BioPharm International Editors

The 17,000 m2 facility will serve as a process development and manufacturing site for Chinese companies developing medicines as well as multinationals with manufacturing requirements in China.

CMIC will work to advance decentralized trials in Japan.

Acorda’s Chelsea, MA facility will serve as a global center of excellence in the Catalent network for spray-dried dispersion and dry powder encapsulation and packaging.

Under the terms of the agreement, operations will be initiated at Lonza’s Houston, TX Center of Excellence where Lonza will handle process development activities for late-clinical and commercial-scale GMP manufacturing of the cell therapy.

The acquisition will give Sanofi full global rights to KY1005, Kymab’s fully human monoclonal antibody that binds to OX40-Ligand, giving it the potential to treat a variety of immune-mediated diseases and inflammatory disorders.

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

A strategic separation is designed to enhance the value and growth of Paraxel’s contract research services and Calyx’s imaging businesses.

WuXi STA served as the marketing authorization holder (MAH) and offered end-to-end support, including drug substance, amorphous solid dispersion, tablet, and packaging for the product.

The company plans to expand its global production capacity across six existing manufacturing facilities in Europe and the United States, as well as a new manufacturing facility in the US.

Bayer will support the development and supply of CureVac’s COVID-19 vaccine candidate, CVnCoV.

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement.

The new facility, which will be operated by Fujifilm Diosynth Biotechnologies, will provide large-scale cell-culture manufacturing of bulk drug substance with 8 x 20,000-L bioreactors.

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

Avacta Group has entered into a license agreement with POINT Biopharma, granting access to its pre|CISION technology for the development of tumor-activated radiopharmaceuticals.

Intravacc and Cristal Therapeutics have entered into a strategic collaboration for the development of novel vaccine programs against human diseases.

The collaboration will utilize ViGeneron’s novel engineered AAV capsids, vgAAV, to transduce retinal cells with intravitreal injections for an undisclosed target.

The transaction will include operations located at different Novasep sites, including its Pompey, France site and sites in the United States, China, and India.

The new facility, to be located in Boston, MA, will contain experimental and analytical equipment for viral vector and advanced therapy process development and will expand the CDMO’s manufacturing capacity.

Angelini will obtain an exclusive license to commercialize Arvelle’s investigational anti-seizure medication, cenobamate, in the European Union and other countries in the European Economic Area.

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%.

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

Honeywell will use Sparta’s expertise to introduce new QMS solutions for life sciences to its customer base.

The companies have entered into an agreement to support the formulation and fill/finish of Moderna’s COVID-19 vaccine supply outside of the United States.

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

The guidance provides information on review timelines during the COVID-19 pandemic.