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 submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Galaxy Medical, Neuronetics, Serpex Medical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Inhibikase, Novavax, Pfizer.
The FDA has cleared Inhibikase Therapeutics Inc.'s IND application for IkT-001Pro for the treatment of chronic myelogenous leukemia (CML). IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, Gleevec (imatinib).
Insulet Corp. got the U.S. FDA’s nod to extend use of its Omnipod 5 automated insulin pump to children aged 2 years and up with type 1 diabetes. The expanded indication, just seven months after FDA cleared Omnipod 5 for patients 6 years and older, represents the first time a tubeless automated insulin delivery (AID) system has been authorized for use in children this young.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lunit, Myriad Genetics.
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.
Integra Lifesciences Holdings Corp., of Plainsboro, N.J., said in its latest 8K filing that it has decided to voluntarily remove all the company’s Cerelink systems – which are indicated for intracranial pressure monitoring – due to customer reports that these monitors were returning inaccurate pressure readings.
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