Newron Pharmaceuticals will expand its Phase 3 evenamide trial outside the U.S. after the FDA decided to maintain a hold on enrollment at American sites.
Tag Archive for: Regulatory
On July 23, Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended the CETP inhibitor obicetrapib for approval after a string of big-name Phase 3 failures over the past two decades. The European Commission’s final approval is expected in the second half of the year.
Launched in 2022, the EU Clinical Trials Information System (CTIS) aims to streamline and centralise the process of applying for clinical trial authorisation, but has also increased typical approval timelines. Several nations are now introducing accelerated pathways that jump the queue, offering one of the fastest routes to the clinic in the world for companies navigating this increasingly complex regulatory landscape.
Berlin-based OMEICOS Therapeutics can move OMT-28 directly into a pivotal Phase 3 trial in primary mitochondrial diseases after receiving supportive feedback from the U.S. Food and Drug Administration (FDA).
After months of regulatory uncertainty, uniQure says the FDA will accept three-year Phase I/II data as the primary basis for an accelerated approval application for AMT-130.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have together compiled ten principles for good artificial intelligence (AI) practice in drug development.
As the regulatory strategy becomes a boardroom-level concern for biotech executives pursuing global expansion, knowing how the Saudi Food and Drug Authority (SFDA) and the European Medicines Agency (EMA) differ is crucial, particularly as Saudi Arabia accelerates its ambition to become a global life sciences hub. Although both regulators adhere to international norms, their differences in review speed, procedural flexibility, and strategic positioning can have a direct impact on competitive advantage, investment planning, and time to market.
FDAEgetis Therapeutics has submitted a rolling NDA for Tiratricol to treat rare MCT8 transporter deficiency. The application for priority review is based on positive ReTRIACt study results.
adobe stock photos - ndomble The European Commission has launched a public consultation to support the development of the European Biotech Act, which is now being prioritised after a previous delay. The Commission plans to publish the legislative proposal by the end of 2025 and is inviting stakeholders across the biotechnology sector to provide feedback on regulatory, financial, and operational barriers.
Medicines for EuropeIn a surprise move, Health Commissioner Oliver Várhelyi announced at the Medicines for Europe Annual Conference that the EU Biotech Act will go ahead this year, reversing its provious delay from Q3 2025 to Q3 2026. The legislation has now been fast-tracked because the Commission recognised biotechnology’s rising geostrategic weight.