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60 Million Doses of the COVID-19 Vaccine is Added to Moderna’s Supply Agreement with the UK
Moderna’s agreement with the UK government includes 29 million COVID-19 vaccine doses for delivery in 2022 and 31 million doses for delivery in 2023.
FDA Grapples with the Promise and Perils of Gene Therapy
High price tags threaten to block patient access to potentially life-saving cures and treatments.
Fujifilm Irvine Scientific Builds Bioprocessing Innovation and Collaboration Center in China
Fujifilm’s center adds local support in Suzhou, China for cell culture media optimization.
Atara Biotherapeutics' MAA for Allogeneic T-cell Immunotherapy Gets EMA Validation
EMA has fully validated the marketing authorization application for Atara Biotherapeutics’ off-the-shelf allogeneic T-cell therapy, tab-cel (tabelecleucel), with an approval decision expected in 2022.
Chinook Therapeutics and Investors Form Joint Venture for Kidney Disease Therapies
Chinook Therapeutics has formed a 50/50 joint venture with investors to develop kidney disease therapies in China.
Sartorius to Invest in Growing Operations in France
Sartorius is investing €100 million (US$113 million) between 2021 and 2025 to expand capacities for production, innovation, and storage at its French facilities in Aubagne, Cergy, and Lourdes.
Sartorius Launches Expansion in South Korea with Mullti-Million Dollar Investment
Sartorius will invest approximately €270 million (US$305 million) to expand its biopharmaceutical manufacturing activities in South Korea’s biopharm hub.
Novozymes and Novo Nordisk Pharmatech Collaborate on Enzymes for Biopharma Production
Novozymes and Novo Nordisk Pharmatech are teaming up to develop best-in-class technical enzymes to support biopharmaceutical production processes.
BeiGene Acquires Property in New Jersey to Build Manufacturing and Clinical R&D Center
BeiGene has acquired property in Hopewell, NJ to build a new manufacturing site and clinical R&D center for advanced new medicines.
Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp to Build mRNA Vaccine Manufacturing Capacity
Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.
Vaccine Makers Seek to Address Omicron SARS-CoV-2 Variant
The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.
EMA Recommends Pfizer and BioNTech’s COVID-19 Vaccine for Children
The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.
GreenLight Biosciences, Samsung Biologics Collaborate to Advance COVID-19 Vaccine Candidate
Samsung Biologics will manufacture GreenLight BioSciences' COVID-19 vaccine candidate for clinical trials and commercial sales.
ACG to Set Up Vast Capsule Manufacturing Plant in Asia
ACG plans to open a capsule manufacturing plant and R&D center in Aurangabad, India.
UCB Announces Positive Top-Line Results from Study Evaluating Bimekizumab
The study found that patients treated with BIMZELX (bimekizumab) achieved 50% or greater improvement in arthritis signs and symptoms relative to those treated with placebo.
MHRA Grants Marketing Authorization for Biogen’s MS Treatment
Biogen received MHRA marketing authorization for VUMERITY (diroximel fumarate) for treatment of relapsing-remitting multiple sclerosis (RRMS).
MilliporeSigma Unveils ColorWheel Flow Cytometry Portfolio
MilliporeSigma’s new ColorWheel flow cytometry portfolio is designed to create antibodies and dyes analogous to a primary conjugated antibody.
Denali Therapeutics and Takeda to Jointly Develop and Commercialize Investigational Treatment for FTD-GRN
Takeda has exercised an option to co-develop and co-commercialize an investigational, brain-penetrant progranulin replacement therapy for the potential treatment of frontotemporal dementia-granulin.
CRB Report Investigates Pharma Facility Trends
Speed to market, flexibility, and digitalization are important topics in biopharmaceutical manufacturing.
Sartorius Offers Redesigned Vacuum Filtration Units with Higher Capacity and Faster Speed
Sartorius’ newly redesigned vacuum filtration units are designed to allow for faster and higher-capacity filtration while offering enhanced stability for sample processing.
Novo Nordisk Acquires Dicerna for $3.3 Billion
Novo Nordisk’s 3.3 billion acquisition of Dicerna gives them access to their RNAi technology.
FDA Authorizes COVID-19 Boosters for All Adults
FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.
Evolution of Aseptic Processing: INTERPHEX Keynote Part 5
Jordi Serrat, Product & Technology Director, Azbil Telstar talks about the role of disruptive and digital technologies in aseptic processing.
Secarna Pharmaceuticals and Achilles Therapeutics Partner on T Cell Therapy Development
Secarna Pharmaceuticals and Achilles Therapeutics have entered into an agreement to optimize the development of T cell therapies in Achilles’ pipeline.
CGT Catapult and Deep Science Ventures Team Up to Boost Innovation in Advanced Therapies
CGT Catapult and Deep Science Ventures have partnered to encourage innovative approaches to overcoming barriers in delivering advance therapies to patients.
GSK Receives European Approval for Three Additional Indications of Nucala
GSK has been granted approval by the EC for its monoclonal antibody therapy, Nucala (mepolizumab), as a treatment for three additional eosinophil-driven diseases.
Celltrion Gains Nod from EC for Regdanvimab
EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.
EMA Begins Evaluation of Novavax COVID-19 Vaccine Marketing Authorization Application
Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.
Lonza Invests in Microbial Development Lab Expansion
Lonza is expanding its microbial development capabilities at its Visp, Switzerland, site to support clinical and commercial drug development programs.
New Cures 2.0 Legislation Advances Biomedical Research and Care
Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.