The Pharma Data

DECEMBER 27, 2020

NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021. CARLSBAD, Calif.–( –( BUSINESS WIRE )– Lineage Cell Therapeutics, Inc.

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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

NOVEMBER 9, 2020

Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in Sept. 2018 for patients with severe asthma, without an eosinophilic phenotype. The trial comprised a five to six week screening period, a 52-week treatment period and a 12-week post-treatment follow-up period.

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The Pharma Data

JULY 15, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

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FDA Law Blog: Biosimilars

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

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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

APRIL 7, 2023

BRAFTOVI + MEKTOVI is currently approved for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. “For more than a decade, Pfizer Oncology has been at the forefront of bringing biomarker-driven treatment options to patients with cancer.

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The Pharma Data

JULY 8, 2021

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. About Biogen.

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. 2018) , Arnold Partnership v. Patent Nos. Ezra Ventures LLC, 909 F.3d 3d 1367 (Fed.

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The Pharma Data

FEBRUARY 8, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. Net sales (€ million).

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The Pharma Data

FEBRUARY 4, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June and will be listed on the NRDL (National Reimbursement Drug List) as of March 2021. At the end of 2020, Dupixent ® was launched in 47 countries with approximately 230 000 patients on therapy. Net sales (€ million).

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The Pharma Data

APRIL 27, 2021

Dupixent ® was approved in China for the treatment of adults with moderate-to-severe AD in June 2020 and is listed on the NRDL (National Reimbursement Drug List) as of March 2021. At the end of the first quarter, Dupixent ® was launched in 49 countries with approximately 260 000 patients on therapy. . Neurology and Immunology.

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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. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5 Recent Events.

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The Pharma Data

APRIL 11, 2021

under the accelerated approval pathway for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. The CHRONOS-3 data signals a much-needed advancement in the iNHL treatment paradigm,” said Pier Luigi Zinzani, M.D., Abstract: CT001. About CHRONOS-3.

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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. The FDA action converts the 2018 accelerated approval to full approval. It does not include an allocation of corporate or other overhead costs.

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FDA Law Blog: Biosimilars

JUNE 23, 2024

However, the well-intentioned statutory language enacted in 1970 did not anticipate important changes in clinical therapies and advances in medical technology, and in some cases has created obstacles both to ensuring needed patient access and successful medical outcomes. 2] Why is this an issue? Highly concentrated opioid formulations (e.g.,

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