Pharma News

General, non-pharmacovigilance fees payable to EMA by applicants and marketing-authorisation holders are increasing by 1.7% on 1 April 2019. Full details of the new fee levels are available in Commission Regulation (EU) No 2019/480 amending Council Regulation (EC) No 297/95 , its implementing rules and the corresponding explanatory note on fees , published on 1 April 2019.

Artificial intelligence and machine learning have the potential to fundamentally transform the delivery of health care. As technology and science advance, we can expect to see earlier disease detection, more accurate diagnosis, more targeted therapies and significant improvements in personalized medicine.

The U.S. Food and Drug Administration approved Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland.

The new and improved EudraVigilance, the European system for managing and analysing information on suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the EU, received more than 2 million reports of suspected side effects in 2018.

EMA and the European Directorate for the Quality of Medicines & Healthcare (EDQM) have reviewed EMA’s sampling and testing programme for centrally authorised medicines on the EU/EEA market, which has been organised yearly since 1998.

U.S. Food and Drug Administration announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.

A clinical trial of an experimental drug designed to treat cravings associated with opioid use disorder (OUD) has begun in the National Institutes of Health Clinical Center. The Phase I trial in healthy adults will assess the safety of the experimental compound, ANS-6637, and how it is processed in the body when given with another drug that is processed by the same liver enzyme pathway.

The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.