Susan Haigney is lead editor of BioPharm International®.
USP Becomes a Member of BARDA’s BioMaP-Consortium
The BioMaP-Consortium includes members of the biopharmaceutical industry and supports BARDA.
Report on COVID-19 Vaccine Strains Promotes Updates on Vaccine Compositions
The outcomes of a workshop organized by WHO and ICMRA regarding COVID-19 vaccine strain updates are presented in a report published by regulators.
Cytiva Showcases Single-Use Mixing System at INTERPHEX 2024
The Xcellerex magnetic mixer, single-use mixing system was designed to address challenges in large-scale mAb, vaccine, and genomic medicine manufacturing processes.
CureVac and MD Anderson Cancer Center Collaborate on mRNA Cancer Vaccines
The collaboration will focus on differentiated cancer vaccine candidates in hematological and solid tumor indications to treat unmet medical needs.
Draft Guidance Issued on Early Alzheimer's Treatment
FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.
LGM Pharma Expands Analytical Services
The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.
Bormioli Pharma Increases Capacity in North America
The Italian company’s North American business has seen an increase of 47%.
Alliance for Building Better Medicine Receives NSF Award
The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.
EMA Expands Real-World Data Capacity
The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.
FDA Releases Guidance on Analytical Procedures
The agency has published final guidance documents regarding validation and development of analytical procedures.
CordenPharma Expands Clinical Peptide Capacity
The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.
Simtra BioPharma Solutions Expands Sterile Fill/Finish Manufacturing Site
The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.
EMA Recommends New ALS Treatment
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
FDA’s Drug Safety Priorities for 2023
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.
EMA and HMA Launch Real-Word Data Catalogues
Two public electronic catalogues will be available for real-world data sources and for real-world data studies.
Nelson Labs Creates Center of Excellence for Parenteral and Ophthalmic Drug Manufacturing
The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.
EMA Accepts Three Organizations into ATMP Pilot Program
The three non-commercial developers of ATMPs will benefit from enhanced support from the agency.
FDA Provides Guidance on Notifying the Agency of Manufacturing Interruptions
The guidance discusses how to timely notify the agency of changes in production of APIs and finished products.
Biovian and 3P Biopharmaceuticals Combine to Form 3PBIOVIAN
The CDMOs are joining together to offer end-to-end development and manufacturing services for protein expression systems and viral vectors in Europe.
EMA Given Grant to Support Establishment of African Medicines Agency
The agency will coordinate intra-regional medicines regulation to strengthen the African regulatory network.
FDA Issues Guidance on CAR-T Cell Product Development
The final guidance provides specific recommendations for CMC, pharmacology, toxicology, and clinical study design for CAR-T cell products.
FDA Give Guidance on Human Genome Editing in Gene Therapies
The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.
EMA Looks Back at Medicines Approved in 2023
The agency recommended 77 drugs for marketing authorization in 2023, including 39 new APIs.
CDER Approved 55 Novel Drugs in 2023
FDA’s Center for Drug Evaluation and Research released its report on new drugs approved in 2023.
EMA Starts Safety Review of CAR T-Cell Medicines
The agency is reviewing data on secondary malignancies related to T-cells for approved CAR T-cell medicines.
Precautionary Measures Recommended in Use of Valproate Medicines
The European Medicines Agency safety committee says there is a potential risk of neurodevelopment disorders in children born to men treated with valproate.
A Platform for mRNA Platforms
Regulators from around the world will gather to help shape the mRNA and RNA therapeutics landscape at an exceptional April 2024 Washington, D.C. convocation.
Cherwell Joins AnalytiChem Group
Cherwell Laboratories’ cleanroom microbiology solutions will join AnalytiChem’s group of seven companies across Europe, North America, and Australia.
WuXi AppTec Expands Peptide and API Manufacturing
The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.
QurAlis Opens European Headquarters in The Netherlands
The new Europe headquarters will be the hub for the company’s European operations, including production of product.