weekly biotechnology news wrap up

April 28, 2017

April 28, 2017

This week’s headlines include: The top 10 pharma R&D budgets in 2016, European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments, FDA approves Samsung Bioepis’ copy of J&J’s Remicade: company, H3, Foundation Medicine Extend Precision Oncology Collaboration, Two-horse race: Auris, Otonomy seek FDA nod for inner-ear therapies, and Florida releases experimental mosquitoes to fight Zika.


“The top 10 pharma R&D budgets in 2016,” Fierce Biotech

“Last year, biopharma won its share of new drug approvals, though not as many as we’re used to in the U.S., as research spending came to fruition. But drugmakers also suffered a number of R&D setbacks, cut research staff, rejigged their operations and refocused their pipelines…”

“European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments,” Regulatory Focus

“The European Medicines Agency (EMA) has revealed it is talking to its counterpart in the US about joint activities covering accelerated assessments. The subject is one of several areas in which EMA and the US Food and Drug Administration (FDA) are considering stepping up their cooperation…”

“FDA approves Samsung Bioepis’ copy of J&J’s Remicade: company,” Reuters

“South Korea’s Samsung Bioepis Co Ltd said on Saturday the U.S. Food and Drug Administration approved its copy of Johnson & Johnson’s rheumatoid arthritis drug Remicade, the first drug developed by the Samsung Group unit approved in the United States…”

“H3, Foundation Medicine Extend Precision Oncology Collaboration,” Genetic Engineering News

“Eisai subsidiary H3 Biomedicine said today it has extended its more than 2-year-old collaboration with Foundation Medicine to discover and develop precision medicines in oncology. The value of the expanded collaboration was not disclosed…”

“Two-horse race: Auris, Otonomy seek FDA nod for inner-ear therapies,” Reuters

“Doctors have struggled for years to deliver medication effectively to the inner ear, but two companies are vying to be first to introduce new treatments which, if successful, could together chalk up some $800 million in peak sales…”

“Florida releases experimental mosquitoes to fight Zika,” CNN

“Thousands of mosquitoes infected with the Wolbachia bacteria were released in an area of the Florida Keys this week, in hopes of a new approach to control the disease-carrying female Aedes aegypti mosquito, which transmits Zika virus, Dengue fever and Chikungunya…”

Recent Articles on Cell Culture Dish and Downstream Column:

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Thursday, May 4, 2017, 11:00 AM ET

hPSC Passaging, Freezing, and Thawing – Tips and Techniques using NutriStem® hPSC Medium

Speaker: Lia Thornberry Kent, Biological Industries USA

Maintaining healthy human pluripotent stem cells (hPSC) is sometimes more of an art than a science. Many culture techniques follow simple protocols, but require a great amount of interpretation to perform. In addition, the exact protocol will vary each time, depending on the ever-changing state and needs of the cells. In order to keep your hPSC cultures healthy, you must determine the best time to passage, what split ratio to use, and how to clean up areas of differentiation. This webinar will cover the basic rules for maintaining excellent cultures, and tips to improve passaging, freezing, and thawing techniques.

Key Topics:

  • hPSC morphology and colony growth characteristics
  • How to determine the best time to passage
  • Enzymatic and manual passaging techniques
  • Tips for successful hPSC cryopreservation and thawing

Cell Culture Events:

Cell Culture World Congress USA 2017 – May 24, 2017, Hilton San Diego Resort and Spa, San Diego, CA

The vision of Cell Culture World USA is to provide new, relevant content on process development for cell culture specific scientists working in bio manufacturing companies developing antibodies and immunotherapies. Over 4 years, the Congress has become a technical and networking forum for bioprocessing professionals to provide cutting-edge commentary, present novel and never-before-seen case studies, and highlight technological advancements to the industry.

Our 2017 event will feature a more focused structure, zeroing in on the topics that interest cell-culture specific scientists the most. Immunotherapies are the talk of the industry, and they’ll be a huge topic for this year’s event as well.

Download Brochure: https://goo.gl/t5ZRvx

Register now: https://goo.gl/KTOdxq

Cell Culture & Cell Therapy: Bioprocessing Conference – June 26-27, 2017, Philadelphia

MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.