Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Ampio, Arca, Astrazeneca, Crinetics, I-Mab, Merck, Otsuka, Harbour and Liminal.
The latest global regulatory news, changes and updates affecting biopharma, including: CDER lays out public speech rules for staff; Health Canada opens quicker path for COVID-19 drugs; EMA OKs COVID-19 use of dexamethasone.
While COVID-19 is responsible for about 14% of the regulatory data collected by BioWorld in 2020 and even though numerous clinical trials have suffered delays, the pandemic does not appear to have slowed the pace of the FDA’s approval process.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, BMS, Eisai, GSK, I-Mab, Junshi, Lilly, Medimetriks, Menarini, Morphosys, Pacira, Pfizer, Roche, Sanofi, Sobi, Vertex.
Spurred by reports of biopharma executives exercising stock options in conjunction with announcements about COVID-19 vaccine developments and government contracts, U.S. lawmakers want to close the loopholes that make such actions legal.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Celltrion, Chemocentryx, Chi-Med, Roche, Sorrento, Zynerba.
Given the minimal accountability written into the 340B prescription drug discount program, a few biopharma companies recently began taking oversight into their own hands by demanding data claims or refusing to extend the mandated discounts to contract pharmacies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AVM, Cura, Mateon, Mediwound, Orphazyme.
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