In the second episode of the Ask the Expert video series, Susan J. Schneipp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.
The company plans to invest approximately €900 million (US$983 million) to expand its peptide platform at its Colorado, US, site and in Europe.
EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.
The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.
Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.
In the premiere episode of the Ask the Expert video series, Susan J. Schneipp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.
A new initiative will advance access to quality medicines and vaccines in Africa.
The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.
The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.
The collaboration and licensing agreement will focus on the discovery and development of RNA exon editing therapeutics.