The Pharma Data

JULY 27, 2021

The acquisition includes Teneobio’s proprietary bispecific and multispecific antibody technologies, which will enable significant acceleration and efficiency in the discovery and development of new molecules that have the potential to treat a wide range of important diseases across Amgen’s core therapeutic areas. Reese, M.D.,

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The Pharma Data

DECEMBER 9, 2020

If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease. 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.

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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The Pharma Data

AUGUST 3, 2021

– Notable pipeline events included positive data readouts for tirzepatide for type 2 diabetes and Jardiance for adults, with or without diabetes, who live with heart failure with preserved ejection fraction (HFpEF). Key Events Over the Last Three Months Regulatory. on a reported basis and increased to $1.87 on a non-GAAP basis.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. Recent Events. The applications are supported by two Phase 3 studies in which Skyrizi demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo. AbbVie Inc.

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Drug Discovery World

NOVEMBER 9, 2023

Peter O’Callaghan, PhD, Head of Expression System Sciences, Biologics and Licensing, Lonza, on: ‘Solve bispecific heavy-light chain mispairing with bYlok technology’. Nick Pittman, Marketing Manager, Global Biopharmaceutical Business, Waters Corporation, on: ‘Robust multi-level LC-MS workflows for biosimilar comparability assessment’.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

SEPTEMBER 16, 2020

Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

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The Pharma Data

SEPTEMBER 20, 2020

” Sotorasib demonstrated confirmed objective response rate (ORR) and disease control rates (DCR) of 35.3% No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). The webcast will be archived and available for replay for at least 90 days after the event.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

OCTOBER 29, 2020

. “Our foundation for the future is stronger than ever, and by maintaining our focus on serving patients and delivering for shareholders, I am confident that we will continue to build on our success to date and further advance our mission of delivering life-changing therapies to people with rare diseases and devastating conditions.”

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The Pharma Data

NOVEMBER 9, 2020

1,2 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity. About Severe Asthma Asthma is a complex and heterogeneous disease affecting an estimated 339 million people worldwide. 6,7 Approximately 10% of asthma patients have severe asthma.

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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. Recent Events. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent, with U.S.

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The Pharma Data

DECEMBER 21, 2020

Severe asthma is a complex, heterogenous disease and many patients continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. 2,3 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.

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The Pharma Data

FEBRUARY 8, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% 2021 financial outlook.

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The Pharma Data

FEBRUARY 4, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (3) at CER, barring unforeseen major adverse events. Rare Disease. Others Rare Disease. Total Rare Disease. In the fourth quarter, Rare Disease sales increased 3.0% In 2020, Rare Disease sales increased 5.7% 2021 financial outlook.

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The Pharma Data

APRIL 27, 2021

Sanofi expects 2021 business EPS ( 1) to grow high single digit (2) at CER, barring unforeseen major adverse events. Rare Disease. Others Rare Disease. Total Rare Disease. In the first quarter, Rare Disease sales increased 4.4% Full-year 2021 business EPS guidance affirmed. Net sales (€ million). Change at CER.

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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. Rare Disease. Internal Medicine. Inflammation & Immunology. Total Revenue. 42%. . . . . . Indicates calculation not meaningful.

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