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Leucid Bio to Use Lonza’s Cocoon Platform for Automated Manufacturing of CAR T Cells
Leucid Bio will collaborate with Lonza to use Lonza’s Cocoon Platform for clinical and commercial manufacturing of CAR T cells for Leucid’s lead candidate.
Sanofi to Acquire Origimm Biotechnology for Vaccine-based Acne Treatment
Sanofi’s acquisition of Origimm Biotechnology will add to its pipeline of vaccine candidates for treating acne.
Taiyo Pharma Tech Adds Gene Therapy Capacity in Japan
A new Cytiva FlexFactory platform will be installed at Taiyo Pharma Tech’s site in Osaka, Japan.
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.
Accelerating Project Delivery with a Lean Alternative to DBB
Lean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.
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.
The Key Elements for Assay Transfer Success
Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.
Spinning Success? The Benefits of University Spinouts
Pharma and biotech are ruling the roost in terms of university innovation, but European spinouts are still experiencing barriers to long-term success.
Pandemic Alters Policies and Practices for Drug Development and Regulation
The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.
Breaking the Rules
We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.
