Search results for " market"
Article
mAbs to Watch in 2016
And there may be many more of these types of proteins on the horizon—as many as 14 are projected to hit the market in 2016, according to data compiled by EvaluatePharma, in collaboration with BioPharm…
Article
GMP Challenges for Advanced Therapy Medicinal Products
In fact, these difficulties could be a prime reason why, up until 2014, only four medicines under the ATMP regulation had been given marketing authorization in the EU’s centralized medicines licensing…
Article
Breakthrough Drugs Raise Development and Production Challenges
Nearly 15 important new therapies have come to market more quickly as a result, contributing to the recent rise in new drug approvals. FDA acting commissioner Stephen Ostroff pointed out at the annual…
Article
Taking a “Development-by-Design” Approach to Cell Therapies
More CDMOs are entering cell therapy market niche
Demand for specialized cell therapy manufacturing and development services is also growing, and has attracted Lonza Bioservices, Cognate BioServic…
Article
Drug Discovery and Development in India
India registers a low score on BMI’s Pharmaceutical Risk/Reward Index (RRI)’s measure of Patent Respect (an index providing a globally comparative and numerically based assessment of a market’s attrac…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
The very nature of aggregation is challenging, says St John Skilton, senior global market manager of biologics at SCIEX, a life-science analytical technologies company. The fact that aggregation is “d…
Article
What Drove Biopharma Development in 2014?
And while QbD may be a federal requirement, the technique has emerged as a tangible tool to speed time to market, reduce recalls and rejects, minimize post-approval changes, streamline data flows acro…
Article
Manufacturers Struggle with Breakthrough Drug Development
Chemistry, manufacturing, and control (CMC) issues are not considered at this point, although they are important for the product to come to market. Consequently, FDA officials urge manufacturers with …
Article
Early Communication with Regulators is Essential for SMEs
…s, evaluation, and above all, scientific advice that can raise the chances of a new medicine gaining marketing approval.
The importance of early dialogue with regulators
Companies a…
Article
Climate Change in Outsourcing
…e gains on their bio/pharmaceutical companies’ investments and encouraged investors to reenter the market.
Rising opportunities
As these forces reshape the bio/pharmaceutical industry, they a…