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While an mRNA vaccine is still missing, 2021 saw Indian companies strike alliances, battle legal action and gain funding while the regulator played a crucial enabling role in the run up to the approval of eight COVID-19 vaccines from zero in 2020.
Heading into the J.P. Morgan Healthcare conference, pharmas have been focusing on discovery alliances. J&J’s deals look into novel tissue-targeted drugs, ionic liquid delivery technology and cancer vaccine R&D. Lilly teams with Entos on novel methods for delivering neurology drugs.
Chinese firm RareStone licenses Rhythm’s Imcivree in greater China and will help enroll label-expansion studies for the drug. Omeros sells ophthalmic surgery drug Omidria and its commercial team to Rayner Surgical Group.
Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.
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