The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
$31m
The US Government has shelled out $31m to technology and solutions provider Cytiva to pitch in on Covid-19 vaccine-related components, including cell culture media and bioreactors.
2
Two high-profile, late-stage Covid-19 clinical trials (Johnson & Johnson’s coronavirus vaccine trial and Eli Lilly’s study of a Covid-19 antibody drug) that have been halted due to safety concerns this month.
$60m
UK manufacturer Abzena is set to spend $60m to build a new 50,000-square-foot biologics facility in San Diego, US.
10,000
Novavax is set to enrol 10,000 people out of 250,000 volunteers aged between 18 and 84 as the company’s Covid-19 candidate enters Phase III trials.
80
Chemists at the University of Tokyo are redesigning the 80-year-old antibiotic Gramicidin A for new medical uses.
Approvals
Inmazeb
The US FDA has approved Regeneron Pharmaceuticals' triple antibody cocktail Inmazeb as the first Ebola virus treatment.
Source: Yahoo News
Mayzent
The National Institute for Health and Care Excellence has recommended Novartis’ multiple sclerosis drug Mayzent for use by NHS England.
Source: Pharma Times
Filgotinib
Gilead and Galapagos have received approval for the rheumatoid arthritis drug filgotinib from the European Commission and from the Ministry of Health, Labor and Welfare in Japan.
Source: Labiotech
Lenalidomide
The Scottish Medicines Consortium has backed the use of Bristol-Myers Squibb’s Revlimid (lenalidomide) in combination with rituximab for the treatment of adult patients with previously treated Follicular Lymphoma.
Clinical Trials
Celltrion launches phase III trial of Covid-19 mAb
South Korean-based Celltrion has initiated a Phase III clinical trial of its Covid-19 targeting monoclonal antibody (mAb) as a preventative treatment. The mAb, CT-P59, will be investigated in approximately 1,000 patients who have been in contact with Covid-19 positive patients.
Source: PMLive
ViiV posts positive long-term data for two-drug HIV regimen Dovato
GlaxoSmithKline subsidiary ViiV Healthcare has reported new data for its two-drug HIV regimen Dovato, with hopes that the long-term data could encourage clinicians to switch from other triple regimen therapies.
Source: Pharma Times
Clinical trial explores new therapeutic for type 1 diabetes
Researchers at the Medical University of South Carolina, US are conducting a clinical trial to test the potential of using umbilical cord derived mesenchymal stem cells for the treatment of patients with new onset type 1 diabetes.
AstraZeneca’s quick Covid-19 vaccine trial restart splits experts
AstraZeneca’s Covid-19 vaccine AZD1222 splits experts as to whether its trials restarted too quickly on the heels of a second volunteer having a neurological event. While some said a more in-depth analysis is needed to conclude these events are truly independent of the vaccine, others noted these cases are unprecedented with the vaccine’s adenovirus vector and so could be due to chance.
Source: Clinical Trials Arena
UK launches clinical trial of BCG vaccine
Doctors in the UK have launched a clinical trial to see whether the cheap and widely available BCG vaccine can boost the immune system enough to prevent healthcare workers from catching coronavirus. Researchers at Exeter University are enrolling up to 2,000 community healthcare workers, particularly from care homes and GP surgeries, including nurses, caterers and administration staff.
Source: The Guardian
FDA puts Voyager study on hold in latest gene therapy speed bump
The US FDA won't allow Voyager Therapeutics to begin a first-in-human trial of an experimental gene therapy for Huntington's disease until the company submits more information on its manufacturing processes.
Source: Biopharma Dive
