February 17, 2017
February 24, 2017
This week’s headlines include: Tom Price Is Confirmed as Health Secretary, uniQure details three-pronged gene therapy trial program, Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike, Emergent Wins BARDA Contract to Develop Viral Hemorrhagic Fever Treatments, Riskiest ideas’ win $50 million from Chan Zuckerberg Biohub, and FDA approves Valeant’s drug to treat plaque psoriasis.
“The Senate early Friday approved the nomination of Representative Tom Price to be secretary of health and human services, putting him in charge of President Trump’s efforts to dismantle the Affordable Care Act….”
“uniQure plots to initiate a three-pronged clinical trial program next year as key assets from its in-house pipeline and Bristol-Myers Squibb collaboration advance. uniQure aims to move its hemophilia B gene therapy, AMT-060, into a pivotal trial while working to advance a Huntington’s disease asset and Bristol-Myers-partnered heart failure candidate into the clinic…”
“Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly…”
“Emergent BioSolutions said today it will develop monoclonal antibody therapeutics for viral hemorrhagic fever under a task order from the Biomedical Advanced Research and Development Authority (BARDA) that is valued at up to $30.5 million…”
“The biomedical research initiative created by Facebook co-founder Mark Zuckerberg and his wife, physician Priscilla Chan, has awarded its first grants to scientists, on topics ranging from the genomics of obscure microbes to a memory-retrieval device…”
“The U.S. Food and Drug Administration on Wednesday approved Valeant Pharmaceuticals International Inc’s Siliq to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35.”
In Case You Missed It
Cell Culture Events:
The BPI West 2017 agenda format is designed to break down silos across multiple departments that work in the same stage of development. With four concurrent tracks focused on early stage process development through commercial manufacturing, attendees can collectively share challenges and discuss the solutions needed to improve the speed, cost and quality of biologics development.
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World Vaccine Congress – April 10-12, 2017, Washington D.C.
The 17th Annual World Vaccine Congress is the place where the global vaccine industry meets to discuss commercial and scientific issues around regulation, strategy, manufacturing, trials, partnering, influenza, cancer, emerging diseases and veterinary vaccines.
Across 150 sessions, you will learn from leading experts across the issues most impacting on the wider vaccine sector, as well as delve into your specialist area of research and job focus in co-located conferences.
Meet over 700 of your peers in one room and take advantage of the multiple extended networking breaks, co-located World Vaccine Congress (including 7 streams on Immune Profiling, Cancer & Immunotherapy, Influenza & Respiratory, Clinical Trials, Emerging Diseases, Partnerships, Veterinary Vaccines and Bioprocessing & Manufacturing) as well as the evening drinks reception.
For more information, please visit the website https://goo.gl/nJ2bZ1
In the present study, the development of a continuous Protein A chromatography process step using KANEKA KanCapA for the capture of a therapeutic mAb is described. The method was developed initially in a batch mode and then transferred to the Cadence BioSMB PD system. This five column process was then successfully scaled-up 150-fold using the Cadence BioSMB Process system. The entire process development and scale-up was completed within four weeks and described in detail along with the process economic benefits of using multi-column chromatography.
While continuous processing has been applied for several decades, the highly regulated biopharm industry has just started to embrace this approach. The team at Pall Life Sciences has leveraged an industry-leading single-use portfolio to deliver innovative continuous bioprocessing solutions to the market. Join our team as they detail the development journey, and highlight critical advances to date.