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BIO urges FDA to release guidance on biosimilars.

2015-01-12 14:31:03| Industrial Newsroom - All News for Today

Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks. BIO calls on the FDA to release final guidance on processes and scientific criteria for approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining biosimilar to be interchangeable with its reference biological.

Tags: release bio guidance fda

 

BIO announces presenters for BIO CEO and Investor Conference.

2014-12-22 14:31:03| Industrial Newsroom - All News for Today

BIO announced preliminary list of presenting companies for 17th Annual BIO CEO & Investor Conference to be held Feb 9–10, 2015. Presenting companies are hand-selected for event, and consist of mid-to-large cap established public companies from around the globe. Participating companies typically have a clinical stage program focused on therapeutics, molecular diagnostics, or a platform technology, as well as an upcoming clinical, regulatory, or corporate catalyst.

Tags: conference bio investor ceo

 
 

BIO Says EPA Must Improve Renewable Fuel Standard administration.

2014-12-18 14:31:02| Industrial Newsroom - All News for Today

According to BIO, EPA delays in administering Renewable Fuel Standard (RFS) generate uncertainty for advanced biofuel industry and undercut investment. BIO President and CEO Jim Greenwood cited EPA's failure to issue final 2014 RFS rule and other administrative delays as misconstrued as indicative of broken program but reassured that that same program has worked to spur innovation and growth in biofuels space and subsequently reduce U.S. GHG emissions and reliance on foreign oil.

Tags: standard improve administration bio

 

BIO CEO/Investor Conference will examine industry trends, outlook.

2014-12-17 14:31:33| Industrial Newsroom - All News for Today

BIO announced preliminary programming for 17th Annual BIO CEO & Investor Conference, which will be held February 9–10, 2015 in NYC and include Fireside Chats with biotech luminaries, Business Roundtables, in-depth Therapeutic Workshops, and forward-looking Plenary Sessions. With 1,800+ partnering meetings are expected and 150 companies planning to present, conference brings industry leaders together to form new partnerships/collaborations and advance medical progress and innovation.

Tags: industry conference trends bio

 

BIO applauds House passage of Ebola treatments bill.

2014-12-15 14:32:37| Industrial Newsroom - All News for Today

BIO applauds unanimous House passage of the Adding Ebola to the FDA Priority Review Voucher Program Act and urges swift action by President Obama to sign into law. Act would add Ebola to FDA's voucher program, under which developers of vaccine or treatment for qualifying tropical disease receive voucher for FDA priority review for another product of choice. Act would also allow vouchers to be sold and transferred multiple times by manufacturers, increasing their value.

Tags: house bill bio passage

 

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