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BIOGEN TO WEBCAST ADUCANUMAB PRESENTATIONS FROM AD/PD 2021 VIRTUAL CONFERENCE ON MARCH 9-13, 2021

The Pharma Data

To access the webinar, please go to the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webinar will be available following the presentation. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. About Biogen. Source link:[link].

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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog: Biosimilars

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap. 11] Jeffrey N.

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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

The following PDUFA dates were obtained from publicly available sources.

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Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., The following PDUFA dates were obtained from publicly available sources. not discontinued) and are available for sale.

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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

The following PDUFA dates were obtained from publicly available sources.

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Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

The following PDUFA dates were obtained from publicly available sources.

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Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

The following PDUFA dates were obtained from publicly available sources.

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