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The companies will develop up to three CD3-engaging T-cell redirecting bispecific antibody therapies using Merus' proprietary Biclonics platform.

ReFIBE sterile cleanroom wipes are sustainable polyester wipes made from recycled post-consumer plastic bottles.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

The CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue.

The new US offices will give the company the ability to support its US-based customers on site while continuing to collaborate with its global team.

Henogen will be integrated into Thermo Fisher’s Pharma Services business within its Laboratory Products and Services segment.

The 40,000-ft.2 facility will feature eight cleanrooms with configurations for the production of cell and viral vector products.

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.

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

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

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.

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.

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.

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.

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.

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.

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 is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.

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

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 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.

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

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 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 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.