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Opinion: Another Ebola outbreak, another missed opportunity for preparedness

STAT

When I learned that an outbreak of Ebola was declared in Uganda last fall, I had a flashback to 2014 when I was working at Merck and an outbreak of Ebola disease caused by a different species of the virus emerged in full force in West Africa.

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STAT+: Pharmalittle: Biogen hires Viehbacher as its CEO; new dengue vaccine rolled out amid safety concerns

STAT

 But he was ousted in 2014 after an embarrassingly public conflict with the Sanofi board. At Sanofi, Viehbacher was largely responsible for repositioning the staid drugmaker and for deepening its partnership with Regeneron Pharmaceuticals. But Continue to STAT+ to read the full story…

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STAT+: Pharmalittle: We’re reading about a Novo weight loss study, a GSK vaccine failure, and more

STAT

No medications are currently approved for the treatment of obesity in children under age 12, though Saxenda was approved for adolescents in 2020 and for adults in 2014. While there were no safety concerns, the trial for a therapeutic vaccine to treat the herpes simplex virus failed to meet its efficacy objective.

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The imperative of fridge-free vaccines

European Pharmaceutical Review

Many of today’s vaccines are produced in ready-to-inject liquid formulations that must be kept cold to maintain stability. However, this greatly complicates both the worldwide distribution and stockpiling of vaccines and other drugs. A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient.

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GlobalData tracks 40 yrs of innovation in USFDA review designations

Express Pharma

This period included the implementation of novel designation types: qualified infectious disease product designation (in 2012), breakthrough therapy (2013), rare pediatric drug designation (2014), and regenerative medicine advanced therapy designation (2017). In 2020, the number of designations awarded reached a peak of 694.

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Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law Blog: Biosimilars

The Tropical Disease PRV program was born the very next year as part of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and expanded in 2014 , which experts heralded as a game-changer for tropical disease therapies.

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10,000 whole genome samples made accessible globally

Express Pharma

The data will serve as a foundation for cutting-edge research and will catalyse innovations in areas such as mRNA-based vaccines, protein manufacturing, and genetic disorder treatments. The Minister also pointed out that India is the largest vaccine producer in the world and the third-largest startup ecosystem.

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