New At the FDA
The FDA has been busy in 2014 with statistics that show positive performance for the agency but also versus other regulators outside the U.S. They have approved 27 novel new drugs, including biologics, so far this year and have chance to match the high of 39 approvals in 2012. The achievement so far matches that for the whole of 2013.
In recent news we learn that the agency has published a list of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations in the form of the “Purple Book.” This is in keeping with the first acceptance of a biosimilar application in July from Sandoz, a unit of Novartis AG.“The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.”
BioCentury noted last week that the Purple Book is supposed to be the equivalent of the Orange Book which “lists all approved generic equivalents for a drug, along with patent and exclusivity information.”
Highlights of This Coming Week’s Many Life Science Events
- BioCentury This Week, See new program Webcast Starting Sunday, Sept. 14, 2014, http://www.biocenturytv.com, Available anytime starting at 9:00 a.m. EDT, Topic: “Battling Ebola: Racing Against Time;” Speakers: Dr. Anthony Fauci, Director, NIH’s National Institute of Allergy and Infectious Diseases; Dr. Robin Robinson, Director, Biomedical Advanced Research and, Development Authority and Donna Altenpohl, Vice President of Public Policy, GlaxoSmithKline
- Bio2Device Group, Tuesday Morning, Sept. 16, 2014; Topic ”Opportunities and Challenges for MedTech Companies in Evolving Reform and Reimbursement Landscape,” Speaker: Jessica Holmes, Director of Reimbursement, Argenta Advisors
- Janssen Labs, Tuesday, Sept. 16, 2014; Topic: “Meet with… NEA;” NEA Participating Representatives: Frank Torti, Principal, New Enterprise Associates, Inc. | Josh Makower, MD, Venture Partner, New Enterprise Associates, Inc. | Ed Mathers, Partner, New Enterprise Associates, Inc.
- Engineering in Medicine and Biology Society (EMBS), Wednesday Evening, Sept. 17, 2014; Topic: “Modeling Health Behaviors Using Mobile Sensing;” Speaker: Anmol Madan, co-founder and CEO, Ginger.io
- SVForum, Wednesday Evening, Sept. 17, 2014; Topic: “Sensors, Wearables, and Interoperability SVForum Healthcare IT Special Interest Group”
- Life Science Leader and GE Healthcare, Thursday Morning, Sept. 18, 2014; Event: “Webinar: Five questions to ask before selecting a raw materials supplier;” Speakers: David Radspinner, PhD . General Manager, HyClone™ Cell Culture Products, GE Healthcare; Trisha Gladd, Contributing Editor, Life Science Leader Magazine and Ed Miseta, Executive Editor, Life Science Leader Magazine
- ShareVault Free Webinar, Thursday Morning, Sept. 18, 2014; Webinar: “What’s Hot & What’s Not in Oncology Licensing;” Panelists: Linda Pullan, Ph.D, Pullan Consulting; Jeff Bockman, Ph.D, Vice President, Defined Health; Paul Juniewicz, Vice President, Oncology Business Opportunities, Sanofi and Ferran Prat, Ph.D, VP of Strategic Industry Ventures, MD Anderson
- NCC ACRP, Thursday Evening, Sept. 18, 2014; Topic: “Changing our Approach: Practical Applications of Root Cause Analysis (RCA) and Corrective and Preventive Action Plans (CAPAs);” Speaker: Nikki Christison, BS., CCRA, Owner, Clinical Resolutions, Inc.
- PBSS, Friday Afternoon, Sept. 19, 2014; Topic: “LC-MS/MS PK Assays for Proteins and Antibodies: Fundamentals, Advances, and Regulatory Considerations;” Speakers: Luna Liu (Genentech), Mark Rose (Amgen), Doug Leipold (Genentech)
- Northern California BioPharmaceutical Project Management, Friday Morning, Sept. 19, 2014; Topic: “Antibacterial Drug Development and Commercialization: Avoiding the pitfalls in pre-market AST device development for post-market success; Speaker: Kevin Krause, Associate Director – Clinical Microbiology, Cerexa, Inc
You can download Audrey’s Picks with complete details on the above and other meetings and conferences through Dec. when you right click on the highlighted title Audreys Picks Sept.14, 2014. I’ve also included JobsThatCrossedMyDeskThrough Sept. 14, 2014 for your information.