With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.” Read More
A revised U.S. label for Glaxosmithkline plc's Nucala (mepolizumab) has expanded the first-in-class anti-IL-5 treatment's approval to hypereosinophilic syndrome (HES), a group of rare disorders associated with persistent eosinophilia. It's the new therapy approved for Americans with HES in nearly 14 years, according to the FDA. An EMA filing in HES is expected later this year. Read More
Anti-infective drugs approved over the last two decades were able to get through the clinical development and FDA approval processes substantially faster than other drugs, according to a new report from the Tufts Center for the Study of Drug Development. Read More
Wellington Life Sciences general partner Regina Hodits, during a talk with CBT Advisors CEO Steve Dickman at the recent Biopharm America meeting, said the disaster scenario feared for European investments when COVID-19 struck “turned out very different. We never have a lot of time off in summer, not as much as we would want to, but this year we certainly had no time off,” as portfolio firms found money and Wellington tapped new opportunities. Read More
PERTH, Australia – Australia’s largest health care venture capital firm, Brandon Capital, announced the launch of Australian biotech company Ena Respiratory Pty Ltd., which has developed a nasal treatment to boost the natural immune system to fight common colds and flu and has proved successful in reducing COVID-19 viral replication. Read More
HONG KONG – U.S. listed Chinese biotech company Zai Lab Ltd. has raised $761 million in its secondary listing on the Hong Kong Stock Exchange. Read More
The U.S. pathway for legally importing certain prescription drugs from Canada to take advantage of lower prices is closer to opening for business with the FDA issuing a final rule and guidance on making it happen. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptinyx, Aurinia, Basilea, Covaxx, Covistat, Eiger, Immunic, Innovent, PTC, Sarepta, Sorrento, Tilray, Tilt, Valirx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aligos, Apollomics, Aquestive, Avrobio, Biomed Valley, Cipla, CSL, FSD, Gilead, Glaxosmithkline, Heron, Huya, Inceptua, Inovio, Khondrion, Orchard, Shionogi, Stemedica, Xcures. Read More
