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Pharmalot Webcast
Shifting Ranks Among Health Care Payers & Players: You Need a Better Scorecard
June 28, 2012 at 1pm ET
Rapidly shifting market channels, Federal health reform, and change among prescription blockbusters - the US health care marketplace is more dynamic than ever. Providers and Payer organizations are forging new roles in response to global payment scenarios. The goals, methods, and influence of key purchasers in the health care value chain - self-funded insurance enterprises, municipalities, school districts - are also shifting rapidly. Are you and your colleagues keeping up with these market changes? Do you know the score? Register Now

> FDA Issues Complete Response Letter for Xarelto
> Novartis Says EU Recommends New Afinitor Approval
> NOXXON Initiates Phase IIa of anti-CCL2/MCP-1 Spiegelmer NOX-E36 for Treatment of Diabetic Nephropathy
> UCB Japan Files for Indication of Pediatric Epilepsy for E Keppra Tablet
> Merck Recalls Batch of MMR Vaccine Released Early
 
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Cardiovascular
 
FDA Issues Complete Response Letter for Xarelto
ENP Newswire - Jun. 22, 2012
Janssen Research & Development said the FDA issued a complete response letter regarding an sNDA for Xarelto (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome Janssen is evaluating the complete response letter and will respond to the agency's questions.
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Sub-Analysis Suggests Pradaxa Associated with Similar Bleeding Rates and Thromboembolic Complications in Surgery Versus Warfarin
From the PharmaLive.com News Archive - Jun. 18, 2012
A new retrospective sub-analysis of the RE-LY trial suggested similar rates of peri-procedural bleeding and thromboembolic complications, such as a stroke or systemic embolism, in non-valvular atrial fibrillation patients undergoing a surgical or invasive procedure treated with Pradaxa (dabigatran etexilate mesylate) capsules 150mg taken twice daily compared to warfarin.
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Oncology
 
Novartis Says EU Recommends New Afinitor Approval
Associated Press - Jun. 22, 2012
Novartis AG said that a panel of European Union regulators says its drug Afinitor should be approved to treat certain types of breast cancer. The Committee for Medicinal Products for Human Use said Afinitor should be approved to treat advanced breast cancer in postmenopausal women whose cancer has recurred or progressed after previous treatment.
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FORMA Therapeutics Teams with TGen Drug Development
From the PharmaLive.com News Archive - Jun. 18, 2012
FORMA Therapeutics and TGen Drug Development announced an agreement to jointly develop transformative cancer therapies, leveraging the synergistic capabilities of both organizations.
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Pain & Inflammation
 
NOXXON Initiates Phase IIa of anti-CCL2/MCP-1 Spiegelmer NOX-E36 for Treatment of Diabetic Nephropathy
From the PharmaLive.com News Archive - Jun. 21, 2012
NOXXON Pharma announced the treatment of the first patient in a Phase IIa clinical trial of its anti-CCL2/MCP-1 (C-C Chemokine Ligand 2 or Monocyte Chemoattractant Protein-1) Spiegelmer NOX-E36 in patients with diabetic nephropathy.
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Central Nervous System
 
UCB Japan Files for Indication of Pediatric Epilepsy for E Keppra Tablet
ENP Newswire - 22 June 2012
Otsuka Pharmaceutical and UCB Japan filed in June 2012 for an additional dosage and administration for the antiepileptic drug E Keppra 250 mg and 500 mg Tablet (levetiracetam) as an adjunctive therapy in combination with other antiepileptic drugs in the treatment of partial onset seizures in pediatric epilepsy in Japan.
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Vascular Cause For Alzheimer's Is Revealed With The Backing Of Science Investor
From the PharmaLive.com News Archive - Jun. 18, 2012
There is a well-known link between Alzheimer's disease and a gene called ApoE4. In fact, people who carry two copies of the gene have approximately 8 to 10 times the risk of getting Alzheimer's than those who do not have the gene.
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Infectious Disease
 
Merck Recalls Batch of MMR Vaccine Released Early
Associated Press - Jun. 21, 2012
Merck & Co. said it is recalling 39,000 doses of a vaccine against measles, mumps and rubella because it was shipped before the company finished an internal approval process. Merck said it accidentally shipped the batch of MMRII vaccine, but its quality, safety and effectiveness were confirmed before it went out.
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EMA Validates Gilead's Marketing Application for Elvitegravir for Treatment of HIV Infection
From the PharmaLive.com News Archive - Jun. 18, 2012
Gilead Sciences announced that its MAA for elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced patients, has been validated by the European Medicines Agency (EMA). Gilead submitted the MAA on May 22, 2012.
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 June 25, 2012
Ask the Experts
Patient Support Programs
Scott Dulitz, MBA
Senior Director
United BioSource Corporation
“In an effort to improve patient adherence many programs are now also experimenting with social media and other electronic communication platforms such as secure email and text messages.”

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