Pharmafile Logo

Orbactiv

- PMLiVE

EMA begins rolling review of AZ’s COVID-19 vaccine candidate

Agency has started evaluating data from non-clinical laboratory studies

- PMLiVE

EMA accepts application for bluebird bio’s Lenti-D in CALD

Gene therapy could become a potentially transformative treatment for cerebral adrenoleukodystrophy

- PMLiVE

GSK’s anti-BCMA drug leads crowded CHMP recommendations

Ten new drugs receive positive recommendations for approval

- PMLiVE

Novartis’ Sandoz division announces antibiotic manufacturing plan

Joint investment agreed with the Austrian federal government

- PMLiVE

EMA to support real-world monitoring of COVID-19 treatments/vaccines

New infrastructure will support real-world studies

- PMLiVE

In virtual meeting, CHMP backs Sanofi’s myeloma drug Sarclisa

Monthly meeting held remotely for the first time due to COVID-19 pandemic

- PMLiVE

EMA calls for pooled EU research into COVID-19 therapies

Asks for a harmonised methodology across member states

- PMLiVE

FDA green lights study of phage-based drug for resistant infections

Possible alternative to conventional antibiotics

EU flag

EMA to consider coronavirus’ impact on EU medicines supply

Steering group will identify EU-wide actions to mitigate medicine supply risks

- PMLiVE

Modest meeting sees only two drugs recommended by CHMP

Lilly’s migraine med Emgality receives negative opinion for label extension

- PMLiVE

GlaxoSmithKline reportedly looking to sell select antibiotic brands

Sale would fund R&D efforts in other key focus areas such as oncology

- PMLiVE

FDA accepts priority review for Merck’s antibiotic combo Recarbrio

If approved would provide new option for hard-to-treat infections

Subscribe to our email news alerts

Latest jobs from #PharmaRole

Latest content

Latest intelligence

Quick links