FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

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Pharmaceutical Technology

FEBRUARY 19, 2023

STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. It is a monoclonal antibody conjugate that acts by targeting f olate receptor alpha (FolR alpha). Sutro Biopharma owns a manufacturing facility in San Carlos, California.

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The Pharma Data

DECEMBER 17, 2020

NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. TARRYTOWN, N.Y. , Yancopoulos , M.D.,

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Pharmaceutical Technology

MARCH 13, 2023

With the acquisition, Sanofi will add a fully owned, first-in-class, disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D), Tzield, to its core asset portfolio in General Medicines. Currently, it is in late-stage clinical development to treat newly diagnosed clinical T1D (Stage 3) in paediatric and adolescent patients.

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The Pharma Data

DECEMBER 13, 2020

Up to 1% of all solid tumors harbor NRG1 fusions, therefore, it is important to identify this patient population and develop therapies that can treat them. [1]. HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird’s proprietary Rational Antibody Discovery platform.

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The Pharma Data

APRIL 15, 2022

The top protein neutralized the virus with similar or greater potency than antibody treatments with Emergency Use Authorization status from the U.S. Notably, the top protein also neutralized all tested SARS-CoV-2 variants, something that many clinical antibodies have failed to do. Food and Drug Administration (FDA).

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Pharmaceutical Technology

NOVEMBER 18, 2022

Under the deal, the companies will work together on the discovery activities for identifying and validating the conditionally active bispecific antibodies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.

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The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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Drug Discovery World

JANUARY 10, 2024

The acquisition includes Aiolos’ AIO-001, a potentially best-in-class, long-acting anti-thymic stromal lymphopoietin (TSLP) monoclonal antibody ready to enter Phase II clinical development for asthma, with potential for additional indications.

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Drug Discovery World

APRIL 12, 2024

The Food and Drug Administration (FDA) has cautioned that continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This latest approval means that Enhertu now has five approved indications, including for breast cancer. In DESTINY-Lung01, ORR of 52.9%

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The Pharma Data

MAY 27, 2022

Roche today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June.

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The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. ” About Ascletis.

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pharmaphorum

AUGUST 5, 2022

MiroBio was formed in 2019 to develop checkpoint agonist antibodies for autoimmune and inflammatory disorders that can be used to apply the “natural brakes” of the immune system. 7 integrin, with three candidates in early-stage clinical development.

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The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. Regeneron Pharmaceuticals, Inc. futility analysis). The results passed the futility analysis (p<0.3

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Pharmaceutical Technology

FEBRUARY 24, 2023

Amivantamab is under clinical development by Johnson & Johnson and currently in Phase I for Colorectal Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is formulated as solution and concentrate for solution for intravenous infusion.

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The Pharma Data

NOVEMBER 10, 2020

The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments. Letaplimab developed by Innovent Biologics, is a recombinant fully humanized IgG4 monoclonal antibody targeting CD47.

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Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. It is specialized in the development and commercialization of immuno-oncology medicines to treat cancers.

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Scienmag

JUNE 2, 2021

Initiate clinical development of a broad-spectrum injectable for COVID-19, with $4.2M Naval Medical Research Center (NMRC) for Phase I clinical development of Centi-B9, Centivax’s SARS-CoV-2 broad-spectrum injectable antibody […].

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Pharmaceutical Technology

FEBRUARY 18, 2023

Gevokizumab is a monoclonal antibody commercialized by Novartis, with a leading Phase I program in Metastatic Renal Cell Carcinoma. According to Globaldata, it is involved in 34 clinical trials, of which 20 were completed, 1 is ongoing, and 13 were terminated. The company offers generic medicines and biosimilars through Sandoz.

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The Pharma Data

MAY 26, 2023

“At ASCO, Pfizer will present new data across the four key areas of our industry-leading portfolio – breast cancer, genitourinary cancer, hematology, and precision medicine – and for the first time, first-in-human data for some of our most exciting pipeline medicines,” said Chris Boshoff, M.D.,

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XTalks

FEBRUARY 24, 2023

Lunsumio is a CD20xCD3 T-cell engaging bispecific antibody that works by targeting the protein CD20 on the surface of B cells and CD3 on the surface of T cells. Laport: Lunsumio (mosunetuzumab-axgb) is the first CD20xCD3 T-cell engaging bispecific antibody approved by the FDA.

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Drug Discovery World

APRIL 26, 2023

Researchers at the Icahn School of Medicine at Mount Sinai have demonstrated in a preclinical study a potential new therapeutic approach to treating the most common form of lung cancer. The strategy involves inhibiting the immune-system molecule TREM2 while enhancing natural killer cells.

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The Pharma Data

DECEMBER 5, 2020

NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Assistant Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York and a trial investigator.

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pharmaphorum

MAY 13, 2022

iTeos Therapeutics has said it is evaluating with partner GlaxoSmithKline whether to conduct additional clinical trials of TIGIT drug EOS-448 following the failure of a key trial for Roche’s rival drug. Other TIGIT drugs from Merck & Co, Bristol-Myers Squibb/Agenus, Gilead/Arcus, and Mereo Biopharma are also in clinical development.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. Senior Vice President and Head of Global Clinical Development at Regeneron.

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XTalks

JULY 17, 2023

In a significant development, Astellas Pharma announced that the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) had accepted their applications for Priority Review and Marketing Authorization respectively for zolbetuximab. Furthermore, atezolizumab is in Phase II clinical development by F.

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pharmaphorum

OCTOBER 16, 2020

Sanofi will shortly start human trials of a second coronavirus vaccine, developed with US biotech Translate Bio, after reporting that it stimulated antibodies against SARS-CoV-2 in preclinical testing. Antibody levels were lower in older recipients, however. million cases and a little over 23,000 deaths.

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. NEW YORK and LONDON, Jan. Graham earned an M.D.,

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024.

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The Pharma Data

JUNE 25, 2021

protofibril antibody for the treatment of Alzheimer’s disease (AD). Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A?)

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The Pharma Data

MARCH 21, 2021

José championed our transformative collaborations with Daiichi-Sankyo in relation to the clinical development of Enhertu (trastuzumab deruxtecan) and datopotamab deruxtecan, two medicines which have demonstrated great potential to benefit cancer patients. Source link:[link].

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Delveinsight

DECEMBER 1, 2020

BASE10 Collaborates with DNA Link for COVID-19 Antibody Test Research. US-based BASE10 Genetics and Korean firm DNA Link announced a collaboration on a research project to appraise the usability of the DNA Link’s antibody test, AccuFind COVID-19 IgG, in a healthcare setting. CABOMETYX is already approved in the U.S.

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The Pharma Data

JUNE 29, 2021

AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course compared to those not expressing AQP4-IgG antibodies. “We Chief Medical Officer and Head of Global Product Development. AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of people with NMOSD.

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The Pharma Data

APRIL 27, 2022

We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”. About Novartis Novartis is reimagining medicine to improve and extend people’s lives.

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The Pharma Data

OCTOBER 25, 2020

Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. SQI is accelerating the clinical development of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.

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