“The pharmaceutical giant GSK, which has held first place in the Access to Medicine Index ever since its introduction in 2008, was ranked first again this week. The index measures how well the world’s top 20 pharma companies do at getting their drugs and vaccines — and often their scientific expertise — to the world’s poorest countries.”
“The European Medicines Agency (EMA), in cooperation with the European Commission and the EU member states, on Tuesday proposed revisions to its 2007 guideline on first-in-human clinical trials as part of an effort to further improve the safety of participants as trial protocols become increasingly complex.”
“Novartis’s investigational drug PKC 412 won U.S. Food and Drug Administration priority review, the Swiss drugmaker said on Monday, keeping up momentum after the prospective treatment for a fast-growing form of leukemia garnered breakthrough therapy status this year.”
“Pfizer said today it will collaborate with the National Cancer Institute’s Center for Cancer Research (CCR) to assess three immunotherapy candidates by arranging and conducting clinical and preclinical trials.”
“The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) has issued a positive opinion recommending that ibudilast (MN-166) receives orphan medicinal product (orphan drug designation) for the treatment of amyotrophic lateral sclerosis (ALS).”
“J&J’s biotech arm has submitted its application to the FDA for its experimental med guselkumab in moderate to severe plaque psoriasis. Janssen said in statement this morning that the app for its mAb, which targets interleukin (IL)-23 – a protein which has been shown to play a key role in the development of immune-mediated inflammatory disease – is based on a series of recent mid-to-late-stage data.”
“Eli Lilly’s Lartruvo has received a conditional marketing approval by the European to treat soft tissue sarcoma (STS). Lartruvo (olaratumab) – the first monoclonal antibody to win regulatory clearance for treatment of the disease – can now be used alongside the chemotherapy doxorubicin in patients with advanced STS when surgery or radiotherapy is not suitable.”
Cell Culture Events
November 17, 2016, 11:00AM ET
Speaker: Lia Thornberry Kent, Technical Training & Scientific Support, Biological Industries USA
This webinar will provide a comprehensive overview of human pluripotent stem cell (hPSC) culture methods. Attendees will learn about the cells’ basic culture requirements and how aspects of the culture environment have developed over time, ultimately to defined culture systems widely used in disease research, and clinically-relevant systems amenable to downstream therapeutic applications. A review of various culture environments in use today will provide a high-level overview of the field and a basic understanding of the requirements for maintaining these unique cells.
This webinar is the first in a series of hPSC tips and techniques – Register Now
Thursday December 1st, 2016 | 9 am -10 am PST
Speaker: Marlin Frechette – Director Quality Systems/ Regulatory Affairs and ISO Management Representative
From pre-clinical research to commercialization, regulatory bodies expect that media used in regenerative medicine and cell therapy applications are manufactured using controlled and traceable materials to ensure lot-to-lot consistency and minimize the risk of contamination by adventitious agents. Irvine Scientific has extensive experience in regulatory compliance and we understand how critical it is to use a Quality by Design (QbD) approach during the design, development and commercialization of cell therapy media. Learn how to identify and implement the best practices and strategies for media development from our Quality and Regulatory expert, Marlin Frechette.
Topics covered will include:
- Quality by Design
- Raw material souring and qualification
- Supply chain management
- cGMP manufacturing
- Cold chain logistics
Presenting a case study that reduces MAb clinical trial development costs by up to 65% using different agarose Protein A chromatography resins
Wednesday 7th December | 14:00 GMT
On Wednesday 7th December, Purolite’s Life Sciences will host a webinar to present a case study that reduces MAb clinical trial development costs by up to 65% using different agarose Protein A chromatography resins.
- New data from a HTPD comparability case study will be shared using three Protein A’s performed on a Perkin-Elmer Janus® BioTx Pro Plus Workstation
- Assessed with Alvotech Biopharmaceuticals supplied biosimilar MAb feedstock
- Key data includes yield, purity, DNA & HCP clearance and protein A leakage.
- ASCB – December 3-7, 2016 – San Francisco, CA http://ascb.org/meetings/
- World Stem Cell Summit & RegMed Capital Conference– December 6-9, 2016 – West Palm Beach, Florida http://worldstemcellsummit.com/
- Antibody Engineering and Therapeutics – December 11-15, 2016 – San Diego, CA http://www.ibclifesciences.com/AntibodyEng/overview.xml
- Global Biomanufacturing Summit – December 12-14, 2016 – San Diego, CA http://biomansummit.com/