The Pharma Data

OCTOBER 29, 2020

If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and to meaningfully change the course of Alzheimer’s disease. If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. CAMBRIDGE, Mass.

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The Pharma Data

DECEMBER 9, 2020

(Tokyo, Japan) announced that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. In addition to the filing in Japan, aducanumab is under Priority Review with the U.S.

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. 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., not discontinued) and are available for sale.

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The Pharma Data

NOVEMBER 6, 2020

With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . About Aducanumab. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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Agency IQ

JUNE 9, 2023

High-priced cell and gene therapies are being increasingly developed for rare diseases. For example, a comparison of some gene therapy reimbursement shows that the single-treatment CAR-T cell therapy Kymriah (tisagenlecleucel) is reimbursed at 320,000 euros (based on outcome) in Italy, Germany, Spain and France.

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Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023.

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Agency IQ

DECEMBER 1, 2023

December 2023 Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior (Proposed Rule) The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB).

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Agency IQ

OCTOBER 27, 2023

December 2023 Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior (Proposed Rule) The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB).

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Agency IQ

JULY 28, 2023

Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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