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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

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.

Phase III Study for Novel Ganaplacide/Lumefantrine-SDF Combination in Adults, Children with Malaria Announced

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

CellVax and Theragent Form Manufacturing Pact for Novel Cancer Immunotherapy Drug Candidate

 Washington Editor, jillwechsler7@gmail.com.

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions. 

Clinical Trial Modernization Raises FDA Compliance Issues

Feliza Mirasol is the science editor for 

One can use modeling methods to generate data and shorten development timelines in preclinical studies.

Adopting a Modeling Approach for Preclinical Studies

Having a clear clinical strategy early on can shave time off overall development projects.

Early Strategizing Tightens Development Timelines

Applying modeling methods in preclinical studies can be a powerful tool for generating data and shortening development timelines.

Using a Modeling Approach to Preclinical Studies

New guidance from FDA and legislation from Congress promote clinical trial diversity.

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