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EC Approves Lupkynis for Treatment of Active Lupus Nephritis
Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.
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.
MilliporeSigma to Invest €130 Million in French Manufacturing Facility
MilliporeSigma’s €130 million (USD$132 million) investment is designed to increase manufacturing capacity of single-use assemblies.
WHO Grants Prequalification to GSK’s Malaria Vaccine
WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.
Emergence Therapeutics to License Synaffix ADC Technology Platform in Deal Worth Up to $360 Million
Emergence Therapeutics will work with Synaffix’s ADC technology platform to develop multiple ADCs against undisclosed targets.
FDA In Limbo as User Fee Renewal Stuck on Capitol Hill
FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.
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.
Avance Clinical Acquires C3 Research Associates
Avance Clinical’s acquisition of C3 Research Associates expands its CRO services to North America.
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.
Roche to Acquire Good Therapeutics for $250 Million
Roche’s acquisition of Good Therapeutics grants them rights to the company's conditionally activated PD-1-regulated IL-2 program.
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.
Lynparza Approved in Great Britain
Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.
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.
Aria Pharmaceuticals Files Applications for Six Provisional Patents
The patent applications are for programs concerning lupus, idiopathic pulmonary fibrosis, and chronic kidney disease.
Hovione Expands its Continuous Manufacturing Offering and Services
Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.
Novo Nordisk to Acquire Forma Therapeutics for $1.1 Billion
Novo Nordisk’s $1.1 billion acquisition of Forma Therapeutics is intended to expand its sickle cell and rare blood disorder portfolio.
FDA Authorizes Bivalent COVID-19 Boosters
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.
Bio-Rad Launches Anti-Evolocumab Antibodies
Bio-Rad’s new antibodies are designed to develop highly selective pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolocumab and its biosimilars.
Roche Launches Digital PCR System
Roche’s Digital LightCycler System is designed to aid in diagnostics for cancer, genetic disease, and infection.
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.