Articles

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

FDA Publishes COVID-19 Pandemic Recovery and Preparedness Plan Summary Report 

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.

Cytiva Delivers Chinese Biomanufacturing Facility to Lonza

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

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. 

FDA Struggles to Fend Off Further Attacks from Trump Administration

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.

Hovione Launches Screening Service for Spray Dried Dispersions

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.

New Jersey Students Launch Foundation to Transfer Unused Medications to Communities in Need

CMIC will work to advance decentralized trials in Japan.

CMIC Joins DTRA as a Founding Company

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.

Catalent to Acquire Acorda Therapeutics’ Manufacturing and Packaging Operations

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. 

Sanofi to Acquire Kymab for $1.4 Billion

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.

Lonza to Partner with Capricor Therapeutics for the Development of Duchenne Muscular Dystrophy 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.



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