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Lonza Signs Biotherapeutics Licensing Agreement with Doer Biologics
Doer Biologics will use Lonza’s XS technology in the production of its proprietary platform technology.
Fujifilm Irvine Scientific Opens European Manufacturing Facility
Fujifilm’s new cell culture media manufacturing facility in the Netherlands has officially opened.
Crown Bioscience Expands In-Vivo Capacity at UK Facility
The additions to Crown Bioscience’s UK facility will increase and expand the company’s current in-vivo offering.
EU Approves Roche’s Treatment for Severe COVID-19
Roche’s Actemra/RoActemra (tocilizumab) is now approved in the EU for the treatment of adults with severe COVID-19 symptoms.
AstraZeneca Signs Blockbuster Deal With Ionis for TTR Amyloidosis Treatment
AstraZeneca struck a deal worth up to more than $3.5 billion with Ionis Pharmaceuticals for the rights to develop and commercialize their transthyretin (TTR) amyloidosis treatment.
FDA Grants Longeveron Orphan Drug Designation for Lomacel-B
Longeveron’s Lomacel-B received an Orphan Drug Designation for the treatment of Hypoplastic Left Heart Syndrome.
Drug Costs Central Issue in Budget Battles
President Joe Biden highlighted how current proposals for curbing outlays on pharmaceuticals will help protect patients’ health and save the government billions.
FDA Panel Recommends Merck’s COVID-19 Pill
Following mixed results from clinical trials, a panel of outside experts voted 13-10 to recommend Merck’s pill for Emergency Use Authorization.
Recordati Acquires EUSA Pharma for $845 Million
Recordati’s blockbuster acquisition of EUSA Pharma gives them access to a portfolio of four drugs that treat rare cancers.
Rituximab Plus Chemotherapy Approved by FDA for Select Pediatric Cancers
Subtitle FDA approved rituximab in combination with chemotherapy for pediatric patients with previously untreated, advanced stage, CD20-positive DLBCL/BL/BLL/B-AL.
Roche Expands PCR-Test Portfolio with Completion of Purchase Agreement of TIB Molbiol
The companies will focus on the rapid development of polymerase chain reaction assays for emerging pathogens and potential health threats, including biological threats.
GSK and the University of Oxford Join Forces to Research Treatment Potentials for Neurological Diseases
This collaboration aims to better understand Alzheimer’s and Parkinson’s disease and increase drug discovery and development success rates.
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.
