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.

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

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

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

Oxular has raised US $37 million in a financing round led by specialist life sciences investor, Forbion.

Arcline Investment Management has acquired ChargePoint Technology, strengthening its global presence.

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

EMA has recommended that Evrysdi be granted marketing authorization in the EU for the treatment of patients with certain types of SMA.

RDIF has announced that the Sputnik V vaccine for COVID-19 has been approved in Slovakia under the emergency use authorization procedure.

Pharmaceutical laboratories must work to maintain lab data integrity practices as the pandemic surges on and cybersecurity risks increase.

The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.

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

Bio/pharma works hard today to change the calendar to tomorrow.

More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

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.

Takeda is divesting the products because they are outside of Takeda’s current business focus, which includes gastroenterology, rare diseases, plasma-derived therapies, oncology, and neuroscience.

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.

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

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

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

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.

Currently, the facility manufactures products for oral diabetes treatment and will be expanded to increase capacity for these products.

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.

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.

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.

NICE has issued guidance recommending the use of TheraSphere Y-90 Glass Microspheres, from Boston Scientific, as a treatment for patients with HCC.

The companies will integrate Welldoc’s digital insulin management solution, BlueStar, into Eli Lilly’s connected insulin solutions.