Search Results for “cancer” – Page 115 – media

Recalls and Shutdowns Worsen Drug Shortage Crisis

By Andy Gooding-Call Pictured: Packs of birth control pills/iStock, towfiqu ahamed At the end of July, Lupin Pharmaceuticals recalled two batches of Tydemy, a birth control drug that the company produces in India, when it was found to have reduced effectiveness. It was the company’s eighth product recall in just 18 months. Lupin was also forced to stop production at one of its Indian plants in 2022 after the FDA issued a warning letter last fall. Around the same time, another generics manufacturer, Intas Pharmaceuticals, made headlines over a failed FDA inspection at a manufacturing plant in Gujarat, India, leading the company to cease operations there. At a moment when drugs already are in short supply, these disruptions are reducing availability even more, putting entire supply chains at risk and forcing doctors and patients to make difficult, life-changing treatment decisions. “It’s hard to know” how the issues at Intas and ...
- Source: drugdu
- 121
- August 31, 2023
AstraZeneca Latest to Sue Biden Administration Over IRA’s Drug Price Negotiations

By Nadia Bey Pictured: AstraZeneca’s San Francisco office/iStock, hapabapa AstraZeneca has joined a growing list of drugmakers suing the Biden administration over a provision in the Inflation Reduction Act that allows the federal government to negotiate Medicare drug prices, the company announced Friday. The British drugmaker is the latest pharma company to file a legal complaint. Boehringer Ingelheim filed a lawsuit Aug. 18, arguing that Medicare price negotiations under the IRA violate the company’s constitutional rights to due process, protection against excessive fines and free speech. Other companies—including Merck, Bristol Myers Squibb, Johnson & Johnson and Astellas—that have sued the U.S. government over the IRA have focused on constitutional arguments. Similarly, the lobbying group Pharmaceutical Research and Manufacturers of America filed a suit challenging the constitutionality of the law. However, AstraZeneca has taken a different approach in its legal complaint filed Aug. 25 in the U.S. District Court for the ...
- Source: drugdu
- 103
- August 30, 2023
Why OneOncology Is Adopting Verily’s Clinical Trial Management System

More than 1,300 oncology drugs are in the development pipeline, waiting to potentially embark on the long journey toward their commercial debut. This journey is usually an arduous one, made even more difficult by the mere 6% participation rate in clinical trials among adult cancer patients in the U.S. To help tackle this issue, OneOncology — a cancer center network that TPG and AmerisourceBergen bought for $2.1 billion in June — recently announced that it is deploying Verily’s clinical trial management software platform across 11 of its community oncology clinics. Verily’s platform, called SignalPath, was designed with the intention of making providers’ complex clinical research ecosystems more manageable. It does this by converting trial protocols from PDFs to automated workflows, enabling centralized site and study management, and facilitating communication across site stakeholders. SignalPath also produces real-time metrics on performance and finances that users can turn into actionable insights. “As a ...
- Source: drugdu
- 121
- August 22, 2023
Chimerix’s Drug Candidate Improves Survival for Patients with Incurable Brain Tumor

By Matt Olszewski Pictured: Adult holding child’s hand/gorodenkoff/iStock Biopharma company Chimerix announced Wednesday positive results from two early-stage clinical trials for its first in-class small molecule imipridone, a potential treatment for an incurable and aggressive type of pediatric brain tumor which demonstrated longer survival in this subset of patients. The data, published Wednesday in the journal Cancer Discovery, showed that Chimerix’s ONC201 nearly doubled survival for patients with H3K27M-mutated diffuse midline gliomas (DMG), as compared to previous patients. Diffuse midline gliomas with the H3K27M mutation are aggressive, with a survival rate of 11 months to 15 months. However, the median overall survival was nearly 22 months for tumors that had not recurred at the time of enrollment in the trial. In addition, almost a third of those patients lived longer than two years. “These data further elucidate the underlying novel mechanism of action for ONC201 in a patient population which ...
- Source: drugdu
- 114
- August 21, 2023
US study finds potential new way of improving immunotherapy for tumours

A new study by the University of Pittsburgh and the University of Pittsburgh Medical Centre (UPMC) in the US has revealed a new way to stimulate the immune system to enable immunotherapy to shrink or eradicate aggressive tumours. By equipping oncolytic viruses, genetically modified viruses, with tumour-inhibiting genetic cargo, researchers found that it ‘warms up’ cold tumours in the immune system and helps immunotherapy tackle the tumour. Oncolytic viruses were previously designed to directly eliminate cancer cells. Researchers found that oncolytic viruses could stimulate the immune system, suggesting their potential use with other cancer therapies to remove the brakes on the immune system for T cells to recognise and combat tumours. “Immune checkpoint inhibitors work only in ‘hot’ tumours, which have already been infiltrated by T cells,” said Greg Delgoffe, associate professor of immunology at Pitt’s School of Medicine and director of the Tumor Microenvironment Center at UPMC Hillman Cancer ...
- Source: drugdu
- 123
- August 21, 2023
FDA approves Talvey for heavily pre-treated multiple myeloma

US Food and Drug Administration (FDA) has approved Talvey (talquetamab-tgvs) for the treatment of refractory or relapsed multiple myeloma in adult patients who have received at least four prior lines of therapy. Talvey is a bispecific antibody targeting T-cell CD-3 receptors and G protein-coupled receptor class C group 5 member D (GPRC5D) developed by Janssen. It received accelerated approval as a weekly or biweekly subcutaneous therapy. University of California multiple myeloma programme director Ajai Chari noted in a press release: “Patients at this stage of the disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.” The approval was based on meaningful overall response rates (ORR) demonstrated in the Phase II clinical trial data. However, continued approval for Talvey is contingent upon further confirmatory trials showing clinical benefit. To that end, Talvey is only available for use via a ...
- Source: drugdu
- 118
- August 21, 2023
Pfizer Bispecific Drug Wins FDA Accelerated Approval for Multiple Myeloma

By Tristan Manalac Pictured: Pfizer office at its South San Francisco campus/iStock, hapabapa The FDA on Monday granted accelerated approval to Pfizer’s bispecific antibody elranatamab, to be marketed as Elrexfio, for the treatment of relapsed or refractory multiple myeloma. Elrexfio’s label covers patients who had been treated with at least four prior lines of therapy, including an anti-CD38 antibody, an immunodulatory agent and a proteasome inhibitor. According to Pfizer’s announcement, Monday’s approval makes Elrexfio the first off-the-shelf, ready-to-use fixed-dose subcutaneous therapeutic that targets the BCMA protein. “With significant responses in a patient population with highly refractory disease, we believe Elrexfio is poised to potentially become the new standard of care for multiple myeloma,” Pfizer Chief Commercial Officer Angela Hwang said in a statement, adding that the company will continue the treatment’s clinical development through its broad MagnetisMM program. The FDA’s approval was supported by data from the Phase II MagnetisMM-3 ...
- Source: drugdu
- 206
- August 17, 2023
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
- 120
- August 16, 2023
ALX Oncology Axes Two CD47 Programs on Disappointing Results

By Connor Lynch Pictured: Doctor holding up hand to stop, courtesy of iStock Clinical-stage oncology company ALX Oncology is dropping trials for two of its anti-CD47 programs after disappointing efficacy findings. In its second-quarter earnings report on Thursday, the San Francisco-based company announced an end to its ASPEN-02 and ASPEN-05 programs, which were evaluating the efficacy of its CD47-inhibitor evorpacept. The protein works by binding to receptors on cancer cells that can potentially enhance the action of both chemotherapy drugs, as well as the body’s natural immune response. The two programs were assessing the effectiveness of evorpacept in concert with chemotherapy drugs to treat myelodysplastic syndrome and acute myeloid leukemia, respectively. Initial findings were promising. The combination of evorpacept and chemotherapy drugs—Bristol Myer Squibb’s azacitidine and AbbVie and Genentech’s venetoclax—proved more effective in combination than apart in early trials for myelodysplastic syndrome, as well as acute myeloid leukemia. However, later ...
- Source: drugdu
- 103
- August 15, 2023
Genentech to pay $158K fine after EPA flagged mishandling of hazardous waste at San Francisco plant

After settling with the U.S. Environmental Protection Agency (EPA) over environmental violations at one of its former plants, Genentech is on the hook for a fine of $158,208.The findings came out of a 2021 inspection of the company’s now-closed plant in South San Francisco. During the visit, EPA inspectors found several instances of the company skirting requirements related to the disposal of hazardous materials, the agency said. For one, the company stored waste without a permit and didn’t correctly monitor air emissions from the materials, according to the EPA. Plus, the overfill protection controls for a hazardous waste tank weren’t maintained at all, the agency said. Inspectors also found manifests for the waste that didn’t include all necessary federal waste codes. “When a company fails to comply with hazardous waste storage and monitoring requirements, that company puts workers and communities at risk of harmful exposures,” EPA pacific southwest regional administrator ...
- Source: drugdu
- 128
- August 14, 2023

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