When it comes to leveling the playing field for foreign-based biopharma and medical device companies, China has made a lot of promises, but delivering on those promises is what matters. Throughout its annual assessment for Congress of China’s commitment to World Trade Organization principles, the U.S. Trade Representative (USTR) noted the many promises China has made over the years that have yet to be kept.
Vericiguat became the first oral soluble guanylate cyclase stimulator to win FDA approval for use in heart failure patients. The drug, branded Verquvo, was developed by Merck & Co. Inc. as part of a $1 billion deal with Bayer AG. But its commercial potential could be hampered by its modest clinical efficacy and increasing competition in the space, as well as difficulties launching a new drug during a pandemic.
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.
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