The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
15 million
According to the UK Government, more than 15 million people across the country have now had their first coronavirus vaccine.
639%
The increase in the number of Covid-19 clinical trials globally between April 2020 and January 2021.
91.6%
Russia’s two-shot vaccine Sputnik V has shown 91.6% efficacy against symptomatic Covid-19 in clinical trials.
39%
Personalised medicines accounted for 39% of the new drugs approved by the US FDA last year.
$5.32bn
According to Research and Markets, the global dry eye medication market is expected to reach $5.32bn by 2023.
Approvals
Rukobia (fostemsavir)
The European Commission has given a green light to the use of ViiV Healthcare’s Rukobia as a treatment for people with HIV that has developed resistance to other antiretroviral therapy.
Source: Pharmaphorum
Libtayo® (cemiplimab-rwlc)
The US Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy treatment indicated for patients with advanced basal cell carcinoma.
Source: PR Newswire
Evkeeza (evinacumab-dgnb)
The US FDA has approved Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia.
Source: Regeneron
Pfizer-BioNTech Covid-19 vaccine
Japan has issued its first approval for a vaccine against the coronavirus, saying that it would use the Pfizer-BioNTech vaccine to begin inoculating frontline health care workers this week.
Source: New York Times
Moderna Covid-19 vaccine
The Qatar Ministry of Public Health has granted an emergency use authorisation to biotechnology company Moderna’s Covid-19 vaccine.
Source: Pharmaceutical Technology
Clinical Trials
Indian firm PNB Vesper completes Phase II Covid-19 drug trials
India-based life sciences company PNB Vesper has reportedly completed the Phase II clinical trials of its proprietary drug, PNB-001 (GPP-Baladol), on Covid-19 patients. In all the initial preclinical studies, the drug has demonstrated positive results, IANS reported.
Source: Clinical Trials Arena
NIHR funds study aiming to improve the lives of people with cystic fibrosis
The UK’s National Institute for Health Research (NIHR) has granted funding to the University of Liverpool and Alder Hey Children’s Hospital for a trial aiming to improve the lives of people living with cystic fibrosis
Source: Pharma Times
Positive phase III data for Roche’s vision loss therapy
New phase III data show Roche’s faricimab is the first investigational injectable eye medicine to extend time between treatments up to four months in two leading causes of vision loss, potentially reducing treatment burden for patients.
Source: Pharmafield
Novo Nordisk’s semaglutide injection effective in weight loss trial
Northwestern University Feinberg School of Medicine in the US has reported that results from STEP 1 clinical trial of type-2 diabetes drug semaglutide (Ozempic) once weekly was linked to a sustained, clinically relevant reduction in body weight in obese adult participants.
Source: Clinical Trials Arena
NIH includes four potential Covid-19 drugs in ACTIV-2 trial
The US National Institutes of Health (NIH) has initiated enrolment in a Phase II/III ACTIV-2 trial to test four potential investigational drugs for treating Covid-19.
The therapeutics are Synaigen’s inhalable beta interferon, AstraZeneca’s long-acting monoclonal antibody combination, AZD7442 and Sagent Pharmaceuticals’ Camostatmesylate.
Source: Clinical Trials Arena
UK trial will evaluate safety of mixing different Covid-19 vaccines
A new clinical study, based in the UK, will investigate alternating Covid-19 vaccine doses with the aim of examining whether different vaccines can safely be used for two-dose regimens.
Source: Pharma Times
