The Pharma Data

NOVEMBER 10, 2020

The event was held in one Chinese session and one English session, with more than 700 investors and analysts watched the webcast and communicated with management team about R&D and other business updates through Q&A. that are fast progressing clinical trials. TYVYT® is the only PD-1 inhibitor included in the NRDL.

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Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . Denmark posts guidance on decentralizing clinical trials.

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The Pharma Data

NOVEMBER 17, 2021

There were no serious events of flushing or expirations due to flushing in the study. The most common adverse events, attained using data from dimethyl fumarate (which has the same active metabolite as VUMERITY), were flushing, abdominal pain, diarrhea and nausea. The difference in the termination rates due to GI tolerability was0.8

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The Pharma Data

APRIL 11, 2021

The adverse event (AE) profile of the combination was generally consistent with previously published data on the individual components of the combination and no new safety signals were identified. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial.

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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. The Phase 2 CRC trial is expected to have a data readout in early 2021.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

New content in this section relates to late phase trials and reduction and handling of missing data. The sponsor should be able to describe the DHT design and technological characteristics, data output provided, and how the DHT measures the event of interest.

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The Pharma Data

MAY 18, 2021

Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. You should not place undue reliance on these statements.

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The Pharma Data

DECEMBER 3, 2021

Zuranolone 50 mg was generally well-tolerated with an overall adverse event profile consistent with data reported earlier and 6.5% of patients discontinuing study drug due to adverse events. Zuranolone is being estimated in the Geography and NEST clinical trial programs. Food & Drug Administration.

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Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. Upcoming E.U.

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The Pharma Data

SEPTEMBER 20, 2020

No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The Phase 2 CRC trial is expected to have a data readout in 2021.

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Clinical Trials Production Trials Government 52

Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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The Pharma Data

SEPTEMBER 10, 2020

We are proud to share the latest insights on our cancer medicines at ESMO this year, including data from the CROWN trial examining the first-line use of our third-generation biomarker-driven therapy in ALK-positive non-small cell lung cancer.”. Chief Development Officer, Oncology, Pfizer Global Product Development. “We Sridhar S. . .

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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The Pharma Data

OCTOBER 14, 2021

About MS PATHS Biogen sponsored the MS PATHS (Partners Advancing Technology and Health Solutions) network to foster collaboration between leading MS centers in the U.S. and Europe to help transform patient care by generating standardized data from a diverse, real-world patient population.

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

JULY 27, 2021

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. Our stock price is volatile and may be affected by a number of events.

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The Pharma Data

MARCH 28, 2022

The adverse events (AEs) were mostly mild to moderate in severity and occurred at a similar rate across BIIB078 and placebo groups. This Phase 1 study was a randomized, placebo-controlled, dose-escalating trial to evaluate BIIB078 administered intrathecally to adults (n=106) with C9orf72-associated ALS.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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The Pharma Data

MAY 2, 2022

Patent Office Patent Trial and Appeal Board declined to institute an Inter Partes Review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex. Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO may cause a worsening in mood, cognition, rigidity, and functional capacity.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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The Pharma Data

JANUARY 26, 2021

Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

JUNE 13, 2023

To quote everyone’s favorite flautist (and TikTok sensation) Lizzo, “ it’s about d@mn time! ” (Sorry for the bowdlerization, but we’re trying to make it past everyone’s filter and HR warned us in any event.) Lastly, and we’re unsure why this requires repeating, and yet, here we are, don’t mess with the clinical trial numbers.

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The Pharma Data

AUGUST 1, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $674 Million; Global Rinvoq Net Revenues Were $378 Million – Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.816 Billion, an Increase of 14.1 percent on an operational basis, due to biosimilar competition.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

SEPTEMBER 17, 2020

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. Our stock price is volatile and may be affected by a number of events.

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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. not discontinued) and are available for sale.

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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

JULY 8, 2021

AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

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The Pharma Data

FEBRUARY 8, 2021

Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% Today, we have an industry-leading portfolio of 24 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, genitourinary, colorectal, blood and lung cancers, as well as melanoma.

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Agency IQ

JUNE 9, 2023

The low prevalence of individual orphan diseases poses challenges for building a scientific knowledge base and poses hurdles for clinical trial conduct, though collectively the diseases have a big impact. population) is considered heterogenous due to the developing physiological characteristics which makes clinical trial conduct challenging.

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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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

DECEMBER 27, 2020

To Our Shareholders, As we reach the end of an eventful 2020, we are inspired by the many healthcare providers and biopharmaceutical companies that worked to combat the COVID-19 pandemic. Finally, we seek to generate compelling clinical data to support moving into late-stage clinical trials and eventual marketing authorizations.

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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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