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The acquisition will give Sanofi access to Principia’s Bruton tyrosine kinase (BTK) inhibitors to add to its portfolio of next-generation transformative treatments for autoimmune diseases.

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01.

The agency provides recommendations for development and labeling of drugs to treat male patients with breast cancer.

In combination with BARDA’s previous award, the commitment for early access to Moderna’s vaccine candidate has now reached to up to $2.48 billion.

ANA will use Quotient’s formulation and manufacturing knowledge to develop and supply the drug product for clinical trials by the third quarter of 2020.

SK bioscience will manufacture the vaccine antigen component for use in the final drug product at its vaccine facility in Andong L-house, South Korea.

The companies will work to establish an operational footprint across North America and Europe that will offer customers supply chain assurance for a combined portfolio of leading solutions.

The company will use the acquisition to further its drug development pipeline in women’s healthcare.

The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.

The expansion will involve using the facilities’ existing central utilities and labs to supplement its small-scale and large-scale assets.

The expanded facility will feature two new 40-L and 300-L manufacturing vessels, a capsule filling line, and six drying tunnels that will add more than 10 million doses per annum to the site.

Healthcare groups met in late July 2020 to discuss the state of the US pharmaceutical supply chain and the impact of COVID-19.

As biopharma companies and research institutes advance the development of COVID-19 vaccines, policy makers and health officials are debating strategies for ensuring fair and equitable distribution of anticipated preventives.

Efforts by regulators seek common approaches to clinical research and biopharmaceutical production needed to wipe out the coronavirus pandemic globally.

The company has begun development of a 3D bioreactor for the cGMP production of extracellular vesicle exosomes.

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The approval comes after positive results were met in a single-arm, open-label study that resulted in FDA Breakthrough Therapy Designation for the one-time therapy.

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.

An LIMS system enables a COVID-19 testing center for employees at their workplace.

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

Pending approval of the Pfizer and BioNTech mRNA-based vaccine candidate against SARS-COV-2, the companies will supply the US government with an initial 100 million doses.

CMIC Bio will offer contract development and manufacturing organization services for biopharmaceutical drug substance.

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?