News
Weekly selection of relevant developments across pharmaceuticals, medical devices, CRO-related innovation and the broader healthcare business landscape.
Open Serbian versionThe Wall Street Journal reported that the FDA plans to reverse its previous rejection and continue reviewing Regenxbio's third rare-disease drug. The move is being read as a meaningful signal for smaller gene therapy and rare-disease programs that depend heavily on a single regulatory outcome.
Source: WSJ
According to The Wall Street Journal, European regulators approved Sanofi's multiple sclerosis drug even though the FDA had previously rejected it. The decision highlights how regulatory outcomes for major drug programs can diverge across regions.
Source: WSJ
The Wall Street Journal reported that Cleveland Clinic startup UpDoc received FDA clearance for an AI-powered clinical workflow product described as a concierge doctor system. The clearance is notable because it moves AI further into regulated care-delivery infrastructure rather than simple documentation support.
Source: WSJ
Business Insider reported that Paradromics implanted its brain-computer interface in a human patient for the first time. The update adds to the momentum around neurotechnology platforms that are moving from early demonstrations into more concrete clinical use cases.
Source: Business Insider
The Financial Times reported that Eli Lilly is building a data-sharing network for AI-driven drug development with external partners including Charles River Laboratories. The initiative is relevant for the CRO ecosystem because it points to rising demand for data, workflow and model-enablement partnerships, not only outsourced execution capacity.
Source: Financial Times
Associated Press reported on a growing wave of state-level action targeting pharmacy benefit manager practices, including a Tennessee law challenged by CVS. The issue matters across the healthcare business landscape because it affects vertical integration, reimbursement economics and the balance of power among PBMs, insurers, pharmacies and manufacturers.
Source: AP
