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Pharmaceutical News Harvest
Click Here for Last Week's Pharmaceutical News Harvest
5/24
Diabetes Treatment Steel Cage Match
GRADE Trial to Compare Top Diabetes Drugs
....
The GRADE trial is a pragmatic, parallel-group, unmasked clinical trial that will enroll 5,000 patients who have been recently diagnosed with type 2 diabetes and have a glycated hemoglobin (HbA1c) of 6.8% to 8.5%. Researchers expect the trial to run for a mean observation period of nearly 5 years
....
[Medpage Today]
5/24
Pharma Looking for a Place in the ACO Game
Chronic disease conditions could attract pharma-accountable care organization collaboration
....
It would be difficult for branded companies to establish that their drugs generally reduce total medical expenditures, because drugs account for a relatively small portion of overall healthcare expenditures and many other factors also affect spending
....
[Financial Times]
5/24
Victoza Shows Strong Weight Loss Results
Phase III study finds Novo Nordisk's liraglutide results in 8-percent average weight loss
....
Results demonstrated that patients in the liraglutide group achieved an average weight loss of 8 percent after 56 weeks, compared with 2.6 percent for those given placebo.... compared to the placebo group, patients who took liraglutide displayed significant improvements in several obesity-related measures, such as hypertension, cardiovascular risk biomarkers, lipids and patient-reported quality of life
....
[First Word Pharma]
5/24
Many Tysabri Patients Prefer PML Risk to Losing Mobility
MS Patients Choose Death Risk With Potent Drug Treatment
....
The risk appears to peak after 24 infusions, when there were 5.13 infections for every 1,000 patients. The number of cases fell over each subsequent six infusion, until there were 2.54 cases for every 1,000 patients on Tysabri for five years
....
[Bloomberg]
5/24
Tecfidera Capturing Patients in MS; Gilenya Holding Share
Social Media Suggests An MS Dogfight Between Biogen And Novartis
....
Of all the patient posts that mention switching from an MS drug to Tecfidera, far fewer expressed interest in switching from Gilenya than any of the other existing MS treatments
....
[Pharmalot]
See also: Predicting Success for Tecfidera through Social Media Analysis [Treato blog]
Editor's Note: Treato is social media research firm focusing on health care
5/24
J&J Developing Alterate Form of Ketamine ("Special K") for Depression
J&J Sees 10 Products Submitted for Approval by 2017
....
The company plans to file for approval by 2017 of medicines including simeprevir for hepatitis C, ibrutinib and daratumumab for blood cancers, sirukumab and guselkumab for diseases of the immune system and vaccines for influenza, rabies and polio
....
[Bloomberg]
5/24
What the Boss Makes
20 Highest-Paid Biopharma CEOs of 2012
....
Rather than limit our executive-pay search to the biggest pharma companies and biotechs, plus the usual suspects who often make CEO-pay rankings, we used a bigger net. We collected compensation information from 50 companies
....
[Fierce Pharma]
5/24
AZN's Naloxegol Successful in Phase 3
Drug Eases Constipation from Opioids
....
During 12 weeks of treatment in a study known as KODIAC-04, 44.4% of patients receiving 25 mg daily of naloxegol responded to treatment, compared with 29.3% of patients given placebo (P=0.001)
....
[Medpage Today]
5/24
Rienso [Feraheme] Off Market in Switzerland; Batch was Only Distributed in that Country
Death leads to recall of batch of Takeda's Rienso in Switzerland
....
Takeda has recalled a batch of its anaemia medicine Rienso (ferumoxytol) in Switzerland following four reports of hypersensitivity reactions, including one death
....
[PMLiVE]
5/24 Internet Drug News Fast Takes:
Researcher Develops Technique to Detect Breast Cancer in Urine
Missouri University of Science and Technology
Parents Unaware of Scope of Teens' Use of 'Study Drugs'
HealthDay News
Merck halts development of experimental Parkinson's drug
Reuters
Drug side effects are probably impossible to avoid
Digital Journal
5/23
Suvorexant Recommended at Lower Dose Only
FDA panel: Merck's insomnia drug effective, safe at low doses
....
The panel voted 13-3, with one abstention, that the drug, suvorexant, is safe for elderly patients at 15 milligrams a day, and is safe for non-elderly adults at 20 milligrams
....
[Reuters]
5/23
After Big Settlement, Ranbaxy Dropping Reps
Ranbaxy to cut one-third of global sales force, mainly in US
....
Earlier this month, Ranbaxy admitted to selling batches of drugs in the US that were improperly manufactured, stored and tested at its Paonta Sahib and Dewas production facilities in India, and agreed to pay $500 million in fines
....
[First Word Pharma]
5/23
Long Read: The Search for a Female-Desire Drug
Unexcited? There May Be a Pill for That
....
For many women, the cause of their sexual malaise appears to be monogamy itself. It is women much more than men who have H.S.D.D., who don’t feel heat for their steady partners
....
[NY Times]
5/23
Pfizer to Distribute Balance of Veterinary Unit
Pfizer to Split Off Rest of Zoetis Animal Health Business
....
Pfizer shareholders will have the option of swapping their shares for Zoetis stock in a tax-free transaction.... If the exchange is fully subscribed, Pfizer will no longer have a controlling interest
....
[Bloomberg]
5/23
Medicare Puts the Brakes on Molecular Diagnostics
Medicare Nixes Coverage For New Cancer Tests
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The new payment system has cut payment rates across the board, by an average of about 20% (and as high as 80% in some cases) from 2012 levels. Most of the new rates are being based on the work of one Medicare contractor, Palmetto GBA
....
[Forbes]
5/23
Pharmacist Webchat (at $400 per Year) Lowers Blood Pressure
Online tool helps control blood pressure long term
....
Blood pressure was controlled — meaning less than 140/90 milliliters of mercury (mm/Hg) — for 60 percent of people who had online access to pharmacists, compared to 48 to 52 percent of those who received usual care or were trained in home monitoring but did not have pharmacist counseling
....
[Reuters]
5/23
Plegridy Filed
Biogen seeks FDA approval for new MS drug
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The new candidate, Plegridy, doesn’t have to be administered as often as existing interferon-based drugs, Avonex included.
....
[Triangle Business Journal]
5/23
Cancer drug spending to grow by 77.4% over the next three years; Hepatitis C to grow 465.8%
Specialty drugs to rocket upward by 67% by 2015
....
Express Scripts unveiled a forecast of 40% growth in the segment by 2014 — and 67% by 2015....
[Fierce Pharma]
5/23
Iclusig Sales and Market Review
Ariad's Cancer Drug Iclusig Extends The Gleevec Magic
....
Iclusig is off to a great start in the U.S. The first quarter sales of $6.4 million represents pure demand... through April over 400 patients in the U.S. were treated with Iclusig obtained through physician prescriptions of the commercially supplied drug
....
[Seeking Alpha]
5/23
If You're Having a Heart Attack, Maybe Your Phone Will Call 9-1-1 by Itself
Mayo device helps monitor heart patients from afar
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Preventice's first product, which incorporates a Mayo Clinic algorithm, goes beyond the exercise space and monitors heart rhythms, respiration and activity with a small system that consists of a peel-and-stick patch that transmits information to a phone that comes along with the kit
....
[MM&M]
5/23 Internet Drug News Fast Takes:
Stimulant Normalizes Brain Activation in Youth With ADHD
HealthDay News
The Compound in the Mediterranean Diet that Makes Cancer Cells 'Mortal'
Ohio State University
Glaxo to Get Up to $200 Million for U.S. Research
Bloomberg
Synageva gets breakthrough designation for candidate aimed at Wolman disease
Boston Business Journal
Costs to treat stroke in America may double by 2030
American Heart Association
5/22 Sanofi, Regeron Asthma Med Has Magic Bullet Potential
- 87% response rate
Regeneron, Sanofi asthma drug seen as potential game changer
dupilumab, an injectable treatment being developed by Regeneron
slashed episodes by 87 percent in a mid-stage trial
meant to attack the underlying causes of the respiratory disease
works by simultaneously blocking proteins that have been linked to inflammation, interleukin-4 (IL-4) and interleukin-13 (IL-13)
.[Reuters]
New Drug May Help Some Asthmatics, Study Finds
number of asthma attacks or other outbreaks of symptoms decreased by 87 percent in those getting the drug, dupilumab, compared with those getting a placebo
three of the patients taking dupilumab experienced a worsening of asthma compared with 23 on the placebo
[NY Times]
5/22 Activis Saves 20% Per Year By Incorporating In Ireland
Actavis Lowers Tax Rate to 17% After Warner Chilcott Deal
major tax advantage that will lower the company's tax rate to 17 percent from about 37 percent over the course of a year
unfortunately for the U.S. taxpayer and the job seeker, that we're forced to move more jobs overseas so we can get a lower tax rate and be competitive
[Bloomberg]
5/22 2013 FDA Drug Approval Calendar
2013 FDA Drug Approval Calendar
[ 10 interesting products including:] Merck Drug/indication: Suvorexant for insomnia, FDA advisory panel: May 22, Approval decision date: June-July
Valeant, Drug/indication: Efinaconazole, toe-nail fungus, Approval decision date: May 23
Zogenix, Drug/indication: Zohydro, chronic pain , Approval decision date: Summer
[The Street]
5/22 Novartis Seeks To Beef Up Alzheimer Portfolio
Novartis Ramping Up Alzheimer's Pursuit as Rivals' Drugs Fail
remains high on our radar, with high unmet medical need
95 percent of Alzheimer's research has been focused on amyloid
sells Exelon, a drug that lessens symptoms of the disease by preventing the breakdown of a substance linked to learning and memory
about $930 million in sales
[Bloomberg]
Value Based Pricing: Important NEW Word For Pharma Marketers:
- VBP = Iceberg that Pharma is on course to collide with
Can Pharma handle pricing for value in this country?
VBR means that the large public and private payers have decided the price they're prepared to pay for any health care product or service will depend upon how much it improves outcomes and reduces overall costs
diabetes pill with an average price of $1.50 in Europe costs $8.20 here
[Philly.com]
5/22 Analyst Questions Forest Pipeline
Is There a Pill For That? Forest Labs' Iffy Pipeline
overpaid when it spent $1.2 billion in 2011 to secure the rights to Vibyrd
heavy generic competition. "The days of the blockbuster antidepressant are largely behind us
Namenda, which owns more than a 35% share of total Alzheimer prescriptions, could face generic challenges as early as 2015
Can a new generation of products turn the tide and float the drug maker back to profitability?
[Ycharts]
5/22 Internet Drug News Fast Takes
Pain Relievers Do Not Cause Asthma, Study Finds
NY Times
Teva Bets on Reformulating Old Drugs as Investors Say 'Show Me'
Bloomberg
Vitamins That Cost Pennies a Day Seen Delaying Dementia
Bloomberg
WellPoint Reaches New 52-Week High
The Street
Warner Chilcott Reaches New 52-Week High
The Street
5/21 Actavis (Formerly Watson) Buys Warner Chilcott For $8.6 Bln
Actavis buying Warner Chilcott in all-stock transaction valued at about $8.5 billion
would create the third-biggest specialty pharmaceutical company in the U.S
announcement follows reports that Actavis had rebuffed takeover bids from generic drugmaker Mylan
[Wash Post]
Related: Actavis 'Moves' To Ireland For A Lower Tax Rate
Actavis is going to declare its new headquarters will be in Ireland, where the drugmaker can pay significantly less corporate tax
clear example of how the U.S. tax rate hurts business
[Pharmalot]
5/21 Merck Sleeping Pill: FDA Staffers Have Dose Related Safety Questions
FDA Staff: Merck Sleep Drug Effective but Some Dosage Concerns
effective but not safe at the higher doses ... concerns about next-day driving impairment and daytime sleepiness that "can be severe and worsen suddenly
[NASDAQ]
Editor's Note: Adds information regarding starting dose and dose for elderly.
5/21 Pharma Walks Away From Ads On Paper, Reprints, Detail Pieces
- iPad is t he paper killer
Pharmas dial back reprints spend, floor it on digital to reach HCPs
Print professional spend plummeted 40% from 2009-2010, and then another 20% between 2010 and 2012, when it clocked in at 41% of HCP promotional budgets
[MM&M]
5/21 XenoPort Pulls Plug On Experimental Spastic MS Pill, Shares Tumble
XenoPort to drop multiple sclerosis drug, shares fall
The drug, arbaclofen placarbil, was XenoPort's only product in late-stage trial
late-stage trial failed to show significant improvement over a placebo.
[Reuters]
5/21 Inotuzumab: Pfizer Pulls Plug On Experimental Lymphoma Drug
Pfizer halts study of lymphoma drug unlikely to help survival
compared with patients who got either Rituxan and Teva's Treanda or Rituxan and the chemotherapy drug, gemcitabine.
independent monitors found it was not likely to improve survival
[Reuters]
5/21 Study: Beta Agonists, Muscarinic Antagonists Equally Cardio-Risky
-Both bronchodilators both gave 28% cardio event risk
Similar Cardiovascular Risk Observed With COPD Drugs
no difference in the increased risk for cardiovascular disease between the two main classes of drugs used in the first-line treatment of chronic obstructive pulmonary disease
long-acting inhaled beta-agonists) and LAMAs (long-acting muscarinic antagonists)
[Forbes]
5/21 Cut Out The Middlemen: Drug Companies Sell Directly To Patient
- Recurring payments, auto-refills, No PBM's mean more sales
A New Drug Sales Model
recurring credit card payment plans
people don't pay close attention to their credit card statements or get accustomed to seeing a recurring bill and start to overlook it,
don't have a middle man to inform them that a generic version of a drug is available, they might not know to switch
[Motley Fool]
5/21 Internet Drug News Fast Takes
9 Most Obese Countries In The World (Mexico = #2)
Motley Fool
Bayer says pulmonary hypertension drug shows promise in prolonged trial
Reuters
Health Canada Recalls quietapine; contaminated with clindamycin
CTV
5/20 EU Backs Cyproterone + Ethinyl Estradiol Diane Despite
Questionable Safety Profile
EU watchdog backs Bayer acne drug for certain patients
benefits outweighed the risks - provided measures were taken to minimize the chance of blood clots forming in veins and arteries
[Reuters]
Acne Pill Diane-35 Linked to 100 Cases of Blood Clots?
authorized for acne treatment in France and for some European countries as a dual contraception-acne treatment solution
used by millions of women worldwide as a contraceptive
[Guardian Express]
5/20 Study: Animal Tranquilizer Ketamine Effective For Depression
Club-Drug Ketamine Relieves Depression in Largest Patient Study
used to anesthetize horses
patients taking ketamine were twice as likely to report improvement than those on a placebo
45.7 percent still reported a response to ketamine, versus 18.2 percent in the placebo
[Bloomberg]
5/20 Big EU Pharma Rack Up Impressive YTD Share Price Gains
- Roche leads pack: 23% up since January
European drug stocks are on a tear
dividend-hungry investors return to a sector previously blighted by a lack of new blockbusters
patent cliff now is in the rear-view mirror for most companies
Roche is up by roughly 19% and GSK shares have posted a 23% jump
[Money.Cnn.com]
5/20 Indian Government Fixes Prices On 652 Drugs
- Up from the 74 currently under price control
Govt to regulate rates of 652 medicines; prices set to fall
adversely impact GlaxoSmithKline and Sanofi Aventis the most
companies incurring significant losses would be forced to take a relook at their business models and many would look at redeploying their sales force
[Economic Times]
5/20 Cell-Death Cancer Drugs: Bristol Myers Leads Pack
With 'Cell Death' Drugs, Bristol-Myers May Win No Matter What
new class of drugs that allow the immune system to attack cancer cells is generating excitement. Bristol-Myers Squibb may have an unmatchable advantage in the field over competitors
[Forbes]
5/20 California Senate Wants Jumbo Printing On Rx Bottles
- Problem is standard labels are too small
California Senate requires larger print for drug labels
state Senate has approved legislation requiring pharmacists to print specific, important information on prescription labels in at least 12-point type.
Pharmacists may be forced to dispense medicine in oversized containers so that the label can be large enough to meet the requirements
[LA Times]
5/20 Oral Insulin To Begin Phase 2 Trials
Oramed: First Trial Of Orally Delivered Insulin
oral insulin capsule ORMD-0801, to begin shipping to clinical sites for human Phase II testing
resists inactivation during digestion and delivers a full therapeutic dose across the intestinal wall with all its components intact
[Seeking Alpha]
5/20 Can Mannkind Inhaled Insulin Succeed Where Pfizer's Exubera failed?
- Afrezza inhaler tiny, dosing simpler
Why MannKind's Afrezza Will Succeed Where Pfizer Failed
patients that used Exubera, quickly went back to injections because administering the proper dosage was horribly complicated
Afrezza insulin cartridges contain a uniform amount of insulin -- unlike Exubera -- adjusting the dosage is simple arithmetic
[Seeking Alpha]
5/20 Internet Drug News Fast Takes
Obamacare: no-cost help for depression, weight loss, smoking, and STDs
TakeApart.com
Impax Labs launches authorized generic version of Zomig tablets, nasal spray
Impax Press Release
J&J Wins Expanded Approval of Simponi for Bowel Disease
Bloomberg
Transition to Propellant-Free Combivent® Respimat® (ipratropium bromide and albuterol) Inhalation Spray Nears Completion
Boehringer Ingelheim Press Release
Mylan Launches Generic Tricor(R) Tablets
Mylan Press Release
Multiple Sclerosis and Hemophilia: Biogen'sJust Getting Started
Motley Fool
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