Industry News
FDA and NIH Enter Rare Neurodegenerative Diseases Partnership
The Public-Private Partnership for Rare Neurodegenerative Diseases will work to enhance understanding and develop treatments for rare neurodegenerative diseases.
Lonza Expands HPAPI Multipurpose Suite
Lonza has expanded its HPAPI multipurpose suite for payload-linker manufacturing.
Clinical Trial Modernization Raises FDA Compliance Issues
Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.
CytoReason Announces Expanded Collaboration Deal with Pfizer
CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.
Civica to Invest $27.8 Million in New Testing Facility
Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.
Novo Nordisk and Microsoft Collaborate to Accelerate Drug Discovery and Development
Novo Nordisk and Microsoft are collaborating to accelerate drug discovery and development using big data and artificial intelligence.
Ensysce Biosciences and Quotient Sciences Announce Partnership
Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.
EMA Recommends Approval of Enjaymo
EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.
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.
Leistritz to Host Twin Extrusion Workshop
Leistritz’s Twin Extrusion Workshop, hosted from Nov. 29 to Dec. 1 in Warren, NJ, will dovetail classroom training and twin screw demonstrations.
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.
Winter is Coming!
As winter approaches, the next generation of COVID-19 vaccines are being prepared and scheduled, ready for distribution across Europe and the world.
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.