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Bio-Rad Expands Portfolio of Anti-Idiotypic Antibodies
Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.
Oregon Freeze Dry Opens $7.5 Million Biopharma Facility
The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.
Novasep-PharmaZell Invests €7.3M to Increase API Production Capacity
Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.
Navigating the Future
Promising applications for targeted delivery may be cresting the horizon.
New Guidance on the Use of Real-World Evidence
Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.
FDA Confirms Ongoing Reliance on Remote Inspection Methods
FDA’s hybrid inspection model will remain a regular means for supplementing onsite inspections and will be further integrated into the agency’s oversight operations.
Demerger and the Future
GSK has completed its demerger of Haleon and has signed an agreement to help support future pandemic preparedness in Europe.
The Stick and Carrot of Quality Management
How can we fix the quality manufacturing issues that come with product shortages?
DuPont Opens Biopharma Tubing Manufacturing Site in South Carolina
DuPont’s new manufacturing site will expand its biopharmaceutical tubing manufacturing capabilities.
The US Purchases 66 Million Doses of Moderna’s COVID-19 Vaccine for $1.74 Billion
The United States has agreed to purchase 66 million doses of Moderna’s bivalent COVID-19 booster candidate for $1.74 billion.
European Commission Approves AbbVie Axial Spondyloarthritis Treatment
The European Commission has approved Rinvoq (upadacitinib) for treatment of active non-radiographic axial spondyloarthritis.
PTC Granted Marketing Authorization by European Commission for AADC Deficiency Treatment
The European Commission has granted marketing authorization to Upstaza (eladocagene exuparvovec) for treatment of aromatic L-amino acid decarboxylase (AADC) deficiency.
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.
Merck and Orion Announce Global Collaboration for Oncology Drug
Merck, known as MSD outside the United States and Canada, and Orion Corporation are collaborating to develop and commercialize a treatment for metastatic castration-resistant prostate cancer.
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.
I Saw the Future of Global Pharmaceutical Production in India
Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.
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.
