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2nd APV Interactive Workshop on ATMP. "Bridging standard pharma concepts and ATMP", 05.10. - 06.10.2021, Frankfurt on the Main, Germany: inform and register now!
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27th of May 2021: Novelties by EMA on medicinal products with genetically modified cells

Updated EMA guideline for medicinal products containing modified cells provides innovations, recommendations and improvements to be implemented.
15th of April 2021: Toxicological assessment continues to gain acceptance for cleaning validation

WHO publishes decision on setting acceptance criteria for cleaning validation.
10th of February 2021: FDA approves Breyanzi®, a new CAR-T cell therapy drug

Fourth approved CAR-T cell therapy soon to be available in Europe?
4th of February 2021: Vaccinations with mRNA-based medicinal products

How do mRNA-based medicinal products work and how safe are they?
8th of January 2021: Integrated Qualification and Validation Guide

New ECA guide helps saving time and money by customer-supplier partnership on qualification and validation.
2th of December 2020: Good Manufacturing Practice (GMP)

The "Good Manufacturing Practice" and the "GMP Certificate" are mandatory for pharmaceutical manufacturers. They ensure the quality of medicinal products and active substances and protect the consumer.

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Nachrichten aus aller Welt

Unser internationaler Pressespiegel zeigt eine Auswahl an Nachrichten und neusten Artikel zu den Themen Arzneimittel neuartiger Therapien (ATMP), Chimäre Antigenrezeptor(CAR)-T-Zell-Therapie, Tumor infiltrierende Lymphozyten (TIL) und biotechnologisch bearbeitete Gewebeprodukte (TEP).

Tumor-on-chip modeling of organ-specific cancer and metastasis

24.07.2021 | Science Direct

Abstract Every year, cancer claims millions of lives around the globe. Unfortunately, model systems that accurately mimic human oncology – ...

Chemotherapy can induce mutations that lead to pediatric leukemia relapse

23.07.2021 | Medical Xpress

Chemotherapy has helped make acute lymphoblastic leukemia (ALL) one of the most survivable childhood cancers. Now, researchers working in ...

Erste ambulante CAR-T-Zell-Therapie

22.07.2021 | Management & Krankenhaus

European Commission Approves Bluebird Bio’s Gene Therapy for CALD - Global Genes

21.07.2021 | Global Genes

Rare Daily Staff The European Commission has granted marketing authorization to Bluebird Bio’s Skysona, a one-time gene therapy for the ...

Money on the Move: July 14 – 21

21.07.2021 | Bio Space

Published: Jul 21, 2021 By Kate Goodwin More money means more progress for potentially life-saving therapies. Here's a peek at some ...

Cancer Immunotherapies: From Efficacy to Resistance Mechanisms – Not Only Checkpoint Matters

21.07.2021 | Frontiers

The immunotherapeutic treatment of various cancers with an increasing number of immune checkpoint inhibitors (ICIs) has profoundly improved ...

FDA Approves StrataGraft for Treating Thermal Burns in Adults

21.07.2021 | U.S. Pharmacist

In a press release on June 15, 2021, the FDA announced the approval of StrataGraft (allogeneic cultured keratinocytes and dermal ...

Direct Biologics Announces FDA Approval for Proceeding With Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome

21.07.2021 | The Canadian Business Journal

Celltrion's Monoclonal Antibody Treatment for COVID-19, regdanvimab (CT-P59), Demonstrates Strong Neutralising Activity Against Delta Variant

16.07.2021 | The Financial Post

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News and Information

Services

News

27th of May 2021: Novelties by EMA on medicinal products with genetically modified cells

15th of April 2021: Toxicological assessment continues to gain acceptance for cleaning validation

10th of February 2021: FDA approves Breyanzi®, a new CAR-T cell therapy drug

4th of February 2021: Vaccinations with mRNA-based medicinal products

8th of January 2021: Integrated Qualification and Validation Guide

2th of December 2020: Good Manufacturing Practice (GMP)

Events

Nachrichten aus aller Welt

Tumor-on-chip modeling of organ-specific cancer and metastasis

Chemotherapy can induce mutations that lead to pediatric leukemia relapse

Erste ambulante CAR-T-Zell-Therapie

European Commission Approves Bluebird Bio’s Gene Therapy for CALD - Global Genes

Money on the Move: July 14 – 21

Cancer Immunotherapies: From Efficacy to Resistance Mechanisms – Not Only Checkpoint Matters

FDA Approves StrataGraft for Treating Thermal Burns in Adults

Direct Biologics Announces FDA Approval for Proceeding With Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome

Pipeline Update: Status of Clinical Development for Multiple Sclerosis

Clinical Catch-Up: July 12-16

BioNTech übernimmt Kites Neoantigen-TCR-Zelltherapie-Plattform sowie Produktionsstätte im amerikanischen Gaithersburg

B7-H3/CD276: An Emerging Cancer Immunotherapy

Generate Life Sciences Establishes Newborn Stem Cell Manufacturing Facility

EMA OKs Biomarin’s New Application to Approve Roctavian

Celltrion's Monoclonal Antibody Treatment for COVID-19, regdanvimab (CT-P59), Demonstrates Strong Neutralising Activity Against Delta Variant

Valicare – competent, reliable & efficient

Business Areas

Any questions?

Stay up-to-date!

Welcome to Valicare!

Services

News

27th of May 2021: Novelties by EMA on medicinal products with genetically modified cells

15th of April 2021: Toxicological assessment continues to gain acceptance for cleaning validation

10th of February 2021: FDA approves Breyanzi®, a new CAR-T cell therapy drug

4th of February 2021: Vaccinations with mRNA-based medicinal products

8th of January 2021: Integrated Qualification and Validation Guide

2th of December 2020: Good Manufacturing Practice (GMP)

Events

Nachrichten aus aller Welt

Tumor-on-chip modeling of organ-specific cancer and metastasis

Chemotherapy can induce mutations that lead to pediatric leukemia relapse

Erste ambulante CAR-T-Zell-Therapie

European Commission Approves Bluebird Bio’s Gene Therapy for CALD - Global Genes

Money on the Move: July 14 – 21

Cancer Immunotherapies: From Efficacy to Resistance Mechanisms – Not Only Checkpoint Matters

FDA Approves StrataGraft for Treating Thermal Burns in Adults

Direct Biologics Announces FDA Approval for Proceeding With Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome

Pipeline Update: Status of Clinical Development for Multiple Sclerosis

Clinical Catch-Up: July 12-16

BioNTech übernimmt Kites Neoantigen-TCR-Zelltherapie-Plattform sowie Produktionsstätte im amerikanischen Gaithersburg

B7-H3/CD276: An Emerging Cancer Immunotherapy

Generate Life Sciences Establishes Newborn Stem Cell Manufacturing Facility

EMA OKs Biomarin’s New Application to Approve Roctavian

Celltrion's Monoclonal Antibody Treatment for COVID-19, regdanvimab (CT-P59), Demonstrates Strong Neutralising Activity Against Delta Variant

Valicare – competent, reliable & efficient

Business Areas

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