Clinical Research Solutions
US Opioid Epidemic: NDA for Drug to Treat Opioid Use Disorder Submitted to FDA
On Tuesday, May 30th, Indivior Plc., a British company focused on addiction treatment, submitted a New Drug Application (NDA) to the FDA for its investigational drug intended to treat...
Clinical Research Solutions
FDA Warns Drug Manufacturers of Recalls due to BCC Contamination
On Monday, May 22nd, the FDA issued a warning for drug manufacturers regarding the contamination risk posed by Burkholderia cepacia complex (BCC). According to FDA’s warning, “BCC and other...
Clinical Research Solutions
FDA Approves 1st Drug to Treat Cancer Based on Genetics of Tumor, Not Location
On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker)....
Clinical Research Solutions
FDA Approves New Drug to Treat ALS
Anyone who was on social media in the summer of 2014 knows what the Ice Bucket Challenge was. Videos of people completing the challenge littered most people’s social media feeds, all in hopes of...
Clinical Research Solutions
NSAID Products Linked to Increased Risk of Heart Attack, Claim New Study Results
According to a recent study published in The BMJ, people who take nonsteroidal anti-inflammatory drugs may have a higher risk of suffering from myocardial infraction (i.e., a heart attack) than...
Clinical Research Solutions
FDA Approves New Drug for Advanced Bladder Cancer
On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab). Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or...
Clinical Research Solutions
CREATES Act Reintroduced in House & Senate
On Thursday, April 27th, the “Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act was reintroduced by members of the Senate & House Judiciary Committees. The CREATES Act is a...
Clinical Research Solutions
Clinical Quality Systems & the Outsourced Model
The landscape of clinical trials is evolving. The changes that are happening are due to the increased number of FDA-regulated trials, as well as a rise in the complexity of clinical protocols. As...
Clinical Research Solutions
FDA Approves First Drug for a Form of Batten Disease
On Thursday, April 27th, the FDA announced the approval of Brineura™ (cerliponase alfa). Brineura, manufactured by BioMarin International Ltd., is an infusion indicated for the treatment of...
Clinical Research Solutions
FDA Warns 14 Companies for Illegally Selling Fake Drugs Claiming to Cure Cancer
On Tuesday, April 25th, the FDA released warning letters that were recently issued to 14 US-based companies. These warning letters were issued with regards to the illegal sale of products that claim...