FDA EXPANDS APPROVAL TO GILEAD’S BIKTARVY FOR PAEDIATRIC HIV-1 TREATMENT

The US Food and Drug Administration (FDA) has approved an expanded indication for Gilead Sciences’ Biktarvy for paediatric subjects to treat human immunodeficiency virus 1 (HIV-1) infection.

The low-dose tablet form of the drug is indicated for kids weighing a minimum of 14kg to under 25kg and are virologically suppressed or new to antiretroviral treatment.

A comprehensive three-drug therapy for HIV-1, Biktarvy comprises bictegravir and emtricitabine/tenofovir alafenamide (Descovy).

To be used once a day, Biktarvy is said to be the smallest, integrase strand transfer inhibitor-based single-tablet regime for HIV-1.

With the latest approval of the supplemental new drug application, Biktarvy is now intended for younger HIV-1 patients.

UMEÅ UNIVERSITY STUDY FINDS MIX-AND-MATCH OF COVID-19 VACCINES REDUCES RISK

Scientists at Umeå University in Sweden have found that individuals who received AstraZeneca’s Covid-19 vaccine as a first dose and the messenger ribonucleic acid (mRNA) vaccine as a second shot had a reduced infection risk in a study.

Co-created by the University of Oxford and Vaccitech, AstraZeneca’s vaccine utilises a replication-deficient chimpanzee viral vector based on an adenovirus.

This shot also comprises the SARS-CoV-2 virus spike protein genetic material.

Various countries had earlier stopped the usage of AstraZeneca’s shot for individuals aged below 65 years.

In this regard, people who were given the first dose of this vaccine were advised to receive an mRNA vaccine as their second shot in the study.

PFIZER AND BIONTECH SUBMIT DATA TO EMA FOR COVID-19 SHOT IN YOUNG CHILDREN

Pfizer and BioNTech have submitted data to the European Medicines Agency (EMA), backing the use of their Covid-19 vaccine, Comirnaty, in children aged five to less than 12 years.

The latest submission to the EMA is intended to modify the Conditional Marketing Authorization (CMA) for the vaccine in the EU.

The messenger ribonucleic acid vaccine is currently authorised for use under CMA from the European Commission to prevent Covid-19 in individuals aged 12 years or above.

Comirnaty is given in a two-dose regimen at a gap of three weeks.

Furthermore, the vaccine has also been authorised under an expanded CMA as a booster shot to be administered a minimum of six months after the second shot in people aged 18 years and above.

BIOTECHNOLOGY STARTUP RECTIFY RAISES $100M THROUGH SERIES A FUNDING ROUND

Biotechnology firm Rectify Pharmaceuticals has raised $100m through a Series A funding round, which was co-led by Omega Funds, Atlas Venture, Forbion, and Longwood Fund.

Rectify plans to use the proceeds obtained from the financing round for its first human proof-of-concept studies.

The company, headquartered in Cambridge, Massachusetts, US, was founded last year by Jonathan Moore, a founding scientist at Vertex Pharmaceuticals, with Atlas Venture, a biotech venture capital firm.

The new start-up is developing a pipeline of positive functional modulators, disease-modifying precision therapies for patients with genetic diseases caused by mutations in adenosine triphosphate-binding cassette transporters.

IMMUSOFT AND TAKEDA TO DEVELOP CELL THERAPIES FOR RARE METABOLIC DISORDERS

Immusoft has signed a research and licensing agreement with Takeda Pharmaceutical for cell therapies in rare inherited metabolic disorders that lead to complications in the central nervous system.

The collaboration will see the discovery, development and commercialisation of cell therapies.

The cell therapies will be developed using Immusoft’s Immune System Programming technology platform.

WHO KEEPS SPUTNIK V’S EUL PROCESS ON HOLD OVER MISSING DATA

The World Health Organization (WHO) has put Russia’s Covid-19 vaccine Sputnik V’s, Emergency Use Listing (EUL) process on hold, citing pending legal procedures and missing data.

In February, Russia had first sought WHO approval for Sputnik V.

It expects these issues to be resolved soon for the EUL process, reported Reuters.

WHO assistant director-general for access to medicines and health products Mariangela Simao said: “We are working almost on a daily basis with the ministry of health in Russia to address the remaining issues to be fulfilled by the Russian Direct Investment Fund.”