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Results For "clinical-development"

444 News Found

Obseva announces U.S. FDA acceptance of new drug application for linzagolix
Biotech | November 23, 2021

Obseva announces U.S. FDA acceptance of new drug application for linzagolix

Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU


Merck showcases potential for several cancers, MS and lupus
News | November 22, 2021

Merck showcases potential for several cancers, MS and lupus

Five potential first-in-class assets aimed at delivering significant long-term growth. Over 14 clinical development programs underway across portfolio and 11 new studies to start in 2022 across early- and late-stage pipeline


CStone and Jiangsu Hengrui sign exclusive licensing agreement for cancer drugs in China
Biotech | November 22, 2021

CStone and Jiangsu Hengrui sign exclusive licensing agreement for cancer drugs in China

CStone granted the exclusive rights to Hengrui for research, development, registration, manufacturing, and commercialization of anti-CTLA-4 mAb CS1002 in the Greater China region


Novo Nordisk to acquire Dicerna Pharmaceuticals for US $ 3.3 bn
Biotech | November 20, 2021

Novo Nordisk to acquire Dicerna Pharmaceuticals for US $ 3.3 bn

Dicerna develops RNAi-based therapies to selectively silence genes that cause or contribute to disease


Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan
Biotech | November 18, 2021

Daiichi Sankyo initiates Phase 2 trial of mRNA Covid-19 vaccine in Japan

It is anticipated to be safe and efficacious by targeting the receptor-binding domain (RBD) of the new coronavirus


Sanofi to invest up to US $ 60 million in Gyroscope
Startup | November 09, 2021

Sanofi to invest up to US $ 60 million in Gyroscope

A Sanofi R&D executive will join the Gyroscope Clinical Advisory Board to advise on matters related to the development of GT005 for geographic atrophy (GA).


Pfizer’s Covid-19 drug a potential game changer
Biotech | November 08, 2021

Pfizer’s Covid-19 drug a potential game changer

In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo


Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone
Biotech | October 21, 2021

Sage Therapeutics and Biogen plan to submit a New Drug Application (NDA) for zuranolone

Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD


Resilience and Harvard announce five-year R&D alliance
News | October 18, 2021

Resilience and Harvard announce five-year R&D alliance

First anticipated spinout from the alliance, Circle Therapeutics, to develop novel muscle stem cell therapies for a variety of skeletal muscle disorders


Exelixis in-licenses second anti-cancer compound from Aurigene
Biotech | October 15, 2021

Exelixis in-licenses second anti-cancer compound from Aurigene

U.S. FDA has accepted the investigational new drug application for phase 1 clinical trial in non-Hodgkin’s lymphoma