Synexa Life Sciences

Synexa Life Sciences is a biomarker and bioanalytical lab CRO, specialising in the development, validation and delivery of a wide range of complex and custom-designed assays.

With a team of over 200 staff across three global laboratory locations; Manchester, Turku (Finland) and Cape Town, we provide innovative solutions to support our customers to achieve their clinical milestones.

Our main areas of expertise include biomarker identification and development, large and small molecule clinical bioanalysis, (soluble) biomarker analysis (utilising MSD, LC-MS/MS, ELISA, RIA, fluorescence and luminescence-based technologies), cell biology (including flow cytometry, ELISpot and Fluorospot) and genomic services to support clinical trials and translational studies.

We pride ourselves on our deep scientific expertise and ability to tackle complex problems, translating them into robust and reliable assays to support clinical trial sample analysis.

NEWS

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Opinion

Patient-Centered Paradigms Can Boost Neuro Candidate Success Rates

Innovative outcome measures coupled with a focus on patient-centered clinical differentiation can help the biopharma industry make meaningful progress in the highly complex area of neuroscience.

December 8, 2025

5 min read

Bruce Leuchter

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS).

Regulatory

In Change That Pushed Pazdur Out, FDA May Lower Clinical Trial Requirements

Commissioner Marty Makary said that the FDA will soon start requiring only one pivotal trial, instead of two, for companies seeking approval for new drugs.

December 5, 2025

2 min read

Dan Samorodnitsky

Red round circle with a pause button or icon against yellow background.

Regulatory

FDA Pauses Denali’s Pompe Plans Due to Preclinical Safety Signals

Hypersensitivity reactions in a mouse model prompted the agency to suspend Denali’s planned Phase I development for DNL952 for Pompe disease.

December 5, 2025

2 min read

Tristan Manalac

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Neuroscience

Praxis Ends Epilepsy Study Early Due to Strong Results, Heads to FDA

Praxis Precision Medicines has also announced a “successful” pre-NDA meeting with the FDA for its essential tremor drug candidate ulixacaltamide, for which an approval application is slated for early 2026.

December 5, 2025

2 min read

Tristan Manalac

Sagittal brain showing cortical thinning and ventricular enlargement associated with Alzheimer disease, displayed on a blue background for anatomical clarity.

Alzheimer’s disease

Eisai Still Confident in Anti-Tau Asset as J&J Becomes Latest Victim in Spiraling Space

Days after Johnson & Johnson’s posdinemab failed to slow clinical decline in patients with Alzheimer’s disease, Eisai Chief Clinical Officer Lynn Kramer expressed unwavering conviction in his company’s own anti-tau asset, while others suggest the Alzheimer’s field is heading in a completely different direction.

December 5, 2025

4 min read

Heather McKenzie

Huntington’s disease

FDA Minutes Confirm Challenging Path Ahead for UniQure’s Huntington’s Gene Therapy

Investor optimism has waned as final minutes from uniQure’s pre-BLA meeting with the FDA convey that data from the company’s Phase I/II studies of AMT-130 are “unlikely” to provide the primary evidence to support a biologics license application.

December 4, 2025

2 min read

Heather McKenzie

2006 James Gathany Captured by James Gathany, Centers for Disease Control's biomedical photographer, this 2006 image depicted the exterior of the new "Tom Harkin Global Communications Center", otherwise known as Building 19, located on the organization's Roybal Campus in Atlanta, Georgia. The facility houses the CDC's Information Center/Library, auditoria and meeting halls, which are used to accommodate in-house staff meetings, and national/international conferences hosted by the CDC, and the National Center for Health Marketing's, Division of Creative Services, which includes a full service television broadcast facility. The exhibit area currently features the "Global Symphony", the first of several permanently installed exhibitions, and changing exhibitions that focus on a variety of public health topics. The exhibits in the Center are self-guided, and require no advance reservations. Additional curriculum-based exhibits and programming will be added in the future. Tom Harkin Global Communications Center Exhibit Area Centers for Disease Control and Prevention - 1600 Clifton Road, N.E., Atlanta, Georgia 30333 - Hours: Monday Friday, 9 am 5 pm, except for federal holidays Admission is free - Government-issue photo ID is required for entry. Please note that CDC is a working federal facility and as such does not provide public tours of its campus and laboratories. - For more information please call 404-639-0830.

Vaccines

Former CDC, FDA Chiefs Decry Vaccine Policy Changes as ACIP Meeting Begins

Writing in separate editorials in two leading medical journals, former chiefs of federal scientific agencies issued warnings about the changes being proposed to vaccine frameworks by current officials.

December 4, 2025

2 min read

Dan Samorodnitsky

Collaboration

Crescent, Kelun-Biotech Swap Therapies in ADC-Bispecific Deal Worth Up To $1.25B

The partnership will focus on Crescent’s PD-1/VEGF inhibitor CR-001 and Kelun-Biotech’s SKB105, both of which the companies plan to push into Phase I/II development for solid tumors early next year.

December 4, 2025

2 min read

Tristan Manalac