Author Archive: BIOtechNOW Editor

BIO Is Almost Here – What To Consider Before Entering New Therapeutic Areas

BIO International Convention

Over the past decade, the biopharmaceutical industry has witnessed a shift towards specialty care. From 2008 to 2014, FDA specialty drug approvals jumped from 33 percent to over 50 percent of all approvals. In 2014, the FDA approved a record 19 specialty care medicines. Given this new reality, companies are expanding the focus of their R&D into new therapeutic areas to address difficult-to-treat, specialty care conditions. Building successful franchises requires a strategic approach to determine the Read More >

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Life Science Leader Asks: What Biopharma Trends Should Pharma Execs Be Paying Attention To?

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In my last installment of this four-part series interviewing Peter Young, executive-in-residence with A.M. Pappas & Associates, I asked what trends should biopharma execs be paying greater attention to and why. Check out my interview to get insights from Peter on upcoming trends! Peter’s session, Inventing Your Own Hub: Evolving Institutional Models for Translational Medicine, will be taking plan June 16 from 3:30 p.m.-4:45 p.m. in room 105AB. If you missed the earlier segments in this series, here is Part 1, Read More >

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The International Space Station Brings Big Buzz and Big Science to BIO 2015

BIO International Convention

This year, the BIO International Convention will raise the bar, yet again, through a collaborative effort with CASIS and NASA to showcase space research at this year’s convention. CASIS, the nonprofit organization that manages the U.S. National Laboratory on the International Space Station (ISS), is pioneering a new wave of innovation in space research by connecting commercial R&D leaders to the world’s unique orbiting research platform. Currently, biosciences are a key focus area for CASIS Read More >

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Life Science Leader Asks: What Areas Are Often Overlooked by Academics Turned Biotech Entrepreneurs?

Life Science Leader

In my third installment of a four-part series interviewing Peter Young, executive-in-residence with A.M. Pappas & Associates, he shared missteps made by academics aspiring to become entrepreneurs and also offered up some advice on partnering with VCs. Check out my interview, which will include lessons that won’t be a part of his 2015 BIO International Convention session, Inventing Your Own Hub: Evolving Institutional Models for Translational Medicine, (June 16, 3:30 p.m.-4:45 p.m., room 105AB) Here is Part 1, Read More >

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Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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