Daria G. Husni is Assistant Editor for BioPharm International.
CPHI Annual Report: VC Capital Investment and Contract Services Growth in 2024
The report indicates a rise in biotech funding and subsequent growth for pharma contract services.
Wheeler Bio Announces Opening of Biomanufacturing Facility in Oklahoma City
Wheeler plans to use the facility to bolster its mission in helping fledgling biotech innovators and startups accelerate their development at an equitable price.
Bristol Myers Squibb Acquires Mirati Therapeutics for up to $5.8 Billion
Mirati’s focus on breakthrough cancer treatments will bolster Bristol Myers Squibb’s oncology portfolio.
Novartis Completes Sandoz Spin-off
Spinning off Sandoz allows Novartis to focus on the areas of cardiovascular, immunology, renal and metabolic, and oncology.
UK Poised to Lead Global Delivery of Next-Gen mRNA Medicines
The BioIndustry Association reports that with a strong foundation in research and development in mRNA the United Kingdom will be a major player in this rapidly growing industry.
Kyowa Kirin Set to Acquire Orchard Therapeutics for $477.6 million
The Japanese biotech company plans to make good use of Orchard’s portfolio, furthering its goal of providing life-changing medical care through cell and gene therapy.
FDA Establishes Pilot Program to Accelerate Rare Disease Therapy Development
The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.
2023 Nobel Prize in Medicine Awarded for Development of mRNA Vaccines Against COVID-19
The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.
BARDA Awards Gritstone bio $433 Million Contract for Phase IIb Study of Next-Gen COVID-19 Vaccine
The contract is part of US Department of Health and Human Services’ ‘Project NextGen’ initiative, aimed at pushing forward new and stronger COVID-19 vaccines and therapies.
FDA Releases Guidance on Using Remote Oversight Tools for Drug Approval
The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.
Alexion Completes Purchase and License Agreement of Rare Disease Gene Therapy Portfolio from Pfizer
The AstraZeneca rare disease group hopes to use these new gene therapy programs to bolster its work on genomic medicine.
A Growing Biologics Market
As more novel therapy approvals trend towards biologics, it is important to take stock of what treatments are shaping the future of the market.
FDA Establishes Stabilization Period for Updated DSCSA Compliance Policies
The new policy will require trading partners to supply, accept, and manage all documentation of product and ownership of prescription drugs electronically.
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.
FDA Approves Biosimilar to Treat Multiple Sclerosis
This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.
Alterity Therapeutics Given European Composition of Matter Patent for Neurodegenerative Diseases
The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.
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.
Absci and Caltech Collaborate to Accelerate Affordable HIV Therapeutic Vaccine
A major grant from the Bill & Melinda Gates Foundation will bolster efforts to fight the global HIV/AIDS epidemic.
Novartis Finalizes Chinook Therapeutics Acquisition in Deal Worth Up to $3.5 Billion
Novartis has completed its acquisition of biopharma company Chinook Therapeutics.
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 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.
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.