Clinical Development,R&D,Bioprocess,Weekly Roundups

Weekly News Round-up – 28/2/20

Proventa International Weekly News 4 years ago By Josh Neil

Covid-19 continues to dominate the news, with pharma companies racing to find the cure. Moderna and Gilead look currently set to lead, with vaccines from both now entering human trials. In other news, Novartis’ Beovu, which appeared in last week’s news update as finally EU-approved, is now facing safety concerns after a number of patients have allegedly suffered vasculitis on it. This setback could have the sales Novartis was intending to make with the drug.

MODERNA BECOMES FIRST COMPANY TO CREATE TRIAL-READY COVID-19 VACCINE – Moderna has become the first pharmaceutical company with a vaccine for Covid-19 ready to enter human trials. The National Institute of Allergy and Infectious Diseases has received vaccine shipments for further testing in humans. The vaccine, should it prove safe, will be distributed in 2021. This marks the quickest turnaround on a vaccine for a global epidemic ever. Gilead has also made news by entering its Covid-19 remedy into phase 3 trials.

BEOVU SAFETY ISSUES COULD COST BILLIONS – Since last week’s news update on Novartis’ ‘wet’ AMD drug Beovu, doctors have raised safety concerns about alleged vasculitis in patients. So far, clinicians have found 14 cases, with 11 serious enough to lead to possible blindness. Since the news broke, Novartis’ shares fell more than 5%. A slower launch could potentially halving the $2.5 billion in peak sales Novartis was hoping for. 

UNREPORTED CLINICAL TRIAL DATA TO BE MADE PUBLIC, NY JUDGE RULES – The sponsors of more than 1,000 clinical trials that have not been published in the last ten years may be forced to post the trial results to ClinicalTrials.gov, following a federal judge’s ruling. According to the decision, reporting requirements from the final rule of 2017 to the FDA Amendments Act apply to trials completed as far back as 2007, not only to 2017, as had been assumed by government agencies to that point. 

In other news: 

R&D
Roche makes deal with biotech Bicycle Therapeutics on cancer immunotherapy discovery platform 

Clinical Trials
Lundbeck’s ‘potential blockbuster’ migraine shot approved by FDA
U.S. and EU begin review of Novartis’ cancer therapy ofatumumab

Manufacturing
Sanofi to spin off pharmaceutical ingredients company to avert shortages in future
Newly synthesised single catalyst could simplify biomanufacturing and reduce costs

That’s all for now. See you next week!

Joshua Neil, Editor
Proventa International

To ensure you remain up-to-date on the latest in clinical development, sign up for Proventa International’s Clinical Operations, Supply Chain & Pharmacovigilance Strategy Meeting 2020, hosted on 11 May in San Diego, USA.

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