Drug Approval | March 21, 2022
Alembic Pharmaceuticals receives USFDA approval for Lacosamide tablets
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
The tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older
mRNA-based therapies involve the administration of mRNA in patients so that patients' own cells can produce the encoded therapeutic antibody
Under the agreement, Lonza will deliver cGMP-standard drug substance for clinical supply
If the government feels that the industry is not complying with the uniform code, it will consider making it a statutory code
Under the agreement, both companies will conduct collaborative research utilizing NuclixBio's proprietary circular mRNA platform named 'ringRNA’ to develop novel mRNA therapeutics that can generate PharmAbcine's antibodies
This is the sixth successful USFDA audit for this facility
The focus is to build collaborative learning and sharing ecosystem
A growing portfolio of chemicals is part of a larger quality management system that sets new standards in bioprocessing
RNA, cell & gene therapies, artificial intelligence, CRISPR and oncology-related deals dominate the landscape
Amit Jaju, Senior Managing Director, India in an interview with Thomas C Thottathil outlined the steps Indian pharma companies should follow to be compliant with global regulatory requirements
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