News

This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.

The collaboration will focus on up to three types of lung and gastrointestinal cancers.

The first four investments of the new program will support clinical-stage biotechnology companies while new investments will include companies focused on oncology, rare disease, and inflammation and immunology.

The acquisition significantly expands Precision Medicine Group’s cell and gene therapy expertise.

A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies.

The service uses Hovione’s Intelligent PROprietary Screening methodology to screen for combinations of polymers, drug loads, surfactants, and solvents with an advanced computational tool.

The Altrui Foundation is a non-profit organization that serves as a center point between manufacturers of unused medications and the charitable organizations that seek them.

As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.

CMIC will work to advance decentralized trials in Japan.

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The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.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 vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

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.

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%.