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.
BEIJING – Canbridge Pharmaceuticals Inc. last week won marketing approval in China for its first rare disease drug, the mucopolysaccharidosis II therapy Hunterase (idursulfase beta injection).
The FDA has granted Plus Therapeutics Inc. fast track designation for its lead candidate, Rhenium Nanoliposomes (RNL), for treating recurrent glioblastoma, propelling it into the sixth cohort of a phase I dose-finding trial.
The latest global regulatory news, changes and updates affecting biopharma, including: NIH adds funding to Latino Alzheimer’s research; Sprout warned for Addyi promotion; Scripps to pay $10M over use of NIH grants.
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