FDA Law Blog

FEBRUARY 29, 2024

156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R. That did not happen. . §

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XTalks

JUNE 12, 2023

This acquisition granted BD access to advanced assays licensed from the EuroFlow Consortium, an independent scientific network in hematology and immunology. This extended BD’s already established 12-year licensing collaboration with EuroFlow, bolstering its portfolio of assays.

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The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.

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The Pharma Data

SEPTEMBER 16, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

SEPTEMBER 20, 2020

We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims.

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The Pharma Data

DECEMBER 12, 2020

Alexion ‘s franchise includes Soliris (eculizumab), a first-in-class anti-complement component 5 (C5) monoclonal antibody. More recently, Alexion launched Ultomiris (ravulizumab), a second-generation C5 monoclonal antibody with a more convenient dosing regimen.

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The Pharma Data

NOVEMBER 9, 2020

About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Amgen will record sales in the U.S. Outside the U.S.,

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The Pharma Data

OCTOBER 18, 2020

AVEO’s earlier-stage pipeline includes several monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb), AV-380 (anti-GDF15 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion as a foundation for innovation.

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The Pharma Data

DECEMBER 21, 2020

About Tezepelumab Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. Amgen will record sales in the U.S. Outside the U.S.,

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The Pharma Data

OCTOBER 29, 2020

Treatment compliance rates across all our medicines have remained strong and continue to be slightly above expectations. ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.

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Camargo

MAY 10, 2021

the Center’s chief of medical oncology, In it, they laid out their analysis of accelerated approvals for 35 oncology indications for anti-programmed death ligand 1 antibodies and reported that for 10 of the 35 indications, the confirmatory trials failed to show a benefit. The meeting was prompted by a publication by Richard Pazdur, M.D.,

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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. million in the second quarter of 2021 for its COVID-19 antibodies. million of revenue in the second quarter of 2021 from COVID-19 antibodies, $170.0 Excluding $148.9

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Pharma in Brief

JANUARY 10, 2024

Case law updates In 2023, the Patented Medicines (Notice of Compliance) Regulations ( Regulations ) turned 30 years old, inspiring our litigators to consider how the Regulations have evolved since 1993 (see here ). billion over three years to help increase drug access and affordability (see here ).The Injunction refused on infringed patent.

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The Pharma Data

JULY 8, 2021

AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab is being developed by AstraZeneca in collaboration with Amgen.

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The Pharma Data

JULY 8, 2021

Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Amgen (NASDAQ:AMGN) announced that the U.S. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca. Reese, M.D.,

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The Pharma Data

AUGUST 6, 2020

announced that the companies submitted the Biologics License Application (BLA) to the U.S. for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Royalties and licensing income. Regulatory.

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The Pharma Data

SEPTEMBER 7, 2021

Bristol Myers Squibb has a global exclusive license to develop, manufacture and commercialize the Rockefeller University’s novel monoclonal antibody (“mAb”) duo treatment that neutralizes the SARS-CoV-2 virus for therapy or prevention of COVID-19. Contributions to Research, Life-Sciences Industry.

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The Pharma Data

JANUARY 9, 2021

. A follow-on procurement contract with HHS is expected for the delivery of raxibacumab, the Company’s Food and Drug Administration-approved anthrax monoclonal antibody therapeutic, to the Strategic National Stockpile (SNS). FOOTNOTES. (1)

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The Pharma Data

APRIL 27, 2021

reflecting lower treatment compliance during the COVID-19 pandemic. CARMEN-LC05, a trial investigating tusamitamab ravtansine , an anti-CEACAM5 antibody-drug conjugate (ADC), in combination with pembrolizumab versus pembrolizumab alone in patients with first-line non-squamous NSCLC started. In the U.S. sales decreased 2.9% Fasturtec ®.

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Roots Analysis

JANUARY 27, 2025

Moreover, such therapies have been shown to have a profound impact on patient compliance as well as therapy adherence, where the patients can self-administer the drugs. It is important to note that, for the purpose of subcutaneous biologics market analysis, the biologics were segregated into antibodies , nucleotides, proteins and vaccines.

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