News in Numbers

20 million

The Centers for Disease Control and Prevention (CDC) endorsed the recommendation for using Covid-19 vaccines in all children 6 months through 5 years of age, thereby expanding eligibility for vaccination to nearly 20 million additional children.

299

As of 10 June, 299 monkeypox cases have been reported from 15 European Union/European Economic Area countries as per the European Centre for Disease Prevention and Control.

350 million

According to the World Health Organization, more than 350 million people are living with Hepatitis B. At a recent assembly, countries recommitted to eliminate viral hepatitis by 2030.

105,000

The Commonwealth Fund projects 105,000 deaths due to drug overdoses in 2021 in the US with increases in almost every region.

38%

As per the trade organization BIO’s annual report on diversity, equity and inclusion in the biotechnology industry, employees of colour only make up 38% of the workforce and 28% of CEOs.

 Approvals

OLUMIANT

The US FDA granted approval for Eli Lilly and Company and Incyte’s Olumiant (baricitinib) to treat Covid-19 in adult patients who need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 

Source: PHARMACEUTICAL TECHNOLOGY

SKYRIZI

AbbVie’s Skyrizi clinched a third indication and its second FDA approval of the year. The therapy, also known as risankizumab-rzaa, is now the first specific interleukin-23 (IL-23) inhibitor cleared to treat adults with moderate to severely active Crohn’s disease (CD). 

Source: Fierce Pharma

ALBRIOZA

Health Canada has granted approval for Amylyx Pharmaceuticals’ Albrioza, with conditions, to treat amyotrophic lateral sclerosis (ALS).  Albrioza is claimed to lower neuronal cell death by mitigating endoplasmic reticulum (ER) stress and mitochondrial dysfunction at the same time. 

Source: Pharmaceutical Technology

DUPIXENT

The US FDA approved Sanofi/Regeneron’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms. This marked  the first FDA approval of a treatment for EoE.

Source: FDA

Clinical Trials

AstraZeneca’s Evusheld prevents disease progression in Phase III Covid-19 trial

AstraZeneca has reported detailed data from the Phase III TACKLE clinical trial where its Evusheld demonstrated to offer clinically and statistically significant protection against progression to severe Covid-19 or mortality from any cause versus placebo.

Source: Clinical Trials Arena

Amytrx begins Phase II trial of topical atopic dermatitis therapy

Amytrx has commenced the Phase II clinical trial of its lead drug candidate, AMTX-100 CF3, to treat atopic dermatitis (AD). A peptide, AMTX-100 CF3 is in a topical ointment formulation that penetrates the skin easily. Made of 87% water, it leaves no odour or residue.

Source: Clinical Trials Arena

AbbVie reports data from Phase II large B-cell lymphoma therapy trial

AbbVie has reported initial data from the large B-cell lymphoma (LBCL) expansion cohort in the EPCORE NHL-1 Phase II clinical trial of epcoritamab (DuoBody-CD3xCD20). Patients in the trial had an overall response rate (ORR) and complete response (CR) rate of 63% and 39%, respectively. 

Source: Clinical Trials Arena

Bharat’s Phase II/III Covaxin trial shows safety in children

Bharat Biotech International has reported that its whole-virion inactivated Covid-19 vaccine candidate, BBV152 (Covaxin), was found to be safe, well-tolerated and immunogenic in paediatric participants in Phase II/III clinical trial.

Source: Clinical Trials Arena

Ultimovacs’ cancer vaccine demonstrates overall survival in Phase I melanoma trial

Ultimovacs reported positive two-year data from the ongoing Phase I clinical trial, where UV1 plus pembrolizumab showed robust overall survival in malignant melanoma. A peptide-based vaccine, UV1 elicits a specific T cell response against telomerase.

Source: Clinical Trials Arena

Elevar reports positive Phase II data of adenoid cystic carcinoma therapy

Elevar Therapeutics reported the Phase II clinical trial results of its small-molecule tyrosine kinase inhibitor (TKI) rivoceranib in progressive recurrent or metastatic adenoid cystic carcinoma (R/M ACC) patients. The study evaluated rivoceranib in 80 patients.

Source: Clinical Trials Arena