Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Astrazeneca, Beigene, Biogen, Cyclo, Enyo, Lilly, Optinose, RDIF, Vaxart.
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.
LONDON – Relaxing of control measures such as mask wearing and social distancing at a time when most of a population has been vaccinated against COVID-19 greatly increases the probability of the emergence of a vaccine-resistant strain, according to a new modeling study.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alzamend, Arrowhead, Basilea, Dicerna, Everest, Fusion, Genentech, Eli Lilly, Nuvox, Oncopeptides, Scancell, Transcenta, Viatris, Vico.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofourmis, Cepheid, Fluxergy, Nanovibronix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aptargroup, BD, Bioventus, Boston Scientific, Consensus Business Group, Draper, EC Healthcare, Graymatters Health, Immunai, Medimaps Group, Medx Xelerator, Medx Ventures Group, Misonix, Nanalysis Scientific, Nebion, One Moon Scientific, Prenetics, Weihai Hengyu Medical Products.
Zydus Cadila Group could make history after applying for approval for the first ever human DNA vaccine in India. But that could be just the start for a technology that could treat a vast array of diseases, including cancer, infectious diseases and chronic diseases.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Apic, Arcturus, I-Mab, Lexeo, Mycovia, Nrx, Pharmamar, Takeda, Xoma.
RSS
