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September 09, 2021
AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the advance purchase agreement for the delivery of Vaxzevria.
The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.
Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.
FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.
Thermo Fisher Scientific plans to expand its Nashville, Tenn., site by establishing a dedicated single-use technology manufacturing facility at the site, doubling capacity.
Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.
September 07, 2021
The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.
Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.
September 03, 2021
The US government has granted Thermo Fisher Scientific a $192.5 million contract that the company will use to expand domestic manufacturing for pipette tips.
September 02, 2021
FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.