Just when everyone thought that the worst of the Covid-19 pandemic may be behind us, the emergence of Omicron, a new coronavirus variant, is causing global concern. Detected first in South Africa on November 24, 2021, Omicron cases have now been reported in at least 15 countries.
Can the Omicron variant evade vaccine immunity? Is the new virus more dangerous than its predecessor, i.e., the Delta virus? All this will be known in the coming days and weeks.
Meanwhile, the month of November saw a number of “firsts” on the regulatory front.
On November 12, the FDA approved PharmaEssentia Corp.’s Besremi injection to treat adults with polycythemia vera. Besremi is the first FDA-approved treatment for polycythemia vera that patients can take regardless of their treatment history, and the first interferon therapy specifically approved for polycythemia vera.
AppliedVR received de novo approval from the FDA on November 16 for its prescription-use medical device named EaseVRx to treat chronic low back pain, becoming the first virtual reality provider to receive FDA de novo approval for a pain indication.
BioMarin’s Voxzogo received FDA approval on November 19 to improve growth in children of five years of age and older with achondroplasia, the most common form of dwarfism.
On November 23, the FDA approved Takeda Pharmaceuticals’ Livtencity, the first and only treatment for adults and pediatric patients with post-transplant cytomegalovirus, refractory to conventional antiviral therapies.
Now, let’s take a look at the companies awaiting FDA decision in December.
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