PharmaFocus Today – Page 149 – media

FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma

Davy James Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) plus cisplatin and gemcitabine in the frontline treatment of adults with unresectable or metastatic urothelial carcinoma (UC).1 The regulatory action adds to an array of approved indications for Opdivo, both as a single agent and in combination therapy, including for patients with unresectable or metastatic melanoma; metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic UC; microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.2 “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients ...
- Source: drugdu
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- March 9, 2024
Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

Novo Nordisk reported its weight loss pill amycretin led to greater weight loss measured at 12 weeks compared to clinical trial results for its blockbuster obesity drug Wegovy. But these results are from a small Phase 1 study and more testing is needed. By FRANK VINLUAN An experimental Novo Nordisk obesity pill led to weight loss of 13.1% in a clinical trial, topping results posted in studies of the company’s approved injectable medication Wegovy. It’s early days and more testing is needed, but the preliminary data suggest that this pill has the potential to offer patients superior weight shedding in a more convenient oral formulation. Phase 1 data for the once-daily Novo Nordisk pill, amycretin, were presented Thursday during a company investor event. The study followed participants for 12 weeks. In that span, those who received a placebo lost 1.1% of their body weight. Wegovy, which is administered as a ...
- Source: drugdu
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- March 9, 2024
Where there is a challenge, there is an opportunity

The challenges and opportunities surrounding Africa becoming a clinical trials global force were discussed on day one of CTS Europe. Révérien Uwacu speaking about the five African countries that have a WHO maturity level of three, signifying high capability of overseeing clinical trials. Image credit: Jenna Philpott/GlobalData. Over 18% of the global population lives in Africa, but less than 3% of clinical trials are conducted there. Is there an opportunity for clinical trials to be conducted in Africa? Experts at the ongoing Clinical Trial Supply (CTS) Europe meeting say the answer is yes, but not without its challenges. Leading the session, “Increasing diversity: supply chain considerations for clinical trials in Africa”, Révérien Uwacu, clinical trial supply management consultant for the pharma company UCB, emphasised the importance of diversity in clinical trials, for scientific, moral, and medical reasons. Révérien cited logistical challenges and regulatory complexities in trial supply management, as some ...
- Source: drugdu
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- March 9, 2024
Gilead and Merus enter trispecific antibody discovery deal

The agreement outlines the potential for Merus to earn up to $1.5bn payments from Gilead. Merus will head the early-stage research works for two programmes, with the option to expand to a third asset. Credit: aslysun / Shutterstock.com. Gilead Sciences has entered a research partnership, option and licence agreement with Merus for the discovery of dual tumour-associated antigens targeting trispecific antibodies. The partnership will leverage Merus’ Triclonics technology and Gilead’s capabilities in the oncology field. The aim is to advance multiple preclinical research programmes that could potentially transform cancer treatment. Merus focuses on the development of full-length, multispecific antibodies named Biclonics and Triclonics, referred to collectively as Multiclonics. These antibodies are created by a common light chain technology. The Triclonics trispecific platform creates antibodies that can target three different antigens simultaneously. Merus will spearhead the early-stage research works for two programmes, with the option to expand to a third asset. ...
- Source: drugdu
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- March 9, 2024
Automated Multiplexing Molecular Diagnostic Platform Revolutionizes Infectious Disease Diagnostics

A new fully automated multiplexing molecular diagnostic platform offers an innovative and cost-effective testing approach by allowing customization of tests along with the ability to process and pay for desired results, thus enabling laboratories to maximize testing efficiencies. Diasorin’s (Saluggia, Italy) new LIAISON PLEX platform provides complete flexibility for the customization of syndromic panels and helps overcome the challenge of the “one size fits all” approach faced by clinical laboratory staff for infectious disease syndromic diagnostics. Custom panels enable adjustments in response to seasonal changes and updates in clinical guidelines, helping prevent unnecessary and costly over-testing – a common issue with fixed, broad syndromic panels currently in use. The user-friendly, fully automated sample-to-answer system offers a streamlined workflow and room-temperature stable consumables, simplifying storage and transport logistics. Additionally, it requires just two minutes of hands-on time per sample and can deliver results in less than two hours. The LIAISON PLEX, ...
- Source: drugdu
- 140
- March 8, 2024
New Testing Strips to Make Rapid Antigen Testing as Powerful as PCR Testing

During the onset of the pandemic, individuals experiencing symptoms had to endure lengthy queues for lab-based PCR testing and then wait around two days for the results, to confirm if they were infected with the COVID-19 virus. This process was not only inconvenient but also involved complex and costly logistics, contributing to testing delays and increasing the risk of spreading the disease. Now, a newly developed biosensing technology enables the creation of gene test strips that can match the quality of traditional lab-based tests. The new technology developed by a team of biomedical engineers at UNSW Sydney (Sydney, Australia) offers test strips that are as accurate as lab-based PCR tests, with the added advantage of quick, on-site disease detection. Described by the researchers as having “PCR in your pocket,” this advancement holds potential for broad applications in biomedical and environmental diagnostics across various sectors, including food, agriculture, and biosafety management. ...
- Source: drugdu
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- March 8, 2024
ViiV Healthcare Reveals Positive Results from Phase I Trial for a Potential Longer-Acting HIV Treatment

Don Tracy, Associate Editor Novel formulation of cabotegravir (CAB-ULA) allows for dosing intervals of at least four months.Image Credit: Adobe Stock Images/alexskopjeViiV Healthcare has announced promising results from a Phase I study on a new formulation of cabotegravir (Apretude), known as cabotegravir ultra long-acting (CAB-ULA) for HIV pre-exposure prophylaxis (PrEP). Findings suggested that CAB-ULA is well-tolerated and has a pharmacokinetic profile supportive of extended dosing intervals. According to a company press release, the formulation allows dosing intervals of four months, resulting in a reduction of clinical visits for HIV patients.1 “The HIV community has told us of their desire for longer-acting medicines that can help alleviate the burden of daily treatment,” said Kimberly Smith, MD, MPH, head of research and development, ViiV Healthcare, in the press release. “ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the ...
- Source: drugdu
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- March 8, 2024
Gilead Sciences Signs Yet Another R&D Alliance for Multi-Target Cancer Therapies

Gilead Sciences’ partnership with Merus could yield novel antibody drugs capable of binding to three targets simultaneously. The alliance follows a collaboration that Gilead started last year with Tentarix Biotherapeutics, a startup also developing antibodies that bind to multiple targets. By FRANK VINLUAN Bispecific antibody drugs have shown that binding to two targets simultaneously can be a powerful and effective way to treat cancer. Binding to three targets could be even better, and Gilead Sciences is turning to biotech company Merus to find out. Under the collaboration agreement announced Wednesday, Gilead is paying Merus $56 million up front and making a $25 million equity investment in the biotech. Netherlands-based Merus focuses on developing antibody therapies that bind to two or three targets at the same time. This capability could block multiple receptors that drive tumor growth and survival. It could also coax a patient’s immune cells to kill tumors. So ...
- Source: drugdu
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- March 8, 2024
BIO-THERA’s Class 1 New Drug BAT7205 (PD-L1/IL-15) for Injection Approved for Clinical Trials in Locally Advanced or Metastatic Solid Tumors

BIO-THERA Bio-Pharmaceutical Co., Ltd (Stock Code: 688177) has recently received a Notice of Approval of Drug Clinical Trial approved by the State Drug Administration for the Company’s investigational product BAT7205 for injection. BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by BIO-THERA and is intended to be developed for the treatment of locally advanced or metastatic solid tumors.IL-15 is a pleiotropic cytokine that is essential for the regulation of many immune functions, particularly the development, proliferation and activation of CD8+ memory T cells and NK cells, and promotes PD-1 inhibitor-naïve CD8 + activation and proliferation of tumor-infiltrating T cells, which is expected to significantly improve the clinical efficacy of PD-1/PD-L1 analogs. BAT7205 consists of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein, which can both block the PD-1/PD-L1 immunosuppressive pathway and activate the immune cells through IL-15, thus achieving the synergistic effect of deregulation of immunosuppression and activation of ...
- Source: drugdu
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- March 8, 2024
Henlius’ Trastuzumab Plots Southeast Asia Expansion, to Enter Thailand and Philippines

Recently, Henlius’ self-developed and manufactured HANQUYOU (trastuzumab, trade names: Zercepac® in Europe, Tuzucip® and Trastucip® in Australia) has been approved for marketing in Thailand and the Philippines under the trade names of TRAZHER® and Hertumab®, respectively, for the treatment of HER2-positive breast cancer and gastric cancer. Up to now, HANQUYOU has been successfully approved in Southeast Asian countries, including Singapore and Cambodia, and in a total of more than 40 countries and regions. Breast cancer is the most prevalent malignancy in Southeast Asia, with nearly 170,000 new cases of breast cancer in the region in 2022. About 15% to 20% of breast tumours are HER2-positive breast cancers. On the other hand, the reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%. Trastuzumab has long been a cornerstone of therapy for the treatment of HER2-positive breast and gastric cancers, and has been included as a ...
- Source: drugdu
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- March 8, 2024

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