Industry News
Pfizer and BioNTech Get Positive Opinion in Europe for Omicron XBB.1.5-adapted COVID-19 Vaccine
The updated vaccine will be ready to ship following a positive European Commission review.
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.
FDA Approves Ipsen Fibrodysplasia Ossificans Progressiva Treatment
Ipsen’s Sohonos (palovarotene) capsules are designed to reduce new, abnormal bone formation in soft and connective tissues in individuals with fibrodysplasia ossificans progressiva, a rare bone disease.
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).
EMA Reviews Data on Paternal Exposure to Valproate
The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.
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.
FDA Approves First Oral Treatment for Postpartum Depression
The new drug could be a powerful tool for patients suffering depressive symptoms after birth.
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 Grants Orphan Drug Designation to Treatment of Malignant Glioma
The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.
FDA Warns that Tydemy May Have Reduced Effectiveness
Lower levels of an active ingredient may result in unexpected pregnancies.
FDA Approves OTC Opioid Overdose Treatment
The nasal-spray drug can be used to reverse the effects of opioid overdose.
A Healthier Tomorrow?
Only a significant joint effort across the supply chain will help to make healthcare more sustainable and reduce the impact of climate change on global health.
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.
FDA Approves Novel Demodex Blepharitis Treatment
Tarsus Pharmaceuticals’ Xdemvy (lotilaner ophthalmic solutions) is designed to treat Demodex blepharitis by directly targeting Demodex mites.
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.
EU Takes Steps to Prevent Antibiotic Shortages Next Winter
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
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.
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.
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 Approves First Nonprescription Daily Oral Contraceptive
Laboratoire HRA Pharma norgestrel is the first daily tablet for nonprescription use to prevent pregnancy.
FDA Converts Eisai Alzheimer’s Treatment to Traditional Approval
Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.
