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Akero’s Three-Step Plan to Win Back Investors

By Jia Jie Chen Pictured: Stocks trending down/iStock, lerbank Shares of Akero Therapeutics crashed this week after the biotech released data from a late-stage trial of its lead candidate, efruxifermin, in nonalcoholic steatohepatitis. Although the Phase IIb study met multiple secondary endpoints, the effect on the primary endpoint was not considered statistically significant. The SYMMETRY trial compared 182 patients with compensated cirrhosis—also known as F4 fibrosis—who were treated with efruxifermin (EFX) with a placebo control group. The data showed that 22% of patients treated weekly with 28 mg of efruxifermin (EFX) saw at least a one-stage improvement in liver fibrosis with no non-alcoholic steatohepatitis (NASH) worsening, while 24% of those treated with 50 mgs of EFX achieved this result; this compared to 14% of patients in the placebo arm who experienced similar improvement. The differences between the placebo group and both experimental arms were not statistically significant, with p-values at ...
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Ozempic’s Pros, Cons and Correct Use Cases

By George Kramb Pictured: Man preparing Ozempic injection/iStock, imyskin Thanks to TikTok, Ozempic has emerged as this year’s go-to weight loss drug. The current debate revolves around a need to understand Ozempic’s true benefits, unmarred by the overshadowing emphasis on weight loss. Ozempic is not a weight loss drug. It is an injectable prescription medicine used “along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes,” according to its label. As such, it is crucial to recognize its multifaceted nature and the responsible approach it demands. Ozempic’s role in the evolving world of healthcare—and inadvertently weight loss—involves both medical benefits and societal perceptions. The Authentic Benefits of Ozempic Amidst the clamor surrounding Ozempic’s media coverage, it’s imperative to redirect the focus to its true advantages when employed for its designated purposes. Ozempic’s primary function lies in regulating blood sugar levels, offering crucial assistance to ...
- Source: drugdu
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- October 16, 2023
Newly discovered synthetic adjuvant materials could make vaccines more accessible, sustainable

New raw vaccine materials that could make vaccines more accessible, sustainable, and ethical have been discovered. Adjuvants are vaccine ingredients that boost a person’s immune response to a vaccine, providing greater protection against disease. One of the most prevalent adjuvant materials used in vaccines is squalene, which is typically sourced from shark livers. Researchers at the University of Nottingham collaborated with the Access to Advanced Health Institute (AAHI) to identify synthetic alternatives to squalene that ensure sustainable, reliable, and ethical sourcing of adjuvant raw materials for vaccines moving forward. New synthetic adjuvant materials were developed from commercially available methacrylate monomers, ensuring that a reliable supply of the material is continually available. The combination of these adjuvant materials are scalable through catalytic chain transfer polymerization, a process that allows high levels of control over the molecular weight of the product polymer. Controlling the molecular weight is key to the use of ...
- Source: drugdu
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- October 16, 2023
How Nemours Children’s Is Working to Solve the ‘Horrendous’ Youth Mental Health Crisis

If you think the state of young people’s mental health in the U.S. hasn’t reached a crisis point yet, you are sorely mistaken, Lawrence Moss said Monday during an interview at HLTH. He is the CEO of Nemours Children’s Health, a pediatric health system with more than 95 locations in four states. Moss gave some sobering statistics on the youth mental health crisis, saying that nearly a quarter of children in the U.S. have a diagnosable mental health disease and that youth suicide rates have quadrupled over the past few years. “When you talk about child health right now, it’s more about behavioral health than physical health. We don’t typically like to think of it that way, but that’s the reality. If you can only do one thing for the health of children in this country, it would be in the behavioral health sphere,” he declared. One of the most ...
- Source: drugdu
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- October 16, 2023
WHO announces €1.1bn collaboration to eradicate polio

The European Commission, the European Investment Bank and the Bill and Melinda Gates Foundation have announced a €1.1bn ($1.17bn) financing collaboration to tackle polio and make healthcare systems more accessible in low-income countries. The funding partnership is expected to include €500m ($531m) for the Global Polio Eradication Initiative (GPEI), including World Health Organization (WHO) and UNICEF, €500m ($531m) in investments and grants to strengthen health systems and €80m ($85m) grants for technical assistance. Polio is a serious viral infection that mainly affects children in low-income countries. The virus attacks the nervous system, leading to paralysis and sometimes death. According to WHO, wild poliovirus cases have decreased by over 99% since 1988. However, wild poliovirus remains an endemic in Pakistan and Afghanistan, with most of the cases being found in just four subnational regions. President of the European Commission Ursula von der Leyen said: “With 1 billion euros supported by our ...
- Source: drugdu
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- October 16, 2023
Birmingham researchers develop nanobodies to understand platelet disorders

Researchers at the University of Birmingham have developed antibody fragments, called nanobodies, in a bid to understand platelet disorders such as thrombosis. The team at the Institute of Cardiovascular Sciences has been able to produce the first binding molecules of defined composition to make platelets clump together in a predictable way. The institute aims to use these nanobodies to develop validated clinical assays for testing patients with platelet disorders such as bleeding or thrombosis, as well as use them as a research tool to study platelet activation. The institute’s work is set to be published in the Journal of Thrombosis and Haemostasis later this week (12 October.) In previous studies carried out by the Birmingham Platelet Group, Professor Steve Watson and Dr Natalie Poulter used novel nanobodies the team had raised to bind to the GPVI (Glycoprotein VI) receptor. This receptor plays a role in thrombosis but only has minor ...
- Source: drugdu
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- October 16, 2023
Almirall and EpimAb partner to develop bispecific antibody therapies

Almirall has signed a licensing agreement with EpimAb Biotherapeutics to utilise the latter’s Fabs-In-Tandem Immunoglobulin (FIT-Ig) platform to develop up to three bispecific antibody targets. EpimAb is eligible for up to $210m (¥1.53bn) in milestone-based payments and net sale royalties. Almirall will hold exclusive global commercialisation rights over the therapies developed during the course of the partnership, based on a 12 October press release. EpimAb’s FIT-Ig platform rearranges the DNA sequences of two monoclonal antibodies to generate bispecific antibodies. “While we have made significant progress in utilizing our platform technology to develop a differentiated portfolio of bispecific antibodies in oncology, the potential of our platform in other areas such as immunology remains untapped,” said EpimAb’s CEOChengbin Wu in the press release. “We believe Almirall is the partner of choice for this endeavour and look forward to exploring the use of our novel bispecific platform to offer additional treatment options for ...
- Source: drugdu
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- October 16, 2023
FDA quells Care Access misconduct concern in Pfizer’s Lyme disease vaccine trial

The US Food and Drug Administration (FDA) has found no misconduct by contract research organisation (CRO) Care Access in Pfizer and French partner Valneva’s Lyme disease vaccine trial. The FDA did not issue a Form 483 – a document sent to a company indicating violations after an inspection. The outcome comes after a nine-day for-cause FDA Good Clinical Practices (GCP) inspection into sites managed by Care Access in Pfizer’s VALOR trial. The inspection reviewed Care Access’s contributions to the trial, including GCP requirements, patient safety and data integrity, the CRO said in an 11 October statement. Care Access CEO Ahmad Namvargolian said in a company statement: “We’re very glad to have had the opportunity finally to undergo this independent, searching review by an FDA expert, which confirmed what we’ve always said about our performance on the VALOR trial and beyond.” In February 2023, Pfizer and Valneva announced it was halting ...
- Source: drugdu
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- October 16, 2023
Noom Offers Clinical Obesity Management Platform to Employers

Noom is now offering Noom Med to employers. The program is intended for patients who need more clinical support in their weight loss journey. It offers access to a clinician and medications, including GLP-1s. Noom, a digital solution that supports weight loss, is now expanding its services for employers to include Noom Med, a clinical obesity management solution. The company made this announcement Monday at HLTH 2023 in Las Vegas. New York City-based Noom helps people build healthy habits through psychological tools like food tracking, coaching and community. Its Noom Med offering, previously only available to consumers, includes all these same services as well as more clinical support. Two groups of patients are eligible for Noom Med: those with a body mass index of 30 or higher, or those with a body mass index of 27 or higher with one or more weight-related conditions. When patients start with Noom Med, ...
- Source: drugdu
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- October 16, 2023
Included Health Has Proved Its Value to Our Virtual Primary Care Program

Walmart’s relationship with Included Health dates back to 2016 when its previous incarnation – Doctor on Demand – began providing virtual urgent care services to Walmart employees in three states. Nearly eight years later, the San Francisco company continues to be the only partner charged with delivering virtual primary care to almost 1 million people in 49 states. In announcing a large expansion of its virtual primary care program on Tuesday, Walmart strongly endorsed its health tech partner charged with providing that care to workers and their families enrolled in its health plans: Included Health. “They’re the partner,” responded Lisa Woods, vice president, physical & emotional wellbeing at the Bentonville, Arkansas retailer, when asked whether Included is simply one of the partners involved in the announcement. Through the expansion, 1 million people including Walmart associates and their family members will be able to access virtual care in 49 states. “Yesterday, ...
- Source: drugdu
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- October 16, 2023

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