Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
Study highlights overlooked role of fathers’ health in pregnancy outcomes
Before, during, and after pregnancy, the mother’s health and behaviors are the main focus when determining pregnancy and child health outcomes. The role of the father’s health and behaviors is secondary and often focused on social aspects postnatally. However, research has increasingly shown the large contribution that the father’s health plays in pregnancy and child health outcomes. In a new study published in The Lancet, researchers provided three case studies showing that a man’s early life experiences can affect his partner’s health and health behaviors, as well as the developing infant’s. The researchers emphasized that not only are these burdens placed on the mother in society, but in research as well, which only reinforces gender bias. They highlighted the need for change at the policy, research, and societal levels for taking men’s role in pregnancy health seriously and equally. “Research into the influence of fathers on pregnancy and parenthood has previously been neglected,” said Keith Godfrey, an epidemiologist and a senior author of the study at the University of Southampton and the National Institute for Health and Care Research (NIHR) Southampton Biomedical Research Centre (BRC), in the press release. “Now this is changing, it is becoming clear that fathers have a real impact on pregnancy.” – Melissa Kay
FDA moves to cut biosimilar development costs by up to 50 percent
The FDA announced new draft guidance on March 9, 2026, aimed at reducing the cost and complexity of developing biosimilar medicines — lower-cost alternatives to expensive biologic drugs. The guidance streamlines clinical pharmacokinetic (PK) testing requirements, potentially saving developers up to $20 million per drug and cutting PK study costs in half, building on a similar October 2025 move that reduced costly comparative efficacy studies. The changes allow developers to use data from non-US-approved comparator products without requiring additional three-way PK studies, when scientifically justified. The FDA framed the move as part of a broader effort to lower drug prices for Americans, noting that biologics — though just five percent of prescriptions — account for 51 percent of all drug spending, often costing hundreds of thousands of dollars annually. With 82 biosimilars now approved, expanding this pathway could significantly improve patient access to treatments for conditions like cancer, rheumatoid arthritis, and diabetes. – Andrea Corona
Mass spectrometry advances toward billion-molecule analysis
Researchers have unveiled a prototype mass spectrometer that can analyze billions of molecules simultaneously, a breakthrough that could one day make comprehensive single-cell protein analysis routine and dramatically speed drug discovery. The device, called MultiQ-IT, was developed by scientists at Rockefeller University and replaces the traditional sequential approach of mass spectrometry with massive parallel processing, allowing rare but biologically important molecules to be detected amid overwhelming background noise. Led by Brian T. Chait, the team reengineered the core ion-trapping chamber so it can hold and sort vast populations of ions at once, boosting sensitivity by up to 100-fold in early tests. The findings, published in Science Advances, offer a blueprint for faster, more sensitive instruments that could ultimately enable routine single-cell proteomics and metabolomics, echoing the parallelization revolutions that once transformed DNA sequencing and computing. – Bree Foster
Aspen’s personalized cell therapy shows early promise in Parkinson’s
Aspen Neuroscience is moving closer to a pivotal test of its personalized cell therapy for Parkinson's disease following encouraging 12-month data from its Phase 1/2a ASPIRO study. The therapy, sasineprocel (ANPD001), uses dopaminergic neuron precursor cells derived from a patient’s own skin cells and does not require immune-suppressing drugs. In results presented on Wednesday at the International Conference on Alzheimer’s and Parkinson’s Diseases, eight participants showed sustained improvements in motor function and quality of life after bilateral intracranial administration. Low- and high-dose cohorts gained an additional 2.1 to 2.4 hours of “ON” time daily, meaning that, on average, patients were able to function normally for roughly 2 extra hours per day without severe motor symptoms. Additionally, scores based on the MDS-Unified Parkinson’s Disease Rating Scale showed that patients’ motor symptoms improved significantly even when they were not benefiting from medication. No serious surgical adverse events were reported. Aspen plans to begin a Phase 3 trial later this year, following productive discussions with the FDA, supported by a $115 million Series C round that will also fund manufacturing scale-up. – Bree Foster
EMA adds new tools to fast-track innovative medicine development
The European Medicines Agency (EMA) announced this week the permanent integration of three new features into its PRIME scheme, which supports the development of medicines targeting unmet medical needs. Following a two-year pilot, EMA is rolling out a regulatory roadmap and product development tracker to flag issues early, an expedited scientific advice tool for fast-track regulatory input on critical development questions, and a submission readiness meeting held roughly a year before application to identify any remaining evidence gaps. The move is designed to foster continuous scientific dialogue between developers and the agency, reduce delays, and better prepare applicants for full evaluation by the Committee for Medicines for Human Use (CHMP). The timing is notable as EMA prepares for a new EU pharmaceutical legislative framework that will formally codify PRIME into law. Future planned enhancements include more agile advice processes, flexible scheduling, digital tracking solutions, and a dedicated EMA Product Development Coordination contact for developers. – Andrea Corona
FDA approves higher-dose Wegovy, delivering around 21 percent mean weight loss
Novo Nordisk announced on March 19, 2026, that the FDA has approved Wegovy HD (semaglutide 7.2mg), a higher-dose version of its blockbuster weight-loss injection, with a US launch expected in April 2026. In the STEP UP trial of roughly 1,400 adults with obesity, the once-weekly injectable delivered a mean weight loss of 20.7 percent, with about one in three patients losing 25 percent or more of their body weight — a notable step up from the 2.4mg dose already on the market. In a separate trial for patients with obesity and type 2 diabetes, the drug achieved a mean weight loss of 14.1 percent. The approval also marks the fourth use of the FDA Commissioner's National Priority Voucher pilot program, which accelerated the review process for products addressing critical national health needs. Wegovy HD, which will be available in a single-dose pen, complements the existing Wegovy 2.4mg formulation already approved for weight management and cardiovascular risk reduction, as well as a Wegovy pill launched earlier this year.– Andrea Corona
