Sidvim LifeSciences Private Limited

  Contents Recent FDA approvals: Fexinidazole General information Revealed: the pharma companies best equipped with AI GSK’s top scientist to quit, become CEO of anti-ageing start-up Intellectual Property Delaware Court held Hikma generic icosapent ethyl does not infringe patents underlying Amarin Pharma’s drug Vascepa Recent FDA approvals: Fexinidazole Fexinidazole was approved for medical use in the United States in July 2021. Fexinidazole was first described in 1978. It was given a positive opinion by the European Medicines Agency in 2018. The development for sleeping sickness was funded by the Drugs for Neglected Diseases initiative in collaboration with Sanofi.  Sleeping sickness is a parasitic disease transmitted by the bite of an infected tse-tse fly. It affects mostly populations living in remote rural areas of sub-Saharan Africa, where about 65 million people are at risk of infection. Left untreated, sleeping sickness is ...

  Contents DMF filings in October 2021 General information Seven drugs likely to hit $1B in annual revenue in the next 5 years WHO recommends two new drugs to treat COVID-19 patients – All you need to know Intellectual Property Fingolimod (Gilenya): CAFC decision DMF filings in October 2021 FDA publishes list of DMF filings at the end of every quarter. We analyse DMFs by Indian companies and other companies. We study molecule selection patten of the company, we try and understand how capable are the companies to handle complex chemistry and regulatory processes. What are the chances of these companies filing ANDA? A lot of information we try to decode by DMF analysis. Every month about 70-80 DMFs are filed and 50% of those could be from Indian companies. Obviously, we cannot present all our findings but glimpses of our finding for the month of DMF filed in October 2021 are as below.  HOLDER SUBJECT Sidvim Comments GLAND PHARMA LTD PROCAINAMIDE HYDROCHLORIDE Three o...

  Contents Patent applications filed by Laurus Labs General information Purdue Pharma can appeal rejection of bankruptcy plan What Sci-Hub’s latest court battle means for research Intellectual Property Formoterol and Budesonide (Symbicort) Federal Circuit affirmed validity and remanded infringement determination of district court Patent applications filed by Laurus Labs We analyse patent applications filed by many companies and assess their development capabilities. We estimate when development would have started for the molecule, stage of the development activity of any particular molecule and try to understand company’s strategy behind that molecule. This week we analysed patent portfolio of Laurus Labs. We studied patent applications filed in last couple of years.  As one would appreciate analysis of all patent applications would be difficult to cover in this newsletter, a glimpse of the analysis is provided in below table.  Publication Number Title  P...