Sidvim LifeSciences Private Limited

  Content DMFs filed in April 2021.  General information.  Delhi HC creates Intellectual Property Division to deal with IPR cases .  Merck scores a win in bellwether Zostavax case, but nearly 2,000 remain .  Intellectual Property.  T 1326/18 of 22.4.2021, Board of Appeals decision for Natco’s α2 crystalline form of Imatinib Mesylate .  DMFs filed in April 2021   In SIDVIM, we analyse DMF filings by Indian companies every quarter. This week we analysed DMFs filed in the month of April 2021. This newsletter will run into several pages if we write about all DMFs, hence only few representative cases are presented here  HOLDER SUBJECT SIDVIM Comments HETERO DRUGS LTD FAMOTIDINE Old API, 11 active DMFs, molecule is still showing some pickup in 2021. 3 DMFs filed in last 6 months! DIVIS LABORATORIES LTD ORLISTAT Complex synthesis if started from basic chemicals. Not many DMFs. ALIVIRA ANIMAL HEALTH LTD (A GROUP CO OF SEQUENT SCIENTIFIC LTD) ALBENDAZ...

  Content API development activities by Piramal  General information.  Chronic Wounds Pipeline Drugs and Companies Insight Report: Analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments .  Pfizer, Sanofi’s Pharmaceutical Rebate Suits Get on FTC’s Radar .  Intellectual Property.  Tavaborole Attorney fee reimbursement litigation .    API development activities by Piramal Piramal Pharma Solutions, as per their website, their R&D team develops novel/non-infringing process for APIs and is supported by a state-of-the-art, ‘best in class’, analytical research capabilities. We tried to dig into their development portfolio using Import/Export database. Piramal has several development centers at different location across the globe.  We attempted to map development activities as per their locations. Below are the glimpses of our analysis, some probable development activities of the center/(s) located n...

  Contents FDA approvals in May 2021.  General information.  Lonza bags three deals in one week .  Here’s how pharma companies can leverage digital to market better .  Intellectual Property.  Degarelix claims construction .  FDA approvals in May 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 wit...