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Ortho-McNeil Inc.

Division of Johnson & Johnson
www.ortho-mcneil.com

Latest From Ortho-McNeil Inc.

Pediatric Studies: Must Sponsors Meet Every Detail Of US FDA Request To Get Exclusivity?

In suit against FDA, Amgen argues it provided sufficient data to obtain exclusivity for Sensipar but agency says too few patients were included in one study; court ruled against FDA in similar 2001 dispute.

Pediatrics Legal Issues

COPD Patient-Reported Outcome Questionnaire Is Early Example of FDA Drug Development Tool “Approval” Process

FDA finalizes the "qualification process for drug development tools." The topic won't get as much attention as Breakthrough Therapy or Accelerated Approval, but the head of the drug center thinks this is a very big deal. A COPD outcomes assessment is an early example of the process in action.

BioPharmaceutical Drug Approval Standards

Contamination Issues Drove Drug Recalls to Record Levels in 2011

How contamination, sterility assurance, OOS and other issues caused drug recalls to spike again last year. What happened at Aidapak, H&P, Ben Venue, Hospira, Teva and other manufacturers to set a new record.

Where Are They Now? Checking In On Four Cardiovascular Start-Ups

It's no secret increasing generic competition and regulatory oversight, combined with the financial challenges of developing a primary care drug, make cardiovascular a tough place for venture-backed biotechs. START-UP takes the pulse of four previously profiled cardiovascular companies -- arca Biopharma, Celladon, NovaCardia and Portola Pharmaceuticals, -- to see what lessons they've learned.
BioPharmaceutical Strategy
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