Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Aptorum, Arcutis, Astrazeneca, Biocelect, BMS, Daiichi, Eutilex, Haisco, Histogen, Impel, Lytix, Merck, Novo Nordisk, Sobi, Taysha, Terns.
Luye Pharma Group Ltd. won marketing approval in China for its risperidone microspheres for injection to treat schizophrenia, which the company said is the first formulation developed by a Chinese company in the space to get a green light. Under the trade name Ruixintuo, the long-acting drug is administered once every two weeks by intramuscular injection.
CAJICA, Colombia – Brazil’s health care surveillance agency, Anvisa, granted the first two emergency approvals for COVID-19 vaccines on Sunday, Jan. 17, giving the green light to Sinovac Biotech Ltd.’s Coronavac and to Covishield, developed by Astrazeneca plc and the University of Oxford.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bioinvent, C4, Dr. Reddy's, Genmab, Gracell, Immunitybio, Khondrion, Metacrine, Molecular Templates, Omeros, Pieris, Precision, Steba, Takeda, Tessa, Tracon, Transgene.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, DBV, Gracell, Pfizer, RDIF, Steba.
COVID-19 undoubtedly will be the top U.S. health care priority for the 117th Congress and the incoming Biden administration, but that doesn’t mean prescription drug prices are no longer an issue. A raft of new-year price increases, many for already costly drugs, is ensuring drug pricing remains high on the congressional agenda.
The latest global regulatory news, changes and updates affecting biopharma, including: HHS posts rule for agency enforcement action; Guidance to help with COVID-19 Mabs; Chinese pharma exec sentenced on U.S. drug charges.
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