The pharma industry briefing
The latest news, approvals and clinical trials you need to know about this month
News in Numbers
11,177
There are 11,177 total confirmed monkeypox/orthopoxvirus cases reported in the US, as per a 12 August Centers for Disease Control and Prevention (CDC) update
8 weeks
The WHO released new guidelines on the use of the long-acting injectable for HIV prevention, cabotegravir or CAB-LA. The first two injections are given 4 weeks apart, followed by a dose every 8 weeks
5
A recent FDA authorization update that allows an intradermal administration of the monkeypox JYNNEOS vaccine will increase the total number of available doses by five-fold
12.44 bn
As per Our World in Data, 12.44 billion doses of Covid-19 vaccines have been administered globally, as of 12 August
$5.4 bn
Pfizer announced it will acquire Global Blood Therapeutics for $5.4 billion to expand its reach in the rare hematological space
Approvals
KINPEYGO
The European Commission (EC) has granted conditional marketing authorization (CMA) for Calliditas Therapeutics’ Kinpeygo to treat primary immunoglobulin A (IgA) nephropathy (IgAN) in adults. The treatment is indicated for IgAN patients at risk of quick disease progression risk with a urine protein-to-creatinine ratio (UPCR) ≥1.5g/gram.
Source: PHARMACEUTICAL TECHNOLOGY
OPZELURA
The US FDA has granted approval for Incyte’s Opzelura (ruxolitinib) cream 1.5% as a topical treatment of nonsegmental vitiligo in adults and paediatric patients aged 12 years and above, becoming the first treatment for repigmentation in patients with vitiligo to receive FDA approval.
Source: PHARMACEUTICAL TECHNOLOGY
STELARA
The US FDA granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J)’s Stelara (ustekinumab) to treat paediatric patients aged six years and above with active psoriatic arthritis (PsA). A completely human monoclonal antibody, Stelara hinders cytokines interleukin (IL)-12 and IL-23.
Source: Pharmaceutical Technology
XOFLUZA
The US FDA has approved Roche subsidiary Genentech's supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for acute uncomplicated influenza in children ages 5 to 12 years old. This marks the first single-dose oral influenza medicine approved for children in this age group.
Source: BIOSPACE
Clinical Trials
ALX starts Phase II trial of colorectal cancer combo therapy
ALX Oncology has begun the Phase II clinical trial of evorpacept plus Erbitux (cetuximab) and Keytruda (pembrolizumab) in refractory microsatellite stable metastatic colorectal cancer (mCRC) patients.
Source: Clinical Trials Arena
Greenwich begins Phase III trial of immunotherapy for breast cancer
Greenwich LifeSciences has initiated the Phase III Flamingo-01 clinical trial of its immunotherapy, GLSI-100 (GP2 + GM-CSF), for preventing breast cancer recurrences in individuals who priorly underwent a surgical procedure.
Source: Clinical Trials Arena
BeiGene reports Phase III tislelizumab data in hepatocellular cancer
BeiGene has reported positive data from the Phase III clinical trial of tislelizumab as a 1L therapy for adult unresectable hepatocellular carcinoma (HCC) patients. The trial met the primary non-inferiority OS endpoint compared to sorafenib.
Source: Clinical Trials Arena
Vial unveils EMR Interface with ModMed to boost trial recruitment
Vial has unveiled the VialConnect interface with ModMed to boost patient recruitment into clinical trials.Research clinics that utilise the EHR EMA of ModMed could easily filter their patient databases using VialConnect to simplify trial recruitment for no cost.
Source: Clinical Trials Arena
Cocrystal selects hVIVO as CRO for Phase IIa Influenza antiviral trial
Cocrystal Pharma has selected hVIVO as a contract research organisation (CRO) to carry out a Phase IIa human challenge clinical trial of its oral antiviral candidate, CC-42344, for Influenza A. The study will be conducted at the facility of hVIVO in the UK.
Source: Clinical Trials Arena
Kintor concludes Phase II androgenetic alopecia trial enrolment
Kintor Pharmaceutical has concluded subject enrolment in the Phase II clinical trial of KX-826 (pyrilutamide) to treat male androgenetic alopecia (AGA) patients in the US. The double-blind, parallel-group, randomised, placebo-controlled, Phase II trial recruited 121 subjects.
Source: Clinical Trials Arena
