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BioWorld - Tuesday, May 26, 2026
Home » Topics » Conferences

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Gears with regulatory words
2023 FDLI Enforcement Conference

FDA tells industry to get serious about UDI compliance

Dec. 7, 2023
By Mark McCarty
The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Thomas addressed an audience at the Food and Drug Law Institute’s annual enforcement conference here in the nation’s capital, acknowledging that the proposed alignment of the Quality System Regulation – also known as Part 820 – with ISO 13485 is no light lift.
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Regulatory icons
2023 FDLI Enforcement Conference

Abiomed warning letter for final deviation seen as opening salvo

Dec. 7, 2023
By Mark McCarty
The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.
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Biomarkers

IGFBP7 SNP tied to the reversal phenotype of amyotrophic lateral sclerosis

Dec. 7, 2023
Researchers have defined an amyotrophic lateral sclerosis (ALS) reversal phenotype as having an initial diagnosis of ALS but subsequently showing a progressive and sustained clinical improvement, based on an unusual case they found.
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Neurology/Psychiatric

TRV-045 demonstrates efficacy for both reversal and prevention of CIPN in mice

Dec. 7, 2023
At the recent American College of Neuropsychopharmacology meeting, Trevena Inc. presented preclinical data for the novel selective sphingosine 1-phosphate S1P1 receptor modulator TRV-045, being developed for the treatment of chemotherapy-induced peripheral neuropathy (CIPN).
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Arvinas, Pfizer broaden scope of ER-targeting therapy after impressive phase Ib breast cancer readout

Dec. 6, 2023
By Jennifer Boggs
While early stage and involving a relatively small patient population, the interim phase Ib readout from the combination cohort testing estrogen receptor (ER)-targeting candidate vepdegestrant in combination with CDK4/6 inhibitor Ibrance (palbociclib) in heavily pretreated patients with ER-positive/HER2-negative breast cancer was impressive enough to prompt partners Arvinas Inc. and Pfizer Inc. to expand development work on the program. The results also struck a chord on the Street, with shares of Arvinas (NASDAQ:ARVN) gaining 31% on the day.
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FDA approved icons and medical professional
2023 FDLI Enforcement Conference

FDA tells industry to get serious about UDI compliance

Dec. 6, 2023
By Mark McCarty
The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.
Read More
Toy bulldozer moving FDA letter blocks
2023 FDLI Enforcement Conference

Post-pandemic inspection load an ongoing struggle for FDA

Dec. 6, 2023
By Mark McCarty
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
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Neurology/Psychiatric

Longboard’s 5-HT2C superagonist yields positive results in preclinical models of epilepsy

Dec. 5, 2023
Serotonin 5-HT2 receptor agonists have shown efficacy in treating seizure disorders, such as epilepsy. At the American Epilepsy Society meeting this week, Longboard Pharmaceuticals Inc. presented data on their 5-HT2C receptor superagonist LP-352 for the treatment of epilepsy.
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Neurology/Psychiatric

Favorable preclinical profile of investigational gene therapy for TLE reported

Dec. 4, 2023
Temporal lobe epilepsy (TLE) is the most common form of focal epilepsy characterized by recurrent seizures originating in the hippocampus and with sprouting of mossy fiber axons that contribute to new recurrent synaptic excitability in the dentate gyrus (DG).
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Brain waves
Neurology/Psychiatric

Iama Therapeutics’ IAMA-6 shows promise in preclinical mesial temporal lobe epilepsy

Dec. 4, 2023
Intracellular chloride levels are crucial for physiological brain development and correct functioning. On the other hand, aberrant expression of chloride importer NKCC1 (basolateral Na-K-Cl symporter, SLC12A2) and exporter KCC2 (K-Cl cotransporter 2, SLC12A5) is involved in neurodevelopmental and neurologic conditions, including mesial temporal lobe epilepsy (MTLE), among others, leading to an imbalance between excitatory and inhibitory signals.
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