News in Numbers

 $5.29bn

Pfizer has signed a deal to supply 10 million doses of its oral antiviral Paxlovid to the US Government upon authorization, for $5.29bn.

8.11bn

More than 8.11bn doses of Covid-19 vaccines have been administered globally.

32

The fast-emerging SARS-CoV-2 variant of concern Omicron is said to have 32 mutations in its spike protein.

14m

The Covid-19 pandemic disrupted malaria services resulting in 14 million more cases being reported in 2020 than the previous year, according to the WHO.

Approvals

COMIRNATY BOOSTER

Pfizer and BioNTech say a booster dose increases antibody protection 25-fold compared to the initial two-dose series, providing a high level of protection against the SARS-CoV-2 Omicron variant in an initial lab study.

Source: CNBC

AML TRIAL HOLD

The FDA has placed a clinical hold on the early-stage programme for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

Source: Endpoints News

ISLATRAVIR STUDY PAUSE

Merck stopped dosing in a trial studying islatravir, a once-weekly oral nucleoside reverse transcriptase translocation inhibitor and MK-8507, for HIV-1 infection after an external Data Monitoring Committee recommendation

Source: BioPharma Dive

Aduhelm safety concerns

Safety concerns with the controversial Alzheimer’s disease drug Aduhelm grew after reports said 41% of patients experienced brain bleeding or swelling, while many were asymptomatic.

Source: New York Times

Clinical Trials

ICR SAYS CANCER TRIAL ENROLMENT DROPS DURING COVID-19 PANDEMIC

The Institute of Cancer Research (ICR), London, in the UK has reported that the number of individuals with cancer entering clinical trials has dropped during the Covid-19 pandemic. Estimates show that the 60% reduction in recruitment to cancer trials was noted during the first year of the pandemic.

Source: ClinicalTrialsArena

AEGLEA’S PHASE III ARGINASE 1 DEFICIENCY THERAPY TRIAL MEETS PRIMARY GOAL

Aeglea BioTherapeutics reported that the Phase III PEACE clinical trial of its therapy pegzilarginase to treat individuals with Arginase 1 Deficiency (ARG1-D), met the primary goal. A recombinant human enzyme, pegzilarginase degrades the amino acid arginine. The decline in plasma arginine from baseline was the trial’s primary goal.

Source: Clinical Trials Arena

IQVIA RELEASES TOOL TO CONNECT NURSES and PHLEBOTOMISTS WITH CLINICAL TRIAL PATIENTS 

To improve the virtual trials process, IQVIA is connecting clinical study patients in their homes with nurses and phlebotomists. The mobile research units will give patients participating in clinical trials access to IQVIA's global network of nurses and healthcare workers who draw a patient's blood. They will provide protocol-required care within a patient's own home.

Source: Fierce Biotech

Platform trials: an opportunity for rare dystrophies or gene therapies?

Designing clinical trials for rare diseases can prove challenging with limited resources and high costs. But platform trials can streamline rare disease research as they evaluate multiple treatments and diseases under a single master protocol and have the flexibility to add and drop treatment arms as data develops.

Source: Clinical Trials Arena

Medable and Vault partner to integrate services for decentralised trials

Medable plans to combine its end-to-end software platform with Vault Health’s capabilities in diagnostics, logistics and remote care services for decentralised trials. The alliance will provide a unified experience by merging Medable’s SaaS platform and Vault’s tech-driven expertise to offer clinical trials to patients through remote monitoring and high-touch services.

Source: Clinical Trials Arena

AstraZeneca to run more clinical trials in people’s homes to improve diversity

It is crucial there is diversity among trial participants, as genetic, social, and cultural factors can affect the way different groups respond to interventions. Heart rate and activity are among metrics that can be monitored at home and it is also possible to take blood samples and evaluate lung function.

Source: Guardian