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Peripheral tumor biomarkers to guide treatment for HPV-associated malignancies

A new review paper was published in Oncotarget’s Volume 14 on August 10, 2023, entitled, “Peripheral surrogates of tumor burden to guide chemotherapeutic and immunotherapeutic strategies for HPV-associated malignancies.” With the rapid adoption of immunotherapy into clinical practice for HPV-associated malignancies, assessing tumor burden using “liquid biopsies” would further our understanding of clinical outcomes mediated by immunotherapy and allow for tailoring of treatment based on real-time tumor dynamics. In their new review, researchers Meghali Goswami, Jeffrey Schlom and Renee N. Donahue from the National Cancer Institute examine translational studies on peripheral surrogates of tumor burden derived from peripheral blood in HPV-associated malignancies, including levels and methylation of circulating tumor DNA (ctDNA), miRNA derived from extracellular vesicles, circulating tumor cells (CTCs), and HPV-specific antibodies and T cell responses. “We review their utility as prognostic and predictive biomarkers of response to chemotherapy and radiation, with a focus on how they may inform ...
- Source: drugdu
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- August 16, 2023
Study reveals coping mechanisms used by South African healthcare workers during the pandemic

A new study by UC Berkeley Anthropology Professor Andrew Wooyoung Kim reveals resilient coping mechanisms used by healthcare workers during the COVID-19 pandemic in metro Johannesburg, South Africa. Titled “Coping strategies employed by public psychiatric healthcare workers during the COVID-19 pandemic in southern Gauteng, South Africa,” Kim’s paper was published in PLOS ONE in August. It explores the diverse coping strategies employed by public psychiatric healthcare workers during the pandemic in the metropolitan Johannesburg area. Andrew Wooyoung Kim, Anthropology Professor, UC Berkeley, said, “This research illuminates the adaptability and creativity of individuals facing unprecedented healthcare challenges. The psychiatric healthcare workers’ ability to innovate in the face of extreme adversity is particularly inspiring. Understanding these coping strategies is vital for building short-term support systems for healthcare workers, providing a roadmap for bolstering psychiatric service delivery while also improving patient outcomes in times of healthcare emergencies.” The study identified seven major coping ...
- Source: drugdu
- 117
- August 16, 2023
NHS England to offer millions of children flu vaccines from September

The NHS has announced that millions of children in England will be offered a flu vaccine as of September 2023 as part of its “life-saving” vaccination programme to protect the country against deadly viruses ahead of winter. School-aged children will receive the flu vaccine either at school or at community clinics, and those who are aged two and three years or have long-term health condition will be offered the vaccine at GP surgeries. The rollout follows the NHS’s winter flu and COVID-19 vaccination programme to provide protection to those eligible from developing serious illnesses and minimise hospitalisations during the winter months. Professor Sir Stephen Powis, NHS England medical director, said: “Vaccinations are our best defence against flu and COVID-19 ahead of what could be a very challenging winter.” By prioritising flu vaccinations for children, the NHS aims to “break the chain of transmission” to the wider population. Earlier this month, ...
- Source: drugdu
- 222
- August 16, 2023
Novartis acquires Chinook for $3.2bn to boost kidney disease pipeline

Novartis has acquired Chinook Therapeutics for more than $3.2bn in a move to bolster its portfolio of drugs targeting kidney disease. With reported sales of $13.62bn in Q2 2023, Novartis is looking to expand its drug portfolio. Just last month, the company acquired DTx Pharma for $1bn for its small interfering RNA (siRNA) treatment portfolio for rare diseases. As part of Chinook’s acquisition, its shareholders would receive $40 per share, totalling $3.2bn. The shareholders would also be eligible to receive an additional $4 per share contingent (totalling $300m) on regulatory milestones. The acquisition comes at a significant inflection point with two high-profile drugs, atrasentan and zigakibart, in Phase III development for the treatment of IgA nephropathy (IgAN). A pivotal data readout for the Phase III atrasentan trial is planned for Q4 2023. IgAN is a chronic kidney disease, in which immunoglobulin A (IgA) is trapped in the glomeruli of the ...
- Source: drugdu
- 117
- August 16, 2023
Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
- Source: drugdu
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- August 16, 2023
Arcturus JV scored $115M in Japanese grants to boost mRNA manufacturing

Right after Daiichi Sankyo picked up Japan’s first mRNA vaccine approval, a potential rival has revealed substantial financial backing from the Japanese government. The Japanese government awarded two grants totaling $115 million to Arcalis to support the production of mRNA vaccines and therapeutics. Arcalis is an mRNA-focused CDMO joint venture by Arcturus Therapeutics and Japanese drug discovery service provider Axcelead. The money was granted in December 2021 and October 2022 to support the construction of Arcalis’ vaccine factory in the Japanese city of Minamisoma and to support the manufacturing of mRNA drug substance and final drug product, respectively, an Arcturus spokesperson told Fierce Pharma. Arcalis completed construction of the drug substance part of the plant at the end of July. The facility occupies an area of 1,933 square meters (nearly half an acre) and boasts total floor space of 7,252 square meters (more than 78,000 square feet). The company plans ...
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- August 16, 2023
FDA Delays PDUFA Date for Valneva’s Chikungunya Shot

By Tristan Manalac Pictured: Sign in front of FDA building/iStock, JHVEPhoto The FDA has delayed its PDUFA action date for Valneva’s investigational chikungunya vaccine VLA1553 to the end of November, the company announced Monday. The original decision was due by the end of August. The regulator extended the review period “to allow sufficient time to align and agree on a phase 4 program,” as required under the agency’s accelerated approval pathway, according to Valneva’s announcement. The FDA did not request additional clinical data to support the application. VLA1553, a live-attenuated investigational shot, could be “the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease,” Valneva Chief Medical Officer Juan Carlos Jaramillo said in a statement. This makes its Phase IV plan all the more important as it will set a “future standard” for the industry. Despite the PDUFA delay, Valneva still expects to launch ...
- Source: drugdu
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- August 16, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
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- August 16, 2023
Clinigen clears out cancer therapies in line with latest growth strategy

UK-headquartered Clinigen announced the divestment of global rights for four of its cancer therapies from its portfolio, as per a 10 August press release. The company gave away the rights of Cardioxane, Savene, Totect and Ethyol (amifostine), as Clinigen shifts its pharmaceutical strategy. The first three drugs use dexrazoxane to treat cardiotoxicity caused by cancer drugs while Ethyol is used to correct the effects of cancer treatment with cisplatin or radiation. Clinigen announced that the four drugs will join CNX Therapeutics’ pharmaceutical portfolio. Based in the UK, CNX Therapeutics commercialises and distributes pharmaceuticals in 40 countries globally. According to its website, the biotech is “seeking to expand its product portfolio in Europe and selected global markets.” This action follows Clinigen’s January 2023 sale of its kidney cancer treatment Proleukin (aldesleukin) to Iovance Biotherapeutics. This deal included an upfront payment of £166.7m ($211.8m), a milestone-based payment of £41.7m ($53m) upon first ...
- Source: drugdu
- 112
- August 15, 2023
Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
- Source: drugdu
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- August 15, 2023

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