A new rule intended to give drug manufacturers the flexibility they need to enter into value-based purchasing agreements with state Medicaid programs and commercial payers could end up hurting patients at the pharmacy counter in the U.S.
PERTH, Australia – The COVID-19 pandemic certainly put pressure on Australia’s Therapeutic Goods Administration during the 2019 to 2020 year, but it also showed that the agency was able to rise to challenge and not buckle under pressure, revealing a number of strengths that the agency will build upon, the TGA said in its annual performance report.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Immunicum.
Chinese regulators granted a first approval for general use to a COVID-19 vaccine to China National Biotec Group’s (CNBG) BBIBP-CorV. “The NMPA granted conditional approval to the vaccine on Dec. 30,” said Chen Shifei, deputy head of the National Medical Products Administration (NMPA) during a Dec. 31 press conference. The company is required to continue with phase III trials as planned, submit subsequent data and report any adverse reactions.
Osmotica Pharmaceuticals plc’s amendment earlier this month to the NDA for arbaclofen in spasticity resulting from multiple sclerosis wasn’t enough to quell the concerns of the FDA, which smacked the firm with its second complete response letter (CRL).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biocure, Chi-Med, Lygenesis, Osmotica, Pharos Vaccine, Tetra, Tracon.
Hopes continue to rise as the COVID-19 vaccine beat goes on and Operation Warp Speed (OWS) lives up to its name, with Moderna Inc. netting another U.S. Department of Defense contract worth about $1.97 billion for another 100 million doses – an order that brings to about $6 billion the company’s government contracts for the product, which was granted emergency use authorization (EUA) earlier this month.
The latest global regulatory news, changes and updates affecting biopharma, including: Arguments against transparency fall flat; CMS unveils push toward digital collection of quality measures.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alkermes, Ampio, Arcturus, Capricor, Celltrion, Clovis, Chi-Med, Moleculin, Novo Nordisk, Pfizer.
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