Regulatory Affairs

The recently inaugurated 47th President of the US signed several executive orders in his first moments back in the Oval Office, one of which was a notice to withdraw the US from the World Health Organization (WHO).

In the run-up to CPHI Milan, we sit down with some of the experts and thought-leaders speaking at this year’s conferences. 

In our monthly series focusing on women in the pharmaceutical industry, we interview leading experts in the pharmaceutical supply and value chain to discuss the importance of gender diversity in healthcare, the workplace, and beyond. 

After the approval of the medical abortion pill, mifepristone, by the US FDA, states across the USA approach the distribution of the pill differently, some ruling against allowing access to the drug. 

Japanese drugmaker Eisai, in partnership with Biogen, have announced that they have begun submitting data on a rolling basis to the US FDA for a marketing application of a subcutaneous injectable form of Alzheimer’s drug Leqembi. 

Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion.  

In the last week, the US FDA has granted approval/accelerated approval to three different oncology drugs, each from different drugmakers with different indications. 

The much anticipated Pharma Awards 2023 were held at CPHI Barcelona this week at the Fira Barcelona. 

Several big pharma companies have added their names to a letter challenging suppliers in the healthcare industry to pledge to sustainability targets.