FDA to Gradually Eliminate Animal Testing for Certain Drugs
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The U.S. Food and Drug Administration (FDA) plans to phase out mandatory animal testing for drug evaluations, considering alternatives such as AI-based computational methods and organ-on-a-chip systems. In two separate Phase 1 trials, stem cell therapy showed promising results for treating Parkinson’s disease, with both trials reporting no serious side effects and improvements in PD symptoms. Finally, President Trump signed an executive order aiming to lower drug prices in the U.S. by working with Congress to remove the “pill penalty” in the 2022 Inflation Reduction Act, which exempts small molecule drugs from Medicare price negotiations for only nine years.
FDA Plans to Reduce Animal Testing for Drugs
The FDA has unveiled a strategy to decrease and eventually replace required animal testing for drugs, especially monoclonal antibodies. Companies utilizing non-animal testing methods like AI-based computational methods and organ-on-a-chip systems may receive an expedited review. Yet, questions about the lack of evidence for non-animal methods persist.
Promising Results for Stem Cell Therapy in Parkinson’s Disease Trials
Two Phase 1 trials, one at Kyoto University Hospital and another at Memorial Sloan Kettering Cancer Center, suggest that transplanting stem cell-derived dopamine-producing neurons could treat Parkinson’s disease (PD). Both trials yielded no serious side effects and showed promising results, including dopamine production and reduced PD symptoms.
eGenesis and OrganOx to Begin Pig Liver Trial
Biotech company eGenesis and medtech company OrganOx have received FDA approval to initiate a clinical trial of their gene-edited pig liver and blood filtration system for acute-on-chronic liver failure (ACLF) patients.
Advancements and Hurdles for Oral GLP-1 Drugs
Eli Lilly announced encouraging results with their oral GLP-1 drug, orforglipron. Meanwhile, Pfizer is discontinuing the development of their oral GLP-1 drug, danuglipron, due to potential drug-induced liver injury in a trial participant.
Executive Order Targets “Pill Penalty” in Drug Pricing Law
President Trump has signed an executive order aiming to lower drug prices by removing the “pill penalty” in the 2022 Inflation Reduction Act (IRA). The order encourages Congress to end the disparate treatment of small molecule drugs and biologics in Medicare price negotiations.
New Blood Test May Predict Skin Cancer Recurrence
A new gene-based blood test for melanoma could predict the cancer’s recurrence earlier than current methods. Approximately 80% of stage III melanoma patients with detectable levels of circulating tumor DNA (ctDNA) in their blood prior to starting treatment experienced recurrence, according to a recent Phase 3 trial.
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