Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

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The Pharma Data

MARCH 5, 2021

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 An archived version of the webinar will be available following the presentation.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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Licensing Licensing Biosimilars Disease 52

Agency IQ

JUNE 2, 2023

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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Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

AUGUST 2, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Science Regulations Biosimilars 40

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

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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