Search Results for “Clinical Trial” – Page 81 – media

Cancer Research UK and Guardant collaborate to advance cancer detection and treatment

Cancer Research UK (CRUK), its innovation unit, Cancer Research Horizons, and Guardant Health have announced a collaboration to advance the development and precision of cancer detection and treatment. The mission-focused collaboration aims to accelerate the discovery and development of cancer drugs and diagnostics for patients. Affecting 20% of people in the UK, rare cancers are forms of cancer that can occur in unusual places in the body, requiring special treatment. Challenging to treat, rare cancer types include melanoma skin cancer, kidney cancer, brain tumours, non-Hodgkin lymphoma and pancreatic cancer. As part of the agreement, the parties will be able to discuss opportunities for collaboration to support CRUK’s research and development activities. In particular, the agreement will focus primarily on the charity’s clinical trials run by its Centre for Drug Development (CDD), including the DETERMINE trial, as well as other CRUK and Cancer Research Horizon research collaborations. The DETERMINE trial is ...
- Source: drugdu
- 87
- December 6, 2023
Pfizer Nixes Twice-Daily Oral GLP-1 Candidate After High Rates of Side Effects

By Tyler Patchen Pictured: Sign at Pfizer’s headquarters in New York/iStock, JHVEPhoto Pfizer on Friday said it is scrapping an investigational twice-daily oral Glucagon-like peptide-1 receptor agonist candidate after topline data from a Phase IIb trial of obese patients without type 2 diabetes showed high rates of adverse events. While the trial did reach the primary endpoint of a statistically significant change in body weight, there were high rates of adverse events. According to Pfizer, the adverse events in the obesity trial for the twice-daily dosing of GLP-1 danuglipron were mild and included gastrointestinal symptoms that were “consistent with the mechanism” of the candidate. However, the company noted high rates of these side effects. Up to 73% of patients experienced ...
- Source: drugdu
- 188
- December 5, 2023
Phenomic scores two deals in two days with Boehringer and Astellas

Canada-based Phenomic AI has landed two strategic collaborations this week with Boehringer Ingelheim and Astellas-owned cell therapy biotech Xyphos Biosciences to develop cancer therapies. Phenomic and Boehringer have teamed up on a target identification collaboration, announced on 29 November. Under the deal, Phenomic will receive an upfront payment of $9m and may be entitled to up to $500m in research funding and milestones. The Canadian company hasn’t disclosed the financial terms of the deal with Astellas, but the companies aim to develop cell therapies with an antibody directed at a novel target of the tumour stroma, utilising Phenomic’s scTx platform. The company singled out colorectal and pancreatic cancers as being stroma-rich, which would be amenable to being targeted by Phenomic’s platform. These developments mark the first deals announced by Phenomic in three years since the company launched in 2020 with $6m in seed funding. Phenomic’s scTx is a single-cell RNA ...
- Source: drugdu
- 119
- December 5, 2023
FDA to investigate risk of T-cell malignancy from CAR-T cell immunotherapies

The US Food and Drug Administration (FDA) has announced its intention to investigate the safety of CAR-T therapies following reports that they could be linked to the development of T-cell cancers. Following reports from clinical trials and post-marketing adverse event data sources, the wide probe is directed at patients who received treatment with all currently approved BCMA- or CD19-directed autologous CAR-T cell immunotherapies. CAR-T-cell therapy is a type of immunotherapy that involves collecting and using patients’ own immune cells to treat conditions including lymphoma, leukaemia and multiple myeloma. T-cell malignancies have been seen in patients treated with several approved products in the class, including Bristol Myers Squibb’s (BMS) Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel), Johnson & Johnson and Legend Biotech’s Carvykti (ciltacabtagene autoleucel), Novartis’s Kymriah (tisagenlecleucel), and Gilead and Kite’s Yescarta’s Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel). Currently, the potential risk of developing secondary malignancies is labelled as ...
- Source: drugdu
- 100
- 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
- 133
- 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
- 137
- December 2, 2023
FDA Accepts New Drug Application for Karuna Therapeutics’ Novel Schizophrenia Drug

Pharmaceutical Executive Editorial Staff KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. The FDA has accepted a New Drug Application (NDA) for Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for schizophrenia in adult patients. The novel muscarinic antipsychotic is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia,” said Bill Meury, Karuna Therapeutics president and chief executive officer, said in a press release.1 Schizophrenia can be a disabling condition, potentially causing a combination of hallucinations, delusions, and extremely disordered thinking and behavior that has a negative impact on the ability to function in daily life. As such, patients with schizophrenia require lifelong ...
- Source: drugdu
- 100
- December 1, 2023
【EXPERT Q&A】What are the processes involved in exporting pharmaceuticals to Japan?

Drugdu.com expert’s response: Exporting pharmaceuticals to Japan involves a complex process with multiple steps, due to the stringent regulatory system of the Japanese pharmaceutical market. Here are the key steps summarized by Dide Medical Trade Network: 1.Understanding Japanese Pharmaceutical Market Regulations Before starting the export process, it is crucial to have an in-depth understanding of Japan’s pharmaceutical regulatory laws. The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are the main regulatory bodies responsible for the approval and supervision of pharmaceuticals. 2.Product Registration and Approval All pharmaceuticals intended for sale in the Japanese market must be registered and approved by the MHLW. This usually involves submitting detailed information about the pharmaceutical, such as clinical trial data, evidence of safety and efficacy, etc. 3.Japanese GMP Certification Japan has strict quality control standards for pharmaceutical production, and pharmaceuticals exported to Japan must be produced in ...
- Source: drugdu
- 258
- December 1, 2023
FDA opens investigation into secondary cancer risk with CAR-T therapies

The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
- Source: drugdu
- 96
- December 1, 2023
FDA Launches Probe of Malignancies Linked to CAR-T Therapies

By Tyler Patchen Pictured: Exterior of an FDA building/iStock, Grandbrothers The FDA announced Tuesday that it is investigating the “serious risk” of malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. The regulator said it has determined that the risk of T-cell malignancies “is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies” including Bristol Myers Squibb’s Abcema and Breyanzi, Johnson & Johnson’s Carvykti, Novartis’ Kymriah and Gilead’s Tecartus and Yescarta. “T-cell malignancies have occurred in patients treated with several products in the class,” according to the FDA, which said it received reports from clinical trials and postmarketing adverse event data. While the agency said that the overall benefits of these products continue to outweigh their potential risks, it “is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the ...
- Source: drugdu
- 110
- November 30, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.