Industry News
Advanced Biopharma Manufacturing Key to White House Cancer Moonshot
The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.
WHO Grants Prequalification to GSK’s Malaria Vaccine
WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.
Salipro Biotech Obtains Patents in US and China for Direct Extraction of Membrane Proteins and Library Generation
Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.
Charles River and Cure AP-4 Announce Manufacturing Collaboration
Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.
ElevateBio and the University of Pittsburgh Announce Creation of Pitt BioForge BioManufacturing Center
In partnership with the University of Pittsburgh, ElevateBio will open its next manufacturing center in the city.
SIRIO Enhances Company Strategy with Addition of Lonza’s Sara Lesina
SIRIO is enhancing its strategy for small and medium nutrition brands as Lonza’s Sara Lesina joins as GM in Europe.
FDA Approves Novel ASMD Treatment from Sanofi
Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.
Lonza and Touchlight Enter mRNA Collaboration
Touchlight will expand Lonza’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material.
Hovione Expands its Continuous Manufacturing Offering and Services
Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.
FDA Authorizes Bivalent COVID-19 Boosters
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.
Lonza Strengthens Micronization Portfolio with the Introduction of X-Ray Powder Diffraction
Lonza has introduced X-ray powder diffraction capability at its Monteggio, Switzerland site.
Forecyte Bio and Cytiva to Collaborate on Cell and Gene Therapy Manufacturing and Development
Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.
Emerson Opens Gas Analysis Solutions Center in Scotland
Emerson’s new gas analysis solutions center, located in Cumbernauld, Scotland, intends to help plants meet sustainability goals.
NIH-Funded Scientists Develop Mouse Embryo Model That Generates Neural Tubes
Scientists have developed a mouse model that could be a promising model system for research into factors affecting mammalian embryonic development and disease.
MHRA Grants Novavax COVID-19 Vaccine Expanded Conditional Marketing Authorization
Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.
Revisions to Annex 1 Officially Published
The European Union publishes long-awaited changes to Annex 1.
Moderna Files Suit Against Pfizer and BioNTech
Moderna is suing Pfizer and BioNTech for allegedly infringing on patents the company filed from 2010 to 2016.
Watson-Marlow and Franz Ziel GmbH Launch Cellefill
Watson-Marlow and Franz Ziel GmbH have launched a new integrated solution to fast-track cell, gene, and biological therapies.
ChargePoint Technology Acquires PuroVaso
ChargePoint Technology has acquired single-use container company PuroVaso.
Anthony Fauci to Step Down in December
Anthony Fauci announced that he plans to step down as Director of the National Institute of Allergy and Infectious Diseases in December 2022.
Grand River Aseptic Manufacturing Completes Phase II of Facility Expansion
Grand River Aseptic Manufacturing has completed phase II of its facility expansion with the installation of two new sterile filling lines.
ProBioGen Executes Master Service Agreement with NextPoint Therapeutics
ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.
Charles River Receives EMA Approval to Commercially Produce Allogeneic Cell Therapy Drug Products
Charles River has received approval to commercially produce allogeneic cell therapy products for distribution in Europe from EMA.
UK Grants Marketing Authorization for Novartis’ Radioligand Therapy for Advanced Prostate Cancer
The UK’s MHRA has granted marketing authorization for Novartis’ radioligand therapy, Pluvicto, for the treatment of advanced prostate cancer in Great Britain.
UK Approves First Bivalent COVID-19 Booster Vaccine
The United Kingdom has approved Moderna’s bivalent COVID-19 vaccine, which targets the original variant and Omicron.
Moderna and European Commission Amend COVID-19 Vaccine Agreement
Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 2022.
FDA Approves Roche’s Influenza Treatment for Use in Young Children
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.
Merck Enters Alzheimer’s Collaboration with Cerevance
Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.
Catalent to Acquire Metrics Contract Services for $475 Million
Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.
