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10/20 Fast Takes
GSK says Ebola vaccine development progressing at 'unprecedented rate'
Reuters
Cegedim  Cool With Being Bought Out By IMS
IMS Press Release
The importance of vaccine perceptions in self-pay markets
MM&M

10/20
Off-Label; Why Is FDA Playing God?
- How FDA twists law from 1938 to shackle Pharma's 1st amendment rights
Better Late Than Never? Congress, Courts May Address Limits On Disseminating 'Off Label' Medical Information … FDA has been reluctant to elaborate on the basic restriction forbidding the promotion of unapproved uses, even in the face of rulings that admonished the agency for being overly restrictive and failing to regulate in a way that is properly sensitive to free speech principles …[Forbes]

10/20
Germany: Anti Death Penalty Activists Put Pressure On Mylan
- Rocuronium bromide is hard to come by
Mylan faces investor pressures over use of drugs in US executions … only US-approved producer of  rocuronium bromide not to have imposed measures to prevent its use in lethal injections. The product is approved as a muscle relaxant during surgery but, at a high dose, can cause paralysis of the breathing muscles …[Ft.com]
Editor's Note: Speaking for myself I would overdose on  drugs than have my brains cooked in the electric chair.  If the activists win the condemned lose.   (Click HERE to See Graphic Image of electrocuted murderer's head )

10/20
Regeneron's Eylea works better vs Avastin and Lucentis in study
Eylea beats Avastin and Lucentis for visual acuity in DME patients … better than expected because in addition to better efficacy, Eylea also showed better safety, especially compared to Lucentis for APTC and cardiovascular events …[Pharma Letter]

10/20
Rx Pill Deaths Down Heroin Overdoses Surge
- Cheap plentiful heroin replaces pricey pain pills
As Rx deaths dip, heroin overdoses surge … Fatal heroin overdoses rose 35% to 5,927, while deaths involving chemically similar prescription painkillers such as OxyContin and Vicodin dropped 5% to 16,007 … [LA Times]

10/20
Embeda Gets Highly Desirable Label
- Can differentiate itself as less likely to be abused; US launch expected early 2015
US FDA backs abuse deterrent labeling for Pfizer's Embeda ER …  Pfizer expects Embeda will be available in the US in early 2015 … updated label states that Embeda has properties that are expected to reduce abuse via the oral and intranasal (ie, snorting) routes …[Pharma Letter]
See Also: Click HERE for 7-day free trial subscription to Pharma Letter

Amgen Sues Sanofi, Regeneron To Block Revolutionary Anti-Cholesterol Drug
Amgen Files Lawsuit Against Sanofi And Regeneron For Patent Infringement … suit alleges that Regeneron and Sanofi are violating three Amgen patents with alirocumab, one of an emerging group of medicines that lower cholesterol by targeting a gene known as PCSK …[WSJ]

Feds Simplify  OpaymentData Interface
- Make it easier to look up doctor by name
Better Late Than Never: CMS Improves The Doctor Payment Website … lets you search by a physician's name, location or specialty, as well as by the names of teaching hospital and companies. The results list each individual payment, which can be sorted from high to low …[Pharmalot]


10/17 Chantix Keeps Black Box
FDA panel votes to keep severe warning on Pfizer anti-smoking drug .... A majority of the panel voted to keep the health regulator's most severe warning label on the treatment, in keeping with the recommendations of FDA staff two days earlier .... [Reuters]

10/17 Why Seniors Skip Their Meds
30% of Medicare Beneficiaries Not Adherent to Medications .... The reasons cited for nonaherence included forgetfulness (n=123; 73%); side effects (n=18; 11%); and feeling that the medication was not needed (n=17; 10%) .... [First Report Managed Care]

10/17 FDA Bypassing Standard Procedures to Meet Ebola Need
Ebola Has the FDA Working Overtime on Reviewing Experimental Drugs .... In the U.S., when physicians ask the FDA for permission to use experimental drugs on their patients, as they have recently in Dallas, the agency responds in a matter of hours—and often, less than one hour. .... [National Journal]

10/17 Harvard Business Review Picked the World's Best CEOs. Four of Top 10 Are Pharma
World's best CEOs? Gilead, Allergan, Novo and Valeant make top 10 .... HBR has a particular slant on CEO quality: It's about market cap growth and shareholder returns .... [Fierce Pharma Marketing]
Direct link: The Best-Performing CEOs in the World [Harvard Business Review]

10/17 21 Million Compounded Bioidentical Menopause Scripts Filled Every Year
Many U.S. women use custom-compounded hormones for menopause .... An estimated 1.4 million U.S. women take custom-compounded bioidentical hormone therapy for menopausal symptoms, and most are unaware that these drugs are not FDA-approved .... [Reuters Health]

10/17 Secukinumab Gets Favorable Staff Review
Novartis psoriasis drug benefits outweighs risk-FDA staff .... The injectable biologic, secukinumab, is part of an eagerly anticipated class of drugs called IL-17 inhibitors that have shown unprecedented success in plaque-psoriasis .... [Reuters]

10/17 Meet the Office of Pharmaceutical Quality
FDA Announces Major Agency Reorganization, With Focus on Drug Quality .... OPQ was envisioned as a way to oversee drug quality throughout the product lifecycle, instead of the fragmented pre-market/post-market approach now taken by FDA .... [Regulatory Focus]

10/17 ‘Shine The Light On Me — My Sugar's Too High’
New diabetes drug is activated with light .... A new drug for type 2 diabetes could be activated exactly when it's needed by shining a blue light on the skin, and might one day give patients with the disease more control over their blood sugar levels .... [Fox News]

10/17 Is 21 Days Quarantine Enough?
Study Questions 21-Day Quarantine Period for Ebola .... There could be up to a 12% chance that someone could be infected even after the 21-day quarantine .... [PTCommunity]

10/17 Can Stem Cells Work for ALS? CEO Gives an No-Hype or BS Look
Brainstorm CEO Offers Investors a Frank Outlook for ALS Therapy .... The laboratory culturing of mesenchymal stem cells into specialized cells documented to produce nerve growth factors sets NurOwn apart from other riskier attempts at stem cell therapy .... [The Street]

10/17 Internet Drug News Fast Takes:
Diet may influence ovarian cancer survival
Reuters
Conventional medical centers may be unable to prevent spread of Ebola
Annals of Internal Medicine
NICE not recommending Dendreon cancer vaccine
Pharmafile
Getting an Appointment With a Psychiatrist Often Difficult
HealthDay News
Parenthood May Push Cancer Patients to Seek More Treatment
HealthDay News

10/16 Esbriet (Roche); Ofev (Boehringer Ingelheim) Approved
FDA approves two treatments from Roche, Boehringer for fatal lung disorder .... The agency's decision marks a crucial milestone in the management of the disease, which affects about 100,000 people in the United States. .... [Reuters]

10/16 AbbVie Puts the Brakes on Tax Inversion Deal with Shire
AbbVie cools on $55 bln Shire deal after U.S. tax changes .... U.S. pharmaceutical company AbbVie said it was reconsidering its $55 billion takeover of Shire in the wake of U.S. government moves to curb deals designed to cut taxes .... [Reuters]

10/16 90% of Terminal Lukemia Patients Respond to Experimental Therapy
Last-resort leukemia treatment produces dramatic remission rate .... The ALL treatment involves training disease-fighting blood cells known as T-cells. Once removed from a patient's body, they are programmed to hunt cancer cells that have a telltale protein on their surface. The specially-trained cells are then re-injected into the patient. The re-engineering process currently costs about $25,000 .... [Reuters]

10/16 Search for "Chest Pain," and Google Might Pop a Live Doc on Your Screen with Help
Google trial lets you chat with doctors when you search for symptoms .... The company is testing a Helpouts-style feature which offers video chats with doctors when you search for symptoms .... [Engadget]

10/16 All Eyes on AbbVie's Pricing for Hep C
If AbbVie Discounts its Hep C Drug, Would Pricing Reach a Tipping Point? .... The cost per patient could fall to below $70,000, on average, across the spectrum of hepatitis C patients .... [WSJ/Pharmalot]

10/16 Lenvatinib Priority Review
FDA grants priority review designation for Eisai's Lenvatinib to treat advanced thyroid cancer .... Lenvatinib is an oral multiple receptor tyrosine kinase inhibitor with a unique binding mode that selectively inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors .... [Pharmaceutical Business Review]

10/16 J&J to Scotland: 'If Our Drug Doesn't Work, You Get Your Money Back'
J&J offers goverment payer hep. C guarantee .... The drugmaker has proposed reimbursing the patient cost for those who are not cured after 12 weeks of treatment with Olysio (simeprevir) .... [MM&M]

10/16 Kinetica Errors Throw Approvals in Doubt
Software issue casts doubt over data used to approve some drugs .... The reliability of clinical tests used to win approval for some medicines -- particularly generic copies of original drugs -- could be in doubt due to an apparent software glitch that may mean data was calculated incorrectly .... [Reuters]

10/16 Copaxone Patent Before Supreme Court
Teva Gets Mixed Reception at U.S. High Court on Copaxone .... The justices suggested they will divide on a federal appeals court's decision to invalidate a patent that would protect Copaxone from rivals until September 2015 .... [Bloomberg]

10/16 Amgen Pipeline Preview
A Quick Look at Amgen's Drug Development Pipeline .... While Amgen has noted that it plans to deliver late-stage data on 10 experimental drugs between 2014 and 2016, there are three developing drugs that are the cornerstone to its future success .... [Motley Food]

10/16 Internet Drug News Fast Takes:
Poll: 40 Percent Of Americans Feel At Risk For Getting Ebola
NPR
FDA Wants to Study if Drug Color, Shape and Size Affect Patient Adherence
Regulatory Focus
This Man's Simple System Could Transform American Medicine
Wired
Biotech's Builder: How The Pharma's Landlord Could Benefit From The Drug Boom
Forbes/Matthew Herper
Was Celgene's Crohn's Disease Drug Worth The Price?
Investor's Business Daily

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