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Pfizer and BioNTech Provide Update on Omicron Variant
Pfizer found that two-dose recipients exhibited a more than 25-fold reduction in neutralization titers against Omicron relative to wild-type.
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.
Salubrent Pharma Solutions Strengthens Analytical Team
Annad Padmanabhan and Maggie Thomasson will fill key roles at Salubrent’s new cGMP analytical laboratory in Kannapolis, NC.
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.
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.
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.
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.
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.
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.
USP’s Nitrosamine Impurity Standard is Now Official
The new General Chapter <1469> “Nitrosamines Impurities” by USP became official on Dec. 2, 2021, in the United States Pharmacopeia—National Formulary.
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.
CordenPharma Adds Highly Potent Capabilities in Germany
CordenPharma will build a clinical trial development facility for manufacture of oral solid dosage drug products at its Plankstadt facility near Heidelberg, Germany.
New Carbon Nanotube-Based Sensor Can Detect SARS-CoV-2 Proteins
Researchers from MIT have developed novel nanosensors for the detection of the nucleocapsid and spike protein of the SARS-CoV-2 virus.
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.
