Search Results for “cancer” – Page 70 – media

FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release. Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year. The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the ...
- Source: drugdu
- 79
- August 23, 2024
New Microfluidics Method to Speed Up Blood Analyses

Researchers have developed a new method to accelerate and potentially scale up the process of separating particles in fluids, a technique that could prove useful for analyzing cancer cells from blood. This speedier and more precise method of elasto-inertial microfluidics was developed by a team led by researchers at KTH Royal Institute of Technology (Stockholm, Sweden) and involves controlling the movement of tiny particles in fluids by leveraging both the fluid’s elastic properties and the inertial forces arising from fluid movement. The microfluidic device features specially engineered channels that accommodate larger volumes of fluid rapidly, making it ideal for applications requiring quick, continuous particle separation. These channels efficiently sort and line up particles, essential for distinguishing different particle types. This high precision is achieved through the use of specially formulated fluids with high polymer concentrations, giving the fluid viscoelastic properties similar to egg whites that can both flow and rebound. ...
- Source: drugdu
- 80
- August 23, 2024
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo and Yervoy Combination for Hepatocellular Carcinoma

August 21, 2024 By Don Tracy, Associate Editor Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma. Image Credit: Adobe Stock Images/magicmine The FDA has accepted Bristol Myers Squibb’s (BMS) supplemental Biologics License Application (sBLA) for an immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for adult patients with unresectable hepatocellular carcinoma (HCC). According to BMS, acceptance of the sBLA was based on promising results from the Phase III CheckMate-9DW trial, which demonstrated that the combination significantly improved overall survival (OS) compared to Lenvima (lenvatinib) or Nexavar (sorafenib).1 “HCC is the most common form of liver cancer and is often diagnosed when surgery is no longer an option. With the number of individuals diagnosed with HCC in the United States increasing over ...
- Source: drugdu
- 77
- August 23, 2024
FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma

Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option. By Frank Vinluan on August 21, 2024 Regeneron Pharmaceuticals already lags companies that have launched new multiple myeloma drugs, and it will have to wait a little bit longer to join them. The FDA turned down Regeneron’s application for its drug candidate, but not for any issues with the therapy itself. The regulator cited problems with the treatment’s third party manufacturer. The FDA rejection for the drug, linvoseltamab, is not a surprise. Regeneron foreshadowed that decision earlier this month during its conference call to discuss second quarter 2024 financial results, disclosing that that the FDA flagged unresolved findings with the contract manufacturer. Those problems centered on another company’s ...
- Source: drugdu
- 73
- August 23, 2024
J&Js Rybrevant plus Lazcluze combination gets FDA approval in NSCLC

Johnson & Johnson’s (J&J) Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) has secured US Food and Drug Administration (FDA) approval as a first-line treatment for patients with some types of non-small cell lung cancer (NSCLC). The indication covers patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. The approval is based on data from the Phase III MARIPOSA study (NCT04487080), which compared the Rybrevant/Lazcluze combination to AstraZeneca’s Tagrisso (osimertinib). Data showed that Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to Tagrisso alone. Additionally, the median duration of response was nine months longer with the combination therapy compared to Tagrisso. The study met its primary endpoint of progression-free survival (PFS) and additional secondary endpoints, including participant race, type of EGFR mutation, and history of brain metastasis. These ...
- Source: drugdu
- 72
- August 22, 2024
Adcendo and Multitude ink ADC deal potentially worth $1bn

The antibody drug conjugate (ADC) dealmaking trend has seen yet another example as Adcendo has signed a licencing agreement potentially worth over $1bn with China-based Multitude for its tissue factor-targeting ADC candidate. The Danish company will acquire the global rights for the development and commercialisation rights for ADCE-T02, except in the Greater China region, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan. The companies were light on financial details noting that upfront and milestone payments will “total over $1bn”. The deal also has the option for “single digit to low double digit” tiered royalties. “We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024,” said Adcendo CEO, Michael Pehl. “The highly ...
- Source: drugdu
- 75
- August 22, 2024
First-Of-Its-Kind AI-Enabled Smart Microscopy Platform to Accelerate Traditional Pathology Workflows

Pathology and tissue analysis are areas poised for transformative advancements. Drug developers and clinicians currently depend on long-established methods for crucial tasks such as diagnosing diseases, quantifying biomarkers, and predicting therapeutic responses. While there have been attempts to innovate by digitizing specimens and adding multiple markers to a single slide, there are still limitations, including the analysis of less than 1% of tissue samples and the inability to depict complex tissue architectures and cellular interactions that are only visible in three dimensions. 3D imaging technology captures significantly more data than traditional slide-based methods by digitizing whole biopsy specimens rather than just thin slices.Artificial intelligence (AI) and machine learning algorithms play a crucial role in quantifying relevant biomarkers and identifying areas for more detailed pathologist examination. Now, a pioneering 3D spatial biology platform can digitize entire tissue specimens quickly and non-destructively while providing AI-enabled quantitative analysis. This technology enhances the precision ...
- Source: drugdu
- 83
- August 21, 2024
Researchers map interactions of 144 active substances to identify drug benefits

Researchers from the Technical University of Munich (TUM) have successfully mapped the interactions of over 100 active substances with around 8,000 proteins to help identify previously unknown benefits of existing drugs. Published in Nature Biotechnology, researchers yielded more than one million dose-responsive curves, which demonstrated the mechanism behind the effects of active substances over the course of treatment. Precision medicine is designed to optimise efficiency or therapeutic benefit for particular groups of patients using genetic or molecular profiling to provide patients with the most individualised treatment possible. To do this, a precise understanding of what is happening at the cellular level is required. Researchers treated cells with various doses of 144 active substances, most of which are already being used in cancer treatment or are in the clinical approval stage. Once extracted, the team analysed proteins using mass spectrometry before studying the cell reactions using the data. In cancer, depending ...
- Source: drugdu
- 64
- August 21, 2024
AstraZeneca wins approval for Imfinzi in NSCLC perioperative setting

AstraZeneca’s Imfinzi (durvalumab) plus chemotherapy has secured US Food and Drug Administration (FDA) approval for non-small cell lung cancer (NSCLC) in the perioperative setting, just weeks after the agency called for an overhaul of perioperative lung cancer trials. This approval is for patients with resectable early-stage (IIA-IIIB) NSCLC and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated in the perioperative setting – a term that refers to the time before, during, and after surgery. In a 25 July meeting, the FDA’s Oncologic Drugs Advisory Committee (ODAC) raised concerns about the design of trials done in this setting. The Imfinzi approval is based on positive data from the Phase III AEGEAN study (NCT03800134), which showed that the perioperative use of the treatment reduced the risk of cancer returning, progressing, or causing death by 32% compared to using chemotherapy alone. ...
- Source: drugdu
- 67
- August 20, 2024
CMS Touts First Negotiated Drug Prices, But Greater Impact Expected in Future Rounds

The first 10 drugs selected for Medicare price negotiations now have new prices set to take effect in 2026. Industry observers note that most of these drugs are older products facing generic competition soon, so greater industry impact will come as the program expands to more drugs in years to come. By Frank VinluanMedicare has unveiled prices for the first 10 drugs selected for its negotiation program, resulting in discounts of as much as 79% off of list prices. Taxpayers will save an estimated $6 billion, the White House said in a Thursday announcement of the new prices. The savings won’t happen right away. New pricing for these products won’t take effect until Jan. 1, 2026 for those with Medicare Part D prescription drug coverage. But these 10 widely used products in therapeutic areas such as diabetes and autoimmune disorders represent the first of many drugs on a path to ...
- Source: drugdu
- 93
- August 19, 2024

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