The National Institute of Standards and Technology (NIST) released for public comment a “Draft Interagency Guidance Framework for Considering the Exercise of March In-Rights” (“March-In Framework”) on December 8, 2023...more
2/5/2024
/ Bayh-Dole Act ,
Biden Administration ,
Comment Period ,
Competition ,
Drug Pricing ,
Healthcare ,
Healthcare Reform ,
Inventions ,
March-in-Rights ,
NIST ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Public Comment
The Federal Trade Commission (FTC) issued a policy statement on September 14, 2023, stating that “[b]rand drug manufacturers may be harming generic competition through the improper listing of patents in the Food and Drug...more
12/5/2023
/ Competition ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 5
On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) to Pharmacyclics LLC. Imbruvica® is the...more
On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone antibiotic, Baxdela® (delafloxacin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Approval...more