Industry News
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.
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.
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.
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.
Catalent to Acquire Metrics Contract Services for $475 Million
Catalent will acquire Metrics Contract Services for $475 million to expand high-potent capabilities and oral development and manufacturing capacity.
FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.
Sanofi and Innovent Enter Oncology Collaboration
Sanofi and Innovent have entered into a strategic collaboration to accelerate development of oncology medicines and expand their presence in China.
Senate Advances Drug Price Negotiations
Democrats approve curbs for Medicare plans, but not for commercial drug coverage.
La Jolla Institute for Immunology Acquires Carterra LSA Platform
La Jolla’s acquisition of Carterra’s LSA Platform is designed to advance their immunological and infectious disease research.
Top Priority for Califf Is Combatting Health Misinformation
Better clinical data are needed, as well as strategies for tackling opioid abuse, tobacco use, and food safety.
CRYOPDP Acquires Polar Expres
CRYOPDP is expanding its footprint to Spain with its acquisition of Polar Expres.
FDA Confirms Ongoing Reliance on Remote Inspection Methods 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.
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.
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.
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.
