Each week we highlight five things affecting the life sciences industry. Here’s the latest.
Pharmaceuticals exempt from tariffs announced this week, but uncertainty remains
- President Trump announced 10% baseline tariffs on most imports and higher reciprocal tariffs on countries with large U.S. trade deficits, Fierce Pharma reports. Pharmaceuticals are exempt from these reciprocal tariffs; however, it is unclear if active pharmaceutical ingredients (API) will be taxed.
- The pharmaceutical industry faces uncertainty over potential future tariffs, including industry-specific tariffs which were discussed in a recent cabinet meeting but have not yet been implemented.
CBER director announces resignation
- Peter Marks, director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), announced his resignation citing concerns about the direction of vaccine oversight and public confidence in scientific standards, according to Fierce Pharma.
- Marks’ exit comes amid broader changes at the FDA, including leadership transitions and workforce reductions. Many in the biopharma industry have expressed concerns about the potential impact on drug approvals, particularly for vaccines, gene therapies and rare disease treatments.
Large pharmaceutical companies continuing to invest in radiopharmaceuticals
- The radiopharmaceutical sector is seeing increased competition, particularly in the oncology space. Per BioSpace, these treatments aim to improve tumor targeting while minimizing side effects, though challenges like supply constraints and potential toxicity remain.
- Large pharmaceutical companies are investing in acquisitions and collaboration arrangements to strengthen their positions in radiopharmaceuticals. Despite a slew of new therapeutic candidates and regulatory submissions, the field faces hurdles such as limited availability of radioisotopes, the need for increased awareness among physicians and patients, and more.
New hemophilia drug receives FDA approval
- The FDA has approved a novel hemophilia treatment that works by inhibiting a protein that prevents blood clotting, rather than replacing missing clotting factors. Clinical trials showed it reduced bleeding rates by about 70%, offering effective prophylaxis for hemophilia A and B patients, including those with inhibitors, BioPharma Dive reports.
- The drug is priced at $642,000 annually, but discounts and assistance programs are available to improve accessibility. Despite its advantages, adoption may face hurdles due to the availability of established treatments and patient hesitancy toward newer genetic-based therapies.
FDA ruling on lab-developed tests struck down by federal court
- A federal judge in the U.S. District Court for the Eastern District of Texas vacated the FDA’s new rule regulating laboratory-developed tests as medical devices, per MedTech Dive. The court remanded the matter to U.S. Health and Human Services Secretary Robert F. Kennedy Jr.
- The ruling, viewed as a victory by the clinical lab industry, prevents new compliance requirements from taking effect, ensuring continued patient access to critical diagnostics without additional regulatory burdens.
For more insights in life sciences, check out RSM’s industry outlook.
