Search Results for “cancer” – Page 75 – media

FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin

The FDA rejected Novo Nordisk’s biologics license application for icodec, citing questions about the manufacturing process for this once weekly insulin as well as its use by type 1 diabetes patients. But there are several high-profile FDA approvals in our recap of recent regulatory news. By Frank VinluanNovo Nordisk’s bid to bring diabetes patients a less burdensome dosing regimen has encountered a setback. The FDA turned down the company’s application for icodec, a slow-acting insulin the company designed for once-weekly dosing as an alternative to daily insulin injections. According to Novo Nordisk, the FDA’s complete response letter raised questions about icodec’s manufacturing process as well as the use of the product in patients with type 1 diabetes. In May, an FDA advisory committee concluded that the available data were not sufficient to show that icodec’s benefits outweigh its risks in type 1 diabetes. Some committee members expressed concerns about icodec’s ...
- Source: drugdu
- 94
- July 16, 2024
MSD closes $1.3bn EyeBio acquisition, plans pivotal trial for lead asset

Two months after MSD (Merck & Co) set its eye on acquiring Eyebiotech (EyeBio), the former has closed the deal, making EyeBio its subsidiary. MSD has acquired all outstanding shares of the privately held UK-based biotech through a subsidiary as part of the agreement. EyeBio’s shareholders will receive approximately $0.50 per share, totalling $1.3bn. Following the acquisition, MSD has gained access to EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway. A Phase IIb/III trial investigating Restoret in patients with DME is expected to begin in H2 this year. In February, EyeBio reported positive data from the Phase Ib/IIa AMARONE trial (NCT05919693) in patients with treatment-naïve diabetic macular oedema (DME) and treatment-naive neovascular age-related macular degeneration (AMD). In the study, Restoret improved vision in 26 participants with DME, leading to an improved best-corrected visual acuity by +11.2 letters and a mean ...
- Source: drugdu
- 55
- July 16, 2024
Publication in Journal of Translational Medicine Highlighting Henlius’ Dual HER2 Blockade Therapy Mechanism of Action

Recently, Journal of Translational Medicine, a prestigious medical journal, published a research article describing mechanism of action (MOA) of Henlius’ innovative anti-HER2 monoclonal antibody (mAb), HLX22, in dual HER2 blockade therapy. The research analysed the structure foundation and mechanisms of action associated with HLX22, further validating its potential in combination with trastuzumab in the first-line treatment of HER2-positive gastric/gastroesophageal junction (G/GEJ) cancer to benefit more patients worldwide. Trastuzumab, the first HER2-targeted cancer therapy, was introduced in clinical practice and revolutionised the treatment of HER2-positive breast cancer and gastric cancer. Trastuzumab in combination with pertuzumab and docetaxel has also verified their synergistic effect in the treatment of HER2-positive metastatic breast cancer, and the combination regimen is now the standard of care in this indication. However, a phase 3 trial that assessed the efficacy of pertuzumab versus placebo in combination with trastuzumab and chemotherapy in first-line HER2-positive metastatic gastric or G/GEJ cancer ...
- Source: drugdu
- 80
- July 15, 2024
Dual HER2 Blockade Therapy Presented on MED and ESMO GI

Recently, results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with HANQUYOU (HLX02, trastuzumab, trade name: HERCESSI™️ in the U.S., Zercepac® in Europe) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The leading principal investigator for this study is Professor Jin Li from Shanghai East Hospital, School of Medicine, Tongji University. The results showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. The results of HLX22-GC-201 were first presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The study data and updated results with another 7.8 months of follow-up were accepted for publication on MED ...
- Source: drugdu
- 60
- July 11, 2024
Rapid Drug Test to Improve Treatment for Patients Presenting to Hospital

A team of researchers is developing advanced solutions to rapidly test for drugs and improve the treatment of patients presenting to the hospital. The researchers from the Colonial Foundation Healthy Ageing Centre (Melbourne, VIC, Australia) are employing mass spectrometry technology to rapidly detect any medications or drugs that might complicate a patient’s treatment. This rapid identification is crucial to ensure that patients receive appropriate care and to minimize the effects of any previously administered medications or drugs. Mass spectrometry identifies and quantifies chemicals in a sample using charged particles, or ions, proving to be more precise than traditional immunoassays, which can sometimes yield false positives. In their recent research, published in the Medical Journal of Australia, the research team demonstrated that traditional testing methods could mistakenly show toxic levels of a heart failure medication due to interference from a common prostate cancer drug. However, when mass spectrometry was used for ...
- Source: drugdu
- 102
- July 10, 2024
Chiatai Tianqing’s Bicalutamide Tablets Approved

On July 5, Chiatai Tianqing received the Certificate of Drug Registration issued by State Drug Administration, approving the company’s bicalutamide tablets for the treatment of advanced prostate cancer. This is the tenth product approved by Chiatai Tianqing this year. Prostate cancer is a common malignant tumor of the male reproductive system, and it is also the second most common malignant tumor in men worldwide, with the incidence rate on the rise globally. BCC Research’s latest report pointed out that the global prostate cancer treatment market reached $35.3 billion in 2022 and is expected to grow to $56.4 billion in 2028, with a compound annual growth rate of 8.3%. . As early symptoms of prostate cancer are not easy to be detected, most patients are found in the middle to late stages. The incidence of prostate cancer is high among middle-aged and elderly men, and with the growing proportion of elderly ...
- Source: drugdu
- 73
- July 10, 2024
Coloplast launches digital leakage notification system Heylo for stoma patients

More than 176,000 people in the UK are living with a stoma, according to NHS data Coloplast has announced the launch of its world-first digital leakage notification system, Heylo, to benefit patients living with a stoma. The new system is now available through the NHS to help alleviate the physical and mental burden of leakage in patients living with a stoma, following an individual consultation and assessment of leakage anxiety. According to NHS data, more than 176,000 people in the UK are living with a stoma, an opening on the abdomen that can be connected to either the digestive or urinary system to remove waste from the body. The most common conditions that can result in stoma surgery include colorectal cancer, bladder cancer, ulcerative colitis, Crohn’s disease and accidental injury. For most patients, leakage of a stoma is currently the biggest challenge, with 92% of people worrying about leakage, impacting ...
- Source: drugdu
- 65
- July 10, 2024
New Labour government backs pharma reform in UK

“Change begins now,” said the UK’s new prime minister, Sir Keir Starmer, in his 5 July victory speech. Ending the 14-year Conservative party reign, the Labour Party has pledged to bolster the UK pharmaceutical sector through increased investment and regulatory action. Starmer’s government is expected to appoint cabinet members in the coming days while junior ministers will be announced today and early into next week. The new members of parliament (MPs) will soon be sworn in from 9 to 11 July. In his final speech as prime minister, Conservative Party leader Rishi Sunak hailed his party’s work to achieve a decreased inflation rate and implement the Windsor Framework for trade in and out of Northern Ireland. However, in a 5 July speech, Starmer said: “Our work is urgent – and we begin it today.” The Labour Party has already promised extensive change to the UK’s life sciences sector, setting forth ...
- Source: drugdu
- 73
- July 9, 2024
New Highly-Sensitive Test to Help More Easily Diagnose B-Cell Lymphoma

B-cell lymphoma, a cancer primarily originating in the lymphatic system, represents about 85% of non-Hodgkin lymphoma (NHL) diagnoses. NHL ranks as the tenth most prevalent cancer globally, claiming over 250,000 lives annually. In its early stages, NHL can manifest with symptoms such as swollen lymph nodes, fever, fatigue, loss of appetite, or a red rash. These symptoms, however, can mimic the body’s typical response to infections, making a precise diagnosis crucial. symptoms of lymphoma can appear similar to the body’s normal reactive response to an infection. Now, a first-of-its-kind assay can offer diagnostic certainty for patients with suspected B-cell lymphoma. Roche (Basel, Switzerland) has introduced the first clinically approved, highly sensitive in-situ hybridization (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, available in regions accepting the CE Mark. This assay stands out as the first clinically approved ISH test designed to detect the entire range ...
- Source: drugdu
- 91
- July 8, 2024
Carvykti Demonstrates Clinically Meaningful Improvement in Patients with Relapsed or Lenalidomide-Refractory Multiple Myeloma After One Line of Prior Therapy

By Don Tracy, Associate Editor Results of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies. Results from the second interim analysis of the Phase III CARTITUDE-4 study, which evaluated Johnson & Johnson’s (J&J) Carvykti (ciltacabtagene autoleucel; cilta-cel) for patients with relapsed or lenalidomide-refractory multiple myeloma after one prior line of therapy showed that the treatment achieved a statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard therapies such as omalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd).1 “Carvykti, a one-time infusion, is now the first cell therapy to significantly improve overall survival versus standard of care for patients with myeloma as early as second line,” said Jordan Schecter, MD, VP, disease area leader, multiple myeloma, Johnson & Johnson Innovative Medicine, in a press release. “As we continue to ...
- Source: drugdu
- 111
- July 8, 2024

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