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Gene Therapy and Pharmacokinetics

Camargo

When developing a clinical development program for these increasingly popular therapies, it is important that sponsors use modeling and pharmacokinetic (PK) analysis to evaluate parameters that can be measured while dosing with gene therapy drugs, to characterize exposure-response data and inform rational dosing.

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Valneva accelerates Lyme disease vaccine R&D project with Pfizer

pharmaphorum

Valneva is paying 30% of development costs and in return Pfizer will pay tiered royalties starting at 19% and will lead late-stage development. VLA15 is the only active Lyme disease vaccine in clinical development today, and covers six strains that are prevalent in North America and Europe.

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Evaxion and ExpreS²ion partner to develop new CMV vaccine

Pharmaceutical Technology

Under a possible development and commercialisation agreement in the future for the CMV vaccine candidate discovered by the parties, Evaxion will be entitled to receive upfront and milestone payments from ExpreS 2 ion. A herpesvirus family member, CMV is spread through body fluids.

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Sanofi/GSK restart COVID-19 vaccine trials after tweaking formulation

pharmaphorum

Sanofi and GlaxoSmithKline are restarting clinical development of their COVID-19 vaccine, which was delayed after hitting a snag late last year. In December interim phase 1/2 trial results showed the vaccine produced a lower immune response in older adults.

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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease.

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Symvivo’s Oral COVID-19 Vaccine Enters Clinical Trials

XTalks

We are exceptionally pleased to commence dosing of our oral DNA vaccine for COVID-19 as we continue scale-up and manufacturing activities for future clinical development,” Symvivo’s chief medical officer Eric Sievers said in a press release from the company. Related: Red Meat Allergy Test Gets FDA Clearance. “We

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AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

pharmaphorum

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response.