Search Results for “cancer” – Page 114 – media

Seagen and Nurix announce oncology partnership worth over $3.4bn

Seagen and Nurix Therapeutics have entered into a multi-year, multi-target strategic collaboration agreement worth more than $3.4bn, to advance a new class of medicines for use in cancer. The companies will work to combine antibody-drug conjugation (ADC) and targeted protein degradation (TPD), aiming to create drugs with new mechanisms of action and improve specificity and anti-cancer activity. Under the terms of the agreement, Seagen will provide an upfront payment of $60m to Nurix, with the potential to receive up to approximately $3.4bn in research, development, regulatory and commercial milestone payments across multiple programmes, as well as mid-single to low double-digit tiered royalties on future sales. As part of the collaboration, clinical-stage biopharmaceutical company Nurix will utilise its proprietary DELigase platform to develop targeted protein degraders against multiple targets nominated by Seagen that are suitable for antibody conjugation. Seagen will conjugate these degraders to antibodies to make a new class of ...
- Source: drugdu
- 103
- September 14, 2023
Gilead’s Trodelvy Shows Potential as First-Line Treatment in NSCLC

By Tristan Manalac Pictured: Gilead’s corporate headquarters in California/iStock, Sundry Photography Early data from the Phase II EVOKE-02 study showed that Gilead’s Trodelvy (sacituzumab govitecan-hziy), combined with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab), demonstrates promising efficacy in patients with metastatic non-small cell lung cancer, the company reported Sunday. However, the trial also detected worrying safety signals, with 18% of participants dropping out due to side effects. One patient died due to treatment-related sepsis. Nevertheless, the overall safety profile of Trodelvy in EVOKE-02 was generally consistent with what had previously been established. The most common treatment-emergent adverse events were diarrhea, anemia and asthenia. EVOKE-02 is an open-label, multi-cohort Phase II study with 224 patients enrolled. The trial assessed the combination of Trodelvy and Keytruda, with or without additional chemotherapeutic agents such as carboplatin or cisplatin. Advanced or metastatic non-small cell lung cancer (NSCLC) patients were enrolled regardless of PD-L1 expression status. The ...
- Source: drugdu
- 247
- September 13, 2023
Coherus acquires immuno-oncology company Surface

Coherus BioSciences has concluded the acquisition of clinical-stage immuno-oncology (I-O) company Surface Oncology in a deal totalling nearly $66.9m. The deal value comprises $40m, along with Surface’s net cash at deal closing of $26.9m. Surface Oncology focuses on the development of immunotherapies that act on the microenvironment of the tumour. With the deal closing, Surface became a completely owned Coherus subsidiary. Following the takeover, Coherus expanded its I-O pipeline by adding clinical-stage antibody immunotherapy candidates of Surface, Casdozokitug (SRF388 / casdozo) and CHS-114 (SRF114). These product candidates can boost the innate and adaptive immune responses to facilitate a strong immunologic response and disease outcomes in cancer patients. Casdozokitug is a new antibody targeting IL-27 and is presently being analysed in Phase I/II clinical trials for lung and liver cancer. An anti-CCR8 antibody, CHS-114 is being evaluated in Phase I/II study as a single agent in advanced solid tumour patients. Coherus ...
- Source: drugdu
- 202
- September 13, 2023
FDA fast tracks Mendus’s acute myeloid leukaemia vaccine vividencel

The US Food and Drug Administration (FDA) has granted fast track designation to Mendus’s cancer vaccine vividencel for the treatment of acute myeloid leukaemia (AML). The FDA’s decision was based on results from the Phase II ADVANCE II trial (NCT03697707), which investigated the vaccine’s use as a maintenance monotherapy in patients with AML in complete remission. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling reviews. In June, the Swedish company, which was previously known as Immunicum, presented comprehensive immunomonitoring data at the European Hematology Association’s 2023 hybrid congress. According to Mendus, the vaccine led to increased levels of activated, cancer-killing T cells and reduced levels of immune-suppressive T cells in the majority of the patients in the Phase II ADVANCE II study. Prior to this, the company published data on the drug’s effects on measurable residual ...
- Source: drugdu
- 160
- September 12, 2023
Roche hits FDA delay with subcutaneous version of Tecentriq amid manufacturing process changes

It’s looking like Roche may not receive an on-time FDA decision for the subcutaneous version of its cancer immunotherapy Tecentriq.The FDA was supposed to dole out a verdict on subcutaneous Tecentriq by next week. But Roche now needs to update the therapy’s manufacturing processes, the Swiss pharma’s drug delivery technology partner Halozyme Therapeutics said in a securities filing Thursday. “These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024,” Halozyme said. Roche is making the changes in response to the FDA’s evolving requirements, a spokesperson with the company’s Genentech unit told Fierce Pharma. The spokesperson confirmed that the company now expects to receive an FDA approval in 2024. Roche filed the under-the-skin formulation to both the FDA and the European Medicines Agency in November. It’s targeting all existing indications of the original intravenous Tecentriq. Last ...
- Source: drugdu
- 162
- September 9, 2023
BMS Accused by HMO of Patent Fraud to Allegedly Sustain Pomalyst Monopoly

By Tristan Manalac Pictured: BMS office in California/iStock, hapabapaBlue Cross and Blue Shield of Louisiana on Tuesday filed a class action lawsuit against Bristol Myers Squibb, accusing the pharma giant of unlawfully extending the market exclusivity for its multiple myeloma drug Pomalyst (pomalidomide), according to Reuters. The Baton Rouge-based health maintenance organization is being joined by HMO Louisiana, a subsidiary of Blue Cross and Blue Shield of Louisiana. The plaintiffs are representing a proposed class of entities in the U.S. and its territories that paid for or reimbursed Pomalyst from October 2020. In the 151-page complaint, the not-for-profit health insurance company alleged that BMS and its subsidiary Celgene committed patent fraud by misrepresenting and concealing data regarding Pomalyst’s properties, formulations and uses that had already been publicly available. The pharma companies also “abused the federal judicial system” by launching a barrage of “sham lawsuits” against generics companies that were trying ...
- Source: drugdu
- 172
- September 9, 2023
Astellas withdraws IRA lawsuit after avoiding CMS’ price negotiations list

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
- Source: drugdu
- 184
- September 8, 2023
Researchers receive $2.5 million award to develop a tailored treatment for glioblastoma

A multidisciplinary team of investigators from the UCLA Jonsson Comprehensive Cancer Center was awarded a $2.5 million Translational Team Science Award from the Department of Defense to develop a tailored treatment for glioblastoma, a deadly brain tumor with limited treatment options. The team -; including David Nathanson, associate professor of molecular and medical pharmacology at the David Geffen School of Medicine at UCLA, Benjamin Ellingson, director of the UCLA Brain Tumor Imaging Laboratory and professor of radiological sciences, and Dr. Timothy Cloughesy, professor of neuro-oncology -; plan to target the epidermal growth factor receptor, a protein that is mutated in about 60% of people diagnosed with glioblastoma. Previous attempts have had limited success improving patient outcomes due to drugs’ inability to cross the blood-brain barrier and target genetic alterations in the protein that are unique to glioblastoma. To overcome these obstacles, the researchers have developed ERAS-801, a brain-penetrant inhibitor that ...
- Source: drugdu
- 107
- September 7, 2023
Illumina Taps Agilent Exec as New CEO Amid Company’s Daunting Challenges

By Kate Goodwin Pictured: Illumina sign in San Diego/iStock, Georgejason After months of upheaval, Illumina named Jacob Thaysen its new CEO Tuesday, replacing Francis deSouza who stepped down in June after losing a proxy fight with billionaire activist investor Carl Icahn. Thaysen, the former senior vice president of Agilent Technologies and president of its life sciences and applied markets group, will take the reins Sept. 25. He has his work cut out for him. The DNA-sequencing technology company has faced a rocky road since its acquisition agreement with cancer diagnostics maker GRAIL in September 2020. The deal faced scrutiny from both the Federal Trade Commission and the European Commission due to concerns over antitrust laws. In April, activist investor Carl Icahn went after then-CEO Francis deSouza and campaigned to replace three of Illumina’s board members. While his efforts only got him one seat on the board, deSouza did step down ...
- Source: drugdu
- 98
- September 7, 2023
Delaware’s Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
- Source: drugdu
- 219
- September 6, 2023

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