The Pharma Data

MARCH 5, 2021

Biogen (Nasdaq: BIIB) today announced it will host webcasts of its pre-recorded presentations and live discussions related to its Alzheimer’s disease investigational therapy, aducanumab, at the upcoming AD/PDTM 2021 Virtual Conference. An archived version of the webinar will be available following the presentation. About Biogen.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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The Pharma Data

SEPTEMBER 10, 2020

Full data from the Phase 3 CROWN study in lung cancer will be presented during the Presidential Symposium. Data to be presented include findings from the Phase 3 CROWN study of LORBRENA ® (lorlatinib)* in first-line ALK-positive non-small cell lung cancer (NSCLC), building on Pfizer’s extensive heritage in precision medicine research.

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Drug Channels

OCTOBER 7, 2024

Other expert and thought leaders from within the industry are slated to present deep dive sessions, workshops and panels that will answer your most pressing questions: What are the latest legislative updates and proposed federal bills impacting PBM operations? You’ll hear from Matthew Gibbs, Pharm.D., And much more !

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g., mL), to be biosimilar to or interchangeable with High Concentration Humira (e.g.,

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Drug Channels

FEBRUARY 22, 2022

We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars. New sections cover: pharmacies’ administration of—and profits from—COVID-19 vaccines; smaller PBMs; PBM purchasing groups and GPOs; 340b split-billing software vendors; and shakeout and consolidation within retail pharmacy.

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FDA Law Blog: Biosimilars

JUNE 24, 2024

HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. Since its inception, the Format has been instrumental in standardizing the submission process, ensuring that critical data is presented in a clear and consistent manner.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

Further, information presented on the adverse reaction data was inconsistent with the PI. With respect to Altren, the webpage fails to contain any risk information, and a Product Sheet presents benefits and effectiveness information in a large, bulleted format while the risk information is in a smaller font on the second page.

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Drug Channels

JULY 11, 2022

Harness data-driven tech offerings to combat the urgent public health crisis and provide patients and stakeholders with unrivaled support services in an all-encompassing state-of-the-art hub.

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The Pharma Data

MAY 4, 2021

The US Food and Drug Administration (FDA) and pharmaceutical industry groups met twice in April to discuss the reauthorization of the Biosimilar User Fee Act (BsUFA) after kicking off negotiations in March. . Posted 04 May 2021 | By Michael Mezher .

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FDA Law Blog: Biosimilars

AUGUST 14, 2023

Farquhar — At the GMP by the Sea Conference ongoing in Cambridge, Maryland, a presentation was made by a representative of FDA’s Center for Drug Evaluation and Research that shows some interesting trends in enforcement. By Douglas B.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An

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DrugBank

AUGUST 9, 2024

Investment Trends in Pharmaceutical Research and Development Investing in the pharmaceutical sector presents a unique set of challenges and opportunities; let’s examine them in more detail.    The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years.

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The Pharma Data

JUNE 25, 2021

An archived version of the webcast will be available following the presentation. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. About Biogen At Biogen, our mission is clear: we are pioneers in neuroscience.

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The Pharma Data

MARCH 22, 2021

An archived version of the webcast will be available following the presentation. To access the live webcast, please visit Biogen’s Investors section at www.investors.biogen.com. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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FDA Law Blog: Biosimilars

APRIL 7, 2025

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

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The Pharma Data

SEPTEMBER 1, 2021

An archived version of the webcast will be available following the presentation. The webcast will be live on Thursday, September 9, at 9:30 a.m. To access the live webcast, please visit Biogen’s Investors section at investors.biogen.com. About Biogen. At Biogen, our mission is clear: we are pioneers in neuroscience.

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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

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The HCF formulation is presented in the same auto-injector as currently available to patients, aiming for an enhanced yet familiar patient experience.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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The Pharma Data

JULY 21, 2021

Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. The ongoing impact from biosimilars, particularly in the US, resulted in a sales decrease of CHF 2.8 Outlook confirmed for 2021.

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The Pharma Data

NOVEMBER 10, 2020

Michael Yu , the founder, Chairman and CEO, attended and presented on the virtual R&D day via live video webcast. During the introduction presentation, Dr. Michael Yu reviewed the history and achievements in the past nine years since the establishment of Innovent.

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FDA Law Blog: Drug Discovery

DECEMBER 20, 2023

Then, in early 2023, CDER and CBER started a slow phase-in of in-person meetings in a hybrid format, with some attendees present only virtually. At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings.

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Eye on FDA

FEBRUARY 10, 2021

Heightened Role for “Bad Ad Program” – A recent interview with the new Acting Director of OPDP revealed that a primary focus for the office this past year was in relation to the biosimilars market. Nothing about risk presentation on mobile sites. The agenda still has a focus on DTC print and television ads.

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DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets. The high costs associated with bringing a new drug to market, estimated to be over $2.6

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FDA Law Blog: Biosimilars

MARCH 27, 2023

Thank you to those who registered for and attended Hyman, Phelps & McNamara’s March 23, 2023 lunchtime webinar addressing the “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps.”

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FDA Law Blog: Biosimilars

JUNE 8, 2023

A teleconference will be conducted by voice only with no projection of presentations or use of video/camera; a videoconference would involve sharing a screen so that a presentation can be viewed by all participants and/or involve the use of video.

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FDA Law Blog: Biosimilars

MARCH 12, 2023

John will present on considerations and his learned perspective for the future of teleprescribing. Last, but certainly not least, we look forward to introducing our newest colleague, John WM Claud , who recently joined HPM from the Department of Justice’s Consumer Protection Branch.

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The Pharma Data

OCTOBER 14, 2021

The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.

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Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Spanogle, Ph.D.

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The Pharma Data

MARCH 16, 2022

” An archived version of the presentation is available on the investors section of Biogen’s website at investors.biogen.com. Additional research data was presented at AD/PD, along with multiple presentations describing various aspects of ADUHELM’s clinical program.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos. 219 and 5195; Decision and Order , 77 Fed. 62,316, 62,342 (Oct. Holiday CVS , 77 Fed. Complaint ¶ 62.

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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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FDA Law Blog: Biosimilars

DECEMBER 12, 2024

Judge Mulrooneys prehearing ruling establishes the schedule for the parties presentations and established hearing guidelines. Parties will have ninety minutes to present the testimony of their witness. Consolidated parties are allowed to present testimony of up to two witnesses during the hearing, a presentation up to 120 minutes.

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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

OCTOBER 18, 2021

One of the world’s first global biotechnology companies, Biogen was innovated in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp.

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