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Globally, according to the World Health Organization, an estimated 10.6 million people fell ill with TB in 2022 and 1.3 million died — over 3,500 people per day. The disease primarily affects people in low- and middle-income countries, and those at highest risk are often living in poverty, with poor living and working conditions and undernutrition. In South Africa alone, around 280,000 people are diagnosed with TB each year.

“The launch of this pivotal Phase 3 trial demonstrates our commitment to harnessing the power of medical innovation to fight diseases like TB that are particularly devastating for low- and middle-income countries,” said Emilio A. Emini, Ph.D., CEO of the Gates MRI. “Clinical study of the vaccine will still require years, but our incredible partners in South Africa and elsewhere who have come together for the Phase 3 study share our hope in the vaccine’s potential.”

The Gates MRI, a nonprofit organization and subsidiary of the Bill & Melinda Gates Foundation, is sponsoring the trial, which is supported by funding from the Gates Foundation and Wellcome. The M72/AS01E vaccine candidate has been in development since the early 2000s. It was originally designed and clinically evaluated by the biopharma company GSK up to the proof-of-concept phase (Phase 2b), in partnership with Aeras and the International AIDS Vaccine Initiative (IAVI) and was funded by GSK and in part by the Gates Foundation. In 2020, GSK announced a partnership with the Gates MRI for further development of M72/AS01E. GSK continues to provide technical assistance to the Gates MRI, supplies the adjuvant component of the vaccine for the Phase 3 trial and will provide the adjuvant post licensure should the trial be successful. An adjuvant is an ingredient used in some vaccines that can help create a stronger immune response.

“Making vaccines accessible and affordable for communities in areas of high disease burden in the long-term is a priority for all trial partners. The Gates MRI has worked with a wide range of stakeholders, including communities around clinical trial sites, to guide the TB candidate vaccine to Phase 3. To this end, the Gates MRI, GSK, Wellcome and the Gates Foundation are working together to understand the potential demand for the vaccine and build an end-to-end plan to ensure long-term sustainable access, should the trial be successful; from supporting research and building an evidence-base for the potential impact of the vaccine and community requirements for uptake, to collaborating with multilateral, regional and country partners required to introduce the vaccine. Additionally, the trial funders are planning to establish an international advisory group comprised of representatives from all these groups to provide input on the overall program,” the release said.

Developing and ensuring access to global health products is a complex task. As such, global collaboration and strong partnerships are a core component of planning for future access to the candidate vaccine.

“Reaching Phase 3 with an urgently needed TB vaccine candidate is an important moment for South Africans because it demonstrates that there is a strong local and global commitment to fight a disease that remains distressingly common in our communities,” said Dr. Lee Fairlie, Director of Maternal and Child Health at Wits RHI at University of the Witwatersrand, Johannesburg, South Africa, and national principal investigator for the trial in South Africa. “South Africa also has considerable experience with TB- and vaccine-related clinical trials and a strong track record for protecting patient safety and generating high quality data essential for regulatory approvals.”

At full capacity, the trial will include up to 20,000 participants, including people living with HIV, at up to 60 trial sites in seven countries — South Africa, Zambia, Malawi, Mozambique, Kenya, Indonesia and Vietnam. Participants will receive either the investigational M72/AS01E vaccine or a placebo in what is known as a double-blind trial, meaning neither the trial participant nor the clinical investigators will know who receives vaccine or placebo. This approach is considered the gold standard for evaluating the safety and efficacy of an investigational vaccine.

“After dedicating over 20 years to developing this essential candidate vaccine, we at GSK are delighted that the Phase 3 trial is underway. Developing and ensuring access to global health products is complex but our collaboration with the Gates MRI, Wellcome and the Gates Foundation exemplifies the transformative power of leveraging diverse partners’ expertise to change the trajectory of challenging diseases, like TB, which place a huge burden on communities around the world,” said Deborah Waterhouse, CEO, ViiV Healthcare and President, Global Health, GSK.

While TB is one of the world’s deadliest infectious diseases — and the leading cause of death amongst people living with HIV — the only available TB vaccine, BCG, dates back to 1921. It protects babies and young children against severe forms of TB, but it offers inadequate protection for adolescents and adults against the pulmonary form of the disease, which is primarily responsible for transmission of the TB bacterium.

“If effective, M72/AS01E could reinvigorate a global fight against TB that has been weakened by the COVID-19 pandemic,” said Alemnew Dagnew, M.D., who leads development of M72/AS01E at the Gates MRI. “I am particularly excited to see this trial get underway because when I was working as a physician in Ethiopia, I saw first-hand what pulmonary TB does to communities — and a vaccine that could help prevent that from happening would be transformative.”

Dagnew noted that TB is both a health problem and a socioeconomic problem. He said the disease primarily affects people during their prime working years, leaving families without income and children without parents. Almost half of TB-affected households face costs higher than 20% of their household income.

“We must continue to move with urgency to develop and equitably deliver innovative tools with the potential to transform the prevention, diagnosis, and treatment of TB. The start of the Gates MRI’s M72 TB vaccine candidate Phase 3 clinical trial marks a pivotal moment in the fight to end TB, which devastatingly afflicts the world’s most vulnerable communities. We think this trial marks the beginning of a series of opportunities that will usher in the most promising pipeline ever of new TB tools. The Gates Foundation remains committed to supporting local and global partners to accelerate the solutions needed to save lives and reduce suffering from this preventable disease,” said Trevor Mundel, President, Global Health, Bill & Melinda Gates Foundation.

Alex Pym, Director of Infectious Disease at Wellcome, said, “While it is a long journey to results, the start of this trial in South Africa brings us a critical step closer to having an effective vaccine to protect those most at risk of TB. Global collaboration with regulators, in-country decision makers and communities affected is crucial if those who need it most are to benefit from this vaccine, should the trial be successful.”

It is anticipated that it will take up to five years to complete the trial, followed by data analysis and then preparation for submission of data to regulatory authorities.

In GSK’s Phase 2b trial, M72/AS01E provided approximately 50% protection (13/1626 versus 26/1663) against progression to active pulmonary tuberculosis for three years in Mycobacterium tuberculosis-infected HIV-negative adults, which was unprecedented in decades of TB vaccine research. The World Health Organization estimates that over a 25-year time span, that level of protection could save 8.5 million lives, prevent 76 million new TB cases and save $41.5 billion for TB affected households.

Read also: Lupin gets CDSCO Panel nod for Rifapentine Dispersible Tablet 150 mg

The practical examination for FCPS candidates is scheduled to be held in April from 1st to 13th April 2024.

TIME-TABLE

IMPORTANT POINTS

1 No candidate will be allowed to enter the examination hall without a hall ticket.

2 It is mandatory for every candidate to wear an apron and roll number card.

3 Every candidate must compulsorily bring an EPD/Log Book.

FCPS is a fellowship program that aims, among other things, to enhance the healthcare profession in rural and remote locations. It is a three-year course and can be done from both government and private institutions with the same quality standards.

To view the official Time-Table, click the link below

New Delhi: Citing there is an unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Emcure Pharmaceutical to conduct the bioequivalence study (BE) of the Ferric Maltol Capsules 30mg, a complexed iron supplement used to treat iron deficiency in adults.

This came after Emcure Pharmaceutical presented its proposal for a grant of permission to manufacture and market the drug along with BE study protocol vide no. VRL-24-001, Version no. 2.0, dated 09.01.2024, along with a request for Phase III Clinical trial waiver before the committee.

Ferric maltol is an iron(III) atom complexed with 3 maltol molecules to increase the bioavailability compared to iron(II), without depositing it in the duodenum as insoluble ferric hydroxide and phosphate.

Ferric maltol dissociates as the iron atom is donated to unknown iron uptake mechanisms, possibly beta 3 integrin or divalent metal transporter 1,6 in the ileum and duodenum. Once the iron is in circulation, it then associates with transferrin and ferritin. Ferric maltol is used to treat iron deficiency (not enough iron in the blood).

At the recent SEC meeting Haematology held on 5th March 2024, the expert panel reviewed the proposal for the grant of permission to manufacture and market the drug along with BE study protocol vide no. VRL-24-001, Version no. 2.0, dated 09.01.2024, presented by Emcure Pharmaceutical.

After detailed deliberation, the committee opined that there was an unmet medical need. Therefore, it is advised that authorization be granted to carry out the bioequivalency study in accordance with the described protocol

Accordingly, the expert panel suggested that the firm should submit the bioequivalence study results before the committee for further consideration.

Also Read: Modify Clinical study protocol of Iptacopan study in aHUS: CDSCO Panel Tell Novartis

Prime Minister Narendra Modi inaugurated the state-of-the-art hospital, Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital built with Indian assistance showcasing the robust development cooperation between India and Bhutan.

The Gyaltsuen Jetsun Pema Wangchuk Mother and Child Hospital is a state-of-the-art 150-bedded facility that has been built with the assistance of the Government of India in Thimphu.

With the State Bank of India (SBI) finally submitting crucial data on the electoral bonds to the Election Commission (EC) yesterday, the EC made public a fresh data set of electoral bonds, including their alpha-numeric numbers that can help match their purchasers with the political parties that received the funds.

Two separate lists of the donors and the recipients have been published by the poll panel on its website after the details were submitted to it by the SBI earlier in the day as per a Supreme Court order.

Busting an illegal sex determination racket in Gujarat’s Sabarkantha district, a doctor was recently caught red-handed for allegedly determining the sex of the foetus of a pregnant woman at Drupad Hospital in exchange for Rs 20,000.

Afterwards, the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Cell of Rajasthan on Wednesday arrested the doctor along with an agent following a decoy operation.

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