The Pharma Data

JULY 29, 2021

up 21% operationally, driven by accelerating demand as the delays in diagnosis and treatment initiations caused by COVID-19 show signs of recovery across several international markets; Inlyta globally, up 29% operationally, primarily reflecting increased adoption in the U.S. Total Oper.

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Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. The International Recognition Procedure (IRP) officially replaces the EC Decision Reliance Procedure (EDRP) in the U.K. Title Call for Evidence Closes Comments Close Planned Adoption Draft E.U.

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (FDA) has granted toripalimab Fast Track designation for the first-line treatment of mucosal melanoma. On December 17, 2018, Toripalimab obtained a conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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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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Agency IQ

AUGUST 2, 2024

Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V. Positive September 2024 Yuvanci (macitentan / tadalafil) Janssen-Cilag International NV Positive September 2024 Eksunbi (ustekinumab)* Samsung Bioepis NL B.V.

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FDA Law Blog: Biosimilars

MARCH 15, 2023

Mammograms A type of medical imaging, mammography uses x-rays to create images (mammograms) of the internal structures of breasts. It can help detect breast cancer in its earliest, most treatment stages, when it is too small to be felt or detected by an alternative method.

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The Pharma Data

JULY 27, 2021

” The acquisition will also add TNB-585, a Phase 1 bispecific T cell-engager for the treatment of metastatic castrate-resistant prostate cancer (mCRPC), and several preclinical oncology pipeline assets with the potential for near-term IND filings. chief executive officer of Teneobio. ” In June 2021, AbbVie Inc.

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The Pharma Data

FEBRUARY 1, 2021

Food and Drug Administration (FDA) has approved a new intramuscular (IM) injection route of administration for Plegridy ® ( peginterferon beta-1a ) for the treatment of relapsing forms of multiple sclerosis (MS). Access to and availability of treatment options have become increasingly important in the current COVID-19 environment.

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The Pharma Data

AUGUST 31, 2020

This is because they did not have access to essential medicines needed for treatment. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. With AMSP, countries don’t have to search the market for supplies.

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The Pharma Data

OCTOBER 29, 2020

(Tokyo, Japan) today announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. Aducanumab is also under review with the U.S. About Aducanumab.

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The Pharma Data

SEPTEMBER 17, 2020

Lilly is currently studying several potential neutralizing antibodies for the prevention and/or treatment of COVID-19 as either monotherapy or in combination. INDIANAPOLIS and THOUSAND OAKS, Calif. Lilly ‘s chief scientific officer and president of Lilly Research Laboratories.

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Agency IQ

OCTOBER 27, 2023

Webinar/ Seminar ( OPEN ) Coordinating Research and Evidence for Medical Devices (CORE-MD) 11/6/2023 11/7/2023 ENVI Committee Meetings in 2023 Committee Meeting ( OPEN ) European Parliament committee on the environment, public health and food safety (ENVI) 11/6/2023 11/8/2023 6th European Training Course on Quality Management for Blood Establishments (..)

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The Pharma Data

NOVEMBER 23, 2020

have partnered with Yangtze River Pharmaceutical Group, a leading Chinese pharmaceutical company, to form an exclusive strategic partnership for the commercialization of eight biosimilar medicines in China. is an attempt on international collaboration of biosimilar medicines. and Alvotech & CCHT Biopharmaceutical Co.,

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The Pharma Data

JUNE 30, 2021

Agreement includes commercializing biosimilar candidate of ophthalmology drug ranibizumab (Lucentis ® ) in Europe, Canada, Israel and global markets. Bioeq has in-licensed the exclusive global commercialization rights to FYB201 from the German biosimilar developer Formycon AG.

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. net revenues of $999 million and international profit sharing of $269 million. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA).

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FDA Production Treatment International 40

The Pharma Data

AUGUST 3, 2021

The FDA has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The European Commission granted marketing authorization for Jardiance ® as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (systolic heart failure).

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Agency IQ

JUNE 29, 2023

Following the release of FDA’s Quantitative Claims proposed survey in April 2023, AgencyIQ speculated that perhaps the delay of the guidance and could be attributable to internal debate about whether to first obtain the results of that research, or to publish the guidance first.

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The Pharma Data

AUGUST 13, 2020

The Final Settlement Date for the Exchange Offers will be promptly after the Expiration Date and is currently expected to occur on August 28, 2020 , the second business day immediately following the Expiration Date.

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Production Government Marketing Regulations 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

A prescription not issued in the usual course of professional treatment or in legitimate, authorized research is not a prescription within the meaning of the CSA and the pharmacist knowingly filling it, along with the prescriber issuing it, is subject to penalties. 21 U.S.C. § 829; 21 C.F.R. Complaint ¶ 58. Complaint ¶ 59.

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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

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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The Pharma Data

AUGUST 13, 2020

Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen , including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K.

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Production Government Regulations Marketing 52

Agency IQ

MAY 3, 2024

Positive *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q2 2024.

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Drug Target Review

JULY 6, 2023

3 Furthermore, the act “removes a requirement to use animal studies as part of the process to obtain a license for a biological product that is biosimilar or interchangeable with another biological product.” A new research paper, co-authored by PETA Science Consortium International e.V., Annals of Internal Medicine.

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Agency IQ

JUNE 9, 2023

Commission Regulation (EC) No 847/2000 set the rules, defining an orphan drug as one “that it is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Community when the application is made.” no available treatment.

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Drug Discovery World

NOVEMBER 9, 2023

Sandra Ergueta-Carballo, PhD, Project Coordinator, University of Cambridge, on: ‘Advancing snake envenomation treatment: designing the next generation of antivenoms’. Nick Pittman, Marketing Manager, Global Biopharmaceutical Business, Waters Corporation, on: ‘Robust multi-level LC-MS workflows for biosimilar comparability assessment’.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA found that marijuana continued to have a high potential for abuse, lacked accepted safety for use under medical supervision and had no currently accepted medical use in treatment in the United States. Schedule I drugs have a high potential for abuse and no currently accepted medical use in treatment in the U.S.

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The Pharma Data

NOVEMBER 9, 2020

NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS.

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Agency IQ

FEBRUARY 15, 2024

AgencyIQ has analyzed the agency’s guidance agendas, user fee commitment letters, statutory obligations and international efforts to determine which guidance documents the agency is actively working on this year (and in some cases, in the years ahead as well). We have tried to sort guidance documents by topic area.

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Agency IQ

SEPTEMBER 29, 2023

Title Type Date Received by OIRA Legal Deadline Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, Neutral Manner in Advertisements in Television and Radio Format Final Rule May 19 None Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses (..)

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The Pharma Data

MARCH 30, 2021

PPH is one of the most common complications of birth, resulting in pharmacologic treatment in up to 10% of mothers and potentially resulting in emergency intervention such as hysterectomy and blood transfusions, and, in some cases, maternal death.

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Agency IQ

JUNE 29, 2023

June 2023 Sunlamp Products; Amendment to the Performance Standard (Final Rule) FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

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The Pharma Data

DECEMBER 21, 2020

“The recent results from our NAVIGATOR trial were impressive, both in terms of the overall clinical data and the reduction in exacerbation rate with tezepelumab treatment, and we continue to work with AstraZeneca on planned regulatory filings in 2021. Detailed results from the SOURCE trial will be presented at a future medical meeting.

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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). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment. ” Amgen Webcast Investor Call Amgen?will

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The Pharma Data

SEPTEMBER 16, 2020

Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Schedule I substances have a high potential for abuse, no currently accepted medical use in treatment in the U.S., This internal mandate may conflict with the state’s current allowance of marijuana for medical or recreational uses. 21 U.S.C. § 812(c)(c)(10). and lack accepted safety for use under medical supervision. 21 U.S.C. §

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