European Medicines Agency (EMA)

Women taking valproate should be told about risks of developmental disorders in offspring

Women taking valproate should be told about the risks of developmental disorders in children exposed to the drug during pregnancy, says the UK medicines regulator.…

Safinamide recommended for approval as Parkinson’s disease therapy

A new medicine that allows Parkinson’s disease patients to spend more of the day symptom-free has been recommended for approval in Europe.…

Increased risk of severe skin reactions with expectorants containing ambroxol or bromhexine

Patients taking expectorants containing ambroxol or bromhexine have a small increased risk of severe skin reactions such as Stevens-Johnson syndrome.…

FDA plays catch-up with Europe as it moves towards first biosimilar approval

The US Food and Drug Administration (FDA)’s oncologic drugs advisory committee has given the green light to Sandoz’s EP2006, a biosimilar version of filgrastim.…

Injectable weight loss drug liraglutide approved by FDA

The US Food and Drug Administration has approved liraglutide, an injectable drug best known as an antidiabetes agent, to treat obesity in combination with lifestyle changes such as a reduced-calorie diet and exercise.…

US approves new antibiotic for life-threatening infections

The US Food and Drug Administration (FDA) has approved the use of a new antibiotic, ceftolozane plus tazobactam (Zerbaxa), for the treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections.…

Targeting disease in the developing world

A new report by the Access to Medicine Index finds that pharmaceutical companies influence access to medicines in developing countries through the development of innovative and adapted products, operating equitable pricing strategies and building local capacity.…

The European Medicines Agency still has a way to go towards clinical trial transparency

Loopholes in the new policy on publishing clinical study reports from the European Medicines Agency need to be closed.…

2014: The Pharmaceutical Journal’s news in review

Looking back at some of the biggest news stories from the past year. …