BioCentury | Apr 1, 2020
Product Development

A primer on the new coronavirus and COVID-19: BioCentury editors in conversation

The rapid pace at which COVID-19 has transformed society has rippled through the biopharma industry, affecting not only companies’ business strategies, but their product pipelines and priorities as many of them adapt on the fly...
BioCentury | Mar 26, 2020
Product Development

COVID-19 roundup: Grifols partners with BARDA, FDA on convalescent plasma; plus Vir, Sorrento, Ascletis, BMS and Ipsen

On the heels of FDA guidance for compassionate use of convalescent plasma for COVID-19, Grifols announced on Wednesday a partnership with the U.S. government to develop the therapy. Meanwhile, Vir and Sorrento are advancing their...
BioCentury | Mar 23, 2020
Product Development

Time for a 21st Century Manhattan Project

Politics, incompetence and disorganization got us into this mess. Science, solidarity and discipline can get us out of it. There’s already a blueprint for organizing science and industry to overcome an existential threat. It was...
BioCentury | Mar 20, 2020
Product Development

Promoting more effective biotech boards

Most would agree that the board of directors plays an integral role in the success or failure of biotech companies, but exactly what makes one board highly effective and another complacent isn’t always clear. In...
BioCentury | Feb 27, 2020
Politics, Policy & Law

Plotting a scientific path to counter COVID-19

In a global online forum Tuesday night, scientific leaders from companies developing vaccines, therapies and diagnostics to address the COVID-19 outbreak discussed opportunities for collaboration, highlighted challenges, and called for sustained global initiatives to create...
BioCentury | Feb 18, 2020
Politics, Policy & Law

Sharpless' homecoming: the NCI chief's lessons from his time at FDA

NCI Director Ned Sharpless has returned from his seven month stint as acting FDA Commissioner aiming to take on the regulatory hurdles that lie ahead for promising technologies, and seeking ways for NCI's grants to...
BioCentury | Feb 15, 2020
Product Development

WHO mapping out COVID-19 vaccines

Scientists from biopharma companies, universities and regulatory agencies met at the WHO Feb. 11-12 to draw a roadmap for the development of vaccines to protect against COVID-19 amid a rapidly shifting terrain. While knowledge about...
BioCentury | Feb 12, 2020
Tools & Techniques

NCATS, FDA meeting shines light on AAV manufacturing innovation

Technologies highlighted at a NCATS-FDA AAV manufacturing workshop could ramp up the production and durability of gene therapies, but questions remain about who will test drive these innovations and where the next wave of them...
BioCentury | Feb 5, 2020
Regulation

EMA’s plan to integrate real-world data across Europe

One of EMA’s top priorities for incorporating real-world data earlier in the regulatory process is establishing DARWIN, a centralized system that would enable it to obtain harmonized data from healthcare systems across Europe. RWD is...
BioCentury | Jan 25, 2020
Product Development

The race is on to develop therapies and vaccines for the coronavirus outbreak

Public release of the genetic sequence of the coronavirus first detected in Wuhan, China acted as a starter pistol, setting off a race to develop medical countermeasures. Beyond the potential for containing and hopefully eradicating...
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