FDA

2.4.2014 Clinical Development

Planning Ahead to Meet Clinical Data Stakeholders’ Expectations

By Sarah Ray, Research Analyst Clinical data transparency has become one of the hottest issues for pharmaceutical and biotechnology clinical development and regulatory teams. From new disclosure policies at PhRMA and the EFPIA to working with the...
 

1.20.2014 Regulatory Affairs

Three Steps Toward a Successful Regulatory Affairs Operation

By Jacob Presson, Research Analyst As regulatory affairs groups in the pharma industry continue their shift into more strategic roles with greater influence on product development, it is vital that these groups are structured efficiently and communicate...
 

1.15.2014 Medical Affairs

Medical Affairs Embracing a Patient-Centric 2014

By Nicole May, Research Analyst As pharma moves into 2014, new technologies will allow medical affairs teams to shape their strategies to be increasingly and innovatively patient-centric.  Although a case could be made to stop using the term, whatever...
 

11.26.2013 Drug Safety

Improving Drug Safety: The Drug Quality and Security Act

By Sarah Ray, Research Analyst Recent events have highlighted the need for increased government regulations to uphold the pharmaceutical supply chain and improve existing drug safety measures. Since the contamination of steroidal injections in 2012...
 

10.1.2013

The Headaches Behind Warning Labels: Tylenol Put Patients First, Brand Second

By Jennifer Harrell, Research Analyst “A flat prediction I’ll make,” claimed esteemed advertising guru Jerry Della Femina in a New York Times article written in October 1982, just days after arsenic-laced Tylenol fatally poisoned seven Chicagoans,...
 

7.30.2013 Lifecycle Management

Sandoz Aims to Launch Biosimilar Version of Enbrel

By Jennifer Harrell, Research Analyst Sandoz, a generic subsidiary of Novartis and an industry leader in the development of follow-on biologics, is launching a Phase III clinical trial of a biosimilar version of Amgen’s Enbrel (etanercept).  Enbrel...
 

7.23.2013 Lifecycle Management

From Phase 3 to Post-Marketing Studies: The Journey of Aripiprazole IM (Abilify Maintena)

By Sarah Ray, Research Analyst Schizophrenia is a complex psychological disease state that distorts patients’ cognitive and emotional responses. Patients may experience positive symptoms such as delusions, hallucinations or disorganized thought...
 

5.2.2013 Marketing

FDA Closer to Regulating Dr. Smartphone

Pharma has been quick to take up its share of social media — companies have already staked out their space on Facebook, Twitter and even Pinterest.  Television ad spending is down as drug companies have increased their use of these new platforms to interact...
 

4.17.2013 Clinical Development

Promising Oncology Drug Receives Third Breakthrough Designation from FDA

Pharmacyclics Inc. recently announced that the FDA granted an additional Breakthrough Therapy designation for its investigational oral agent ibrutinib as a monotherapy to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma with deletion...
 

3.26.2013 Clinical Development

Pharma, Drug Safety and REMS (Oh My!): Risk Mitigation and Pharmaceutical Companies

Pharmaceutical companies may not take the Hippocratic Oath, but, through dedicated pharmacovigilance programs, companies ensure that drug safety remains a top priority among their medical affairs responsibilities.  Within companies’ medical affairs teams, evaluating...