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The House Appropriations Committee has signed off on a fiscal 2021 measure that would give the FDA $3.2 billion in funding, an increase of $40.8 million from fiscal 2020, and give the agency power to require recalls. The legislation is now headed to the full House for consideration, although no date has been set. Read More
Moderna has tapped Spanish pharma company Laboratorios Farmacéuticos Rovi to conduct large-scale, commercial fill-finish manufacturing of its COVID-19 vaccine candidate in order to bolster international supply. Read More
More than 20 leading drugmakers have teamed up on a new program to develop innovative antibiotics in the coming decade to help curb the global threat of antibiotic-resistant infections. Read More
The FDA issued a warning letter to active pharmaceutical ingredient (API) manufacturer Vega Life Sciences for violations of good manufacturing practices (cGMP) at its facility in southern India. Read More
A new clinical trial network formed by the National Institute of Allergy and Infectious Diseases (NIAID) aims to accelerate COVID-19 vaccine research by using a standardized protocol to test multiple vaccine candidates, allowing results of the trials to be compared more easily. Read More
Merck and Eisai have received a complete response letter (CRL) from the FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read More
Chinese drugmaker Clover Biopharmaceuticals has received a $66 million investment from the Coalition for Epidemic Preparedness Innovations (CEPI) to support clinical development and manufacturing of its candidate COVID-19 vaccine. Read More