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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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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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. The EC is expected to deliver its final decision on Venclyxto combination therapy for use in AML in 2Q 2021. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties.

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The Pharma Data

FEBRUARY 8, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. In 2020, Dupixent ® sales reached €3,534 million, up 73.9% In the U.S.,

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The Pharma Data

FEBRUARY 4, 2021

At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. In Europe, where the product is commercially available in several countries and has a temporary license to be sold in France, sales were €12 million. In 2020, Dupixent ® sales reached €3,534 million, up 73.9% In the U.S.,

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The Pharma Data

OCTOBER 29, 2020

million , a 26 percent increase compared to the same period in 2019. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. million in the third quarter of 2019. million in the third quarter of 2019, representing a 5 percent increase. in the prior year.

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Financial results for 2020 and 2019 are presented on both a reported and a non-GAAP basis. Central time.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area. Priority B List.

FDA 40

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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The Pharma Data

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

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Trials Production Clinical Trials Government 52

The Pharma Data

DECEMBER 21, 2020

In September 2018 , the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype. Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs.

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Trials Production Clinical Trials Government 40

The Pharma Data

APRIL 27, 2021

At the end of the first quarter, Dupixent ® was launched in 49 countries with approximately 260 000 patients on therapy. . to €24 million, primarily due to the COVID-19 pandemic, which has led to a decrease in infused immune reconstitution therapies such as Lemtrada ®. Neurology and Immunology. Net sales (€ million). Change at CER.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

DECEMBER 1, 2023

The following PDUFA dates were obtained from publicly available sources. Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig.

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The Pharma Data

MAY 4, 2021

Multiple innovative and biosimilar products across our portfolio delivered growth, demonstrating the strength of our business and the depth and breadth of our growth drivers. in December 2019; and. First-quarter 2021 operational growth was primarily driven by: BNT162b2, which contributed $3.5

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