PharmaFocus Today – Page 252 – media

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
- 106
- 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
- 112
- 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
- 222
- 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
- 209
- 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
- 137
- 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
- 111
- October 16, 2023
After Novo’s Ozempic logs victory in kidney disease trial, dialysis heavyweight DaVita raises doubts

An apparent win for Novo Nordisk’s GLP-1 blockbuster Ozempic in chronic kidney disease (CKD) could herald a shift in how the condition has been treated for decades. But dialysis bigwig DaVita—whose future business could be on the line—is making its skepticism known. Based on the inclusion criteria for CKD patients in Novo Nordisk’s FLOW trial, which stopped early this week after hitting pre-specified criteria for efficacy, DaVita believes there may only be “limited application” of the findings to the overall CKD population. DaVita, which shares a significant chunk of the dialysis industry with its German rival Fresenius, admitted it’s “nearly impossible” to draw any conclusions from Novo’s study at this point, given that the detailed results are still under wraps. Emboldened by Ozempic’s performance thus far, Novo on Wednesday said it would begin powering down FLOW on the advice of the study’s independent data monitoring committee. The company expects the ...
- Source: drugdu
- 136
- October 14, 2023
Biogen’s Aduhelm headache returns as appeals court revives part of investor lawsuit

For more than a year, Biogen has been working to turn the page from its Aduhelm fiasco and focus on its newer Eisai-partnered Alzheimer’s disease medicine Leqembi. But a new ruling from the U.S. Court of Appeals for the First Circuit will make that effort a little tougher. After Biogen last year won the dismissal of an investor lawsuit surrounding disclosures into its Aduhelm research, the appeals court has reversed the ruling—in part—by focusing on one statement made by Biogen’s former chief medical officer Al Sandrock. Specifically, the appeals court flagged Sandrock’s statement from the company’s second-quarter earnings call in 2020. During the call, Sandrock stated that “[Y]ou really need to get to the higher dose,” adding, “I think our data are all consistent with that.” The court dubbed this the “all data” statement and painstakingly broke down the context behind the remark. To refresh readers’ memory, Biogen in March ...
- Source: drugdu
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- October 14, 2023
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
- Source: drugdu
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- October 14, 2023
Biogen Lays Off 113 Reata Employees Weeks After Completing $7B Acquisition

By Tristan Manalac Pictured: Biogen sign/The Boston Globe via Getty, John Tlumacki Biogen is laying off 113 employees from Reata Pharmaceuticals’ Plano, Texas site, according to a Worker Adjustment and Retraining Notification notice. The layoffs, set to take effect in late November, come just months after Reata was acquired by Biogen for $7.3 billion in July 2023. At the time, Biogen had just launched a sweeping cost-reduction program which involved terminating around 1,000 employees in an effort to save $1 billion in operating expenses by 2025. Late last month, Biogen completed the acquisition of Reata. In an emailed statement to Endpoints News, a Biogen spokesperson confirmed the job cuts which will mostly affect “roles where there are existing synergies at Biogen.” The positions include general and administrative services, as well as some development-focused jobs. “We are retaining those colleagues who have been essential to the launch of Skyclarys to ensure ...
- Source: drugdu
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- October 14, 2023

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