Industry News
Vaccine for Respiratory Syncytial Virus in Infants Granted Breakthrough Therapy Designation
The immunization, meant to protect infants aged six months or lower, is given to pregnant individuals at a gestation period of 32 to 36 weeks.
Akari Therapeutics Establishes US Headquarters in Boston
The expanded operations will also support the start of proline/alanine/serine (PAS)-nomacopan clinical trials in geographic atrophy (GA).
FDA Grants Accelerated Approval to Pfizer’s Multiple Myeloma Treatment
FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
CPHI to Return to Milan in 2024
CPHI 2024 will return to the Fiera Milano in Milan, Italy.
United Kingdom Biotech Report Finds 29% Uptick in Funding
A report from the UK Bioindustry Association report indicated that biotech venture and public financing rose from £295 million in the first quarter to £382 million in the second quarter.
FDA Releases Guidance on Intake Limits for Nitrosamine Drug Substance-Related Impurities
The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.
AGC Biologics Completes Expansion at CGT Manufacturing Site in Milan
The site was acquired by AGC Biologics in July 2020, and the Milan location is the first cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.
FDA Releases Guidance on Standards Related to Pharmaceutical Quality
The program aims to aid submissions from external stakeholders and FDA staff.
FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals
The guidance document outlines recommendations to limit potential carcinogenic risk.
SCG Therapy Opens Cell Therapy Manufacturing Facility in Singapore
The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.
Congress Leaves Town with Major Drug-Related Bills on Hold
Pandemic, PBM, and other policies on hold during the summer recess.
Biovian Invests €50 Million in Manufacturing Facility in Finland
The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.
Update on Storm Damage to Pfizer Facility in North Carolina
The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.
EMA Extends OPEN Framework to More Medicines
The framework is now expanded beyond COVID-19 vaccines and treatments.
EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.
FDA Approves Preventative Therapy for Respiratory Syncytial Virus in Infants and Toddlers
The new drug may help vulnerable children resist RSV in the coming fall and winter season.
FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
EU Takes Steps to Prevent Antibiotic Shortages Next Winter
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
Westlake Village BioPartners Announces $450 Million Venture Capital Funding Pool
Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.
FDA Converts Eisai Alzheimer’s Treatment to Traditional Approval
Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.
EMA Reviews GLP-1 Receptor Agonists for Self-Harm Risk
The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.
Large Clinical Trial Supports Alzheimer Drug Full Approval
FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition
FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
FDA Approves Pfizer Human Growth Hormone Analog
FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.
NCI Launches Persistent Poverty Initiative
The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.
FDA Approves UCB Generalized Myasthenia Gravis Treatment
UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.
Gene Therapy for Duchenne Muscular Dystrophy Approved by FDA
The agency approved Elevidys to treat pediatric patients four through five years of age with Duchenne muscular dystrophy.
Maurice Michel of Sweden Wins 2023 Eppendorf Award for Young European Investigators
The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.
FDA Releases Draft Guidance for Section 505G of Food, Drug, and Cosmetic Act
The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.
FDA Releases Updated COVID-19 Vaccine Guidelines
The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.
