News Notes

September 17, 2020

A compilation of recent notable news developments that pertain to the clinical trials industry.

Parexel and Pfizer enter next phase of partnership

Parexel has signed a new master service agreement (MSA) with Pfizer to continue the CRO’s decade-long partnership with the big pharma company. The agreement is for a three-year term with an option to extend for an additional two years.

The strategic focus of the new arrangement is focused on driving cycle times for Pfizer’s development efforts. Parexel will provide Pfizer clinical development services via full-service, hybrid, and functional service provider (FSP) models across all therapeutic areas, including rare diseases, oncology, inflammation, and immunology, and internal and hospital-based medicines.

Antibody cocktail collaboration

Regeneron Pharmaceuticals and Roche are joining forces in the fight against COVID-19 to develop, manufacture, and distribute REGN-COV2, Regeneron’s investigational anti-viral antibody cocktail, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic. This collaboration is expected to increase supply of REGN-COV2 to at least three and a half times the current capacity, with the potential for even further expansion.

If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.

Bayer to acquire UK-based biotech

Bayer will acquire KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, to expand the pharma company’s drug development pipeline in women’s healthcare. Under the terms of the deal, Bayer will pay an upfront consideration of $425 million, potential milestone payments of up to $450 million tied to KaNDy’s lead investigational compound, followed by potential additional triple-digit million sales milestone payments.

Pact struck around real-world data

Trialbee, a provider of patient matching and engagement technology in clinical trials, has entered into a partnership with medical data informatics company Clinerion designed to accelerate time to market by shortening patient recruitment and enrollment timelines. The deal combines Clinerion’s focus in leveraging real-time, real-patient, and real-world electronic health record data for clinical research with Trialbee’s multiple-step qualification process, which includes online qualification and nurse practitioner interviews to ensure patient matches prior to obtaining consent and enrollment.

— Staff and wire reports

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