Uniqure NV has received FDA clearance of its IND application for AMT-260, the company’s gene therapy candidate that represents a potential one-time administered approach to treating refractory mesial temporal lobe epilepsy (MTLE).
The U.S. FTC’s antitrust challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc has been resolved. Amgen agreed to do what it said it would do all along: not bundle pharmacy benefit manager rebates on high volume blockbuster drugs Tepezza and Krystexxa.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alcresta, Astrazeneca, Biontech, Daiichi Sankyo, Mallinckrodt, Pfizer.
Magassist Co. Ltd. has been granted a breakthrough device designation by the U.S. FDA for its interventional ventricular assist device (VAD), which is expected to accelerate the development and approval of the product.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapid Medical.
The German med-tech associations Bvmed and VDGH have hit out at the shortcomings of the EU medical device regulations and are calling for action to improve implementation, predictability and transparency of the system.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Livanova.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Alzamend, Asieris, Inflarx, Menarini, Northwest, Nrx, Oncomatryx, Outlook, Zealand.
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