Biotecnología
Biotecnología
Ginkgo Bioworks, Novo Nordisk Expand R&D Alliance
11/04/2024 -
Aims to improve the manufacturing of Novo Nordisk's medicines for serious chronic diseases, including diabetes and obesity medications.
NIIMBL Unveils 8 New Technology & Workforce Development Projects
11/04/2024 -
Will help address key opportunities for innovation in biopharmaceutical manufacturing.
Novel Drug Approvals for 2015
11/04/2024 -
Novel drugs (2015): A report on the more innovative products approved by FDA. These products often help advance clinical care to another level. Each year, FDA approves hundreds of new medications,...
Sartorius Partners with TheWell Bioscience for Animal-Free Hydrogels & Bioinks
11/04/2024 -
Aims to enable more customers to get more relevant insights in less time, accelerating time to market.
Microbiome digital twins enable disease prediction in infants
11/04/2024 -
Researchers at the University of Chicago (IL, US) have unveiled an AI tool capable of predicting neurodevelopmental deficits in infants by modeling their gut microbiome. This...
Charles River & Axovia Partner to Support Development of Gene Therapies for Ciliopathies
10/04/2024 -
Axovia will leverage Charles River’s plasmid platform and expertise in plasmid DNA production to accelerate time to clinic.
FDA Roundup: April 9, 2024
10/04/2024 -
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Novel Drug Approvals for 2017
10/04/2024 -
When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every...
FDA CBER Webinar: Human Gene Therapy Products Incorporating Human Genome Editing - 02/29/2024
10/04/2024 -
The FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) is hosting a virtual public webinar on Thursday, February 29 at 1:00 pm.
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
10/04/2024 -
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Waters Corporation Introduces Alliance iS BioHPLC System
10/04/2024 -
The new system is designed to help biopharma QC analysts boost efficiency and eliminate up to 40% of common errors.
Basilea Awarded CARB-X Grant to Develop Antibiotics
10/04/2024 -
Initial funding of up to $0.9 million will support initial preclinical activities on the antibiotics program recently acquired from Spexis.
Lonza, NeuroSense Enter Alliance for ALS Candidate
10/04/2024 -
Lonza will provide the development, optimization, and qualification of a method measuring biomarkers from NDEs.
Ascend Acquires Florida Facility and Expertise, Bolstering Gene Therapy Development
10/04/2024 -
Enters long-term partnership with Beacon to continue manufacturing its products for clinical and commercial use.
Federal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy Machines
10/04/2024 -
The federal court entered a consent decree of permanent injunction against Philips Respironics following a recall of certain sleep therapy machines manufactured by the company.
AstraZeneca, Daiichi Sankyo's Enhertu Approved in Solid Tumors
09/04/2024 -
Becomes first tumor-agnostic approval of a HER2-directed therapy and ADC by the FDA.
ViiV Healthcare Receives FDA Approval for Dovato for Adolescents
09/04/2024 -
Expanded indication marks the first time an oral, two-drug, single-tablet regimen is available for adolescents between 12 & 18 living with HIV.
Regulatory Education for Industry (REdI) Annual Conference 2024: Biologics Track
09/04/2024 -
The Biologics Track will focus on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products.
Ayana Pharma Signs Master Service Agreement with Scinai Immunotherapeutics
09/04/2024 -
Scinai to provide drug development and cGMP manufacturing services.
Regulatory Education for Industry (REdI) Annual Conference 2024: Drugs Track
09/04/2024 -
The drugs track will address major advances and innovation across various aspects of the drug development spectrum.
Multimedia Education Materials | Biosimilars
09/04/2024 -
FDA offers a variety of materials in multiple formats to help promote understanding of biosimilars and interchangeable products.
