Biotecnología
Biotecnología
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
14/05/2024 -
The U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture have developed a plan to update, streamline, and clarify their regulations and...
Ongoing | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
06/05/2024 -
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
Viatris Welcomes Corinne Le Goff as Chief Commercial Officer
16/04/2024 -
Le Goff is a biotechnology and pharmaceutical executive with more than 25 years of experience leading and building teams globally.
Inteligencia artificial en la industria farmacéutica
Parte 1: Desarrollo y fabricación de medicamentos
06/03/2024 -
La inteligencia artificial (IA) se refiere a la capacidad de las máquinas o programas de computadoras de realizar tareas que, normalmente, requieren la presencia de una persona que, a...
Genetic Metabolic Diseases Advisory Committee (GeMDAC) Charter
25/01/2024 -
The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and...
FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop - 02/26/2024
19/01/2024 -
This workshop will explore the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe. TDM...
Roche compró una biotecnológica especializada en tratamientos contra la obesidad
12/12/2023 -
Roche entra en el negocio de los tratamientos contra la obesidad. El gigante farmacéutico desembolsó u$s 2700 millones para comprar Carmot...
“La biotecnología está revolucionado el mundo”: cinco hitos que marcan el pulso del futuro de la ciencia, según Hugo Sigman
04/12/2023 -
El fundador de uno de los gigantes farmacéuticos más importantes del mundo -Insud Pharma- habló con Infobae sobre su apuesta constante por la innovación y la...
El Gobierno nacional inaugura en el INTI la primera planta pública para la innovación en producción farmacéutica
30/10/2023 -
Los ministros de Salud, Carla Vizzotti, y de Ciencia, Tecnología e Innovación, Daniel Filmus, junto con el secretario de Industria y Desarrollo Productivo de la Nación,...
FUJIFILM Diosynth Biotechnologies Names Maja Pedersen Chief Quality Officer
05/10/2023 -
Pedersen has 20 years of leadership experience in the life sciences and biopharma space.
Fujifilm Diosynth Biotechnologies Unveils Strategic Customer-Focused Business Structure
28/08/2023 -
New unit to provide tailored support to large-and small-scale biopharmaceutical customers.
Aurigene Pharmaceutical Services Expands Biologics CDMO Capacity
05/06/2023 -
Invests $40 million in an R&D and pilot scale facility at a biotechnology park in Hyderabad.
Ongoing | Non-malignant Hematology, Neurological Disorders, and Other Indications Accelerated Approvals
05/06/2023 -
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
Verified Clinical Benefit | Non-malignant Hematological, Neurological, and Other Disorder Indications Accelerated Approvals
05/06/2023 -
Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint
ABC Compounding Company Inc - 576953 - 05/02/2019
23/05/2023 -
Failure to Comply with Drug Listing Requirements/Misbranded, ABC Compounding Company Inc
Generic Drugs Program Monthly and Quarterly Activities Report
23/05/2023 -
Monthly and quarterly metrics of the FDA Generic Drugs Program.
Thousand Oaks Biologics, GeneQuantum Partner for ADC Drug Development
23/05/2023 -
GQ will leverage TOBio's expertise in CMC and commercial manufacturing.
Jessie Commodity Co., Ltd. - 576935 - 05/20/2019
23/05/2023 -
Failure to Comply with Drug Listing Requirements/Misbranded, Jessie Commodity Co., Ltd.
FDA Approves Drug Product Filled with Berkshire Sterile’s Low Loss Fill Process
22/05/2023 -
Low fill process was designed and validated in 2022 to limit drug product loss for high-value medicines.
Spotlight on CDER Science
19/05/2023 -
FDA scientists carry out laboratory, clinical and analytical research to address knowledge gaps in drug development, healthcare technologies and post-market drug monitoring. Spotlight on CDER Science...
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
19/05/2023 -
Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act
