Regulatory affairs

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People on the Move: September 2021

By Jenni Spinner

This month’s news on new hires, board launches, acquisitions, and other important news includes items on Pfizer, Javara, Clinical Ink, and other companies.

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Latest COVID-19 updates from the FDA

By Jenni Spinner

The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.

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Tech Innovations: August 2021

By Jenni Spinner

This month’s roundup of equipment, decentralized technology, partnerships and other items includes news from Medidata, PerkinElmer, Syneos and other firms.

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FDA lead calls for independent inquiry into Biogen drug approval

By Jane Byrne

Acting US FDA commissioner, Janet Woodcock, has called for an independent federal review of interactions between officials at her agency and representatives of Biogen, prior to the recent approval of the pharma company’s treatment for Alzheimer’s disease....

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Recent FDA COVID-19 actions and updates

By Jenni Spinner

The agency has been busy with actions related to the virus behind the pandemic, keeping an eye on vaccinations, emerging variants, and other concerns.

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FDA approves Biogen’s Alzheimer's drug, Aduhelm

By Rachel Arthur

The US Food and Drug Administration (FDA) has approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s: making it the first new treatment approved for the disease since 2003.

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FDA rebuff for Keytruda in breast cancer indication

By Jane Byrne

A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

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