EEUU autoriza el ensayo de un medicamento con células madre de cordón umbilical para tratar la artritis reumatoide

by Secuvita

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) ha aprobado la investigación con un fármaco con células madre mesenquimales de cordón umbilical para tratar la artritis r...

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Life cycle in process validation. Continued Process Verification

by Telstar

This article introduces the concept of life cycle applied to process validation and how this idea was already underlying the first FDA reports on the challenges that the pharmaceutical industry had to...

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The FDA licenses Chemotargets CLARITY platform

by IMIM - Institut Hospital del Mar d'Investigacions Mèdiques

Chemotargets -a global leader in the development of intelligence platforms and drug design prediction, headquartered in the Barcelona Science Park- has signed a license agreement for its CLARITY® pla...

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NDMA | Ranitidine medicines

by Asphalion

In September 2019, the European Commission (EC) requested EMA to start a review of ranitidine medicines after tests showed that some of these products contained the impurity N-nitrosodimethylamine (ND...

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Grifols announces collaboration with US Government for a treatment against Covid-19

by CataloniaBio

Grif​ols, a CataloniaBio & HealthTech member, has entered into a formal collaboration with the Food and Drug Administra​tion (FDA) and other public health agencies of United States to collect plas...

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Approval review of pemigatinib for patients harbouring FGFR2 fusions

by OncoDNA

The FDA have granted priority approval review of pemigatinib for patients harbouring FGFR2 fusions, based on interim data from the phase II FIGHT-202 study showing ORR 36%

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VHIO investigators establish ‘user-friendly’ criteria to capture hyperprogression in patients treated with immune checkpoint inhibitors

by VHIO

While cancer immunotherapy continues to show promise in improving outcomes for patients across several tumor types, we must collectively strive to potentiate and personalize this armory to successfull...

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ANACONDA BIOMED S.L. secures €20 Million round of funding

by Anaconda BioMed

​Anaconda​ Biomed S.L., a medical technology company developing next-generation th​rombectomy systems for the treatment of ischemic stroke, has closed €20 million in new funding. The funding w...

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IMMUNOTHERAPY: Risk of Immunotherapy Related Toxicity in Patients with Rheumatoid Arthritis

by OncoDNA

Patients with coexisting autoimmune disorders were generally excluded from checkpoint inhibitor (CPI) trials due to concerns over toxicity. A small cohort study suggests this patient group can safely ...

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Minoryx Therapeutics receives FDA Orphan Drug Designation for leriglitazone in Friedreich’s Ataxia

by Minoryx Therapeutics

Leriglitazone (MIN-102) is a novel, brain penetrant, orally bioavailable and selective PPARγ agonist Second Orphan Drug Designation granted by the FDA for leriglitazone in addition to X-linked adr...

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3P Biopharmaceuticals recibe aprobación de la FDA

by 3P Biopharmaceuticals

La FDA clasifica como aceptables las instalaciones de 3P para la fabricación de su última molécula, así como apropiadas para su comercialización en el mercado de Estados Unidos, una vez que el pr...

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FDA aims to start deactivating outdated drug listing records to ensure the patient safety

by Asphalion

The Food and Drug Administration (FDA) announced its intention to clean the drug listing database from outdated and uncertified records. This action is not limited only to listings for finished dru...

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