Search Results for “ oncology” – Page 34 – media

EU’s IVD guidelines continue affecting early clinical work

The implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) by the European Union (EU) continues to be a disadvantage for companies looking to start their clinical trials in the EU, said Malte Oppermann, senior director of clinical operations at Medigene. Oppermann spoke at a session of the Clinical Trials in Oncology (CTO) Europe 2023 conference in Munich, Germany, which took place 28 – 29 November. The session focused on the impact of IVD regulation changes on early-stage clinical trials and the challenges that come with clinical trials that incorporate IVDs. In a nutshell, IVDs are tests carried out on patient samples that can be used to prevent and treat diseases. In oncology, IVDs are used to detect biomarkers, which have become increasingly important in precision medicine. Examples of established biomarkers with approved therapies include the prognostic biomarkers HER2 and BRCA1. The IVDR came into effect on 26 May ...
- Source: drugdu
- 99
- December 4, 2023
FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer

Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy in these patients RAHWAY, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date ...
- Source: drugdu
- 138
- December 2, 2023
Phase 3 Trial for GSK’s Blenrep Yields Positive Results in Relapsed or Refractory Multiple Myeloma

Don Tracy, Associate Editor Blenrep significantly extended the time to disease progression or death against existing care methods as a second-line treatment for relapsed or refractory multiple myeloma. GSK announced positive results from an interim analysis of its DREAMM-7 head-to-head Phase 3 trial evaluating belantamab mafodotin (Blenrep) as a second-line treatment for relapsed or refractory multiple myeloma. According to a company press release, the trial met its primary endpoint of progression-free survival (PFS) and showed that Blenrep when combined with bortezomib plus dexamethasone (BorDex) significantly extended the time to disease progression or death versus daratumumab plus BorDex, an existing standard of care for relapsed/refractory multiple myeloma.1 “Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible and have novel mechanisms of action,” said Hesham Abdullah, SVP, global head, oncology, R&D, GSK, in a press release.1 “We are particularly encouraged by the potential for belantamab mafodotin ...
- Source: drugdu
- 104
- December 2, 2023
Amgen and MSD-backed start-up wins $10m for drug and device development

Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based company has a library of multimodal and longitudinal data along with the accompanying biospecimens, Culmination Bio’s CEO Lincoln Nadauld told Pharmaceutical Technology. The data for Culmination’s library consists of de-identified HIPPA-compliant data from Intermountain Health. This allows the company to “identify specific patient cohorts and proactively or prospective rapidly recruit them”, which can accelerate drug discovery and clinical trial recruitment. Nadauld said that having biospecimens is instrumental in validating diagnostic devices, adding: “An example would be a liquid biopsy company validating their novel technology in the liquid biopsy space, for cancer. They often need fresh samples from patients with defined diseases, and we can deliver not only the biospecimens but the accompanying multimodal data that ...
- Source: drugdu
- 141
- December 2, 2023
Pharma’s engagement with healthcare providers has slipped in recent years

In recent years there has been a downward trend in health care provider (HCP) contact in the pharmaceutical industry with 65% of HCPs limiting access to three or fewer companies, said Aaron Bean, the vice president of commercial business consulting at Veeva Europe. At the Veeva Commercial Summit 2023, Bean discussed HCP engagement with the pharmaceutical sector at a media roundtable. He suggested that HCPs’ increased selectiveness could be a result of increased “time pressure” and changes in the way they consume information. Bean was presenting data from Veeva’s February 2023 Pulse Field Trends Report which showed geographic differences in HCP engagement. In data taken from April to September 2022 from European countries, the UK led the shift with 94% of HCPs only contacting three or fewer pharmaceutical companies, compared to 50% in Spain. The same dataset showed that differences also appeared when comparing therapy areas. In oncology, approximately 25% ...
- Source: drugdu
- 124
- December 2, 2023
Pepper wins $6.5m to develop ‘transomic’ drug discovery platform

Boston-based start-up Pepper Bio has raised $6.5m in oversubscribed seed funding to develop its Compass drug discovery platform. The financiers included venture capital companies such as NFX, Silverton Partners, Mana Ventures and others. Pepper’s CEO Jon Hu told Pharmaceutical Technology that the Compass platform provides biological maps for insight into different “-omics”- genomics, transcriptomics, proteomics and phosphoproteomics. The success rate of drug development from pre-clinical studies to regulatory approval is 3%-10%, says Hu. If one can improve this success rate, it can bring down the cost of drug approval, he adds. According to Hu, the high cost of development is driven by the cost of failed iterations of the therapy. Pepper sources its database consists of publicly and commercially available data in addition to its proprietary data, which was either generated in-house or acquired through partnerships. Hu added that public and commercial data undergoes a series of transformations including an ...
- Source: drugdu
- 96
- December 2, 2023
MS Expands Cardio Partnership with Avidity in Potential $2.3B Deal

By Kate Goodwin Pictured: Bristol Myers Squibb building in Munich/iStock, Tati Campelo Bristol Myers Squibb is upping the ante in its partnership with Avidity Biosciences. The San Diego-based biopharma announced Tuesday an expansion of its previous collaboration with BMS, with the latter paying $100 million upfront and adding up to five cardiovascular targets. With potential cumulative payments of up to $2.3 billion plus low double-digit royalties, the partnership could be a lucrative one for the RNA biopharma. The deal expansion sent Avidity’s suffering stock soaring around 35% in premarket trading. A welcome reprieve to the 72% tumble it took earlier this year. Avidity will get a $60 million upfront cash payment in addition to BMS scooping up $40 million of its stock to deliver new cardiovascular treatments utilizing the former’s antibody oligonucleotide conjugates (AOCs). Avidity’s AOCs combine the targeting specificity of monoclonal antibodies with the precision of oligonucleotide therapies to ...
- Source: drugdu
- 106
- November 30, 2023
FDA investigates ‘serious risk’ of secondary cancer following CAR-T treatment

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. The FDA unveiled the probe Tuesday. The agency said it has received reports of T-cell malignancies, including CAR-positive lymphoma, among patients who received BCMA- or CD19-directed CAR-T cell immunotherapies. Some patients involved have had to be hospitalized or died, according to the agency. The cases stem from clinical trials and postmarketing adverse event surveillance, the FDA said. The FDA has determined that the potential risk is applicable to all currently approved CAR-T therapies, as T-cell malignancies have occurred after patients received several different products. The FDA is now weighing potential regulatory action—even as the potential risk of developing secondary cancer is already included as a class warning on the labels of the CAR-T therapies. Currently marketed CD19 CAR-Ts include Yescarta and Tecartus from Gilead ...
- Source: drugdu
- 230
- November 30, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Insurers and PBMs are increasingly implementing white-bagging policies, which require oncology practices to obtain physician-administered infusions and other medications from designated specialty pharmacies often owned by or affiliated with insurers and their PBMs. By DR. JAMAL MISLEH Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified ...
- Source: drugdu
- 99
- November 27, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified designated specialty pharmacy associated with the patient’s pharmacy benefit manager. Eventually, we were able to negotiate coverage through our practice’s internal inventory, but by the time the patient was able to receive the drug four weeks had ...
- Source: drugdu
- 152
- November 25, 2023

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