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Thermo Fisher Scientific Opens Viral Vector Manufacturing Site in Massachusetts
Thermo Fisher Scientific’s new 300,000 ft² facility, located in Plainville, Mass., will specialize in manufacturing viral vectors.
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.
Canvax Releases New Inorganic Pyrophosphate
Canvax’s new inorganic pyrophosphate is designed for in-vitro transcription reactions.
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.
Alcon to Purchase Aerie Pharmaceuticals for $770 Million
Aerie to be purchased by Alcon after recently bringing two glaucoma drugs to market.
Tavneos Gains Nod from NICE as Treatment for Two Main Forms of AAV
NICE has recommended the use of Tavneos (avacopan) in combination with rituximab or cyclophosphamide regimen.
Treatment for Moderate-to-Severe CKD-Associated Pruritus Gains Swiss Approval
Kapruvia (difelikefalin) has been granted approval by Swissmedic as a treatment for moderate-to-severe pruritis associated with CKD.
European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare
The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.
CPHI Report Predicts Significant Shifts in Global Outsourcing Strategies
The latest CPHI report has been published, predicting that a significant shift in outsourcing strategies is being experienced globally.
EMA Starts Review of Oral Fixed-Dose Combination Treatment for AML
EMA has accepted the marketing authorization application for an oral fixed-dose combination treatment as an initial treatment for adults with AML.
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.
Validair Diamond Scientific Installs New Cleanroom
Validair Diamond Scientific has installed a new cleanroom for in-house testing, research, and training.
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.
CYTENA Unveils Fully Automated Single-Cell Dispenser for Microorganisms
CYTENA’s B.SIGHT cell dispenser is designed to streamline single-cell isolation in microbiology research.
New England Biolabs Releases Novel Enzymatic mRNA Capping Solution
The Faustovirus Capping Enzyme launched by New England Biolabs is designed to increase capping efficiency and scalability of mRNA manufacturing workflows.
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.
FDA to Host Multi-Day Global Access Virtual Conference
FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.
Pfizer to Acquire Global Blood Therapeutics for $5.4 Billion
Pfizer’s $5.4 billion acquisition of Global Blood Therapeutics is expected to strengthen its sickle cell disease portfolio.
Sartorius to Acquire Albumedix for £415 Million
Sartorius’ £415 million (US$429 million) acquisition of Albumedix is intended to bolster its portfolio with recombinant albumin-based solutions.
