Search results for " 2015"
Article
Biopharma in 2015: A Year for Approvals and Innovations
As of September 2015, FDA received six biosimilar applications to reference products (including Zarxio), the latest filed in early October. Of equal importance, some 57 biosimilar products for 16 refe…
Article
Framing Biopharma Success in 2016
Peters
The US biopharmaceutical industry turned a new page in 2015 when FDA approved Zarxio (filgrastim-sndz), the first biosimilar approved for use in US markets, in March 2015. Biotechnology sto…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
GBSI conducted an online survey to determine why cell authentication and the STR standard specifically is not used more broadly, the results of which will be shared in 2015. As a central component of …
Article
Vaccine Development and Production Challenges Manufacturers
Vaccine development was discussed as important for global security at the World Economic Forum in Davos, Switzerland in January 2015. The first draft of the US House of Representatives “21st Century C…
Article
Technologies and Practices Must Evolve to Meet Demand
The optimistic outlook continues for planned spending in 2015; 53.3% said their spending in 2015 will increase compared to 40% reporting an increase in the 2014 survey. Only 2% expected a decrease in …
Article
Innovative Therapies Require Modern Manufacturing Systems
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and agency officials expect this pace to continue. Manufacturers are testing a full pipeline of importa…
Article
mAbs to Watch in 2016
Brodalumab—Valeant and AstraZeneca’s IL-17 therapy, brodalumab, for the treatment of psoriasis got some bad press in May 2015 when Amgen dropped out of the co-development project with AstraZeneca afte…
Article
Modular Manufacturing Platforms for Biologics
The first example of this type of unit, constructed to produce oral solid-dosage drugs, was delivered on March 17, 2015. Final site acceptance and commissioning are in process. The continuous processi…
Article
Continuous Manufacturing: A Changing Processing Paradigm
20, 2015.
3. K.B. Konstantinov and C.L. Cooney, “White Paper on Continuous Bioprocessing,” presentation at the International Symposium on Continuous Manufacturing of Pharmaceuticals: Implementatio…
Article
Finding Opportunities in Brazil
The following facts may show what the scenario might be for Brazil in 2015.
Relevant statistics
The gross domestic product (GDP) in Brazil expanded 0.10% in the third quarter of 2014 over th…