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
FDA
FDA Commissioner Marty Makary presented a new idea to staff this week: bonus payments for employees that complete regulatory review processes faster than expected.
Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.
FDA
Aside from creating a toxic work environment, CBER Director Vinay Prasad has also been accused of berating his staff and retaliating against reviewers who questioned his decisions.
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
Without naming a specific product, Commissioner Marty Makary referred to an investigational therapy, delivered surgically into the brain, that the FDA was “pressured” to approve even after finding no clinical benefit to patients.
Analysts are cautiously optimistic about an IPO rebound for biopharma. BioSpace is keeping track of companies that seek to trade on the public markets this year.
The BioSpace team hit the ground running at the J.P. Morgan Healthcare Conference earlier this month to bring you the news from the streets of San Francisco.
After a rocky 2025, Sarepta Therapeutics’ executives admit they have work to do to bring patients back into the fold as sales of Duchenne muscular dystrophy gene therapy Elevidys continue to decline.
FDA
Last week, the FDA made its one pivotal trial policy official, sparking myriad questions from industry leaders, including around specific evidence required for the single study and why it hasn’t been implemented across all therapeutic areas before now.
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