The Dish’s Weekly Biotechnology News Wrap Up – May 29, 2015
This week’s biotechnology news headlines include, FDA approves Actavis, Editas Medicine signs deal worth up to $737 million, Merck’s Keytruda gets recommendation for EU approval, EMA issues new guideline on Gene Therapy, J&J plans to file at least 10 new drugs by 2019, House committee approves bill to speed drugs to market, and Amgen publishes pivitol T-Vec data.
Cell Culture Events
Workshops:
High Performance Tour 2015
Discover how to improve efficiency and productivity for your bioprocessing workflows during our exclusive High Performance Tour.
Learn how the choice of chromatography media (resins), hardware, and services can dramatically affect your process performance.
Register now to reserve your seat at this special event where you can gain insights in improved process efficiency and productivity.
Coming to these Cities:
- Boston, MA – June 3, 2015
- Philadelphia, PA – June 5, 2015
- Raleigh-Durham, NC – June 22, 2015
- San Diego, CA – September 15, 2015
- San Francisco, CA – September 17, 2015
To Register – https://promo.gelifesciences.com/na/K15104/landing.html
Conferences:
May
- ISCT – May 27-30, 2015 – Caesars Palace Hotel, Las Vegas, NV http://www.isct2014.com/
June
- Empowered Antibodies Congress 2015 – June 17 – 18 2015, Barcelona, Spain http://www.informa-ls.com/event/empoweredantibodies15
- Annual Meeting of the International Society for Stem Cell Research – June 24-27, 2015, -Stockholm, Sweden http://www.isscr.org/home/annual-meeting/isscr2015
- BIO International Convention – June 15-18, 2014 – Philadelphia, PA http://convention.bio.org/
- Viral Safety and Raw Materials Congress – June 24-25, 2015 – Austria Trend Hotel Savoyen – Vienna, Austria http://www.informa-ls.com/CQ3546VSRMCONGRESScellcultureJoin us at this year’s Viral Safety and Raw Materials Congress taking place in Vienna on the 24th-25th June to network and exchange with leading industry representatives, regulatory bodies and top level technology providers from across the globe to discuss and debate the latest trends in this changing sector.Packed with case studies, interactive tutorials, discussion panels and workshops, the conference agenda will provide you with key take home messages to benchmark your businesses’ strategies with regards to safeguarding against viral contamination enhancing the quality of your products.Covering all the key topics within the field of viral safety for biologics and raw materials, hear the latest on next generation detection technologies, supplier auditing, risk assessment techniques and raw material analytics from leading players including Roche, Genzyme, Sanofi Pasteur, Crucell and Abbott.For more information, please visit the event website: www.vsrm-congress.com (please hyperlink to: http://www.informa-ls.com/CQ3546VSRMCONGRESScellculture)
August
- The Bioprocessing Summit – August 3-7, 2015 – Westin Copley Place – Boston, MA http://www.bioprocessingsummit.com/
Headlines
“FDA approves Actavis, Valeant drugs for irritable bowel syndrome,” Reuters
“U.S. health regulators approved new irritable bowel syndrome drugs from Actavis Plc and Valeant Pharmaceuticals International Inc on Wednesday, validating big investments both companies made to acquire the products.”
If you like this story, please see our blog titled “Improving Continuous Process Efficiencies Through Development of a High-Performing Perfusion Media”
“Medical start-up signs deal worth up to $737 million,” The Boston Globe
“Editas Medicine, a Cambridge medical researcher, has signed a deal with a Seattle biopharmaceutical company worth as much as $737 million.”
If you like this story, please see our blog titled “Continuous Downstream Processing – A Tool to Address Key Manufacturing Challenges”
“Merck follows Bristol with EU green light for immune cancer drug,” Reuters
“European regulators have recommended approval of Merck & Co Inc’s immune system-boosting cancer drug Keytruda, following a similar green light last month for Bristol-Myers Squibb Co’s rival product Opdivo.”
If you like this story, please see our blog titled “Materials and Assay Systems Used for 3D Cell Culture”
“EMA Issues New Guideline on Gene Therapy,” Regulatory Focus
“The European Medicines Agency (EMA) is seeking feedback on a new draft guideline aimed at clarifying the scientific evidence necessary to support the authorization of new gene therapies.”
If you like this story, please see our blog titled “A New Model for Continuous Processing in Downstream Purification”
“Johnson & Johnson Says It Will File at Least 10 New Drugs by 2019,” The Wall Street Journal
“Johnson & Johnson said Wednesday that its Janssen Pharmaceutical segment plans to file for regulatory approval of at least 10 new drugs by 2019, each with the potential to exceed $1 billion in revenue.”
If you like this story, please see our blog titled “2014 FDA New Drug Approvals – 11 Biologics Receive Approval”
“House committee approves bill to speed new drugs to market,” Reuters
“A U.S. House of Representatives committee on Thursday unanimously approved a bill to speed new drugs to the market, overcoming last-minute wrangling over how to pay for the legislation.”
If you like this story, please see our blog titled “Closed Systems in Biomanufacturing Offer A Variety of Benefits”
“Amgen publishes pivotal T-Vec data as it awaits FDA decision,” Fierce Vaccines
“Riding momentum from an FDA advisory committee recommendation last month, Amgen ($AMGN) rolled out its data from a pivotal study of its cancer vaccine talimogene laherparepvec (T-Vec) on Tuesday as it awaits the agency’s final decision, expected later this year.”
If you like this story, please see our blog titled “Cool Tool – Cedex Bioprocess Analyzers for Vaccine Manufacturing”