News in Numbers

8.8%

According to International Monetary Fund, global inflation is expected to rise to 8.8% in 2022 but then decline to 6.5% next year.

$1 billion

As per a recent executive order, the US Department of Defense will invest $1 billion over five years in bioindustrial manufacturing infrastructure.

215.61 million

India has administered 215.61 million Covid-19 vaccine booster doses, the highest in the world, as per Our World in Data.

70

Since the beginning of 2022, the EMA has given 70 positive opinions on marketing authorisation applications, as per a September statistics report.

1.5%

Dementia-related research represents less than 1.5% of the total health research output, as per the World Health Organization’s Chief Scientist Dr. Soumya Swaminathan.

 Approvals

RELYVRIO

The US FDA has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). The EMA is also reviewing an application for the same indication.

Source: PHARMACEUTICAL TECHNOLOGY

ULTOMIRIS

The European Commission (EC) has granted approval for AstraZeneca division Alexion’s Ultomiris (ravulizumab) as an add-on to standard therapy to treat generalised myasthenia gravis (gMG) in adults. The treatment is indicated for gMG patients who are anti-acetylcholine receptor (AChR) antibody-positive.

Source: PHARMACEUTICAL TECHNOLOGY

BOOSTRIX

The US FDA approved GSK’s Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for pregnant women during their third trimester to prevent pertussis (whooping cough) in newborn infants.

Source: Pharmaceutical Technology

RYALTRIS

Health Canada has granted approval for Bausch Health and Glenmark Pharmaceuticals subsidiary Glenmark Specialty’s Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) as a symptomatic therapy for moderate to severe seasonal allergic rhinitis (SAR).

Source: Pharmaceutical Technology

Clinical Trials

Pistoia Alliance introduces CoI to measure carbon footprint of trials

The Pistoia Alliance has introduced the Clinical Trials Environmental Impact Community of Interest (CoI) for assessing and comparing the carbon footprint of centralised and decentralised trials. The Alliance member Syneos Health started the initiative and submitted it for further development. 

Source: Clinical Trials Arena

VigiLanz unveils new solution to identify clinical trial patients

VigiLanz has launched a new solution to enable researchers to identify more eligible subjects for enrolment in clinical trials accurately and in near real time. The new VigiLanz Research solution will help clinical trial sites that seek to expedite recruitment by automating patient identification.

Source: Clinical Trials Arena

G1 Therapeutics concludes subject enrolment in Phase III TNBC therapy trial

G1 Therapeutics has completed enrolment in the Phase III PRESERVE 2 clinical trial of its therapy, Trilaciclib, to treat patients with metastatic triple negative breast cancer (TNBC) receiving chemotherapy. The interim OS analysis is expected in the second half of next year.

Source: Clinical Trials Arena

Immune-Onc and BeiGene sign clinical trial partnership and supply agreement

Immune-Onc Therapeutics and BeiGene have signed a clinical trial partnership and supply agreement to evaluate IO-108 and IO-202 with tislelizumab. IO-108 and IO-202 are Immune-Onc’s first-in-class myeloid checkpoint inhibitors while tislelizumab is BeiGene’s anti-PD-1 antibody.

Source: Clinical Trials Arena

Revive to submit revised protocol for Phase III Covid-19 oral drug trial

Revive Therapeutics is set to submit a revised protocol to the US Food and Drug Administration (FDA) with a new primary efficacy endpoint for its Phase III clinical trial of oral drug Bucillamine for mild to moderate Covid-19. Bucillamine is said to have anti-inflammatory, as well as antiviral properties.

Source: Clinical Trials Arena

Ro and NIA enter an agreement to diversify trial registration

Ro has entered an agreement with the National Institutes of Health (NIH) unit National Institute on Aging (NIA) to diversify registration in clinical trials, leveraging its telehealth platform. The parties will create the ‘Registry for Equal Access to Clinical Trials in Alzheimer’s Disease (AD)’ (REACT-AD) initiative.

Source: Clinical Trials Arena