With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more
2/10/2025
/ BPCIA ,
Hatch-Waxman ,
Healthcare Reform ,
Legislative Agendas ,
New Legislation ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Proposed Legislation ,
USPTO
On November 21, 2023, the FDA published its final rule changing how prescriptions medicines are advertised to consumers. The FDA first issued its proposed rule in 2010, which subsequently went through three public comment...more
11/30/2023
/ Advertising ,
Direct to Consumer Sales ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Marketing ,
Misleading Impressions ,
Pharmaceutical Industry ,
Prescription Drugs ,
Television Commercials
On October 9, 2017, California Governor Jerry Brown signed the new drug price transparency bill SB 17. The new law requires pharmaceutical companies to give 60 days’ notice to state and health insurers if they plan to raise...more
The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose cancers have a specific genetic feature (biomarker). The FDA has traditionally approved cancer treatments...more
On December 23, 2016, the U.S. Food and Drug Administration approved SPINRAZA™ (nusinersen), an antisense oligonucleotide directed to survival motor neuron-2 (SMN2) transcripts for the treatment of spinal muscular atrophy...more