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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.

Vaccines 150
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J&J ducks out of Bavarian Nordic vaccine partnerships

pharmaphorum

Johnson & Johnson has halved the size of its collaboration with Bavarian Nordic on vaccine development, jettisoning its stake in shots targeting human papillomavirus (HPV) and hepatitis B virus (HBV). The aim of both alliances was to study MVA-BN in a prime-boost vaccine regimen with Janssen’s own AdVac vaccine technology.

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Acuitas Files Suit Against CureVac Alleging Incorrect Inventorship on COVID MRNA-LNP Vaccine Patent Family

Big Molecule Watch

Patents related to COVID-19 mRNA-LNP vaccines and assigned to CureVac, namely U.S. Acuitas goes on to state that “Acuitas and CureVac have been collaborating on therapeutics that use Acuitas’s LNP technology since 2014. (“Acuitas”) filed a complaint on November 13 against CureVac in the U.S. Patent Nos. The case (C.A.

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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.

Vaccines 111
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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.

Vaccines 104
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West Africa prepares for Ebola vaccination program

pharmaphorum

A global emergency stockpile of Ebola vaccine is being deployed to curb the epidemic, although experts are confident that synergies in public health practises will ensure a rapid response to both. During the 2014-2016 Ebola outbreak, Guinea was one of the worst impacted countries and saw more than 2,543 deaths. “Our

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Trying to get clarity on CDF and VPAS and implications for the IMF

pharmaphorum

Exemptions include exceptional central procurements, centrally procured vaccines, small company sales, and low-value sales (when the NHS list price is less than £2). The PPRS changed over time, and the 2014 PPRS first introduced a cap to NHS branded medicines spending delivered via rebates. No mention of the CDF is in the annexes.