Apr 29, 2025
Table of Contents
Boston Scientific has announced that tariffs are expected to add approximately $200 million to its costs this year, but the company remains confident in its ability to absorb the financial hit. Despite the tariff burden, the company reported robust growth across its cardiology and urology divisions, reflecting strong overall performance.
In its Q1 2025 earnings report, the company posted total sales of $4.66 billion, a 22.2% increase from the previous year. Significant contributions came from its medical-surgical division, which saw urology net sales rise by 24.5%, partly driven by its kidney stone treatment devices. Meanwhile, cardiovascular revenue surged to $3.09 billion, with electrophysiology sales jumping by 145%, fueled by the success of its Farapulse pulsed field ablation system.
Article in PDF
CEO Mike Mahoney expressed confidence in the company’s ability to manage the tariff costs. “Our ability to absorb the tariffs, I think, is more unique than most companies, given the strength of the growth and the leverage that we’re driving,” Mahoney noted during the earnings call. He added that while the tariffs are “unfortunate,” the company’s global manufacturing presence and strong operations allow it to maintain high performance.
He further emphasized, “There’s no major adjustments other than continuing investments to support the long-term growth of the company.” Mahoney also mentioned strategic reductions in discretionary spending, such as cutting back on travel, while maintaining its global manufacturing footprint, including investments in new facilities in Georgia and expanding its capacity in Minnesota.
Northstrive Biosciences, a subsidiary of PMGC Holdings Inc. announced that it has received preliminary feedback from the FDA regarding its Type B pre-Investigational New Drug (pre-IND) meeting. The meeting was requested to discuss its clinical development plans for EL-22, a novel engineered probiotic, administered in combination with GLP-1 receptor agonists for the treatment of obesity.
The FDA’s responses confirmed that Northstrive’s pharmacology studies support EL-22’s activity and that the nonclinical studies are sufficient to support its safety and efficacy in overweight and obese human populations. Based on this positive feedback, Northstrive plans to proceed with the IND application in 2025, followed by a Phase II clinical trial to assess the combination therapy in patients. The company is currently engaging with cGMP manufacturing partners to prepare for EL-22 production.
EL-22 is designed to express myostatin on its surface, targeting the myostatin pathway to support muscle health, a critical concern for patients undergoing weight loss treatments like GLP-1 receptor agonists. Preclinical studies, including research in mdx mice and a completed Phase I trial in South Korea, have shown promising results in terms of safety and efficacy.
Deniel Mero, Co-founder of Northstrive Biosciences, commented, “This positive reinforcement from the FDA is a critical milestone in the development of EL-22 to address obesity’s unmet need of preserving muscle during weight loss treatment, particularly for patients on GLP-1 therapies.”
Roche is actively working to mitigate the impact of tariffs by moving production of its medicines to the U.S. and seeking an exemption from the Trump administration. CEO Thomas Schinecker explained that Roche is negotiating with the U.S. government to avoid tariff consequences, proposing that if the company exports as much as it imports, it should be exempt from the tariffs. Schinecker added that Roche’s strong U.S. manufacturing presence gives the company the ability to absorb the $200 million tariff cost.
The company is also engaged in discussions with governments in Switzerland, China, and the EU about the broader impact of tariffs. In conjunction with these talks, Roche has pledged a $50 billion investment over five years to expand manufacturing and R&D facilities in the U.S., marking a strategic move to strengthen its local operations. Roche has already started shifting its pharmaceutical production to the U.S. as part of this effort.
Roche’s focus on mitigating tariff exposure includes increasing U.S. manufacturing for four of its medicines, which represent 92% of its potential tariff impact. For three of these drugs, Roche plans to boost domestic production, while for the fourth, the company has begun a tech transfer to enable U.S. production. Schinecker stated, “We are operating in the U.S. at 50% drug substance capacity,” which provides ample room to scale up manufacturing.
Roche’s $50 billion U.S. investment does not affect its capital expenditure budget, which remains at 3.5 to 4 billion Swiss francs annually. The focus of these investments is on cutting-edge technologies, including continuous glucose monitoring and manufacturing innovations for incretin and amylin peptides. Despite the U.S. focus, Roche continues expanding its presence in other key markets like China, Switzerland, and Germany, emphasizing its global manufacturing strategy.
Verastem Oncology has received clearance from the FDA for its Investigational New Drug (IND) application for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor. This marks a significant step toward advancing clinical evaluation, with plans to initiate a Phase I/IIa trial in mid-2025 for patients with advanced solid tumors, including pancreatic cancer, colorectal cancer, and non-small cell lung cancer. The study will also explore combination therapies through multiple expansion cohorts.
At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, Verastem’s partner GenFleet Therapeutics will present initial safety and efficacy data from the VS-7375 Phase I/II study. The oral presentation will feature findings from GenFleet’s initial dose escalation phase, which demonstrated promising results, including partial responses in patients with pancreatic and advanced lung cancers.
“We’re excited to advance the clinical program for VS-7375 in the U.S.,” said Dan Paterson, CEO of Verastem Oncology. “The early data from GenFleet’s study show strong potential for VS-7375, and we believe there is a significant opportunity to improve efficacy beyond existing KRAS G12D-selective agents.”
The Phase I/IIa trial will begin in the U.S., potentially expanding globally, to evaluate the safety and efficacy of VS-7375 in treating KRAS G12D mutant solid tumors. Initial dosing will be based on prior data from GenFleet’s study, aiming to accelerate the trial’s progress.
ASCO 2025 Presentation Details:
BlackfinBio Ltd has announced that the FDA has cleared its Investigational New Drug (IND) application for a Phase I/II clinical trial of BFB-101, a novel AAV gene therapy designed to treat Hereditary Spastic Paraplegia, Type 47 (SPG47) — a rare and debilitating neurological disorder in children. The trial, which will be conducted at Boston Children’s Hospital, is expected to begin enrolling patients by the end of 2025. The FDA has also granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) to BFB-101.
SPG47 is a progressive genetic disorder caused by mutations in the AP4B1 gene, leading to spasticity, developmental delays, and intellectual disability. Currently, no approved treatments exist. BFB-101 delivers a functional copy of AP4B1 via an intracisternal magna (ICM) injection, a delivery method aimed at efficiently targeting the central nervous system. Preclinical studies have shown promising safety and therapeutic potential.
The Phase I/II trial will be an open-label study involving up to five pediatric patients with genetically confirmed SPG47. Its primary goal is to evaluate the safety and tolerability of BFB-101, with secondary endpoints assessing motor function, development, and quality of life improvements.
“This IND clearance marks a significant step forward in our mission to address rare neurological diseases,” said Peter Nolan, CEO of BlackfinBio. Lead investigator Dr. Darius Ebrahimi-Fakhari and CSO Professor Mimoun Azzouz echoed the urgent need for innovation in treating SPG47, emphasizing the potential of BFB-101 to deliver transformative outcomes for affected children and their families.
Article in PDF
