Biotecnología
Biotecnología
Sartorius, SPARTA Biodiscovery Partner on Nanoparticle Analysis Platform
29/09/2023 -
SPARTA technology aims to accelerate development, manufacture and QC of nanoparticles used for gene therapies, vaccines, and cancer drugs.
FDA Seeks Fines Against 22 Retailers for Selling Illegal Youth-Appealing E-Cigarettes
29/09/2023 -
The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design e-cigarettes, a popular youth-appealing brand.
Viralgen Vector Core, Elpida Partner on SPG50 and CMT4J Clinical Trials
29/09/2023 -
Aims to enable the efficient manufacture of the AAV9 based therapies for use in Elpida Tx's clinical trials.
Written Requests Issued
29/09/2023 -
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies
Public Meeting on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) - 09/28/2023 - 09/28/2023
29/09/2023 -
Public Meeting on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program (OMUFA) - 09/28/2023
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment
29/09/2023 -
The purpose of this guidance is to assist sponsors in the clinical development of drugs, biological products, therapeutic devices, and cell processing devices for the prevention or treatment
Ono, Admid Partner on Novel Antibody Drugs in Oncology
28/09/2023 -
Ono will evaluate and develop antibody product candidates at the preclinical and clinical stages.
Theradaptive Awarded DOD Clinical Trial Award of up to $7.4M
28/09/2023 -
Award will help Theradaptive scale up the production of its OsteoAdapt regenerative therapeutic product for spine and trauma repair.
WuXi Vaccines Launches Vaccines CDMO Site in China
27/09/2023 -
Aims to add drug substance and drug product capacity, with services for diversified vaccines.
MilliporeSigma Launches Integrated mRNA Services
27/09/2023 -
Opens two new GMP-grade mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany.
Repligen Acquires Fluid Management Company Metenova
27/09/2023 -
Gains magnetic mixing and drive train technologies that are widely used by global biopharmaceutical companies and CDMOs.
FDA Roundup: September 26, 2023
27/09/2023 -
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Chime Biologics, Kings Pharm Partner to Accelerate Biosimilar Launch
27/09/2023 -
Chime will provide cell line development, process development, global GMP manufacturing, commercialization, and regulatory filing support.
Abbott Labs, mAbxience Enter Biosimilars Mfg. Pact
27/09/2023 -
mAbxience will manufacture the biosimilars at its GMP approved facilities in Spain and Argentina.
Altasciences Selected by Virpax to Support Flu Drug
27/09/2023 -
The project has completed safety assessment utilizing intranasal administration at Altasciences’ nonclinical site in Columbia, MO.
Merck KGaA Enters Strategic AI-driven Discovery Alliances
27/09/2023 -
Partnerships with BenevolentAI and Exscientia aimed at driving accelerated drug discovery with higher probability of success.
MedRhythms Selects Curavit for MR-001 Trial in Stroke Impairment
27/09/2023 -
Curavit is responsible for managing all aspects of MedRhythms’ hybrid decentralized clinical trial.
Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - 04/04/2023
27/09/2023 -
The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic...
Charnwood Molecular Rebrands to Charnwood Discovery
27/09/2023 -
Specializes in enhancing the experience and success of complex drug discovery for clients.
Pierre Fabre, Vernalis Enter Oncology Drug Discovery Alliance
27/09/2023 -
Aims to identify preclinical candidates against multiple oncology targets.
Eftilagimod Cleared for Clinical Trial Use in the UK
27/09/2023 -
Comparability of drug substance and drug product manufactured at 2,000L scale achieved.
