The Pharma Data

OCTOBER 29, 2020

29, 2020– Alexion Pharmaceuticals, Inc. NASDAQ:ALXN) today announced financial results for the third quarter of 2020. Non-GAAP diluted EPS for the third quarter of 2020 was $3.24 , a 16 percent increase versus the third quarter of 2019. ” Third Quarter 2020 Financial Highlights. 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. 3, 2021 /PRNewswire/ — AbbVie (NYSE: ABBV) announced financial results for the fourth quarter and full year ended December 31, 2020. Percent on a Reported Basis, or 12.5

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Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. See AgencyIQ’s analysis of these changes here.

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The Pharma Data

SEPTEMBER 16, 2020

16, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) announced today that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) Virtual Congress 2020, Sept. 19-21, 2020. 20, 2020 , from 2:25 p.m. – 21, 2020 , from 2:25 p.m. – 20, 2020, at?11:00

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FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. The federal telemedicine flexibilities (i.e.,

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. However, this is actually relatively aligned with the number of new active substances seen prior to and during the first year of the pandemic: 39 in 2020 ; 30 in 2019 ; 42 in 2018 and 35 in 2017. for the years 2020 to 2022.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

FDA recognizes that the FD&C Act exempts licensed healthcare practitioners from certain device regulations if they manufacture devices solely for use in the course of their professional practice. For example, FDA’s regulations have exempted from certain regulatory requirements (e.g.,

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

FDA cited February 16, 2021, as the first date on which another manufacturer could have marketed its NMN-containing dietary supplement lawfully after submitting an NDIN to the Agency on December 3, 2020. FDA did not disclose the exact date of the IND because that information is confidential.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The $63 billion acquisition of Allergan by AbbVie in 2020 stands as a prime example.

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Drug Target Review

JULY 6, 2023

million scientific procedures involving live animals were carried out in 2020. 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.” 2020 [cited 2023Feb24].

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The Pharma Data

JANUARY 24, 2021

Toripalimab was included in the 2019 and 2020 Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma. Both supplemental NDAs received priority review designations from the NMPA in July 2020. and a disease control rate (DCR) of 86.2% The median progression-free survival (mPFS) was 7.5

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

The PTO’s ORDER TO SHOW CAUSE points out that: According to the published Federal Register Notice of July 17, 2020, Lilly requested withdrawal “(revocation)” of its BLA for the human biological product LARTRUVO® (olaratumab). 9,273,141 was submitted on September 18, 2020 (Docket No. 9,273,141 [] for [PTE] request under 35 U.S.C. §

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The Pharma Data

FEBRUARY 8, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. In the fourth quarter of 2020, Sanofi sales were €9,382 million, down 2.4% Full-year 2020, Sanofi sales reached €36,041 million, down 0.2% to €982 million).

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The Pharma Data

AUGUST 3, 2021

billion in comparison to the second quarter of 2020, driven by higher unit demand, partially offset by lower net selling prices. billion in the second quarter of 2020 driven by a difference in the timing of tax payments. Total product sales increased 3% for the second quarter of 2021 versus the second quarter of 2020.

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The Pharma Data

AUGUST 3, 2021

Revenue growth was 12 percent when excluding effects of 2020 COVID-related stocking patterns, revenue from COVID-19 antibodies and recent business development. ” $ in millions, exceptper share data Second Quarter % 2021 2020 Change Revenue $ 6,740.1 $ 5,499.4 on a reported basis and increased to $1.87 on a non-GAAP basis.

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The Pharma Data

FEBRUARY 4, 2021

Q4 2020 sales growth (2) of 4.2% Full-year 2020 performance. In 2020, cost savings of €1,680 million were realized of which approximately 60% were reinvested. In the fourth quarter of 2020, Sanofi sales were €9,382 million, down 2.4% Full-year 2020, Sanofi sales reached €36,041 million, down 0.2% to €982 million).

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The Pharma Data

APRIL 27, 2021

due to COVID related stocking in Q1 2020 and low demand for cough and cold brands in Europe. Following the communication of our ESG strategy at the end of 2020 and embedding it into our business priorities, we have recently created the Sanofi Global Health Unit, dedicated to increasing access to 30 medicines considered essential by the WHO.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) expanded the notification requirement to include reasons contributing to the discontinuance or interruption (e.g., API and its source and any alternative sources; associated medical devices), and expected duration of the interruption.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

PhRMA successfully challenged that amendment, and on May 17, 2022, the United States District Court for the District of Columbia ordered that the 2020 rule be vacated and set aside. To implement the court order, CMS now proposes to eliminate the offending text and revert to the original exclusions. 1396r-8(b)(3)(C)(i).

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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., FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.”

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The Pharma Data

NOVEMBER 6, 2020

06, 2020 (GLOBE NEWSWIRE) — Today, the U.S. With the opinions expressed at the Advisory Committee and the data presented, the FDA will continue the review process with a decision on whether to approve the aducanumab Biologics License Application by March 7, 2021. . CAMBRIDGE, Mass. and TOKYO, Nov. About Aducanumab.

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The Pharma Data

OCTOBER 27, 2020

Novartis has been granted an option to in-license global rights of MP0420 and MP0423 – multi-targeted direct-acting antiviral therapeutic candidates demonstrating potential efficacy against COVID-19. Upon option exercise, Novartis would be responsible for all further development and commercialization activities.

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The Pharma Data

OCTOBER 29, 2020

30, 2020 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. CAMBRIDGE, Mass. and TOKYO, Oct. Since October 2017 Biogen and Eisai Co.,

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Agency IQ

SEPTEMBER 29, 2023

The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).

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The Pharma Data

DECEMBER 9, 2020

09, 2020 (GLOBE NEWSWIRE) — Today, Biogen (Nasdaq: BIIB) and Eisai, Co., Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. If approved, aducanumab would become the first treatment to meaningfully change the course of Alzheimer’s disease. CAMBRIDGE, Mass.

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The Pharma Data

SEPTEMBER 20, 2020

20, 2020 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that updated data from the full Phase 1 cohort of the CodeBreaK 100 clinical study, evaluating sotorasib (proposed INN for AMG 510) in 129 patients across multiple advanced solid tumors, were published in the New England Journal of Medicine (NEJM). 20, 2020, at?11:00

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Agency IQ

JUNE 29, 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., FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.”

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. a leading clinical-stage CRISPR genome editing biotechnology company, announced that they have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics. Quarter Ended March 31, 2021 and 2020.

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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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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. Results for the first quarter of 2021 and 2020 (5) are summarized below. OVERALL RESULTS. . . . . ($ in millions, except. per share amounts). 47%. . . .

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The Pharma Data

MAY 5, 2022

Nasdaq: BIIB) and MedRhythms have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis (MS). Biogen Inc. MedRhythms is headquartered in Portland, Maine. Source link: [link].

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. 2020; 29: 190137. THOUSAND OAKS, Calif. ,

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The Pharma Data

NOVEMBER 9, 2020

9, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive topline results from the Phase 3 NAVIGATOR trial in which the investigational medicine tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma. Last accessed: September 2020 ].

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FDA Law Blog: Biosimilars

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. effective May 12, 2020), Patent Term Extension Applicant OPKO Biologics Ltd., exclusively licensed U.S. and OPKO Ireland Ltd. through OPKO Ireland Ltd., 7,553,941 to Pfizer Inc.

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Agency IQ

DECEMBER 1, 2023

FDA finalized a ban on these devices in 2020, but the D.C. FDA issued an interim response in June 2020 that said the petition requires “further review and analysis by agency officials.” The following PDUFA dates were obtained from publicly available sources. Circuit vacated the final rule in 2021.

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Agency IQ

SEPTEMBER 1, 2023

on February 1, 2020 started a year-long transition period; The E.U. The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” from the E.U. market more quickly. or E.A.A.

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Agency IQ

JULY 28, 2023

Those concerns have proven serious enough that in September 2020 the FDA published a final guidance document calling on manufacturers of drug products to take two steps. That would leave 19% of staff affected by furloughs. Some of the affected former NDAs were approved using drug master files (DMFs).

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