Drug News

Added 13 hours ago Drug news

AstraZeneca to divest US rights to Synagis to SOBI.

AstraZeneca has agreed to sell US rights to Synagis (palivizumab) used for the prevention of serious lower respiratory tract infection...

Added 13 hours ago Drug news

FDA accepts sNDA for Gattex for pediatric patients with Short Bowel Syndrome.- Shire plc

Shire plc announced that the FDA has accepted for filing the supplemental new drug application to extend the indication of...

Added 13 hours ago Drug news

FDA gives 510(k) clearance for BD Phoenix CPO detect test to identify carbapenemase-producing organisms- Becton Dickinson

Becton, Dickinson and Company announced the FDA has given 510(k) clearance of the BD Phoenix CPO detect test, which will...

Added 13 hours ago Drug news

Phase IIIb EXPEDITION-8 study of Mavyret shows sustained response in hepatitis C.- AbbVie.

AbbVie announced new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, Mavyret (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated...

Added 13 hours ago Drug news

FDA accepts sBLA for Tecentriq plus nab-paclitaxel for first line treatment of triple negative breast cancer.- Genentech /Roche

Genentech announced the FDA has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab)...

Added 2 days ago Drug news

Phase III DECLARE-TIMI 58 results for Farxiga show reduced risk of hospitalisation from CV events.- AstraZeneca.

AstraZeneca announced positive full results from the DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for Farxiga (dapagliflozin) which showed that...

Added 2 days ago Drug news

PIONEER-HF trial of Entresto for heart failure published in NEJM.- Novartis.

Novartis announced results of the landmark PIONEER-HF trial showing that in-hospital initiation of Entresto (sacubitril/valsartan) tablets provided superior benefit compared...

Added 2 days ago Drug news

Phase III ODYSSEY OUTCOMES trial of Praluent shows fewer deaths from CV events-. Sanofi + Regeneron.

New analyses on mortality from the 18,924-patient phase III ODYSSEY OUTCOMES trial of Praluent (alirocumab), from Regeneron, shows it is...

Added 2 days ago Drug news

Real-world evidence on patients aged 80 and older presented from ARISTOPHANES study evaluating oral anticoagulants among patients with non-valvular atrial fibrillation- BMS + Pfizer

The Bristol-Myers Squibb-Pfizer Alliance presented new real-world evidence (RWE) from a sub-analysis of the ARISTOPHANES study comparing the safety and...

Added 3 days ago Drug news

NICE does not recommend Lynparza as maintenance treatment for ovarian cancer. AstraZeneca + Merck Inc.

The National Institute for Health and Care Excellence (NICE) in draft guidance, has recommended against expanding coverage of Lynparza as...

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