thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

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...

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