Columbus Venture Partners and ABE Capital Partners acquire a majority stake in Sermes CRO

by Sermes CRO

ABE Capital and Columbus Venture Partners have reached an agreement to acquire a majority stake in Sermes CRO, a Spanish contract research organization specializing in end-to-end management of clinica...

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AI in drug development. A CRO’s strategic roadmap

by Pivotal

The AI revolution in Pharmaceutical R&D is transitioning from experimental curiosity to operational necessity. This transformation is supported by quantifiable operational improvements: AI-enabled dis...

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Understanding the Manufacturing Responsibilities for Drug Substances and Drug Products

by 53Biologics

Understanding the responsibilities involved in Drug Substance and Drug Product manufacturing is essential for making the right strategic decisions. Many biotech companies approaching clinical phases d...

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Successful Rescue and Accelerated Restart of a Clinical Trial for NTRK-Fusion-Positive Advanced or Metastatic Solid Tumors

by Pivotal

A multi‑country oncology study regained momentum through structured transition planning, seamless cross‑functional collaboration and decisive operational oversight, regulatory recovery, and discip...

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3PBIOVIAN Animal Health

by 3PBIOVIAN

3PBIOVIAN provides end-to-end CDMO services for animal health, supporting the development and GMP manufacturing of veterinary vaccines and biologics. With proven expertise in recombinant proteins, vir...

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How to Scale Manufacturing Without Losing Quality or Compliance

by 53Biologics

Effective scale up in manufacturing requires building predictive understanding, not just replicating conditions. At 53Biologics, their Process Development Services focus on identifying scale-dependent...

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53Biologics drives its expansion in GMP biomanufacturing with an investment led by Ren Life Sciences and supported by Inveready

by 53Biologics

Biotechnology company 53Biologics, specialized in the development and manufacturing of biologic drugs, has announced the closing of a strategic funding round led by European private equity firm Ren Li...

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Cómo optimizar la selección de centros en oncología para acelerar los plazos de un ensayo clínico

by Sermes CRO

La selección de centros en oncología es uno de los factores que más influye a la hora de acortar los tiempos de un ensayo clínico. Por ello, elegir bien dónde abrir un ensayo es casi tan crítico...

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Why GMP Readiness Starts During Drug Development, Not at Clinical Phase

by 53Biologics

Most biotech teams assume GMP readiness begins when a product enters clinical phases. In reality, the foundations of GMP are built much earlier, during drug development, often without being explicitly...

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Nueva guía de la EMA para la gestión de ensayos clínicos en emergencias sanitarias

by Sermes CRO

Las crisis no deben paralizar la investigación, pero tampoco justificar atajos que pongan en riesgo a los participantes o la validez de los resultados. Este es el leit motiv de la nueva guía de la E...

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Curapath and Nacalai Tesque Partner to Expand Access to next generation Polymers and PEG-Free Shielding Lipids in Japan

by Curapath

​Curapath has partnered with ​Nacalai Tesque to expand access to its portfolio of next-generation polymers and PEG-free shielding lipids for advanced drug delivery applications in Japan.

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Navigating EU-UK Dual-Track Clinical Trial Regulation in Parallel

by Pivotal

How sponsors can leverage both the EU Clinical Trials Regulation and UK’s reformed framework to achieve cost efficiencies, faster timelines, and stronger regulatory positioning.

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