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Kiefel Launches Modular Form-Fill Seal Machine
Kiefel’s new machine is designed to form, fill, and seal up to 6,000 infusion, parenteral nutrition, or dialysis bags per hour.
Streamlining Downstream Processes
Process automation technologies aid modernization and enable closed systems.
FDA Releases Guidance on Standards Related to Pharmaceutical Quality
The program aims to aid submissions from external stakeholders and FDA staff.
Biogen to Acquire Reata Pharmaceuticals for $7.3 Billion
Biogen’s acquisition of Reata will grant them access to Reata’s FDA-approved treatment for Friedreich’s ataxia.
AstraZeneca and Pfizer Ink $1 Billion Rare Disease Deal
AstraZeneca, via its subsidiary Alexion Pharmaceuticals, will purchase a portfolio of preclinical rare disease gene therapies from Pfizer in a deal worth up to $1 billion.
FDA Guidance on Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals
The guidance document outlines recommendations to limit potential carcinogenic risk.
SCG Therapy Opens Cell Therapy Manufacturing Facility in Singapore
The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.
Congress Leaves Town with Major Drug-Related Bills on Hold
Pandemic, PBM, and other policies on hold during the summer recess.
Biovian Invests €50 Million in Manufacturing Facility in Finland
The expansion project is aimed to be completed in December 2024 and the new facility will be fully operational by 2025.
Teva Pharmaceuticals and Alvotech Expand Existing Biosimilars Partnership
Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.
Roche and Alnylam Strike $2.8 Billion RNAi Deal
Roche will pay up to $2.8 billion for the rights to Alnylam’s RNA-based hypertension therapeutic.
EMA Gives Positive Opinion on Two of Janssen’s Bispecific Antibodies
Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.
MilliporeSigma Expands Production Facility for Cell Culture Media
MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.
AbbVie Expands Collaboration with Calibr to Advance Clinical Assets
The partnership is an extension of the collaboration from AbbVie and Scripps Research that was formed in 2019, according to the press release.
Update on Storm Damage to Pfizer Facility in North Carolina
The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.
EMA Extends OPEN Framework to More Medicines
The framework is now expanded beyond COVID-19 vaccines and treatments.
EMA Publishes Draft Reflection Paper on Artificial Intelligence in Medicine
The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.
Crossbow Therapeutics Debuts with $80 Million in Series A Financing to Advance Antibody Therapeutics
Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.
Bristol Myers Squibb and Evotec Extend Neuroscience Pact
Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.
Sandoz Spin-off Gets Green Light from Novartis Board
The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.
Pfizer and Flagship Pioneering Enter Innovation Partnership
The partnership will see Flagship and Pfizer work to create a new pipeline of innovative medicines.
Sanofi and Scribe Therapeutics Expands Genomics Collaboration
The expanded deal, now potentially worth more than $1.2 billion, will work to develop in vivo therapies, including sickle cell disease.
Novartis Acquires DTx Pharma in Deal Worth Up to $1 Billion
Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.
FDA Approves Preventative Therapy for Respiratory Syncytial Virus in Infants and Toddlers
The new drug may help vulnerable children resist RSV in the coming fall and winter season.
FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products
The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.
EU Takes Steps to Prevent Antibiotic Shortages Next Winter
These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
Upperton Completes New Development of GMP Manufacturing Facility
The goal for Upperton is to become fully operational by Q4 of 2023 for development and non-GMP manufacturing and a target start of GMP operations in January 2024.
Neurogene and Neoleukin Announce Merger
After the completion of the merger, the company is expected to operate under the name “Neurogene Inc."
Vector Laboratories Acquires Quanta BioDesign
Vector Laboratories announced the acquisition of Quanta BioDesign on July 17, 2023, which further expands the former’s portfolio of bioconjugation linkers and dyes, as well as its manufacturing sector, according to the press release.
Westlake Village BioPartners Announces $450 Million Venture Capital Funding Pool
Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.
