Agency Alerts
General Regulatory
May 25, 2017
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)....
Agency Alerts
General Regulatory
May 16, 2017
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...
Agency Alerts
General Regulatory
May 11, 2017
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...
Agency Alerts
General Regulatory
May 5, 2017
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...
Agency Alerts
General Regulatory
May 4, 2017
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...
Agency Alerts
General Regulatory
May 2, 2017
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...
Agency Alerts
General Regulatory
May 1, 2017
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...
Agency Alerts
General Regulatory
April 27, 2017
FDA Approves 5th Biosimilar Product
On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab)....
Agency Alerts
General Regulatory
April 25, 2017
FDA Mandates Texas & Arizona to Destroy or Export Lethal Injection Drugs
On Thursday, April 20th, the FDA formally ordered both Texas and Arizona to refuse and either destroy or export all execution drugs within 90 days. Background Texas was the first state to begin...