Pink Sheet

HIV PrEP Patent Dispute Escalates As HHS Files Suit Against Gilead

By Mandy Jackson 27 Nov 2020

Trump administration wants the HIV drug maker to license HHS patents related to pre-exposure prophylaxis. Lawsuit follows Gilead’s request in August for the USPTO’s PTAB to conduct an inter partes review of the four-year-old patents.

Topic Infectious Diseases

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Health Sector On High Alert As Wuhan Coronavirus Spreads

By Brian Yang 27 Nov 2020

The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”

Topic China Infectious Diseases Policy & Regulation Coronavirus

Pink Sheet

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

By Derrick Gingery 27 Nov 2020

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.

Topic FDA Vaccines Infectious Diseases Coronavirus

Pink Sheet

Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives

By Bridget Silverman 27 Nov 2020

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.

Topic Infectious Diseases Vaccines Coronavirus

Pink Sheet

China Coronavirus Outbreak Response Critical As First US Case Confirmed

By Brian Yang 27 Nov 2020

A quickly spreading coronavirus outbreak in China could upend the country’s healthcare priorities as the health regulators and reimbursement agency officials gear up to “control and prevent” the worst public health emergency since the deadly SARS outbreak in 2003.

Topic China Coronavirus Infectious Diseases Policy & Regulation

Pink Sheet

Stress Test: Coronavirus Challenges China Emergency Approval Mechanism

By Brian Yang 18 Feb 2020

72 Products Approved Under Expanded Emergency Pathway A regulatory pathway set up in China post-SARS is under stress test in the latest coronavirus outbreak, while emergency measures adopted by the country's regulator mean it’s much less burdensome to obtain approvals than before.

Topic Regulation Infectious Diseases Coronavirus

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Moderna Inovio Coronavirus Vaccine Candidates Fast-Tracked By International Coalition

By Andrew McConaghie 30 Jan 2020

The Coalition for Epidemic Preparedness Innovations adds new deal with mRNA specialist Moderna for rapid development of coronavirus vaccine.

Topic Company Analysis Coronavirus Infectious Diseases Vaccines

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O’Day Lays Out Plan For Gilead’s Continued HIV Dominance

By Joseph Haas 15 Jan 2020

Biktarvy’s powerful sales growth and the potential of a first-in-class capsid inhibitor in both prevention and heavily treatment-experienced patients are key to Gilead’s plan for staying on top in HIV.

Topic Business Strategies Infectious Diseases Life Cycle Management

Topic immuno-oncology Infectious Diseases