Articles By Cyndi Root

1. Weekly FDA Enforcement Report For Drugs 10/1/14 10/6/2014

   The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for October 1, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification. 

2. Drug Shortages: Actavis, Janssen, Teva, Sandoz, And More — 10/2/14 10/6/2014

   The Food and Drug Administration (FDA) has published its new and updated list of Drug Shortages through 10/2/14. The federal agency publicizes recalls on its website as press releases are not issued for all shortages. View the recalls by New and Updated.

3. Weekly FDA Enforcement Report For Drugs 9/10/14 9/15/2014

   The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for September 10, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification.

4. Weekly FDA Enforcement Report For Drugs 9/3/14 9/9/2014

   The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for September 3, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification. 

5. Weekly FDA Enforcement Report For Drugs 8/27/14 9/4/2014

   The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for August 27, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification. 

6. Recipharm Invests In Isofol And Chemotherapeutic Agent Modufolin 8/28/2014

   Recipharm has announced in a press release that it has invested SEK 8 million ($1 million) in Isofol Medical AB and has agreed to collaborate on Isofol’s lead drug candidate Modufolin. The biomodulator has shown promise in increasing the efficacy of chemotherapeutic agents and decreasing the side effects.

7. Novo Nordisk Acquires Manufacturing Facility From Olympus Biotech 8/28/2014

   Novo Nordisk announced in a press release that it has acquired a manufacturing facility in West Lebanon, New Hampshire, from Olympus Biotech. Primarily used for mammalian cell manufacturing, all production ceased at the site early in 2014. Novo Nordisk will produce active pharmaceutical ingredients at the facility for its biopharmaceutical products. The two companies did not disclose the financial terms of the transaction.

8. New and Updated Drug Shortages List 8/27/14 8/28/2014

   The Food and Drug Administration has published its new and updated Drug Shortages through 8/27/14. The federal agency publicizes recalls on its website as press releases are not issued for all shortages. View the recalls by New and Updated.

9. Weekly FDA Enforcement Report For Drugs 8/20/14 8/22/2014
   The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for August 13, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action.
10. U.K.’s NICE To Re-Review Ferring’s Firmagon 8/21/2014
    Ferring Pharmaceuticals confirmed the U.K.’s National Institute for Health and Care Excellence (NICE) Appeals Panel has upheld Ferring’s appeal regarding Firmagon (degarelix). The panel listened to Ferring’s oral arguments at a hearing in London and agreed that the agency’s Final Appraisal Determination (FAD) was improper. Appeals by the British Uro-Oncology Group (BUG) and Tackle Prostate Cancer were also upheld.