Welcome to this week’s edition of the Life Sciences Voice Top Five Newsletter, your go-to source for the latest breakthroughs in the life sciences industry! This time, we’re taking a look at the consequences of Trump’s proposed tariffs on medical costs and supplies, the XBridge Program by BioMedX, meant to support medical initiatives in the U.S following cuts to the NIH, cuts made by OPM following Servier’s exit, and other top news! Stay informed and inspired by the innovations driving life sciences forward!
Proposed Tariffs on Pharmaceutical Imports Raise Supply and Cost Concerns
The U.S. may soon impose tariffs on pharmaceutical imports to boost domestic manufacturing, according to President Donald Trump. Though specific rates and timelines remain unclear, the plan has sparked concern among patient advocates and analysts, who warn it could worsen drug shortages and raise costs. Generic drugs, which make up 90% of U.S. prescriptions and often rely on foreign ingredients, are especially vulnerable. Experts argue that tariffs may disrupt already fragile supply chains and deter production. While some companies are investing in U.S. facilities, meaningful reshoring is a long-term process with limited short-term relief.
German Initiative Offers Interim Support for U.S. Researchers Facing NIH Funding Cuts
Amid ongoing funding instability and layoffs in U.S. research institutions—especially within federal health agencies—Germany’s BioMed X Institute has launched the XBridge Program to support scientists at risk of losing NIH funding. The program allows researchers to submit their NIH grant proposals, which are then shared with BioMed X’s network of pharmaceutical partners, including Roche and Sanofi. Interested companies may invite selected researchers to pitch their work. While not a replacement for federal grants, the initiative aims to maintain research continuity in human disease by linking scientists to private sector sponsors during periods of financial uncertainty.
Oncodesign Precision Medicine Faces Financial Strain After Servier Withdrawal
Oncodesign Precision Medicine (OPM) has cut executive salaries and laid off five employees following Servier’s exit from a Parkinson’s disease collaboration. Servier had co-sponsored a phase 1 trial of OPM-201 but withdrew before its results, disrupting OPM’s financial projections and halting an expected milestone payment. With only €5.1 million in cash at 2023’s end, OPM is reducing costs by focusing on priority programs like OPM-101 for metastatic melanoma. OPM is now seeking new partners for OPM-201 to continue advancing the program independently.
FDA Requests Additional Efficacy Data for Aldeyra’s Dry Eye Drug Reproxalap
The FDA has issued a second complete response letter to Aldeyra Therapeutics regarding its NDA for reproxalap, a RASP-modulating drug for dry eye disease (DED). While safety and manufacturing concerns were absent, the agency concluded that the updated data did not adequately demonstrate symptom relief, a key approval requirement. Despite prior trials—TRANQUILITY and the Dry Eye Chamber study—showing statistically significant improvements in redness and favorable trends in pain, the FDA is calling for an additional controlled study focused on symptom efficacy. Aldeyra, which reported consistent safety across 2,500 participants, plans to resubmit its application later this year.
Rallybio Halts RLYB212 Program Following Phase II Failure in FNAIT Study
Rallybio has terminated development of RLYB212, its monoclonal antibody for preventing fetal and neonatal alloimmune thrombocytopenia (FNAIT), after a Phase II study failed to meet pharmacokinetic and efficacy targets. The trial showed RLYB212 did not reach the minimum effective plasma concentration, and further dose adjustments were deemed unfeasible. Enrollment and screening have been discontinued, though patient safety monitoring will continue. The company will now focus on RLYB116, a C5 inhibitor in Phase I development for complement-mediated disorders. Other pipeline assets include REV102 for hypophosphatasia and RLYB332 for iron overload conditions, as Rallybio reallocates resources toward more promising programs.
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