Agency IQ

APRIL 12, 2024

The regulations also explain that this trait can be demonstrated via appropriate laboratory tests or adequately controlled clinical data. Overall, potency—while critical to product integrity—is just one component which the agency uses to assess product quality, alongside identity, strength and purity.

Production

Drug Target Review

OCTOBER 10, 2024

In the context of preclinical research, using healthy cells to study disease-specific mechanisms, cell-cell interactions, and immune responses can result in faulty data, missed therapeutic targets, and unanticipated immune responses.

Therapies

Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. Good Laboratory Practice (GLP)-adherent toxicology studies (carcinogenicity, developmental and reproductive toxicology, etc.)

FDA

Creative Biolabs

JULY 12, 2020

They are currently working with Boehringer Ingelheim to further identify and develop these antibodies. They are expected to enter clinical development later this year. ” The researchers studied the SARS-CoV-2 antibody response of 12 people who recovered from COVID-19.

Immune Response

PerkinElmer

JANUARY 25, 2023

Laboratory professionals in all areas of science have experienced significant changes in recent years, and 2022 was no exception. Experts in the diagnostics and life sciences industry look back on 2022 and lend their insights on the major trends and technologies shaping laboratories in 2023.

Science

The Pharma Data

NOVEMBER 1, 2020

Results from studies, conducted in our laboratory have established that nasal administration of anti-CD3 induces Tregs that can suppress inflammation and ameliorate diseases in animal models. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses shown to cause lung damage in COVID-19.

Clinical Trials

The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Furthermore, nasal anti-CD3 dampens cytotoxic CD8 T cell responses that are known to cause lung damage in COVID-19 patients.”.

Clinical Trials

The Pharma Data

DECEMBER 29, 2020

(NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Senior Vice President and Head of Global Clinical Development at Regeneron. futility analysis). .

Hospitals

The Pharma Data

OCTOBER 26, 2020

In addition, the observed median PFS shows that the regimen can induce a sustained and durable response, which is also shown consistently by the induction of a specific immune response.

Vaccine

The Pharma Data

JULY 18, 2021

Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease.

Disease

Drug Target Review

JULY 17, 2024

While current polyclonal antibody (pAb) therapies are derived from plasma, GigaGen has developed single-cell discovery and development platforms to produce diverse and potent recombinant pAb therapies that are made in the laboratory. It aims to clear HBsAg, to support HBV-specific immune responses and to achieve functional cure.

Immune Response

The Pharma Data

APRIL 4, 2023

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment.

Treatment

New Drug Approvals

APRIL 8, 2025

By blocking the recruitment to the tumor microenvironment (TME) and activity of CSF1R-dependent tumor-associated macrophages (TAMs), vimseltinib inhibits the immunomodulating activity by macrophages and enhances T-cell infiltration and anti-tumor T-cell immune responses, which inhibits the proliferation of tumor cells. 2] The US. .

FDA Approval

Drug Target Review

MAY 8, 2025

ADC developers must implement rigorous analytical controls to maintain an optimal DAR range throughout manufacturing and clinical development. The combination of these methods ensures a more holistic evaluation of ADC behaviour, supporting both regulatory submissions and clinical development efforts. ADC Review.

Pharmacokinetics