Entos Pharmaceuticals’ Post

A few months back I highlighted this company's continued efforts to develop a mAb for COVID PrEP. Despite all the mAbs that were developed and launched during the pandemic none are still active. This biotech has stayed the course and is now offering the only mAb prevention option for those patients who are at risk but who cannot respond well to a vaccine. It's noteworthy that even at this time a EUA can be obtained when we find ourselves back in a no option scenario thanks to evolution of the virus. This EUA has relied on immunobridging to data from a prior similar mAb the company was developing but which lost activity during development when Omicron arrived. But, they went back to the lab, re-engineered their mAb, entered p1 March 2023 and have an EUA barely 1 year later. For PrEP mAbs like this to remain an option, this type of development & regulatory approach, which moves molecules forward at speed will continue to be needed. https://lnkd.in/gxJJsumq

I recently wrote an article on the #pharmaceutical #medtech and #biotech industries where I recognised the failures of my industry and also the greatness of it. We at Culture Works Consortium now work to help companies achieve in the industry (and others) through their people. This is yet another example of one of those medical needs that flies below the radar. Persistent or recurrent #UTI is a significant quality of life problem, half of the participants remained infection free for 9 years!! #uromune from ImmunoTek Bio Centers, LLC is a classic meeting of unmet medical need that will save resources, #QoL and make patients and families so much happier. Making long term game changers like this requires trust and commitment from the people and team. its always about the people. Releasing the passion and potential of people to drive is what matters. https://lnkd.in/eDkbpGDV

Discover how WuXi Vaccines is driving acceleration in vaccine development!

Bharath Biotech Gets CDSCO Panel Nod To Manufacture Cholera Vaccine, Inactivated, Oral For 1 Year Age And Above Noting the outcome of inspections of clinical trial sites conducted by the Central Drugs Standard Control Organization (CDSCO), the Subject Expert Committee (SEC) functional under the CDSCO has granted approval to the vaccine makers Bharat Biotech for manufacturing Cholera vaccine (Inactivated, Oral) for the age group of 1 year and above. This came after the vaccine maker Bharat Biotech presented the Phase-III clinical trial report, including immunogenicity and safety results as per the approved protocol for granting manufacturing permission for the Cholera vaccine (Inactivated, Oral). #choleravaccine #cholera #cdsco #bharatbiotech #oralcholeravaccine

🌟 **Breaking News in the Biopharmaceutical World! 🌟** Exciting Announcement Alert! 🎉 The World Health Organization (WHO) has just prequalified the first vaccine against MPOX! 🦠✨ Curious to know more about this groundbreaking development and what it means for global healthcare? Dive into our latest blog post where we explore the implications, significance, and future prospects of this milestone in biopharmaceutical history. 🔗 Read the full article here: https://lnkd.in/dkKuEpf7 Stay informed, stay inspired, and join the conversation on the latest advancements in the fight against MPOX. Your insights matter! #Biopharmaceuticals #WHO #VaccineInnovation #MPOX #BlogPost #HealthcareAdvancements

We are thrilled to share this insightful article authored by Jian He, PhD, CMC Head, highlighting the remarkable strides WuXi Vaccines is making in the field of vaccine development. The article underscores our commitment to advancing the industry by harnessing cutting-edge technologies that accelerate the journey from vaccine discovery to commercialization. Our dedication to innovation is exemplified through the implementation of more automated processes, which empower our talented scientists with high-throughput end-to-end solutions. At WuXi Vaccines, we are proud to be at the forefront of redefining the vaccine development landscape, and we look forward to continuing our mission to provide safe and effective vaccines to protect global health. #VaccineDevelopment #VaccineCDMO #Innovation #WuXiVaccines https://lnkd.in/e2MvVzwb

This is part of our scientific output/series in the #Ebola virus vaccine theme. Apart from #safety & #efficacy, the #perception of the #HCW on the disease (#EVD) and the #vaccine and other #trial related activities are equally important. Nice reading! #GlobalHealth #multidisciplinary

Next time you hear a pharma executive claim their drugs are expensive because of R&D, ask how much of that was funded by the feds. Imagine having your R&D funded by the government and essentially being guaranteed a contract during a public health emergency (contrived or not). That's the reality for Moderna, who recently received $176 million from HHS through the Biomedical Advanced Research and Development Authority (BARDA). The award was made through BARDA’s new Rapid Response Partnership Vehicle (RRPV) Consortium, which is a 10-year, "multi-purpose acquisition vehicle and consortium partnership designed to support advanced research and development of medical countermeasures, such as vaccines, therapeutics, and diagnostics. The consortium creates flexible, strategic partnerships with industry that foster innovation and promote collaboration." This seems to be government speak for "government covers the costs and risks, while private "strategic partners" stand to gain the financial rewards. Moderna’s COVID-19 vaccine, developed with substantial government support, generated $18.4 billion in 2023 alone. This financial model, where government-funded R&D and guaranteed contracts converge is lucrative for companies but problematic for tax payers. And not just the cost, but the financial incentive to push a vaccine at all costs (in the name of profit). Public health preparedness is key, but we must scrutinize these financial dynamics and learn from the past, lest we repeat it. But of course, that may be the very outcome the stakeholders are seeking.

FDA Authorizes New Long-Acting Monoclonal Antibody for Pre-exposure Prevention of COVID-19 in Certain Immunocompromised Individuals Today, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).   Pemgarda is authorized for individuals: who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2; and  who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.  FDA used an immunobridging approach to determine if Pemgarda may be effective for prevention of COVID-19. Immunobridging is based on the relationship between neutralizing antibody titers and clinical efficacy identified with other human monoclonal antibodies against SARS-CoV-2. This includes adintrevimab, a monoclonal antibody like Pemgarda, and certain other monoclonal antibodies that were previously authorized for the prevention of COVID-19. The serum neutralizing antibody titers of Pemgarda were consistent with the titer levels associated with efficacy in prior clinical trials of adintrevimab and certain other monoclonal antibody products.  #fda #drugapproval #EA #covid19 https://lnkd.in/gHBDKUrf

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