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MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker

Merck (MSD) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. The Phase III Keynote-811 study (NCT03615326) met its progression-free survival (PFS) endpoint for treating human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in the intent-to-treat population. A pre-specified interim analysis of trial data found a “statistically significant” improvement in PFS compared to placebo in the ITT group. In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum. Based on the latest Keynote-811 results, MSD now plans to work with the ...
- Source: drugdu
- 157
- June 20, 2023
Single hospital study finds transgender teenagers rarely choose to discontinue hormone therapy

A three-year-long retrospective cohort study of a single Atlanta hospital’s patient population found transgender and gender-diverse teenagers rarely chose to discontinue gender-affirming hormone therapy, according to a study being presented Sunday at ENDO 2023, the Endocrine Society’s annual meeting in Chicago, Ill. Among 82 transgender and gender-diverse adolescents treated at an academic pediatric endocrinology center from beginning of 2016 to end of 2018, only three chose to halt gender-affirming hormone therapy. None of them resumed identifying as their assigned sex at birth. One participant stopped hormonal therapy due to insurance issues, one participant stopped treatment temporarily to conceive a baby, and one stopped testosterone to transition to a nonbinary gender. “In the infrequent cases in which a person discontinues their gender-affirming hormone therapy, it is often due to external factors as opposed to true retransitioning to the sex assigned at birth,” said lead researcher Pranav Gupta, M.D., a fellow at ...
- Source: drugdu
- 108
- June 20, 2023
Medivis Snags $20M to Enhance Surgical Navigation With Augmented Reality

Gone are the days when augmented reality’s primary use cases centered on gaming and entertainment. Investors are now betting on the technology’s promise to enhance surgical navigation. This shift is evidenced by Medivis’ recent funding round — the New York City-based medical augmented reality (AR) company raised $20 million in Series A financing on Tuesday. The round, which takes Medivis’ total funding to $25 million, was led by Thrive Capital. Other investors included Mayo Clinic, Initialized Capital, Disney CEO Bob Iger and NBA star Kevin Durant. Medivis was founded in 2016 by neurosurgeon Osamah Choudhry, who serves as CEO, and radiologist Christopher Morley, who serves as president. Their mission has always been to establish AR as the new standard in surgical navigation, Choudhry shared in a recent interview. “Traditionally, surgeons have relied on 2D flat images, requiring them to mentally reconstruct their patient images into a 3D representation. However, with ...
- Source: drugdu
- 121
- June 17, 2023
Study reveals a link between short telomeres in ATII cells and lung fibrosis in post-COVID-19 patients

A new research paper was published on the cover of Aging (listed by MEDLINE/PubMed as “Aging (Albany NY)” and “Aging-US” by Web of Science) Volume 15, Issue 11, entitled, “Short telomeres in alveolar type II cells associate with lung fibrosis in post COVID-19 patients with cancer.” The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is responsible for the coronavirus disease 2019 (COVID-19) pandemic. The severity of COVID-19 increases with each decade of life, a phenomenon that suggests that organismal aging contributes to the fatality of the disease. In this regard, researchers Paula Martínez, Raúl Sánchez-Vazquez, Arpita Saha, Maria S. Rodriguez-Duque, Sara Naranjo-Gonzalo, Joy S. Osorio-Chavez, Ana V. Villar-Ramos, and Maria A. Blasco, from Spanish National Cancer Centre (CNIO), Hospital Universitario Marqués de Valdecilla, Institute of Biomedicine and Biotechnology of Cantabria (IBBTEC), Instituto de Investigación Marqués de Valdecilla (IDIVAL), and Universidad de Cantabria, and others have previously shown that COVID-19 severity ...
- Source: drugdu
- 135
- June 17, 2023
New research shows illusions are in the eye, not the mind’s neurons

Numerous visual illusions are caused by limits in the way our eyes and visual neurons work—rather than more complex psychological processes, new research shows. Researchers examined illusions in which an object’s surroundings affect the way we see its color or pattern. The paper, published in the journal PLOS Computational Biology, is titled “A model of color appearance based on efficient coding of natural images.” Scientists and philosophers have long debated whether these illusions are caused by neural processing in the eye and low-level visual centers in the brain, or involve higher-level mental processes such as context and prior knowledge. In the new study Dr. Jolyon Troscianko, from the University of Exeter, co-developed a model that suggests simple limits to neural responses—not deeper psychological processes—explain these illusions. “Our eyes send messages to the brain by making neurons fire faster or slower,” said Dr. Troscianko, from the Center for Ecology and Conservation ...
- Source: drugdu
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- June 17, 2023
Scientists develop universal donor stem cell therapy to treat degenerative brain diseases in a preclinical study

Scientists at City of Hope have developed universal donor stem cells that could one day provide lifesaving therapy to children with lethal brain conditions, such as Canavan disease, as well as to people with other degenerative diseases, such as Alzheimer’s and multiple sclerosis. The study was recently published in Advanced Science. “The off-the-shelf approach City of Hope is taking can easily be extended to improve the quality of life of cancer patients who are experiencing cognitive impairment or impaired motor function as a side effect of chemotherapy or radiation,” said Yanhong Shi, Ph.D., chair of the Department of Neurodegenerative Diseases and the Herbert Horvitz Professor in Neuroscience at Beckman Research Institute of City of Hope. Shi has been working on this research for 12 years. This is the first time stem cells have been engineered to become universal donors for cell therapy targeting diseases of the central nervous system, Shi ...
- Source: drugdu
- 139
- June 17, 2023
AbbVie Files Patent Infringement Lawsuit Against BeiGene’s Brukinsa

By Alejandra Manjarrez www.biospace.com Pictured: Judicial gavel and scales of justice/iStock AbbVie has filed a lawsuit accusing China-based BeiGene’s new blood cancer drug Brukinsa (zanubrutinib) of infringing on its patent for Imbruvica (ibrutinib). Imbruvica was co-developed by J&J’s Janssen and AbbVie’s Pharmacyclics and approved in 2014 by the FDA as a treatment for chronic lymphocytic leukemia. Brukinsa, which gained its FDA approval in January 2023, had its patent issued on Tuesday. Through its complaint, filed that same day in federal court in Delaware, AbbVie is seeking a declaratory judgment of infringement plus damages, Bloomberg Law reported. BeiGene’s shares in Hong Kong and mainland China have fallen more than 10% since the announcement. Both Brukinsa and Imbruvica are BTK inhibitors designed as oral medications to treat the slow-growing blood cancers chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). They are different forms of the same disease and account for about ...
- Source: drugdu
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- June 17, 2023
FDA Puts Mersana’s Ovarian Cancer Trials on Partial Clinical Hold

By Tristan Manalac www.biospace.com Pictured: FDA Building/courtesy of Grandbrothers/Adobe Stock The FDA has placed Mersana Therapeutics’ UP-NEXT and UPGRADE-A trials on partial clinical hold, the company announced Thursday. Both studies evaluate Mersana’s investigational antibody-drug conjugate upifitamab rilsodotin in platinum-sensitive ovarian cancer. The regulatory pause was triggered by an aggregate safety report containing information from around 560 patients who had received upifitamab rilsodotin (UpRi). Mersana’s data showed a higher rate of serious bleeding events, though most of these episodes were low-grade. Still, five cases of serious bleeding were fatal. The exact causes of bleeding are still unknown and are currently being investigated. Mersana’s stocks fell 60% in pre-market trading Thursday in response to the news. The FDA has yet to provide Mersana with a formal written communication regarding the partial clinical hold. However, the company expects the regulator to request a more comprehensive evaluation of UpRi’s safety data. Mersana is working ...
- Source: drugdu
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- June 17, 2023
Blue Water Biotech shores up portfolio with purchase of six FDA-approved treatments

Blue Water Biotech has expanded its commercial portfolio with the purchase agreement of six assets from WraSer. The agreement includes an $8.5m cash payment and the offering of one million restricted shares. Blue Water’s deal includes treatments across cardiology, otic infections, and pain management indications and will see Zontivity (vorapaxar), Trezix (acetaminophen-caffeine-dihydrocodeine), Nalfon (fenoprofen calcium), Conjupri (levamlodipine), Otovel (ciprofloxacin and fluocinolone acetonide) and Cetraxal (ciprofloxacin) all exchange hands to Blue Water’s ownership. All six treatments are US Food and Drug Administration (FDA) approved. At market open, shares in Blue Water surged 90% higher than the previous day’s (13 June) market close. The company has a market cap of $20m. Blue Water’s major purchasing agreement comes at a time when pharma mergers and acquisitions are beginning to pick up after a slow start to 2023. Included in the agreement are the patents related to Zontivity – a medication for patients with ...
- Source: drugdu
- 107
- June 17, 2023
Phastar’s DIA 2023 Global Inspire Award for Community Engagement winner to present at this year’s conference

A statistics manager at specialist biometrics contract research organization (CRO) Phastar, has been chosen to receive the DIA 2023 Global Inspire Award for Community Engagement. Stephen Corson said it was a ‘fantastic bonus’ to be recognized by the DIA community and says it is already privilege enough to share his knowledge. The award recognizes outstanding contribution of DIA Community Chairs who ‘consistently drive engagement and promote knowledge sharing, while advancing thought leadership within the membership community’. He said: “The DIA Community is such a constructive, collaborative space with everyone inspired by their work which can really benefit people. It already feels a privilege to be able to share what knowledge I can bring to the table, so it is a fantastic bonus to be recognized by the DIA community. “Education around data science is crucial to making clinical trial processes more efficient and I get such a buzz from working ...
- Source: drugdu
- 137
- June 17, 2023

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