Brazilian regulatory agency Anvisa reported that it is participating in an investigation that launched Aug. 25 into alleged crimes of smuggling, misrepresenting, distributing and delivering proxalutamide related to a clinical trial in Brazil.
For the first time since they’ve had access to U.S. capital, biopharma and med-tech companies based in China and Hong Kong are having to comply with the same accountability standards companies in the U.S. and other countries must follow as a condition of trading on U.S. markets.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bluebird, Innovent, Moderna, Pfizer, Pharmazz, Plus, Polpharma, Tracon.
If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Inhibikase, Novavax, Pfizer.
Three of the biggest COVID-19 vaccine developers are heading into a legal battle. Moderna Inc. said it has filed lawsuits alleging the Pfizer Inc.-Biontech SE Comirnaty vaccine infringes patents Moderna filed between 2010 and 2016 that cover its mRNA technology. Pfizer and Biontech “unlawfully” copied the technology without permission, according to Moderna.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Astrazeneca, Biomarin, Biontech, Century, Erytech, Iovance, Janssen, Moderna, Pfizer, Savara, Therapeutic Solutions.
A dozen years after the Dodd-Frank Act was signed into U.S. law, the SEC adopted a final rule Aug. 25 implementing the law’s so-called “pay-vs.-performance” provisions related to executive compensation.
In an effort to keep up with the advances being made in manufacturing technologies, the European Commission (EC) is updating its 2007 technical guidance on good manufacturing practices for sterile drugs.
RSS
