The latest global regulatory news, changes and updates affecting biopharma, including: And now the state cases; Advamed urges administration to communicate on DPA; Looking for GCP volunteers.
Busting a logjam of inadequate data sharing methods and communications between pharmas and health authorities around the world is the impetus behind the creation of nonprofit Accumulus Synergy Inc., whose common, cloud-based platform is designed to make the regulatory process easier for everyone involved. The coalition’s initial membership is a Who’s Who of big pharma: Amgen Inc., Astellas Pharma Inc., Bristol Myers Squibb Co., Glaxosmithkline plc, the Janssen Pharmaceutical Cos. of Johnson & Johnson, Eli Lilly and Co., Pfizer Inc., Roche Holding AG, Sanofi SA and Takeda Pharmaceutical Co. Ltd.
Clinical and regulatory data reported in 2020 are up 24% and 47%, respectively, over the prior year, proving to be the busiest 12 months on record for the biopharma industry, in spite of, or perhaps because of, a deadly global pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocryst, Clinigen, Exelixis, GC, Helsinn, Incyte, Ono, Viiv.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Addex, Eubiologics, J&J, Medolife, Menarini, RDIF, Roche, Turn, Ultragenyx.
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.
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