Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Corstasis, Daiichi, Krystal, Merck, Novo Nordisk, Som.
The U.K.’s failure to join the dots from discovery research to patient access to innovative drugs was cited repeatedly by pharma leaders, who were called to an emergency hearing in parliament on Tuesday to explain decisions to pull out of promised capital investments.
CSL Ltd. inked a potential $2.1 billion deal with Dutch biotech company Varmx BV to develop VMX-C001 as a new treatment to restore blood coagulation in patients taking a factor Xa inhibitor.
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.
Dualitas Therapeutics Inc. exited stealth mode with a $65 million series A investment that was co-led by Versant Ventures and Qiming Venture Partners USA.