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The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.

Clinical Data on Moderna COVID-19 Vaccine Published

The agency is working to identify and obstruct scammers looking to profit from the pandemic.

FDA Protects Consumers Against COVID-19 Scams

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

Rolling Review of Sputnik V COVID-19 Vaccine Begins in Europe

The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.

FDA Publishes Guidance on Changes to COVID-19 Container Closure Systems

The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.

EC Launches Structured Dialogue to Address Medicines Supply Vulnerabilities

A recent survey by SwedenBIO has demonstrated a major upswing in the Swedish life science industry. 

Survey Demonstrates Upswing in Swedish Life Sciences Growth

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.

Merck to Manufacture J&J Vaccine

AstraZeneca has announced that the mass rollout of its COVID-19 vaccine has begun via the COVAX initiative. 

AstraZeneca Progresses Rollout of COVID-19 Vaccine to Low- and Middle-Income Countries

Under the terms of the acquisition, OXGENE will become a fully owned subsidiary of WuXi Advanced Therapies, WuXi AppTec’s cell and gene therapy contract testing, development, and manufacturing organization business unit.

WuXi AppTec Acquires OXGENE to Increase Cell and Gene Therapy Offerings

The companies intend to design and implement algorithms for the early stages of research for drug discovery and development of drug candidates to treat Alzheimer’s disease.

Roche and Cambridge Quantum Computing Use Algorithms for Early Alzheimer's Drug Research

The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.

SPT Labtech Strengthens Automation Services with BioMicroLab Acquisition

The new ultra-sensitive second-generation micro-chip technology is a key enabler in advanced single-cell proteomics workflow.

PharmaFluidics Offers Second-Gen µPAC Technology for Single Cell Proteomics

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Documents Achievements and Plans for Future

Through the acquisition, Merck will have access to Pandion’s pipeline of precision immune modulators targeting critical immune control nodes, including its lead candidate, PT101.

Merck to Acquire Pandion Therapeutics for $1.85 Billion

Through the partnership, Seven Bridges will centralize and manage terabytes of raw and processed scRNASeq data using its cloud-based bioinformatic analysis platform while working to expand Pfizer’s cloud platforms and capabilities.

Seven Bridges to Support Pfizer’s Data Management Solution for Single-Cell RNA Sequencing

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health. 

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

J&J Vaccine Approved for Emergency Use

EMA's CHMP has started a rolling review of regdanvimab (CT-P59), which is a monoclonal antibody being developed by Celltrion for the treatment of COVID-19.

EMA Commences Rolling Review of Regdanvimab

The site will house development and GMP production capacities for cell and gene therapies, next-generation vaccines, and biopharmaceuticals, to support clients from early clinical trials through commercialization.

Celonic to Establish New Cell and Gene Therapy Production Site in Switzerland

The company will join the network of approved manufacturers of the lipid excipients. 

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