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Shimadzu’s Nexera XS Inert Chromatography System Enhances Biopharma Analysis
Shimadzu’s new ultra-high performance liquid chromatography system is designed to solve common problems in biopharma analysis.
Roche Launches Dual Antigen and Antibody Hepatitis C Diagnostic Test
Roche’s new test is the first available immunoassay that allows for simultaneous, independent determination of the hepatitis C virus antigen and antibody status.
WuXi STA Opens a New Large-Scale Continuous Manufacturing Plant
WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.
FDA Continues to Grapple with Accelerated Approval Issues
Scrutiny of accelerated approvals has generated a range of reform proposals to accelerate the conduct of confirmatory studies.
Discovery Life Sciences Acquires AllCells
Discovery Life Sciences’ acquisition of AllCells is intended to bolster its cell and gene therapy products and services.
AstraZeneca to Acquire TeneoTwo in Deal Worth Up to $1.26 Billion
AstraZeneca's acquisition of TeneoTwo will give the company access to its clinical-stage T-cell engager, TNB-486, strengthening their hematological cancer pipeline.
WHO Declares Monkeypox Spread a Global Health Emergency
WHO has determined that monkeypox constitutes a public health emergency of international concern.
EMA Recommends Eleven New Medicines
The agency’s human medicines committee recommended drugs to treat breast cancer, lupus nephritis, type 2 diabetes and more.
EMA Endorses Statement on International Collaboration of Real-World Evidence
A joint statement calling for international collaboration on the creation and use of real-world evidence has been published by the International Coalition of Medicines Regulatory Authorities.
Hospira Issues Voluntary Recall for One Lot of Propofol Injectable Emulsion, USP
Hospira has issued a voluntary nationwide recall for one lot of Propofol Injectable Emulsion, USP (containing benzyl alcohol), due to the potential presence of visible particulate.
TFF Pharmaceuticals Expands R&D Operations with New Facility
TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.
PerkinElmer Introduces New Cytometry Management Service
The PerkinElmer Flow Cytometry Instrument Concierge Services will provide biopharmaceutical labs with expert, on-site flow cytometry specialists.
Cytiva Acquires Chromatography Resins Manufacturing Facility in Muskegon, Michigan
Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment.
Health Canada Authorizes Moderna’s COVID-19 Vaccine in Young Children
Health Canada has authorized Moderna’s COVID-19 vaccine for use in young children aged six months to five years.
Gamesmanship Escalates over FDA User Fee Legislation
US legislators are devising strategies ahead of the reauthorization deadline for the FDA User Fee legislation.
Royalty Pharma Acquires Royalty Rights to COPD/Asthma Treatment for $1.6 Billion
Royalty Pharma is paying $1.6 billion for the royalty rights to Trelegy Ellipta, a treatment for COPD and asthma.
FDA Issues Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted
FDA has granted an Emergency Use Authorization to Novavax’s COVID-19 vaccine.
EMA Publishes Guidance on Preventing Medicine Shortages
The European Medicines Agency guidance highlights key principles and examples of good practices to prevent and manage shortages of human medicines.
Vertex to Acquire ViaCyte for $320 Million
Vertex’s $320 million acquisition of ViaCyte will give the company complementary capabilities for its Type 1 diabetes therapy program.
FDA Regulation of Nonprescription Drugs in Spotlight
Application for OTC contraceptive highlights efforts to broaden access to medicines.
Merck Digital Sciences Studio Supports Early-Stage Startups
Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.
Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA
Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.
Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center
Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.
Coya Therapeutics Secures Rights to Exosome Engineering Technology from Carnegie Mellon University
Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.
Bio-Rad Launches CFX Opus Deepwell Real-Time PCR Detection System
Bio-Rad’s CFX Opus Deepwell Real-Time PCR Detection System is designed to support researchers in developing nucleic acid detection assays.
Bio-Rad Launches New Chromatography Column Packs
Bio-Rad’s EconoFit Chromatography Column Packs support resin screening experiments in the development of protein purification workflows.
FDA Drug Regulation Challenged by Anti-Abortion Campaign
Some states look to block access to approved drugs.
US Government to Support Expansion of Croda Lipid Systems Capability
Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.
VeriSIM Life and Mayo Clinic Team Up to Co-develop New Therapies
VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.
LG Chem Renews License with Avacta for IND Studies
LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.