News in Numbers

$35

In his State of the Union speech, US President Joe Biden re-emphasized his plan to push for the cost of insulin to be capped at $35 per month for all Americans.

85,000

As per a February address by WHO Director General Dr Ghebreyesus, there has been a sustained decline in the number of mpox cases. More than 85,000 cases have now been reported to the agency.

6.6%

Global inflation is expected to fall from to 6.6 percent in 2023 from 8.8% in 2022, as per the International Monetary Fund’s World Economic Outlook report.

65%

The number of young people with type 1 diabetes could increase by approximately 65% in the next 40 years, as per the Centers for Disease Control and Prevention (CDC).

22.1 million

According to the American Cancer Society, an estimated 22.1 million or more Americans will be cancer survivors by the start of 2030.

 Approvals

TEZSPIRE

The US FDA granted an approval to Amgen and AstraZeneca’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above.

Source: Pharmaceutical Technology

TRODELVY

The US FDA granted an approval for Gilead Sciences’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer adult patients.

Source: PHARMACEUTICAL TECHNOLOGY

FORXIGA

The European Commission (EC) has granted approval for AstraZeneca’s Forxiga (dapagliflozin), a first-in-class, oral, once-daily SGLT2 inhibitor, to treat symptomatic chronic heart failure (HF).

Source: Pharmaceutical Technology

EYLEA

The US FDA has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants.

Source: Pharmaceutical Technology

CALQUENCE

The EC has granted approval for AstraZeneca’s tablet formulation of Calquence (acalabrutinib) to treat chronic lymphocytic leukaemia in adult patients.

Source: Pharmaceutical Technology

Clinical Trials

Frontera commences subject dosing in trial of gene therapy for XLRP

Frontera Therapeutics has announced the dosing of the first subject in a clinical trial of its recombinant adeno-associated virus gene therapy drug, FT-002, to treat X-linked retinitis pigmentosa (XLRP).

Source: Clinical Trials Arena

Aldeyra initiates Phase II clinical trials of ADX‑629

Aldeyra Therapeutics has commenced Phase II clinical trials of its new investigational oral RASP modulator, ADX‑629, to treat minimal change disease and Sjögren-Larsson Syndrome. The Phase II clinical trials are designed to assess the efficacy and safety of ADX‑629.

Source: Clinical Trials Arena

Vial and Egnyte announce partnership for eTMF solution integration

Tech-enabled, next-generation contract research organisation (CRO) Vial has announced a partnership to integrate Egnyte’s Life Sciences electronic trial master file (eTMF) solution into its clinical trial platform.

Source: Clinical Trials Arena

Valneva concludes enrolment for trial of chikungunya vaccine

Valneva has announced the completion of subject enrolment and vaccination for the Phase III VLA1553-321 adolescent trial of VLA1553 for chikungunya. Initial results from the placebo-controlled trial are expected in the middle of this year. 

Source: Clinical Trials Arena

Vaxart doses first subject in bivalent norovirus vaccine trial

Vaxart has dosed the first participant in the Phase II clinical trial of its oral tablet bivalent norovirus candidate. The dose-ranging trial has been designed for assessing the safety and immunogenicity of the oral norovirus vaccine in healthy adults.

Source: Clinical Trials Arena

3H Medi Solution to expand decentralised research with Thread

3H Medi Solution has selected Thread for expanding the delivery of decentralised clinical trials (DCTs) and enhancing access to research for Japanese patients. This offering is aimed at powering modern, patient-centered clinical research in the country.

Source: Clinical Trials Arena