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NewAmsterdam’s CETP renaissance gathers pace

pharmaphorum

The ROSE2 study found that obicetrapib was able to reduce LDL cholesterol (LDL-c) levels when added to high-intensity statin therapy, raising the prospect that it could help patients struggling to manage their cholesterol levels with current drug therapy.

Pharma 59
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FDA delays decision on Biogen’s ALS hope tofersen

pharmaphorum

A few weeks ago the delay would have been a big deal for Biogen, as tofersen was among its most important near-term launch prospects. Around 2% of cases of ALS – also known as motor neurone disease (MND) – are linked to mutations in the SOD-1 gene. There are around 31,000 patients with ALS in the US.

FDA 52
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VR Training For Medical Device Maintenance Personnel

Infuse Medical

Brief Overview of the Importance of Medical Device Maintenance Medical device maintenance ensures patient safety, operational efficiency, and regulatory compliance in healthcare settings. Training ensures adherence to stringent regulatory requirements, maintaining device safety, and preventing malfunctions that could risk patient well-being.

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Transgene and BioInvent report positive data for oncolytic virus

Pharmaceutical Technology

According to the companies report, the BT-001 single agent treatment was completed in 18 patients and no safety concerns were reported. The independent Safety Review Committee has now approved initiation of the combination part of the trial with pembrolizumab.

Safety 52