New FDA Approvals, Biosimilars Highlight SPT Week in Review


Top news of the week from Specialty Pharmacy Times.

5. Investigational Drug Reduces Cluster Headache Attacks in Phase 3 Study

Eli Lilly’s investigational drug for the prevention of episodic cluster headache met its primary endpoint in a phase 3 study. Read more.

4. FDA OKs Truvada to Reduce HIV Risk in Adolescents

Gilead Sciences, Inc. announced that the FDA approved once-daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Truvada) in combination with safe sex practices, to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. Read more.

3. Biosimilars: The Last 'Patent Dance'

In an unprecedented unanimous ruling on June 12, 2017, the Supreme Court ruled that biosimilar drug manufacturers applying for approval from the FDA “may provide notice of commercial marketing to the branded biologic drug manufacturer before obtaining a license.” Read more.

2. Novel Preventive Migraine Treatment Gains FDA Approval

Officials with the FDA have approved erenumab-aooe (Aimovig, Amgen) for the preventive treatment of migraine in adults, making it the first approved preventive migraine treatment of its kind. Read more.

1. FDA Approves Epoetin Alfa Biosimilar

The FDA granted approval to epoetin alfa-epbx (Retacrit) as a biosimilar—not an interchangeable drug—to epoetin alfa (Epogen/Procrit). Read more.

Related Videos
male pharmacist using digital tablet during inventory in pharmacy | Image Credit: sofiko14 -
Pharmacist holding medicine box in pharmacy drugstore. | Image Credit: I Viewfinder -
Pharmacy Drugstore Checkout Cashier Counter | Image Credit: Gorodenkoff -
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk -
Capsules medicine and white medicine bottles on table | Image Credit: Satawat -
Human cell or Embryonic stem cell microscope background | Image Credit: Anusorn -
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg -
Biosimilar pharmaceutical drug bottle on blue background. | Image Credit: Carl -
© 2024 MJH Life Sciences

All rights reserved.