AstraZeneca outlicense lung disease to Mereo BioPharma
AstraZeneca is licensing exclusive rights of AZD9668 — an oral inhibitor of an enzyme called neutrophil elastase for lung disease to Mereo... Read More
China FDA (CFDA) approves Ebola vaccine co-developed by Cansino Biologics and the military
Posted on29 Oct 2017
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China has approved a domestically developed vaccine for the deadly Ebola virus and is now the third country in the world, after... Read More
What is the benefit of randomization in randomized control trial (RCT)?
A randomized control trial (RCT) is a type of scientific (often medical) experiment which aims to reduce bias when testing a new... Read More
Case Study: US FDA grants of priority review status for Lynparza sNDA
US FDA grants priority review status for Lynparza sNDA in metastatic breast cancer AstraZeneca and Merck & Co., have announced that the... Read More
What is an open label extension study?
An open–label trial or open trial is a type of clinical trial in which both the researchers and participants know which treatment is being administered. This... Read More
Novartis EXTEND study of Revolade shows long-term disease control for chronic/persistent ITP
Novartis has announced long-term study results supporting the positive safety and efficacy of Revolade (eltrombopag) in adults with chronic/persistent (enrolling patients that... Read More
US FDA approval of Stryker’s cementless Mako Total Knee with Triathlon Tritanium
Posted on24 Oct 2017
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Stryker’s Joint Replacement division has announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the... Read More
Case Study: US FDA priority review grants for BMS’s sBLA for Opdivo to treat patients with resected high-risk advanced melanoma
Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application... Read More
What is QIDP designation by USFDA?
Under the Generating Antibiotic Incentives Now (GAIN) Title VIII of the FDA Safety and Innovation Act (FDASIA), at the time of approval... Read More
Lupin acquires US firm Symbiomix Therapeutics for $150 million
Lupin Ltd annouced its US subsidiary has acquired Symbiomix Therapeutics LLC for a cash consideration of $150 million. Why this deal? Lupin... Read More