Regulatory Index News: 16/03/2018

Welcome to your Regulatory Index News digest. Positive trial results for one but a clinical hold for another, whilst the Chinese FDA may see a complete overhaul.

FDA place Advaxis’ and AstraZeneca’s cancer combination study on clinical hold after patient death

The FDA has placed a clinical hold on a phase 1/2 study assessing the Advaxis’ axalimogene filolisbac and AstraZeneca's Imfinzi combination effects in patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical as well as HPV-associated head and neck cancer. This action was taken by the regulators upon learning of a cervical cancer patient had developed a respiratory failure and died (Grade 5 Serious Adverse Event) after receiving their sixth combination cycle of the trial. Enrollment and dosing in the trial are now on hold whilst Advaxis, AZ and the FDA investigators determine what happened. If you would like to read further from a PharmaTimes article, please click here.

Chinese drug regulator overhaul

The China Food and Drug Administration (CFDA), which has been a standalone agency for around five years, is to merge into an overseeing national market administration, with drug regulation as a second-tier department. The decision comes after China’s legislative body annual conference held on Tuesday, where the government proposed a combination of the CFDA with other agencies which regulate business registration, quality control, pricing and anti-monopoly efforts. Whilst the details are not set in stone, it seems the specialised drug department will only focus on drug approvals and related processes whilst post-marketing oversight will be handled by the larger agency it belongs to. These proposed changes are expected to be formally approved by China’s congress within a week. Please click here to read further from a FiercePharma article.

Positive, yet not overwhelming, pivotal trial results for Alexion’s Soliris successor

Soliris is Alexion’s rare disease blockbuster which treats paroxysmal nocturnal hemoglobinuria (PNH). Since under new management, the biotech company has concentrated greatly on Soliris’ successor, ALXN1210, to maintain their position in the market. Alexion have now revealed that the first of two pivotal trial studies for PNH showed that ALXN1210 is non-inferior to Soliris. Unfortunately however, the drug failed a key measure of superiority, meaning the biotech is working on advertising the similarities of the drugs and the improved dosing schedule possibilities. Regardless, the announcement led to a stock increase of 9% for Alexion and several believe the data sets up ALXN1210 well for an approval in the near future. Please click here to read more on this from Endpoints News.

M L

Author

Max Lymbery

Date Published

16th March 2018

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