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Home » Topics » Regulatory

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Epileptic brain and abnormal EEG wave discharges
Neurology/Psychiatric

Uniqure’s AMT-260 gene therapy cleared by FDA to enter clinic for mesial temporal lobe epilepsy

Sep. 5, 2023
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).
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Digital handshake

Amgen-Horizon deal is back on as FTC steps back

Sep. 1, 2023
By Lee Landenberger
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.
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Regulatory actions for Sept. 1, 2023

Sep. 1, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alcresta, Astrazeneca, Biontech, Daiichi Sankyo, Mallinckrodt, Pfizer.
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Magassist wins FDA breakthrough nod for ventricular assist device

Sep. 1, 2023
By Doris Yu
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.
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Regulatory actions for Sept.1, 2023

Sep. 1, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Rapid Medical.
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Map of Europe, Medical Device Regulation (MDR) text

Med-tech associations take aim at onerous EU regulations

Sep. 1, 2023
By Nuala Moran
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.
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Regulatory actions for Aug. 31, 2023

Aug. 31, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femasys, Livanova.
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Regulatory actions for Aug. 31, 2023

Aug. 31, 2023
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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Clash over drug prices continues as IRA negotiations kick in

Aug. 30, 2023
By Karen Carey
In response to the Biden administration announcing on Aug. 29 the first 10 medications up for price negotiations with the Centers for Medicare & Medicaid Services as part of the Inflation Reduction Act of 2022, U.S. Senate and House Republicans are firing back, calling the imposed “price-controls set by Washington bureaucrats” part of a scheme that “will lead to higher prices for new drugs coming to market, stifle the development of new cures and destroy jobs,” ultimately driving up costs for seniors.
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Woman taking Amsler grid eye exam

Outlook says CRL for wet AMD is a surprise

Aug. 30, 2023
By Lee Landenberger
After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”
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