FDA Law Blog: Biosimilars
JUNE 8, 2023
The pandemic had changed the way people live, work and communicate. Department of Health and Human Services declared the long-awaited end of the federal COVID-19 Public Health Emergency. Such changes are not limited to personal circumstances. The pandemic also deeply impacted how industry and the government conduct their operations.
Viseven
JUNE 12, 2023
from 2022 to 2027. Though South Korea is the third largest biopharma innovation hub, Suyoung admits that local pharma companies have low HCP engagement rates because marketers still use traditional methods of communication such as email, phone calls, and face-to-face visits. And it makes sense.
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FDA Law Blog: Biosimilars
JUNE 7, 2023
Recall that CMS will require manufacturers of selected drugs to negotiate a maximum fair price (“MFP”) with the agency according to the following timeline (the dates apply from applicable year 2027 onwards). Second, Merck argues that the parody of a negotiation and a fair price compels speech in violation of the First Amendment.
European Pharmaceutical Review
NOVEMBER 2, 2022
The report suggested health research is a key area for R&D investment to align activity with broader social goals, communicate a clear strategic direction and improve R&D funding by crowding novel investment. . The government would need to invest an extra £1 billion in R&D by 2027. billion over a decade.
FDA Law Blog: Biosimilars
JUNE 14, 2023
In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).
Putting Patients First Blog
JANUARY 10, 2024
Failure to Reconcile (FTR) Process: The NHC views the proposed changes to the FTR process positively as safeguarding consumers’ health coverage access, particularly for those with chronic conditions, by enhancing education, aligning with consumer protection principles, and ensuring clarity and accessibility in communication strategies.
PharmaShots
FEBRUARY 22, 2023
In the US, Trulicity is protected by a compound patent (2027) and by biologics data protection (2026).
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