European Medicines Agency (EMA)

Orlistat side effects were underreported, study shows

Adverse effects that occurred during clinical trials of Roche’s obesity drug orlistat in the 1990s appear to have been substantially underreported in both published papers and summarised clinical study reports submitted to the European Medicines Agency for drug approval, an analysis has found.…

EMA recommends two new kidney cancer drugs for approval

Two new drugs for the treatment of adults with advanced kidney cancer are being recommended for fast track approval across the EU. …

Dozens of generic drugs face EU ban

Dozens of generic drugs — including 24 available in the UK — face being banned from use across the EU because of doubts about the data collected to support their marketing approval.…

EMA recommends approval of Truvada as HIV pre-exposure prophylaxis

The first drug for HIV pre-exposure prophylaxis has been recommended for approval across the EU.…

European regulator reviews first in human trial guidelines following death

The European Medicines Agency (EMA) has launched a public consultation on proposals to change its guidance on first in human (FIH) clinical trials.  The consultation is part of an EMA review into FIH best practice following an incident in Rennes, France, in January 2016 in which one man d…

FDA approves first OTC retinoid for acne

The first retinoid acne treatment to be made available over the counter in the United States has been approved by the US Food and Drug Administration.…

European Medicines Agency announces safety review of prolonged-release paracetamol

A safety review of modified and prolonged-release paracetamol has been launched following reported cases of acute overdose, the European Medicine’s Agency has announced.…

Antibiotics should be prescribed during idelalisib treatment, concludes review

All patients given the cancer drug idelalisib (marketed as Zydelig) should be prescribed antibiotics during treatment and for two to six months after treatment has ended to prevent pneumonia, according to a new Europe-wide proposal.…

EMA recommends cell-based therapy to reduce complications from stem cell transplants

A genetically modified cell-based therapy that can reduce the risk of complications following a stem cell transplant in patients with certain blood cancers has been recommended for conditional marketing authority by the European Medicines Agency.…

Brexit could cause ‘significant’ delays in getting new drugs to patients, industry warns

The UK pharmaceutical industry association has warned that if the UK adopts a stand-alone medicines licensing system following the referendum vote to leave the EU, there could be significant delays to patients receiving new drugs.…