The recent decades have shown an accelerated development and evolution in the technology world, leading to unexpected growth in digital health companies. With the aid of health information technology, wearable […]readmore
Shots: In H1’21, Celltrion plans to initiate P-III trial for CT-P41 and is expected to commercialize in Feb 2025 when Amgen’s patents for Prolia expire in the US Celltrion is […]readmore
Shots: The US FDA has approved Evrysdi to treat SMA in adults and children ≥ 2mos. The approval is based on two clinical studies designed to represent a broad spectrum […]readmore
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Cadila expanded its footprints in India with the launch of its two […]readmore
Shots: The new agreement involves, Daiichi to get royalties on sales of Movantik plus payments each year starting from 2021 to 2023. RedHill to take care of all the responsibilities […]readmore
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it The outbreak of the respiratory disease was first detected […]readmore
Shots: Sangamo to receive $75M upfront within 30 days, $720M milestone payments including up to $420M in development milestones and up to $300M in commercial milestones plus royalties on sales […]readmore
Shots: The P-III EMPEROR Trial involves assessing of Jardiance (10 mg) vs PBO in two studies EMPEROR-Reduced [NCT03057977, N=3,730] & EMPEROR-Preserved [NCT03057951, N=5,990] in patients with HFrEF & HFpEF respectively […]readmore
Shots: The BT designation is based on P-III ADAURA trial which involves assessing Tagrisso (80 mg) vs PBO in 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete […]readmore
Biosimilars
Regulatory
Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval
Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed […]readmore