Shots: The initiation of the post-exposure prophylaxis clinical trial follows Korean MFDS’ IND approval on Oct 08, 2020 The study will assess the preventive effect & safety of CT-P59 in […]readmore
Tags : Launch
Shots: Roche plans to launch a high-volume SARS-CoV-2 Antigen test to aid the diagnosis of SARS-CoV-2 infection. Roche intends to file US FDA’s EUA while the test is expected to […]readmore
Shots: Qiagen to launch the QIAprep& Viral RNA UM Kit, designed to simplify and accelerate PCR swab analysis and remove key testing bottlenecks for Covid-19 and other RNA viruses The […]readmore
Shots: Fitbit’s ECG app has received the US FDA’s 510 (k) clearance and EC’s CE marking to assess heart rhythm for atrial fibrillation (AFib). The ECG app will be available […]readmore
Shots: The companies have launched Semglee (insulin glargine injection) in a vial and pre-filled pen at WAC of $147.98/ package of (5) 3ml pens and $98.65/ 10ml vial, representing the […]readmore
Shots: Cadalimab will be available in 40mg/0.8ml as a pre-filled syringe and is targeted for the reduction in signs and symptoms of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Psoriatic […]readmore
Shots: Amazon launches the Halo fitness band and a subscription service by the same name. The smart band combines a suite of AI-powered health tool with an innovative and stylish […]readmore
Shots: The companies launch Nepexto, a biosimilar referencing Amgen’s Enbrel, and is indicated for the mod. to sev. RA, JIA from the age of 2yrs., active and progressive PsA, severe […]readmore
Shots: Qiagen reports the launch of the Access Anti-SARS-CoV-2 Total test that runs on a portable device and provides accurate results on Total Ig Abs (IgA, IgM, IgG) in 10mins. […]readmore
Biosimilars
Regulatory
Samsung Bioepis’ Aybintio (SB8, biosimilar, bevacizumab) Receives the EC’s Approval
Shots: The EMA’s CHMP positive opinion was provided in June and is the fifth product which received the EU approval for autoimmune diseases and tumor diseases The P-III study results […]readmore