Published: Mar 15, 2021 By Alex Keown
BSIP/UIG Via Getty Images
With more European countries pausing dosing of
AstraZeneca’s COVID-19 vaccine over concerns about potential blood clotting side effects, Russia is seeking to fill in the gaps with its Sputnik V vaccine.
Kirill Dmitriev, chief executive officer of Russian Direct Investment Fund, which has spearheaded Sputnik V, said RDIF has been coordinating with the governments of Italy, Spain, France and Germany to launch production of Sputnik V. This will bolster supplies of the vaccine to Europe once the preventative medication receives authorization from the European Medicines Agency.
“We are now actively working with EMA as part of the rolling review procedure. In addition, RDIF and partners are ready to start supplies to those EU countries that independently authorize Sputnik V,” Dmitriev said in an email to BioSpace.
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NEW YORK CITY (dpa-AFX) - Today s Daily Dose brings you news about KemPharm scoring regulatory nod for its ADHD drug, expanded FDA approval for Pfizer s Lorbrena, United Therapeutics scrapping the development of Trevyent, Vir Biotechnology closing the enrollment in VIR-7831 arm of ACTIV-3 trial, and Takeda securing global rights to Ovid s investigational medicine Soticlestat.
Read on.
1.KemPharm Scores FDA Nod For ADHD Drug
KemPharm Inc. (KMPH) soared more than 42% on Wednesday, following FDA approval of AZSTARYS (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older.
-3.32% gained 1.3% in premarket trading on Friday, the day after the biotech and GlaxoSmithKline GSK,
+0.36% said they started dosing patients in a late-stage clinical trial for an experimental antibody-based COVID-19 treatment. The Phase 3 study is part of the National Institutes of Health s Accelerating COVID-19 Therapeutic Interventions and Vaccines Program. The companies are testing VIR-7831 in patients who have been hospitalized due to COVID-19 infections. The investigational treatment has the potential to neutralize the virus and kill infected cells, [which] could allow this treatment to be effective for patients in hospital settings, where other antibodies have so far not shown an impact, GSK chief scientific officer Dr. Hal Barron said in a statement. While at least two coronavirus vaccines have showed an efficacy rate of about 95% in clinical trials, making them highly effective at preventing symptomatic forms of the disease, efforts to develop t