Girish Malhotra argues in CPhI Annual Report that shorter approval times and financial incentives are needed to promote manufacturing improvements. / read more /
Check out the PharmTech Europe Supplement on APIs,
Excipients, and Manufacturing,
includes the
CPhI Worldwide
Planning Guide.
The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV). / read more /
FDA proposed in a Federal Register notice that bumetanide, nicardipine hydrochloride, and vasopressin should not be included on the list of bulk drug substances that outsourcing facilities may use in compounding. / read more /
Pfizer Consumer Healthcare is recalling one lot of Children's Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups. / read more /
The European Commission (EC) has approved Novartis' chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. / read more /
A year's worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification. / read more /
This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.
