Search Results for “ oncology” – Page 44 – media

AstraZeneca’s STRIDE shows improved outcomes for liver cancer patients

AstraZeneca has announced impressive results for its STRIDE regimen, delivering significantly improved outcomes for advanced liver cancer patients. The treatment regimen was evaluated in the ongoing HIMALAYA Phase III study (NCT03298451), conducted with 1324 hepatocellular carcinoma (HCC) patients. Participants were randomised to receive either STRIDE or sorafenib, one of the tyrosine kinase inhibitors that comprise the current standard of care for various liver, kidney, and thyroid cancers. After four years of follow-ups, AstraZeneca announced that STRIDE reduced the risk of death by 22% compared to sorafenib, with 25.2% of patients alive at the four-year mark compared to 15.1% with sorafenib. While a one-in-four survival rate may not be comparable, advanced-stage HCC carries a poor prognosis. Five-year survival rates for the condition are only 7%, one of the lowest across all oncology, so even minor improvements in overall survival can make a major difference. Despite this improvement, adverse events recorded during ...
- Source: drugdu
- 215
- July 2, 2023
Generics to Novartis’ leukemia drug Tasigna to reach poor countries under 4 MPP licenses

More than a year ago, eight pharma giants partnered to provide cancer medicines to many of the world’s most needy nations where oncology treatments often are non-existent.On Thursday, the effort took a major step toward fruition as the United Nations-backed Medicines Patent Pool (MPP) signed up four generic drugmakers to produce copycat versions of Novartis’ myeloid leukemia blockbuster Tasigna (nilotinib). The agreement allows BrightGene of Indonesia and three Indian manufacturers—Dr. Reddy’s, Eugia and Hetero—to produce generic nilotinib, even though it remains on patent in the U.S. The generic companies plan to make their copycats in six countries—Egypt, Guatamala, Morocco, Pakistan, the Philippines and Tunisia—and supply it to 44 territories. “We have seen great gains in cancer survival in the richest countries over the last decade, however, the benefit of our innovation is not reaching everyone,” Lutz Hagemann, Novartis’ president of global health and sustainability, said in a release. “Through public-private ...
- Source: drugdu
- 193
- June 28, 2023
Amgen’s supplemental Biologics License Application for Blincyto approved by FDA

Amgen has announced the full approval by the US Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab). Blincyto is used to treat adults and children with CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL), who are in their first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approved after additional data was submitted from two phase 3 studies, Blincyto’s accelerated approval is now a full approval. David Reese, executive vice president of research and development at Amgen commented that the treatment was “the first FDA-approved CD19-directed CD3 T-cell engager BiTE immunotherapy, and the first to be FDA-approved for MRD in 2018″. He added that the “full approval underscores the clinical benefit of Blincyto for people living with B-ALL”. Blincyto is a bispecific T-cell engager (BiTE) immune-oncology therapy that targets CD19 surface antigens on B cells. Helping the ...
- Source: drugdu
- 108
- June 27, 2023
New white paper on challenges and opportunities in theranostics education

Leaders from 12 nuclear medicine organizations around the world have issued a white paper about the challenges and opportunities in theranostics education. Published in the June issue of The Journal of Nuclear Medicine, the report outlines the current theranostic educational and accreditation offerings across the globe. It also provides guidelines to assist countries in developing educational and training curriculums that enable physicians to confidently and safely perform nuclear theranostics procedures. The concept of theranostics refers to the integration of therapeutics and diagnostics into a single management approach. Through their high sensitivity and specificity, theranostic radiopharmaceuticals have started to play a major role in precision medicine by significantly improving patient disease management, particularly in oncology. “As exciting as it sounds, the clinical implementation of theranostics radiopharmaceuticals in nuclear medicine faces significant challenges. The practice of a fully integrated diagnostic and therapeutic nuclear medicine specialty requires an in-depth knowledge in many different ...
- Source: drugdu
- 107
- June 25, 2023
ADVANZ PHARMA and Veeva Systems link for digital operations in Europe

ADVANZ PHARMA has collaborated with Veeva Systems to set up a unified digital-first commercial foundation in Europe. ADVANZ intends to drive a unified field strategy across all markets and strengthen field engagement with healthcare professionals (HCPs) using Veeva Commercial Cloud, a family of data, software and services for advancing commercial excellence in life sciences. ADVANZ is also using Veeva OpenData and Veeva CRM Suite to consolidate its operations and to gain a clear understanding of customers throughout the healthcare ecosystem, with a focus on products within oncology, anti-infectives, critical care, endocrinology and rare diseases. This allows the company’s newly merged field teams to coordinate more effectively with HCP touchpoints across channels and regions. Veeva Europe commercial strategy vice-president Philipp Luik stated: “With Veeva Commercial Cloud, ADVANZ now has a digital foundation to sustain growth as it expands operations in Europe. “By reaching the right people sooner and leading more impactful ...
- Source: drugdu
- 116
- June 23, 2023
Tessa Therapeutics Hodgkin’s Lymphoma CAR-T therapy shows promising Phase I data

Clinical-stage cell therapy company Tessa Therapeutics have announced positive safety and efficacy data from the trial (NCT04288726 of TT11X, its off-the-shelf CD30.CAR-modified EBVST (Epstein Barr Virus Specific T Cells) therapy in patients with relapsed or refractory (R/R) Hodgkin lymphoma. In tandem with Baylor College of Medicine, Tessa enrolled 18 patients with R/R Hodgkin’s Lymphoma in the trial, all of whom had been heavily pre-treated. Patients were administered with TT11X across four dosing levels, resulting in an overall response rate (ORR) of 78%. Higher doses produced improved clinical response, and no dose-limiting toxicities were observed. Treatment works by utilising highly specialised T-cells able to recognize and kill infected cells, whilst activating the body’s immune system to produce a coordinated response. The company claimed that early trials have demonstrated a strong safety profile and efficacy. TT11X is the lead allogenic cell therapy in Tessa’s planned pipeline of treatments built with its CD30.CAR ...
- Source: drugdu
- 172
- June 20, 2023
MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker

Merck (MSD) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. The Phase III Keynote-811 study (NCT03615326) met its progression-free survival (PFS) endpoint for treating human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma in the intent-to-treat population. A pre-specified interim analysis of trial data found a “statistically significant” improvement in PFS compared to placebo in the ITT group. In 2021, as part of the same Keynote-811 trial, the US Food and Drug Administration (FDA) granted accelerated approval to Keytruda for treating locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma, in combination with trastuzumab and chemotherapy containing fluoropyrimidin and platinum. Based on the latest Keynote-811 results, MSD now plans to work with the ...
- Source: drugdu
- 155
- June 20, 2023
Kura Hopes to Raise $100M in Public Offering on Heels of Clinical Data

By Connor Lynch Pictured: Person holding a cell phone in front of computer with stock data/iStock Just two days after releasing late-breaking Phase I/II data for one of its flagship drugs, biopharma Kura Oncology on Tuesday announced plans for a $100 million underwritten public offering. The company intends to use the public offering to fund the development of its three candidate drugs, in invest pipeline research and development, and provide a source of general working capital. According to first-quarter 2023 financial results, Kura has roughly $406 million in cash, cash equivalents and investments, which the company expects will fund current operations until the fourth quarter of 2025. The pre-market share value slipped by 8.1% to $11.7 after the public offering. The offering’s bookrunning managers are BofA Securities, Jefferies and SVB Securities. The lead managers are Cantor and BTIG, while JMP Securities—a Citizens Company—and H.C. Wainwright, are the co-managers. The announcement ...
- Source: drugdu
- 111
- June 16, 2023
Mark Cuban’s Cost Plus Drug Company projects huge savings over Medicare for generic cancer medications

By Neha Mathur Reviewed by Benedette Cuffari, M.Sc. In a recent article published in the Journal of Clinical Oncology, researchers reveal significant cost savings when generic oncology drugs are purchased through the Mark Cuban Cost Plus Drug Company (MCCPDC) as compared to Medicare. Study: Projected Savings for Generic Oncology Drugs Purchased via Mark Cuban Cost Plus Drug Company Versus in Medicare. Image Credit: Celil Kirnapci / Shutterstock.com Background There is an urgent need to reduce spending across the system in a dynamic healthcare landscape like that of the United States, which is possible with the equal participation of patients and sponsors. The Medicare program contributes a substantial proportion of prescription drug spending in the U.S., which was already high and continues to increase over time. In fact, in 2019, Medicare and its beneficiaries accounted for 27.2% of the fee-for-service program. Although oncology prescription drugs constituted only 0.6% of overall sales ...
- Source: drugdu
- 96
- June 15, 2023
Samsung Biologics, Pfizer partner for biosimilars portfolio manufacturing

Samsung Biologics has announced a strategic collaboration with Pfizer for the long-term commercial manufacturing of the latter’s multi-product biosimilars portfolio. Initially, the companies signed a manufacturing agreement in March last year for a Pfizer product. As per the new agreement terms, Samsung Biologics will provide Pfizer with more capacity for manufacturing for the biosimilars portfolio. The portfolio will cover inflammation, oncology and immunology. Samsung will use its new facility, Plant 4, for the products manufacturing. Samsung Biologics president and CEO John Rim said: “We are pleased to extend the strategic collaboration with Pfizer as we share and support their strong vision to bring innovative solutions for patients around the globe. “This new meaningful partnership comes just as our Plant 4 is fully completed early this month as we had previously committed and are on the move for future expansion into our second campus in order to provide our clients with ...
- Source: drugdu
- 116
- June 12, 2023

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