Celularity has gained FDA clearance for its investigational new drug application for its natural killer cell therapy CYNK-001 designed to treat glioblastoma multiforme. The company announced plans to launch their first-in-human clinical trial in the US to test CYNK-001 in patients with relapsed glioblastoma multiforme.
Moderna has gained funding from the Coalition for Epidemic Preparedness Innovations to accelerate the development and manufacture of an mRNA vaccine to be used in combating the novel coronavirus dubbed 2019-nCoV that is causing an epidemic in China. The National Institute of Allergy and Infectious Diseases is collaborating with Moderna for the vaccine's design and will be handling studies that will lead to the filing of an investigational new drug application and an early-stage clinical trial.
PACT Pharma gained $75 million from a Series C financing round that will be used to support its expansion plans to boost the company's cell therapy manufacturing capacity.
Results from the annual State of the Industry poll conducted by the American Fruit Grower found that a majority of farmers, 53.9% of those surveyed, believe in man-made climate change, but data showed varying results when asked if they would grow biotech crops if these were made available to them. Of those surveyed, 49% said they would not grow a biotech crop, but 47.5% said they would, with 33.8% of those who responded affirmatively indicating they would grow such crops if these provided production advantages to the farmer.
The FDA has issued final guidances on drug-drug interaction testing using both clinical and in vitro studies. "Together, the two final guidances describe a systematic risk-based approach to evaluation and communication of DDIs," the agency said.
The FDA launched a challenge to urge the public to develop computational algorithms that can be used to automatically detect adverse event anomalies using publicly available data.
Certain cornbread dressing and bread stuffing distributed to nine states are being recalled by Savannah Food Company due to possible Listeria monocytogenes contamination.
A bipartisan group of senators introduced a bill called The Resources to Prevent Youth Vaping Act that would require e-cigarette manufacturers to pay user fees to the FDA. The user fees would be used to improve oversight of the vaping industry and raise awareness on the dangers of vaping.
Misonix is offering 1.62 million shares of its common stock at $18.50 each in hopes of raising $30 million in gross proceeds. The offering is available until Jan. 27, and net proceeds will be used for corporate purposes including sales and marketing.
A round of financing has brought in $26 million for Israel-based digital X-ray device manufacturer Nanox. The company, which now has around $55 million in total funding, will use the proceeds for the development, commercialization and deployment of its two-pronged system that includes the Nanox.ARC in-hospital device and the Nanox.Cloud companion cloud software platform.