) Alex Gorsky--even if he fell far short of Regeneron chief Len Schleifer [$42 Mln] …[Fierce Pharma]

US Drug Spending Goes Stratospheric; Specialty, Cancer Maed Blamed
- Hepatitis C, diabetes blamed, specialty drug blank check mentality a factor
Why Did Prescription Drug Spending Hit $374B in the US Last Year? Read This … spending on diabetes drugs jumped 30.5% to $32.2 billion last year, which was the second-highest therapeutic category in terms of spending growth after hepatitis … specialty medicines increased by $54 billion in the last five years …[Pharmalot]
Related: Growth In Drug Spend Is Hitting A 13-Year High. Note To Pharma: Innovation Pays. …[Forbes]

Actavis Unrepentant Regarding Namenda Forced Switch Scheme
- Lawsuit claims tactic's sneaky way to nuke competition
U.S. court weighs whether to let Actavis drop Alzheimer's drug … lawsuit claimed that by forcing patients to switch to the new version, Actavis hoped to stave off competition from drugmakers who are expected to release generic versions of Namenda IR in July …[Reuters]

4/15 FDA Staff Reviews Cangrelor Favorably
FDA staff backs Medicines Co's once-rejected blood clot preventer .... The FDA rejected the blood thinner in April last year, after its reviewers took issue with the way a pivotal trial, called Champion-Phoenix, was conducted, and asked the company to reanalyze its dataset .... Reuters

4/15 Raise the Bar for Diabetes Drug Approvals?
Should The FDA Require CV Outcome Studies For Diabetes Drugs Before Approval? .... [Skeptics say] that there are already a lot of drugs on the market that lower blood sugar and that adding another, even one that acts by a totally new mechanism with great promise for reducing diabetic complications, should not be done without a full understanding of the long-term safety of the new entity .... Forbes/John LaMattina

4/14 Generic Viagra as Soon as December 2017
Mylan settles Viagra patent litigation with Pfizer .... Drugmaker Mylan N.V has settled a patent litigation with Pfizer Inc related to the generic version of Viagra .... Reuters

4/14 Roche Pulling Out All the Stops on Immunotherapy Drug
Roche aims for 11 late-stage trials in cancer immunotherapy drug this year .... The Basel-based company's MPDL3280A, which is being tested in melanoma, as well as lung, bladder, kidney, bowel and blood cancers but has not yet been approved to treat any type of cancer, is the furthest developed of this class of drug .... Reuters

4/14 Health Plans Fear Fishing Expeditions in Gene Pool
Aetna, Cigna balk as Angelina effect spurs genetic cancer testing .... The new panel tests, which can cost between $2,000 to $4,900, analyze 20 or more genes at once. That allows healthcare professionals to establish possible DNA links to other cancer-related conditions such as Lynch syndrome and Li-Fraumeni Syndrome earlier. .... Reuters

4/14 California Aims to Tame Exorbitant Specialty Copays
Covered California Considers Capping Specialty Drug Prices For Consumers .... Consumers wouldn't pay more than $500 per prescription for specialty drugs under a current proposal prepared by California's health insurance exchange staff. .... Capital Public Radio (Sacramento, Calif.)

4/14 State Medicaid Programs Rocked by Drug Price Hikes
Medicaid drug-spending hikes rile lawmakers, but there's no end in sight .... Bristol-Myers Squibb's antipsychotic Abilify rang in as the most expensive drug in Missouri's Medicaid program, costing the state more than $75 million in 2014 for 15,000 patients. The drug, which contributed $2.02 billion to BMS' sales in 2014, is set to go off patent this May .... Fierce Pharma

4/14 Next Frontier for Pharma–Patient Communication: Portals
Patient portals open door to lasting relationships with patients, 'Digital Doctor' says .... Companies can build their presence on sites patients are comfortable using, and, with the right information and tools, create a direct relationship with patients--and brand loyalty that is "hard to replicate" .... Fierce Pharma Marketing

4/14 Coordinating the Coordinators
The Tangle of Coordinated Health Care .... Once primarily nurses and social workers, coordinators can now be what Mr. Baker calls "care managers in name only. They may make a phone call, but they don't really do much." Some may remind you to make an appointment; others can make appointments for you, perhaps earlier ones than you could get yourself. They may not be qualified to answer questions about medications .... NY Times

4/14 Watson Everywhere
IBM Announces Deals With Apple, Johnson And Johnson, And Medtronic In Bid To Transform Health Care .... IBM's pitch is that it will be able to create a new middle layer in the health care system—linking the old electronic records systems, some of which have components dating back to the 1970s, with a new, cloud-based architecture, because of its deep breadth of experience .... Forbes

4/14 Internet Drug News Fast Takes:
FDA Warns Researchers on Claims of Drug to Detect Brain Disease
NY Times
FDA Says Some Wrinkle Creams May Be Overstating Claims
ABC News
US fast-track for Horizon's Actimmune
Pharma Times
Most commonly prescribed stroke drug linked to fatal brain bleeds and death
Express [UK]
Wait Times for Doctors Decrease, Even as More Americans Enter Health Care System

Glaxo Plans Update To Wacky Sales Rep Incentive Comp Scheme
- Current system ignores sales results focuses on product knowledge, tests
Glaxo Plans Changes to Compensation Program for U.S. Sales Team … bonuses are based on scientific knowledge, selling competency, customer evaluations and overall performance of the representative's business unit, rather than linked to meeting sales targets … critical that our focus be on driving performance, and that we use the removal of the simulations to increase business performance …[Bloomberg]

Zoloft (Sertraline) Birth Defect Lawsuit Kicks Off
-Similar lawsuit against Paxil (paroxetine) cost Glaxo $4 Bln
Pfizer Accused of Knowing Zoloft Posed Birth-Defect Risk … internal report on the antidepressant found that newborns of women taking the mood-altering drug were at risk of suffering congenital anomalies …  birth-defect allegations against Zoloft mirror claims against GlaxoSmithKline over its Paxil antidepressant …[Bloomberg]

Gilead Works Hard To Prevent Gray Market Solvaldi From Reaching Non-Authorized Nations; Medical Activists Cry Foul
- Holds distributors accountable to fight diversion from India, Pakistan
Gilead combats wider distribution of cheap drugs from EM … had initially wanted patients to return empty bottles of their medicine before they received the next batch … Along with the prospect of some generic sofosbuvir reaching western patients, Gilead is concerned about the potential flow of Indian-made generics to 51 middle-income countries …[FT]

Walgreens To Shutter 200 US Stores In Bid To Streamline
Walgreens to Close 200 Stores as It Expands Cost Cuts … ixes are needed as Walgreens deals with higher costs for generic medicines and reimbursement rates from drug plans that are chipping away at profit … part of a further $500 million in cost cuts planned by the company  …[WSJ]

New Cystic Fibrosis Med Costs $10 Mln Per Patient
Vertex's Kalydeco combo could run payers $10M-plus per life, PBM figures … tandem therapy could benefit 8,500 U.S. patients age 12 and older. Eventually, the Massachusetts outfit believes, its lumacaftor launch could help it reach 10 times as many patients as Kalydeco currently does….[Fierce Pharma]

Horrible Publicity For Onglyza: FDA Staffer Notes Increased In Death Rate
- Panel meeting this week
AstraZeneca's Diabetes Drug May Raise Death Risk, FDA Says … increased risk of death in an analysis by U.S. regulators of a clinical trial on the heart effects of the treatment … "significant or near-significant" increases in death from all causes, not just heart problems …[Bloomberg]
Safety scare with AstraZeneca's diabetes drug could shake up the DPP-4 field …  increases in all-cause mortality among patients taking the drug, particularly from heart failure. At the same time, the same group reviewed outcomes data on Takeda's DPP-4-blocking Nesina and found no significant increase in mortal risk …[Fierce Pharma]

Why Do Drug Names Have Such High Scrabble Values?
What's in a name? For drugs, a lot of Zs and Xs … drug names use the letter Q three times as often as words in the English language. For Xs, it's 16 times as much. Zs take the cake, at more than 18 times the frequency you'd find them in English word … ranges from $75,000 to $250,000 for developing a single drug brand name … [CNBC]

4/10 25% Staff Cut at Eisai
Struggling Eisai will slash 450 jobs as sales revenue slides .... In the first 9 months of the company's 2014 fiscal year, revenue declined 8% and profits plunged 47% compared to the same period a year ago .... Fierce Biotech

4/10 Onglyza Has Some 'Splaining To Do With 27% Higher Heart Failure Rate
FDA Onglyza panel review set for April 14 .... AstraZeneca's diabetes medication Onglyza (saxagliptin) is going before an FDA advisory panel, and the anticipated shakeout is that a bad review could do more harm to AstraZeneca's drug than to any other member of this class of medications .... MM&M

4/10 Cystic Fibrosis Therapy Pegged at $1.01 PMPM
New combo for cystic fibrosis could be a budget buster .... In their [AMCP] poster, Bowen and Gleason say that about 4.5 out of every 100,000 members would meet the criteria for the new cystic fibrosis combination drug and that 90% would take the drug. So for Prime Therapeutics population, that translates into increased cost of $1.01 PMPM, or $150 million per year ....

4/10 Generics Offer Could Set Off New Round of Musical Chairs
Mylan Bid for Perrigo May Make Both Drugmakers Targets .... Regardless of what Teva decides to do, there still could be other suitors for Perrigo. It's possible that Johnson & Johnson, which also sells to drug stores, or health-products distributor AmerisourceBergen Corp. could take a look .... Bloomberg

4/10 How Much Did Texas Spend on Sovaldi Last Year Q1–Q3? Ans: $0
States limit access to hep C meds amid pricing battle .... Most states are still hesitant to open access to all eligible patients and will continue to limit access to individuals with advanced liver damage .... Fierce Pharma

4/10 Once the FDA Got Involved in Colchicine, It Ruined Everything
Drug regulations tied to fewer prescriptions of effective gout drug .... The odds of a familial Mediterranean fever patient being prescribed colchicine within 30 days of receiving such a diagnosis dropped by 7.6 percent per month after the regulations were put in place, while the odds for gout sufferers dropped by 0.5 percent per month. They also found that average patients' monthly total prescription bills rose from $418 to $651 .... Journal of General Internal Medicine via Medical Express

4/10 No 'Standing-O' for Tablet Presentations, Just Polite Nods
Pharma tablet presentations falling short .... Researchers said that about half of the 145 surveyed managed-care executives said reps made effective tablet presentations. But the survey found that not one drugmaker presentation was rated as effective by more than 70% of participants .... MM&M

4/10 Tecfidera, Psorinovo Use Suspected in PML Cases
Dimethyl fumarate linked to development of PML .... Based on these reported cases and other studies, doctors believe that dimethyl fumarate may affect a person's immune system if taken for an extended period, potentially opening the door to PML .... NEJM via Medical Xpress

4/10 Good News for Mice Who Can't Afford Sovaldi
At 50 Cents a Pill, Allergy Drug Could Beat $1,000 Sovaldi, Harvoni .... Researchers from the National Institutes of Health (NIH) reported chlorcyclizine prevented hepatitis C infection in a petri dish and in humanized mice .... Healthline

4/10 Whipsawed by Rising Generic Drug Prices
Pharmacists Raise Concerns for Patient Access to Generic Drugs .... Most pharmacists report that it takes third-party payers one month or more to update pharmacy reimbursement rates after acquisition cost hikes .... HealthDay News

4/10 Inside the Advisory Panel on Biosimilars
Biostatistician helps FDA approve first biosimilar drug .... A key difference is the narrower scope of the clinical trials to show that the characteristics of the new drug and the outcomes for patients are close to those of the existing drug. It's foreseeable that the measurements might not line up .... Medical Xpress

4/10 Internet Drug News Fast Takes:
Drug Pump's Security Flaw Lets Hackers Raise Dose Limits
A single dose of a new HIV drug weakens the virus for 28 days
The Verge
Cancer Immunotherapy Is All Over The Science News -- And Now It Has Its Own Stock Index
Forbes/Luke Timmerman
Migraine Medication Linked to Eating Disorders in Teens
HealthDay News
Artificial Sweeteners May Change Our Gut Bacteria in Dangerous Ways
Scientific American

Fast Takes
Hospira cited for sterility issues in warning letter for Italian plant | Hospira gets fifth FDA warning in two years
InPharmaTechnologist                                                MMM
Kicked Off Flight, Misses Cheemo Because Stewardess Thought She Looked Ill, Demanded Doc's Note
Huff Post
Study: Tylenol ineffective for lower back pain
First HIV Immunotherapy Treatment in Humans Proves Successful

4/9 Mylan Offers to Buy Drugmaker Perrigo for $28.9 Billion
Mylan Offers to Buy Drugmaker Perrigo for $28.9 Billion …  $205 a share in cash and stock for Perrigo, [a 25% premium] deal would be Mylan's biggest, more than four times the size of anything else it has attempted … Mylan was founded in 1961 in West Virginia by two Army veterans who sold drugs out of the back of a Pontiac Bonneville …[Bloomberg]
Mylan Offers Mega-Deal For Perrigo Just Months After Closing Inversion … Just months after closing a $5.3 billion purchase of the non-U.S. and generics businesses of Abbott Laboratories ABT +0.91%, which shifted its tax headquarters to the Netherlands …[Forbes]
Mylan Factoid: Mylan is one of the few mega- pharma companies run by a woman, Heather Bresch.(who happens to be the daughter of a United States Senator).

Merck's Answer To Harvoni Hep C Pill Heads To FDA, Gets Fast Track Review
Merck Faces Hep C Pricing Dilemma to Counter Gilead, Abbvie … two drugs, grazoprevir and elbasvir, formulated into a single pill … Overall, 12 weeks of treatment with Merck's doublet therapy led to early hepatitis C cure (SVR4) rates of 95%. The SVR4 cure rate was boosted to 98% when patients also took ribavirin …[The Street]
Editor's Note: One drawback is that the best cure rates were for people who concomitantly took side effect laden ribovirin;  adds that certain subpopulations got 100% cure rates; another great report from Feuerstein.

Tresiba (Novo's Long Acting Basal Insulin) Races Towards Approval,
Lilly Won't Be Heavily Discounting Biosim
Novo's Tresiba news injects uncertainty in insulin market, particularly for Sanofi … instead of taking two months for the application [for Tresiba] to be submitted and the FDA to respond, as some analysts predicted, it has been two weeks … Lilly expects not to just grab Lantus market-share but to expand the market by selling to some patients for which Lantus doesn't offer as much protection … [Fierce Pharma]

4/9 LA Times: Erectile Dysfunction Drugs Have Non-Sexual Ailments
Erectile dysfunction drugs may help fight throat, neck cancer, study shows …  significant decrease in cells that feed the tumor, while at the same time, an increase in cells that attack cancerous growths … may actually someday help fight everything from liver disease and Alzheimer's …[LA Time]

Gilead Submits Next-Gen HIV Pill To FDA
Gilead's low-dose, high-impact HIV drug heads to the FDA … combination of Gilead's emtricitabine and tenofovir alafenamide, or TAF -- is the second so-called F/TAF drug submitted to the FDA … equal in efficacy to Stribild and had fewer kidney and bone side effects than Stribild …[Biz Journals]

4/8 ED Drugs Rated, Viagra Gets Top Score
Erectile dysfunction drugs vary in effectiveness, side effects .... A 50- or 100-milligram (mg) dose of Viagra appeared to be the most effective treatment. It performed about 50 percent better than a placebo. Smaller doses were less effective. Stendra, in doses ranging from 50 to 200 mg, was among the least effective - only 20 to 30 percent more effective than a placebo .... Reuters

4/8 Expensive Cancer Drugs Don't Work Any Better
No real rationale for rising cancer drug prices, JAMA researchers conclude .... Drugs approved based on response rate had median costs per year of treatment higher than those approved on the basis of survival data--almost $138,000 for the response-rate drugs, compared with $112,370 for those OK'd on overall survival numbers and $102,677 for progression-free survival approvals .... Fierce Pharma

4/8 If You Didn't Like the Previous Story, Here's One with a Different Conclusion
High cancer costs associated with better outcomes .... In higher-spending countries every $1,000 spent on cancer was associated with 1.6 fewer cancer-related deaths for every 100,000 people, compared to the 0.39 reduction in mortality when looking at composite results for the 16 OECD countries .... MM&M Online

4/8 Tresiba Back on Track
FDA accepts Novo Nordisk's resubmitted application for insulin drug .... The U.S. Food and Drug Administration has accepted a resubmitted application for Novo's key insulin drug, Tresiba, based on interim analysis data from a clinical trial .... Reuters

4/8 Immunotherapy Intellectual Property Case Settled
Patent dispute settlement to benefit Penn cancer therapy partnership .... Novartis Pharmaceutical Corp. settled its patent dispute with Juno Therapeutics, removing any potential litigation obstacles from the immunotherapy partnership between Novartis and the University of Pennsylvania .... Philadelphia Business Journal

4/8 Putting the CAR-T Before the Cure
Big pharma turns to small biotechs for edge in cancer treatment .... Perhaps the greatest buzz surrounds a technique called adoptive cell therapy. This involves removing immune cells from the patient's body and re-engineering them into chimeric antigen receptor T-cells able to hunt and destroy tumours. Novartis is at the forefront with its CART-19 leukaemia treatment but others are crowding in .... Financial Times

4/8 FDA Warning Letters Have Cost Hospira $450 Million in Past Three Years
Hospira gets new FDA warning over facility in Italy .... The company has received five warnings from the FDA in less than two years. The FDA said it found problems with procedures that are supposed to prevent sterile products from being contaminated and found fault with Hospira's inspections procedures .... Colorado Springs Gazette

4/8 16 Hours, Not 12 — Shire Working on Even Longer-Acting Version of Adderaal
Shire could use boost from adult ADHD med to hit $10B goal .... The long-delayed SHP465, which shares an active ingredient with former lead product Adderall XR, could launch as soon as the second half of 2017 .... Fierce Pharma

4/7 Eye Drug Flops in Phase 3
Ocular's eye drug misses a main goal in second late-stage study .... The drug, OTX-DP, was effective in reducing pain in patients who had cataract surgery, but failed to reduce inflammation in the eyes .... Reuters

4/7 Simpler, Office-Based Test for Gastroparesis
FDA Approves New Test That Helps Diagnose Gastroparesis .... The GEBT breath test, on the other hand, can be administered in the doctor's office, and is conducted over a four-hour span after an overnight fast. It allows doctors to see how fast the stomach empties solids by measuring carbon dioxide content in a patient's breath .... Doctors Lounge

4/7 Contrave Due to Take Lead in Obesity by Year-End
Arena: Belviq Scripts See Modest Gain, Competitors Are In The Wings .... There are currently three new drugs in the space and Contrave is seeing the best front-end new script growth (NRx). Contrave is gaining on Belviq in new scripts, refills, as well as overall scripts (TRx). Contrave passed Qsymia from Vivus in NRx about a month ago and total scripts last week .... Seeking Alpha

4/8 Internet Drug News Fast Takes:
24 health systems named as 'best employers' by Forbes
Advisory Board
N.J. printing company duped in drug ring banned from producing prescription pads
With diabetes, fewer meals may mean less hunger, depression
Mortality and blood pressure directly linked to relationship quality
Oxford University Press USA
Private health exchange an attractive option as enrollment doubles
Drug Store News
Rituxan may have rare-disease use

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