A pesar de vivir en la era de los satélites y la inteligencia artificial, la Tierra sigue siendo un catálogo de misterios sin abrir. Cada año, expediciones a las fosas marinas más profundas o a selvas casi impenetrables nos revelan que la naturaleza tiene una imaginaci&oa …
Durante siglos, hemos observado cómo las margaritas cierran sus pétalos al atardecer o cómo los girasoles agachan la cabeza cuando el sol se retira. Pero, ¿es simplemente una reacción mecánica o existe un proceso biológico similar al sueño huma …
Principal Scientist Anders Cai Holm Hansen explains how CDMO AGC Biologics uses its global, single-use network and a strategy emphasizing “scale-out” manufacturing, to derisk demand uncertainty, speed timelines and conserve cash for emerging drug developers.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
FDA’s CRL transparency policy is boosting biopharma accountability Read More »
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
FDA flexibility isn’t absent but evolving regulations come with growing pains Read More »
Habiendo completado buena parte del trayecto de vuelta a la Tierra, los astronautas de la misión Artemis 2 afrontaron una anomalía técnica inesperada en las comunicaciones entre su nave Orión y la Tierra. Se perdió la señal durante una transmisión de …
Llegan a la Tierra los astronautas de la misión lunar Artemis 2 Read More »
Mergers and acquisitions in the first quarter hit multi-year highs after providers pumped the brakes last year on deal-making due to financial stress and policy uncertainty from Washington, according to a new study from Kaufman Hall.
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
Replimune’s advanced melanoma drug rebuffed by FDA for second time Read More »
The agency showcased dozens of tools Thursday, about 8 months after the CMS first announced the initiative that aims to ease health data sharing and improve access to digital health and AI products.
CMS unveils first wave of health tech tools as it pushes data sharing initiative Read More »
The company disclosed that it expects a material impact on first-quarter financial results. However, it does not expect an effect on full-year results.
