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1/18 40 Pay-for-Delay Deals Last Year; Cost $8.3 Billion
FTC Says Pay-for-Delay Settlements Rise to Most Since '03 .... The agreements, the most since the agency began collecting data in 2003, involved 31 different brand-name drugs with combined sales of more than $8.3 billion .... [Reuters]

1/18 MedImmune Folded in to AZN
MedImmune unit split 3 ways in AstraZeneca shake-up .... AstraZeneca managers will take over MedImmune's marketing, sales and production .... [Fierce Pharma]

1/18 Vestiq Strategy: Grow by Acquisitions
Vestiq Pharma opens for business with two approved drugs .... Vestiq has acquired two recently-approved drugs, namely Oravig, (miconazole), a treatment for oropharyngeal candiasis, and Zuplenz (ondasetron), for chemotherapy-induced nausea and vomiting .... [Pharma Times]

1/18 11% of Clinical Trials Get No Patients at All
Patient enrollment issues "a major cause of pharma R&D delays" .... Nine out of 10 clinical trials worldwide meet their patient enrollment goals, but meeting those targets typically means that drug developers need to nearly double their original timelines .... [Pharma Times]

1/18 When Will $300,000 Drugs Break the System?
Orphan Drugs & Value Propositions: Randy Vogenberg Explains .... The pricing of Gattex marked the fourth time in the past year that an orphan drug was approved and the price per patient was set at more than $200,000 annually .... [Pharmalot]

1/18 Analysts Make the Case for Procysbi
Raptor's Drug Procysbi Ready For FDA Approval .... Procysbi, is under FDA review for the treatment of nephropathic cystinosis, an orphan disease afflicting 2,000 patients worldwide, 500 of whom are in the US .... [Seeking Alpha]

1/18 Two Lung Cancer Drugs to Get Accelerated Action
FDA fast tracks two new lung cancer drugs .... Boehringer was granted priority review for its epidermal growth factor receptor (EGFR) inhibitor afatinib in NSCLC patients with locally advanced or metastatic disease who test positive for the EGFR mutation.... Roche and Astellas have been given a fast-track review for their EGFR inhibitor Tarceva (erlotinib) in first-line NSCLC .... [PMLiVE]

1/18 1.2 Million Cancer Deaths Avoided
Cancer mortality down 20 percent from 1991 peak .... Cancer death rates decreased from their peak of 215.1 per 100,000 in 1991 to 173.1 per 100,000 in 2009. Death rates continue to decline for all four major cancer sites: lung, colon and rectum, breast, and prostate .... [American Cancer Society]

1/18 Trying the Provenge Approach for Kidney Cancer
Personalized immunotherapy could signal first combination treatment for renal cell carcinoma patients .... Renal cell carcinoma is the most common form of kidney cancer. Arcelis uses a sample of the tumor and the patient’s own dendritic cells to create an antigen to fight the cancer. .... [Medcity News]

1/18 Take Viagra — Fat Cells Melt Away; Love Handles Vanish (At Least if You Are a Mouse)
Viagra converts fat cells .... The drug converts undesirable white fat cells and could thus potentially melt the unwelcome "spare tire" around the midriff. In addition, the substance also decreases the risk of other complications caused by obesity. .... [University of Bonn, (translated)]

1/18 Internet Drug News Fast Takes:
Boehringer Ingelheim Pharmaceuticals starts phase-3 trial of HCV drug
Drug Store News
Genentech takes Exelixis drug into Phase III melanoma trial
San Francisco Business Times
Healthgrades Releases Clinical Excellence Hospital Rankings
HealthLeaders Media
J&J wins European nod for once-daily Prezista pill
Fierce Pharma
Fasting Plasma Glucose Beats HbA1c for Diabetes Screening
HealthDay News
Want to ace that interview? Make sure your strongest competition is interviewed on a different day
Association for Psychological Science

1/17 Broader Indication Could Hike Tysabri Market Share to 15%
Biogen, Elan seek okay for first-line Tysabri use in MS .... Now that there is a test for the virus to predict if patients are at risk of developing PML, it opens the possibility that Tysabri could be used more widely and at an earlier stage of treatment .... [Reuters]

1/17 Pfizer Takes on Shire in $4 Billion ADHD Market
Pfizer enters ADHD market with Quillivant XR launch .... Quillivant XR has a child-friendly formulation that provides an extended treatment effect and so avoids any need for dosing during the school day. .... [PMLiVE]

1/17 Gold Rush for Rare Disease Drugs
Hundreds of rare disease drugs in testing .... Pharmaceutical and biotech companies are running patient tests of more than 5,400 potential new medicines, including nearly 1,800 for rare diseases .... [AP]

1/17 New Flu Vaccine; Uses Bug Parts but No Chicken Eggs
FDA approves new seasonal influenza vaccine made using novel technology .... The agency has approved Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology .... [FDA]

1/17 Aranesp No Help for Heart Failure
Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients .... The trial did not meet the primary endpoint of reducing the composite endpoint of time to death from any cause or first hospital admission for worsening heart failure .... [Forbes]

1/17 If You Introduce a Branded Drug, You May Be Liable Even For its Generics
Man Taking Generic Drug Can Sue Branded Maker .... Although the decision applies only to Alabama, it is likely to be closely read by lawyers with similar cases pending around the country .... [NY Times]

1/17 USS Vomit Comet
Sydney Vomiting Bug Poses Risk for Cruise-Line Passengers .... While long-term care facilities and schools are especially prone to outbreaks, new epidemics of acute gastro often emerge on cruise ships, where control is hindered by close living quarters and shared dining areas .... [Bloomberg]

1/17 Five-Way Attack on Flu
5 flu vaccines that could shake up the influenza prevention market .... NanoBio Corp‘s flu vaccine is a nasal spray designed to offer short-term infection prevention and reduce transmission of the virus between humans. .... [MedCity News]

1/17 Another Delay for Ravicti
FDA will miss target decision date on Hyperion drug .... The news appears to put a crimp in Hyperion's plans for Ravicti, a nearly tasteless and odorless drug that helps manage urea cycle disorders... Hyperion once planned to market the drug in early 2013 .... [San Francisco Business Times]

1/17 Internet Drug News Fast Takes:
Feces transplant may help relieve severe diarrhea
Skin cancer phone apps aren't very accurate
Amgen will spend $200M on Singapore drug facility
EU Expands J&J Zytiga Label
Many doctors screen for prostate cancer without permission
Advisory Board
Giffen releases STD-prevention app
Drug Store News

1/16 2013: Pharma's Getting Its Grove Back
- New biotech drugs, Novo's new insulin, hepatitis C drugs, etc
Analysis: Drug industry bets on new blockbusters in 2013 … industry regaining some of its swagger after winning 39 new drug approvals last year - a record only beaten in 1996 - there are signs the improving trend could continue through 2013 … One of the most highly anticipated approvals of the year, likely to come in the first quarter, is for Biogen's multiple sclerosis (MS) drug BG-12 …[Reuters]
Editor's Note: Click the above link to read about 10 new molecules including a potential $10 Bln per year cholesterol treatment from Glaxo.

Three Blockbuster Drugs Expected To Launch In 2013
3 Drug Launches You Need to Know in 2013 … disorder that Eliquis has been approved to combat stroke risk for -- affects millions of patients in the U.S. alone … NPS Pharmaceuticals' Gattex, designed to combat short-bowel syndrome, or SBS … . Last month's FDA approval of leukemia-busting drug Iclusig from Ariad Pharmaceuticals …[Motley Fool]

NYC Asks Drugstores: Stock Decoy Narcotic Bottles With GPS Chips
- Purdue will provide the decoys free of charge
Police to Put GPS Devices In Pill Bottles To Stop Theft … decoy pill bottles appear to be sealed bottles of oxycodone …  bottles will not actually contain any painkillers … GPS device that will allow detectives to track thieves in the interval immediately after a robbery or burglary …[NY Times]
Editor's Note: FDA has already approved an ingestible, teeny tiny gps chip; however, RFID chips are easily defeated  by various means; ask any professional shoplifter.

Does CVS Make Tylenol Hard To Find On Purpose? 
- Walgreen's says it has no problems obtaining enogh brand name Tylenol
Hey, where's my Tylenol? CVS pulls popular pain-reliever from some stores … CVS and other retailers have been putting more emphasis on their private-label products, which cost less than brand-name products but can be more profitable … Under the new plan, CVS will try to have Tylenol in stores in each market, but will not have it in every store … [NY Daily News]

New AZN CEO Cleans House
- Heads of R&D, commercial operations forced out
AstraZeneca's new CEO removes R&D, commercial heads … clearing the decks … removing the heads of research and commercial operations in a management revamp …  strips out a layer of senior management and means executives in charge of different divisions will have a seat at the executive top table …[Reuters]
AstraZeneca's Mackay, Zook to Leave Company This Month …[Bloomberg]

Indians Invalidate Patent Protection For Herceptin, Sprycel, Ixempra
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Drug pricing: Govt decides to bypass three patents …  "Most patented cancer drugs cost $5,000-6,000 a month. How many patients in India, where there is no public insurance facility, can afford these prices?" … domestic companies can manufacture and market generic versions, paying a royalty to the patent holder company …[Business Standard India]

Prevnar Vaccine Is Effective, So Why Do Some Hate It?
A Vaccine Eliminated A Deadly Killer Of Infants. So Why Do Some People Fear It? … Prevnar 13 now costs $508 per course, and generates $4 billion in global annual sales … fewer pneumococcal infections occur in people over 65 who have never gotten the vaccine, because the germs are no longer circulating. It has, quite simply, changed the world for the better …[Forbes]

Internet Drug News Fast Takes
CVS, Rite Aid See Flu Shot Shortages Amid Demand Surge

1/15 Glaxo Files Long Awaited Once-Weekly GLP1 Albiglutide
- Analysts predict moderate sales based on comparative efficacy
Glaxo to enter packed field of diabetes drugs … shown to be inferior to Victoza's once-daily treatment when tested for effectiveness in company studies. For that reason, the prospects for the drug's success are questionable … [MSN]

Abilify: Otsuka, BMS Win; High Court Blows Off Apotex Plea
To Invalidate Patent
Otsuka Can Block Generic Abilify as Court Rejects Appeal  … Apotex said the active ingredient aripiprazole belongs to a class of compounds that have been known since the early 1980s and were covered by a patent that expired in 2005.
Supreme Court Rejects Generic Challenge to Otsuka's Abilify Patent … Two lower courts ruled the patent was valid … justices declined to review the case …[FOX]
FYI: Abilify is a $5 BLN per year drug.

Pfizer Launches Time Release Methylphenidate Liquid
Pfizer Announces Availability Of Quillivant XR™ (methylphenidate hydrochloride) CII For Extended-Release Oral Suspension …  first once-daily, extended-release liquid methylphenidate for ADHD and is now available by prescription. … approved by the U.S. Food and Drug Administration (FDA) on September 27, 2012 for the treatment of ADHD in patients aged 6 years and above … [Pfizer Press Release]
Editor's Note:  It's available as 300mg, 600mg, 750mg and 900mg per bottle units.  It must be reconstituted only by the pharmacist and not by the patient or caregiver. After reconstitution, the product is a light beige to tan viscous suspension containing 25 mg per 5 mL (5 mg per mL) of methylphenidate hydrochloride.  Pfizer has made available a $100 Quillivant XR coupon that is good for savings of up to $1,200 per year.

Trending: Bodega Clinics Cater To Latino Immigrants;
Officials Scratch Heads
As 'Bodega Clinicas' Fill Void, Health Officials Are Torn … staffed with Spanish-speaking medical providers, treat ailments for cash: a doctor's visit is $20 to $40; a cardiology exam is $120 … parallel health care system, serving a vast number of uninsured Latino residents … [NY Times]

Internet Drug News Fast Takes
Armstrong Semi Confesses: Testosterone, Erythropoetin Was Cocktail for Bicycle Superstardom
Santarus Gets  FDA Nod  For  UCERIS (Budesonide) In Ulcerative Colitis, Will Launch Soon
Santarus Press Release
Obamacare to Increase Out-of-Pocket Premium Costs, Despite Lavish Subsidies

1/14 Merck Issues Global Recall Of Tredaptive
- Never caught on anyway
Merck begins overseas recall of HDL cholesterol drug … annual sales of less than $20 million … not approved in the United States but the U.S. drugmaker sells it in about 40 countries … combines niacin with another drug meant to reduce facial flushing, a side effect of niacin … [Reuters]

CDC: USA In Grip Of Flu Epidemic
- Patients scramble for moderately effective vaccine, possibly effective Tamiflu
Flu reaches epidemic level in U.S., says CDC … This year's flu vaccine is 62 percent effective … early start and fast spread of flu this season - especially after 2011-2012's very mild outbreak …[Reuters]
Flu season strikes early and, in some places, hard …[AP]

Synthroid Recall; Dose Mix-up; 2nd Recall Since July
- OOPs; we put the wrong label on the bottle
Former Abbott Drug Unit Recalls Synthroid Again … lot of 150-microgram Synthroid tablets was recalled because one bottle was found to contain lower-dose, 75-microgram tablets …  more than 28,520 bottles …  second recall of the drug in six months. …[4-Traders]

Elequis: Lipitor Of New Age Blood Thinners?
Eliquis: the third shoe drops in the blood-thinner category …  stands to benefit from stronger pre-market vetting, clear messaging and lessons learned from earlier-to-market competitors … expects Eliquis will be a "relatively slow initial launch that picks up over time …[MM&M]

DEA Demands Vicodin Go From Schedule III To  Schedule II
- No phone orders, refills
FDA might tighten reins on Vicodin … most restrictive category of medically accepted drugs …DEA's second attempt to get the FDA to elevate the powerful painkillers from Schedule III to Schedule II. In 2008, the FDA rejected the DEA's initial request submitted in 2004 …[USA Today]

No Guarantee FDA Will Rubber Stamp Canagliflozin's Expert Panel Nod
- Cardio safety question has potential to delay full approval
Can J&J Get Its Diabetes Drug Past the Safety-First FDA? …… After heart issues with Glaxo's Avandia were discovered, the FDA required all drugmakers to  … problem has to do with a potential for increased cardiovascular risk. The advisory panel was asked about that issue specifically and only voted 8-7 that the drug isn't associated with an unacceptable cardiovascular risk …[Motley Fool]

Formulary Wins Seen As Qsymia Sales Propellant
Will Qsymia's Stellar Sales Growth Continue? … market expectation is that sales of Qsymia will eventually grow into the billions of dollars, but early sales were comparatively disappointing … Express Scripts, the nation's largest benefits manager for prescriptions, added Qsymia … sales were being hurt by high co-pays and limited insurance coverage, and, as a result of these costs, a lot of prescriptions were not being filled …[Motley Fool]

Internet Drug News Fast Takes
Teva Badmouths  Biogen Idec's Experimental MS Pill
Japan allows online sales of OTC drugs
Forest Reaches New 52-Week High
The Street


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