Industry News

Nov 05, 2014
Most new injectable drugs and biologics are being designed as combination therapies, presenting difficult regulatory and production issues for manufacturers. FDA policies are encouraging this trend.
Nov 05, 2014
By BioPharm International Editors
FDA gives orphan drug designation to Merrimack Pharmaceuticals' MM-141 for the treatment of pancreatic cancer.
Nov 04, 2014
M&A transactions accounted for nearly $15 billion more this year than for the same period a year ago.
Oct 30, 2014
By BioPharm International Editors
Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.
Oct 30, 2014
The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.
Oct 28, 2014
The company receives backing to continue its work in research services, process development, and cGMP manufacturing activities.
Oct 20, 2014
By BioPharm International Editors
FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.
Oct 20, 2014
By BioPharm International Editors
The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.
Oct 16, 2014
Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.
Oct 15, 2014
By BioPharm International Editors
The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.
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