News in Numbers


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


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



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.



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.



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


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.


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