Regulatory Index News: 25/05/2018

Welcome to your Regulatory Index News update today. Take a read here for reports on a new EU biosimilar approval, a rejection from the FDA and a phase 1/2 trial kick-off.

Sandoz’ Remicade biosimilar awarded EU approval

The European Commission have approved Sandoz’ (Novartis unit) Remicade biosimilar, Zessly, marking it as the fourth biosimilar of its kind on the market. The drug has been approved for all of Remicade’s indications including rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. It works by blocking the activity of the tumour necrosis factor (TNF) alpha which can be overly expressed to cause the onset of autoimmune diseases and inflammation. The company believe that biosimilars are the key in creating a sustainable healthcare system, with the NHS adopting the possible savings quickly. Please click here if you would like to read more from a PharmaTimes article.

Recro Pharma shares plummet after FDA rejection for non-opioid pain shot

Recro Pharma’s share price took a steep dive of more than 50% on Thursday morning, after the company reported receipt of a Complete Response Letter (CRL) from the FDA rejecting its non-opioid pain shot. The US regulators acknowledged meloxicam (IV administration) met its primary goals in late-stage pivotal studies, but concluded it did not meet FDA’s benchmark in analgesic effect. Recro, who anticipated approval, believe there is lack of clarity or ambiguity in the reviewer’s analysis of the data. The plans they made will now have to remain on pause. Please click here for further information from a BioPharmaDIVE article.

Pfizer kick-off RSV vaccine testing in healthy adults

Pfizer have initiated testing of its experimental respiratory syncytial virus (RSV) vaccine in healthy adult volunteers in hope to develop a vaccine for populations at highest risk of the respiratory infection. The phase 1/2 trial will include two age groups (18-49 and 50-85 years) in a randomised, placebo-controlled, observer-blind, dose-ranging study in parallel to support both maternal and older adult indications. The primary endpoints of the study include safety and tolerability whilst the secondary endpoint is immunogenicity. If you would like to read more, please click here for a PharmaTimes article.



Max Lymbery

Date Published

25th May 2018

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