Sidvim LifeSciences Private Limited

  Contents FDA approvals in September 2022 General information Advaxis enters merger deal with biotech firm Ayala Drugs Should Be Priced Based On One Factor – Value Intellectual Property FDA approvals in September 2022 On 29 September 2022 FDA approved RELYVRIO. A new treatment for amyotrophic lateral sclerosis, or ALS. It is developed by Amylyx Pharmaceuticals. This oral medication can be taken as a standalone therapy or with other treatments, according to the company, and it has been shown to slow disease progression. But there’s still some uncertainty about the drug’s efficacy. Amylyx’s submission for approval is based on data from a small Phase 2 trial, and the FDA’s own advisory committee initially voted this spring that the data didn’t show that the drug was effective, before changing its opinion this month. A larger Phase 3 study is still underway. As per the press release, the 28-day prescription of RELYVRIO will be priced at $12,504, about $158,000 per year before in

  Contents Patent filings by Alembic General information Seven Trends Shaping the Future of Pharmaceutical Formulation Development Making pharmacy more sustainable Intellectual Property Rifaximin tablet composition patent revoked by EPO Patent filings by Alembic We analyse IP portfolio of many Indian companies. This week we analysed patent portfolio of Alembic Pharmaceuticals Limited. Some of our observations are as below. Publication Number Sidvim comments WO2019150253A1 The invention relates to solid state forms of Venetoclax, particularly relates to alkali metal salt and/or DMF solvate form of Venetoclax or its salt. It claims the process for the preparation Venetoclax crystalline forms. Venetoclax was approved in 2016. Alembic filed DMF in 2019 and must be using this process in their DMF filings WO2022090953A1 The invention relates to pharmaceutical compositions comprising a solid dispersion of ponatinib. It further claims the process of preparation of such compositions

  Contents FDA approvals: Futibatinib General information Zydus gets USFDA nod, 180 days shared exclusivity for Brivaracetam Merck KGaA says it'll consider 'larger-scale' acquisitions from 2023 onward Intellectual Property CAFC affirmed PATB (Board) decision in Sitagliptin FDA approvals: Futibatinib We follow FDA approvals, specifically small molecules. We study chemistry, a brief IP landscape.  Futibatinib is a kinase inhibitor with the chemical name 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]- 1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]prop-2-en-1-one. It has the following chemical structure:  Futibatinib is a white crystalline powder. The solubility of futibatinib is pH dependent with decreasing solubility with increasing pH, being practically insoluble at pH 3 or higher. Futibatinib  can be synthesized using the procedure described in WO 2013108809, in which futibatinib is described as example 2. The filing date of WO2013108809 is 17 January 20