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The expanded operations will also support the start of proline/alanine/serine (PAS)-nomacopan clinical trials in geographic atrophy (GA).

Akari Therapeutics Establishes US Headquarters in Boston

The initial collaboration between the two companies began in 2017 with an extension announced in 2021.

Regeneron Pharmaceuticals to Acquire Decibel Therapeutics 

The partnership is an extension of the collaboration from AbbVie and Scripps Research that was formed in 2019, according to the press release.

AbbVie Expands Collaboration with Calibr to Advance Clinical Assets

The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

Good Clinical Practice Draft Guidance Revealed for Clinical Studies

clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.

Adaptive Biotechnologies Announces Collaboration with Takeda for Minimal Residual Disease Measures

The efficacy data across multiple clinical endpoints and a favorable safety profile support the potential of AMB-05X as a best-in-class therapy for the treatment of TGCT regardless of surgical resectability. 

AMB-05X Receives EMA PRIME Designation for Treatment of Tenosynovial Giant Cell Tumor

The merged company will operate under the name Ayala Pharmaceuticals and will target the development and commercialization of Ayala’s lead program, AL102, for the treatment of desmoid tumors. 

Advaxis, Ayala Pharmaceuticals Complete Merger

Additionally, 89 human medicines have been recommended for approval by the EMA, and the organization also analyzed a new vaccine against dengue and two diabetes treatments that address important public health issues outside the EU.

EMA Executive Director Sends Message of Promoting Stronger Public Presence for Safety, Efficacy of Medicines

In addition, the Clinical Trials Regulation is set to become a single-entry point for sponsors and regulators in January 2023 for the submission and assessment of all new clinical trials.

Highlights of December 2022 EMA Management Board Meeting 

The decision to move forward in Phase III development stems from the threat of resistance to current malaria treatment growth. 

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