Chief executive of NICE to leave role in 2020
Sir Andrew Dillion will be stepping down from his role as chief executive of NICE next year, after holding his position for 20 years.
List view / Grid view
News
Novo Nordisk files lawsuit against Mylan for generic application
The two pharmaceutical companies are facing a legal battle after Mylan filed a new drug application for a generic of Novo Nordisk’s Victoza.
XTANDI® treatment granted priority review by FDA
XTANDI® sNDA seeks to add an indication for men with prostate cancer that's spread but is sensitive to hormone therapy.
OTC drug manufacturer receives warning letter for data integrity issues
Ningbo Huize Commodity Co has been sent a warning letter for cGMP violations, including data integrity issues.
Imfinzi combination fails advanced lung cancer study
A late-stage clinical trial for Imfinzi and an experimental treatment has not extended the lives of patients with advanced non-small cell lung cancer.
FDA and EMA align on 90 percent of marketing authorisation decisions
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
$23m aid announced for Ebola vaccine manufacture
The US HHS has committed to a contribution to help Merck manufacture its investigational V920 vaccine for the treatment of Ebola.
US and India receive most warning letters from FDA
New research has found that of the 38 warning letters handed out by the FDA in 2019, the US and India received the vast majority.
Terrosa® osteoporosis biosimilar treatment launched in Europe
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
Brand-name drug prices found to be rising at a slower pace in lower amounts
Drug companies are still raising prices for brand-name prescription medicines but not as often or by as much as they used to.
Jonathan Brüün to leave CEO role at the British Pharmacological Society
Brüün has announced he will be leaving his role as CEO at the BPS and moving to a new role at the Royal College of Anaesthetists.
Investigational Zika vaccine receives Fast Track designation
An investigational Zika vaccine currently being evaluated in a Phase I study has been given a Fast Track designation by the FDA.
Emcure Pharmaceuticals receives warning letter from FDA
A warning letter has been sent to Emcure Pharmaceuticals after an FDA facility inspection found that the company did not adequately investigate sterility failures.
FDA approves IND application for coeliac treatment
The FDA has accepted an IND application for AG017, a new drug designed to treat the causes of coeliac disease which will soon enter new trials.
Complete response letter handed to Sarepta Therapeutics
The pharmaceutical company has received a complete response letter for its golodirsen injection, which had been submitted for accelerated approval.
