Category: Bharat Biotech

  • PharmaShots Weekly Snapshots (July 05 – 09, 2021)

    Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene Therapy, GM1 Gangliosidosis Jazz’s Vyxeos (daunorubicin and cytarabine liposome) for Injection Receives Health Canada Approval for the Treatment of High-risk Acute Myeloid Leukemia Published: July […]

  • Ocugen preps filings for COVID-19 vaccine Covaxin on new data

    Armed with new data from its development partner Bharat Biotech, Ocugen is planning to press ahead with plans to file for approval of their COVID-19 vaccine Covaxin in the US and Canada. Covaxin has already been approved for restricted emergency use in India, getting the green light in January months before the final results from […]

  • PharmaShots Weekly Snapshot (Nov 16-20, 2020)

    Eli Lilly and Incyte Receive FDA’s EUA for Baricitinib + Remdesivir to Treat Hospitalized Patients with COVID-19 Published: Nov 20,2020 | Tags: baricitinib, COVID-19, Eli Lilly, Emergency Use Authorization, FDA’s, Incyte, receives, Remdesivir Novartis Signs a License Agreement with Mesoblast to Develop and Commercialize Remestemcel-L for ARDS Published: Nov 20,2020 | Tags: Agreement, ARDS, Commercialize, […]

  • Bharat Biotech Initiates P-III Study for Covaxin Against COVID-19

    Shots: Following the successful completion of the interim analysis from the P-I & P-II clinical trials of Covaxin, the company has received the DCGI approval to conduct a P-III study of its COVID-19 vaccine The study will assess Covaxin (6mcg, IM at an interval of 28days) vs PBO in ~26,000 volunteers in a ratio (1:1) […]

  • Insights+ KOL Articles: The New Normal and Covid-19 Vaccine Development

    Since the virus outbreak in China, all eyes are on the most awaited Covid-19 vaccine offering a glimmer of hope. Abide by social distancing, wearing a mask, and frequent hand washing – until we have a vaccine. This new mantra amidst all misery has created hope in the hearts of many. We have to accept […]