Articles by Anna Rose Welch

  1. 90 Studies Prove Biosimilars' Safety And Efficacy: What Now? 3/27/2018

    This review sought to answer two questions which have been plaguing the biosimilar industry since day one: will biosimilar switching have any impact on safety, and will biosimilars be the harbingers of increased immunogenicity? And it has provided us with far more than just answers to these questions.

  2. DIA Biosimilars Conference Reveals “More Questions Than Answers” 10/31/2017

    During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”

  3. Could 96 Percent FDA Drug Approval Rate Harm Biosimilar Market? 9/1/2015

    Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?

  4. FDA News Roundup: Otsuka, AstraZeneca, Ipsen, And More 7/17/2015

    What FDA decisions have you missed recently?

  5. Venture Philanthropy: Is It Really Promoting Patient Centric Drug Development? 7/14/2015

    Within the last 10 years, a number of nonprofit groups, including the Michael J. Fox Foundation and the Multiple Myeloma Research Foundation, have taken a similar approach to ensuring that their targeted patient populations are being well represented in pharma R&D.

  6. FDA News Roundup: Pfizer, Eli Lilly, Vertex, And More 7/10/2015

    What FDA decisions have you missed recently?

  7. Is Pharma Truly Equipped For Transparency? 7/8/2015

    As the call for transparency grows louder in the pharma industry, the question arises: are drugmakers equipped with all they need to be transparent — especially when it comes to demonstrating their drugs’ economic value?

  8. Will Biotech Employment Continue To Rise As The Industry Evolves? 6/30/2015

    A report from the Bureau of Labor Statistics found that nationwide employment in “pharmaceutical and medicine manufacturing” sunk from 291,795 in 2003 to 277,113 in 2013, The Philadelphia Inquirer reported recently. But it’s not the same story for biotech R&D: employment hit 142,475 in 2013 — up from 135,424 in 2007.

  9. 3 Steps To Patient Centric Clinical Trials 6/25/2015

    Kelly Franchetti, executive director of global patient insights and engagement for Mapi Group, had one big recommendation for pharma at the 2015 Patients As Partners in Clinical Trials conference. According to Franchetti, one of the best ways for pharma to see clinical trials through a patient-centric lens is for those running the clinical trials to recognize themselves, too, as patients.

  10. FDA Roundup: Sanofi, Genentech, Apitope, Retrophin, And More 6/11/2015

    What regulatory decisions have you missed recently?