Latest From Biotech Now

House Agriculture Subcommittee Seeks Answers from the Agricultural Marketing Service


On June 25, 2015, the House Agriculture Subcommittee on Biotechnology, Horticulture, and Research held a hearing to review the United States Department of Agriculture’s (USDA) Marketing Programs. Mr. Craig Morris, Deputy Administrator of Livestock Poultry and Seed Program of the Agricultural Marketing Service (AMS) at the United States Department of Agriculture was the only witness to testify in front of the Subcommittee. Specifically, Mr. Morris discussed some of the management system audits offered by the Read More >

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GMO Answers on the IARC Assessment of 2,4-D as a Possible Carcinogen

GMO Answers

The International Agency for Research on Cancer (IARC) creates Working Groups to periodically consider lifestyles, workplaces, and compounds that may have carcinogenicity potential. IARC is an agency under the World Health Organization (WHO) but is not responsible for regulating pesticides. On Monday, IARC classified 2,4-D as “possibly carcinogenic” to humans (Group 2B — same category as coffee and carpentry). Will this classification affect your daily life? Most likely — no. What is 2,4-D? 2,4-D is Read More >

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ASCO Publishes New “Value Framework” for Cancer Treatment Options


On Monday, the American Society of Clinical Oncology (ASCO) published “A Framework to Assess the Value of Cancer Treatment Options” in the Journal of Clinical Oncology intended to ‘assess the value of new cancer therapies based on treatment benefits, toxicities, and costs.’ The framework, developed by the ASCO Value in Cancer Care Task Force, is intended to ‘ultimately serve as the basis for user-friendly, standardized tools that physicians can use with their patients to discuss the relative value Read More >

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IP Sessions at BIO 2015: The Impact of the Inter Partes Review on (BIO)Pharma


The Intellectual Property Track at the BIO International Convention was a chance for IP thought leaders in the biotech sector to discuss some of the most pressing issues impacting the industry. Let’s recap what we learned from one of the IP sessions at BIO 2015: The Impact of IPRs on (BIO)Pharma On Tuesday, patent litigation experts met to discuss inter partes review proceedings and how they are impacting biotechnology. Panelists from The Impact of IPRs Read More >

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FDA Acts on Biosimilars


The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be implemented.  The U.S. Food and Drug Administration has issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act.  The Guidances were expressly “draft” in nature, and were the subject of public hearings with the Agency welcoming Read More >

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