OR WAIT null SECS
June 23, 2021
Ilya Pharma has been granted approval by the Swedish Medical Product Agency and Swedish Ethical Review Authority for initiation of a Phase II clinical trial of its ILP100 gene therapy.
June 22, 2021
FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.
EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.
Vectura has signed an agreement with Incannex Healthcare for the pre-clinical development of IHL-216A, an inhaled drug product for the treatment of traumatic brain injury.
June 21, 2021
The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.
The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.
Exscientia has entered into a binding agreement to acquire the artificial intelligence precision-based medicines company, Allcyte.
RECOVERY trial results have shown that Regeneron’s investigational antibody combination therapy reduces the mortality risk for seronegative hospitalized patients with severe COVID-19.
June 18, 2021
CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.
The US government will invest $3 billion from the American Rescue Plan into a COVID-19 antiviral development strategy.