The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
The first person to receive the Pfizer Covid-19 jab was 91-year-old Margaret Keenan in the UK
The number of doses of the Pfizer/BioNTech vaccine that will be dispensed in the UK over the next few weeks
The US Government has launched the first phase of its $250m campaign to build public confidence in the Covid-19 vaccine
In its final meeting of the year, the European Medicines Agency committee for Medicinal Products for Human Use recommended 15 new medicines for approval
The US Government has now ordered enough Covid-19 vaccine doses from Moderna and Pfizer to vaccinate 100 million people
Ga 68 PSMA-11 Injection
The US Food and Drug Administration (FDA) has approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) for positron emission tomography imaging of prostate-specific membrane antigen positive lesions in men with prostate cancer.
AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been approved in the EU for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease.
Y-mAbs Therapeutics has received US FDA approval for DANYELZA 40mg/10ml in combination with granulocyte-macrophage colony-stimulating factor for the treatment of paediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
Source: Y-mAbs Therapeutics
The US FDA has approved Genentech’s supplemental Biologics License Application for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older.
Third vaccine candidate begins clinical trials in UK
Global pharmaceutical company Janssen is beginning clinical trials of a potential Covid-19 vaccine in the UK. Around the country, 6,000 volunteers are taking part in phase-three trials of the Covid-19 vaccine at 17 National Institute for Health Research sites.
Source: Sky News
Africa's largest Covid treatment clinical trial launched by 13-country network
The Anticov study, involving Antwerp’s Institute of Tropical Medicine and international research institutions, aims to identify treatments that can be used to treat mild and moderate cases of Covid-19 early and prevent spikes in hospitalisation that could overwhelm fragile and already overburdened health systems in Africa.
Source: The Guardian
Incyte’s ruxolitinib fails to meet primary endpoint in Covid-19 trial
Incyte has announced that the Phase III RUXCOVID study of JAK1 /JAK2 inhibitor ruxolitinib (Jakafi) for treating patients aged 12 years and above with Covid-19-associated cytokine storm did not meet its primary endpoint. Cytokine storm is a severe immune overreaction due to viral infection. It can lead to serious complications such as pneumonia and acute respiratory distress syndrome.
Source: Clinical Trials Arena
Sanofi and GSK face Covid-19 vaccine trial delay
Sanofi and GlaxoSmithKline (GSK) have delayed their Covid-19 vaccine programme after phase I/II results found a low immune response in older adults who received their investigational vaccine. In a phase I/II study of Sanofi/GSK’s adjuvanted recombinant protein-based vaccine, interim results found the jab induced an immune response comparable to recovered Covid-19 patients in adults aged 18 to 49 years.
Source: Pharma Times
CG Oncology doses first patient in oncolytic immunotherapy trial
Clinical-stage biotechnology company CG Oncology has dosed the first patient in Phase II CORE1 clinical trial of CG0070 for Non-Muscle-Invasive Bladder Cancer (NMIBC). CG0070 will be evaluated in combination with Keytruda (pembrolizumab) for treating patients with NMIBC unresponsive to Bacillus Calmette-Guerin
Source: Clinical Trials Arena
Lilly surges on positive phase III readout from diabetes contende
Eli Lilly’s decision to throw large amounts of research dollars at its next-generation diabetes drug tirzepatide could be vindicated, according to its first phase III trial readout. Results from the phase III SURPASS trial showed tirzepatide led to a reduction in both blood sugar and body weight in adults with type 2 disease, compared with placebo.