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Clinical / R&D

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Latest From Research & Development

US Researchers Working Toward Universal Coronavirus Vaccine

The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.

Vaccines Manufacturing

Novel Ticagrelor Reversal Agent Wins Place On EMA’s PRIME

Only two of seven recent applications for entry into the European Medicines Agency’s priority medicines scheme for getting treatments for unmet medical needs to patients faster made the grade.

Europe Regulation

For Coronavirus, US FDA Is At The Podium But Not On The Task Force

The FDA is curiously not one of the HHS entities coordinating the US response to the outbreak, but must monitor for manufacturing disruptions and shortages, as well as approve new treatments and diagnostics.

FDA Infectious Diseases

Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point

Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.

Pink Sheet Perspectives User Fees

Gilead's PrEP Research Deal With CDC Is Factor In Outcome Of HIV Patent Suit

Patent board won't review IPR petitions challenging HHS patents, but Gilead says it has additional defenses against government's infringement suit, including a breach of contract claim.

Intellectual Property Legal Issues

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

US FDA’s Medical Countermeasures Initiative authorities like emergency use authorization have not yet had much of an impact on drugs and biologics, but agency is committed to supporting a swift response to the new strain of coronavirus.

Review Pathway Vaccines
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