The chief of AstraZeneca Pascal Soriot said during the Big Pharma’s financials this morning that he wants a “science-led FDA” as President Donald Trump’s administration looks to slash regulations, and potentially staff, from across the agency.
In the Q4 update call to journalists and analysts, Soriot said: “We actually believe in a strong, science-led FDA. We are a science-led organization that thrives to hit high scientific standards and so we would expect the FDA to be well staffed and focused also on those standards.”
But he said that there are always opportunities to “do things better” and so “we continue to engage with the FDA to do what that have done very successfully in oncology over the past few years, which is finding new pathways to accelerate approvals of new drugs or indications.
“If you look back over the past few years, quite a number of breakthroughs in cancer in oncology have been brought to patients in the U.S., and the oncology department [from the FDA] has been trailblazing from the point of view.”
He cautioned that there is a limit to “how fast we can go in doing those things well.”
This comes as Trump sat down with a number of Big Pharma chiefs earlier this week and said he was seeking to cut down on regulations at the FDA, and was also likely to, as part of a broader hiring freeze across the country for federal employees, reduce headcount at the agency in the coming years through attrition.
Trump said at the meeting: “We’re going to get rid of a tremendous number of regulations. We’re going to be cutting regulations like nobody has ever seen before. And we’re going to have tremendous protections for the people, perhaps even more protections for the people. We’re going to streamline the FDA.
“We have a fantastic person [to lead the Agency] that I think I will be naming very soon. We’re going to streamline the FDA. You’re going to get your products either approved or not approved but it’s going to be a quick process. It’s not going to take 15 years.”
This was largely backed by biopharma groups BIO and PhRMA, but was criticized by U.S. lawmakers.
By Ben Adams
Source: Fierce Biotech
CureVac and the University of Texas’s MD Anderson Cancer Center have announced a co-development and licensing agreement to develop novel messenger ribonucleic acid (mRNA)-based cancer vaccines. The strategic collaboration will focus on the development of differentiated cancer vaccine candidates in selected haematological and solid tumour indications with high unmet medical needs.
FUJIFILM Corporation is planning to invest $1.2 billion to expand the planned FUJIFILM Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina, US. This news follows the organisation’s announcement of a $2 billion investment in the facility in March 2021. This additional financial boost totals the investment to over $3.2 billion, FUJIFILM confirmed.
Sanofi’s global restructuring and downsizing is now fully underway, with layoffs stretching to the company’s Belgian offices. Belgian newspaper De Tijd reports that 67 employees have been laid off at a site in Ghent and 32 jobs are on the chopping block at Sanofi’s Belgium HQ in Diegem.
