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API and IP Newsletter

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  Contents FDA approvals in April 2021.  General information.  Chinese patent reforms to bolster pharma innovation .  Private investment in the healthcare industry: The road ahead . Intellectual Property.  APIXABAN formulation patent decision by EPO ..    FDA approvals in April 2021   Every month we follow approvals by USFDA and comment about processes followed to manufactured small molecule APIs.  No. Drug Name Active Ingredient FDA-approved use 1 Lybalvi Olanzapine/Samidorphan To treat schizophrenia in adults and certain aspects of bipolar I disorder in adults 2 Truseltiq Infigratinib To treat adults with cholangiocarcinoma whose disease meets certain criteria 3 Lumakras Sotorasib To treat adults with non-small cell lung cancer whose disease meets certain criteria 4 Pylarify Piflufolastat F 18 Injection For positron emission tomography imaging of prostate-specific membrane antigen-positive lesions in men with prostate cancer 5 Rybrevant Amivantamab-vmjw To treat adults with subset of

API and IP Newsletter

Contents   Bromo derivatives used in early stage of development  General information.  Biophore applies to DCGI for emergency-use approval for COVID-19 treatment drug . China on the Move: An Improving Regulatory Landscape with New Challenges Ahead –Genomics and National Security.  Intellectual Property.  Claim construction decision by NJ Court about Levomilnacipram ..  Bromo derivatives used in early stage of development In our firm we analyse import/ export database. We analysed several types of compounds, usually required in API manufacturing. We study import databases to understand development progress of many Indian Gx companies. In our assessment, bromination and manufacturing of bromo derivatives would always be a challenge for Indian manufacturers. The most of bromo derivatives are being imported from China. We listed several bromo derivatives which are being imported by Indian companies for their APIs which are under development. In this news article, we are providing glimpses