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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.

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.

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

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

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

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.

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.

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

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.

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.

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.

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

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.

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.

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

Under the terms of the partnership, ICQ Consultants will provide consulting and engineering services for the installation, maintenance, qualification, and support of Yokogawa's bioreactor systems and related products in the US.

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

Through the acquisition, PharmaLex will expand its capabilities in the biopharma sector while enhancing its global market reach with a new location in Australia.

Michael J. Hennessy Jr., president and CEO of MJH Life Sciences™, parent company to BioPharm International, named to MM&M’s second annual 40 Under 40 list.

The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.

The new facility is part of Bristol Myers Squibb’s investment into the clinical and commercial manufacturing of cell therapies for patients with aggressive hematological cancers.

Through the acquisition, Catalent will establish pDNA development and manufacturing services at its Rockville, MD, facility and will gain Delphi’s team of R&D and genetic engineering scientists, technicians, and regulatory specialists.

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

With the acquisition, Eurofins gets Beacon’s G-protein coupled receptor research knowledge and its compound library.

Once the vaccine has been authorized, Sanofi will provide Johnson & Johnson with access to its vaccine manufacturing plant in Marcy l’Etoile, France, to formulate and fill vials of the vaccine, at a rate of 12 million doses per month.

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

The second phase of the Myford facility expansion in California will add upstream and downstream processing suites.

The companies will co-develop and commercialize Rigel's R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications.