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FDA clears stereotactic guidance system from ClearPoint Neuro

ClearPoint Neuro (Nasdaq:CLPT) announced today that it received FDA 510(k) clearance for its SmartFrame OR stereotactic system. Solana Beach, California–based ClearPoint Neuro developed its SmartFrame OR system with two main components. It features the SmartFrame OR technology with the ClearPointer optical navigation wand. SmartFrame OR offers stereotactic guidance for placing and operating instruments or devices in neurological procedures. It helps during the planning and operation processes of these procedures, performed in conjunction with using a compatible optical stereotaxic navigation system using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placements and electrode introduction. ClearPoint Neuro’s ClearPointer works with SmartFrame OR and a compatible stereotactic optical navigation system. It helps with patient registration and navigation. SmartFrame OR can be used with or without available bone screw fiducials. ClearPoint Neuro plans to begin a limited market release of the system in the first half of 2024. It earmarked the second ...
- Source: drugdu
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- February 6, 2024
Hengrui ADC Innovative Drug SHR-A1811 HER2 Positive Gastric Cancer Indication Proposed to be Included in Breakthrough Therapy Variety

This study was led by Professor Jin Li of Dongfang Hospital, Tongji University, with the participation of a total of 17 centers across China. Previously, four other indications of SHR-A1811 have been included in the list of breakthrough therapeutic varieties by the Drug Evaluation Center of the State Drug Administration, and the indications are: recurrent or metastatic breast cancer with low expression of HER2, HER2-positive recurrent or metastatic breast cancer, HER2-mutated advanced non-small-cell lung cancer that has failed previous platinum-containing chemotherapy, and advanced non-small-cell lung cancer that has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan, and has failed previous treatments of oxaliplatin, fluorouracil, and irinotecan. irinotecan treatment failure, and HER2-positive colorectal cancer. In 2020, gastric cancer ranks 5th in global cancer incidence and 4th in mortality. HER2-positive gastric cancer is a unique disease subtype that requires different treatment strategies from HER2-negative gastric cancer. The global HER2-positive rate of gastric ...
- Source: drugdu
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- February 6, 2024
默沙东PD-1抑制剂可瑞达®联合化疗在华获批治疗局部晚期或转移性胆道癌新适应证

中国上海，2024年2月4日——默沙东宣布，其PD-1抑制剂帕博利珠单抗（商品名：可瑞达®）已获得中国国家药品监督管理局（NMPA）批准联合吉西他滨和顺铂用于局部晚期或转移性胆道癌（BTC）患者的一线治疗。此次新适应证的获批是基于全球III期临床试验KEYNOTE-966的数据。默沙东全球高级副总裁兼中国总裁田安娜表示：“我们很高兴看到，在健康中国2030战略全面实施的带动下，创新药物审评审批进程持续提速，尤其在临床急需的新药方面可及性大幅提升，近年来，胆道恶性肿瘤发病率呈上升趋势，且晚期患者治疗选择有限。作为肿瘤治疗领域领导者，我们将致力于覆盖更多发病率及死亡率高、总体生存率低、治疗难度大的恶性肿瘤，并以更快速度为癌症患者带来更多创新治疗选择。” 胆道恶性肿瘤是一种起源于胆管上皮细胞的恶性肿瘤，具有早期诊断困难，根治性切除率低，复发率高等特点。胆道癌主要包括胆囊癌和肝内外胆管癌。其中，肝内胆管癌是仅次于肝细胞癌的第二大原发性肝癌，约占原发性肝癌的10%~15%。网址：https://mp.weixin.qq.com/s/FJ4prENGNtAl-LmO9s70dw
- Source: drugdu
- 80
- February 6, 2024
Barbra Streisand’s nonprofit runs PSA to educate women about heart attack symptoms

Barbra Streisand’s Women’s Heart Alliance wants people to know when to ask, “what’s up, doc?” In a new PSA campaign, the nonprofit is trying to educate women about the gender-specific symptoms of heart attacks to stop them dying at a higher rate than men. The PSA moves quickly to catch the viewer’s attention, opening with the line: “Listen up, women and everyone who loves a woman, heart disease kills one of us every 80 seconds, and we die of heart attacks at twice the rate of men.” Those statistics are displayed in unmissable, screen filling text as the voice-over reads them out. In the next section, the voice-over explains a reason for the discrepancy in health outcomes, stating that “when a woman is having a heart attack, our symptoms are too often missed, or dismissed, even by doctors.” The situation is “a serious crisis.” The alliance sees education as the ...
- Source: drugdu
- 80
- February 6, 2024
FDA sets date for high-profile CAR-T adcomm for Bristol’s Abecma, J&J’s Carvykti

Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting to discuss applications for Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti. The FDA will convene its Oncologic Drugs Advisory Committee (ODAC) for a full-day meeting March 15 to review the applications for BMS and 2seventy bio’s Abecma and J&J and Legend Biotech’s Carvykti in earlier treatment of multiple myeloma, a government filing shows. External experts invited by the FDA will review clinical data from Carvykti’s CARTITUDE-4 trial and Abecma’s KarMMa-3 study. In both cases, overall survival data will be the focus of the discussions. The meeting is expected to carry a lot of weight in the oncology community. For one, industry watchers are trying to take the FDA’s pulse around the benefit-risk profile of CAR-T cell therapies amid an investigation into a new safety signal ...
- Source: drugdu
- 97
- February 6, 2024
As Humira plummets, AbbVie dials up Rinvoq and Skyrizi estimates to a combined $27B

As AbbVie slogs through sharp revenue declines for Humira, the company is looking to the immunology light at the end of the tunnel. During the final quarter of 2023, sales of Humira—which once sat pretty as the world’s best-selling drug—plunged nearly 41% to $3.3 billion globally. The rate of erosion seems to have gathered steam in the fourth quarter and outpaced the med’s full-year sales decline of around 32%. Still, AbbVie and investors knew this blow was coming. The plan—following the entry of Humira biosimilars early last year—is to weather the brunt of the attack in 2024 before charting a return to growth in 2025 and beyond, Robert Michael, AbbVie’s chief operating officer, said on a call with investors Friday. Specifically, AbbVie will rely on its roster of growth products, including Humira’s immunology heirs Rinvoq and Skyrizi, to help “absorb the largest loss of exclusivity event to date across our ...
- Source: drugdu
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- February 6, 2024
BMS runs first branded TV spot for Camzyos, focusing on moments its $13B heart disease drug makes

Bristol Myers Squibb is stepping up promotion of its $13.1 billion heart disease drug Camzyos, launching the first branded TV spot as it seeks to penetrate the market ahead of the anticipated arrival of a rival. The 90-second commercial focuses on Mike, a person living with symptomatic obstructive hypertrophic cardiomyopathy (HCM), as he hikes through an idyllic landscape. As Mike says in the voice-over, “there were some days I was so short of breath I thought I’d have to settle for never stepping foot on this trail again.” Now, Mike takes Camzyos, and his symptoms have improved. After talking through his experience with HCM, Mike delivers a closing piece to the camera, telling the audience that “this is my Camzyos moment.” BMS decided on “My Camzyos Moment” as the focus of its direct-to-consumer campaign after talking to patients. “We have consistently heard from patients about moments that seemed little, but ...
- Source: drugdu
- 75
- February 6, 2024
Neural Network Recognizes Breast Cancer on Histological Samples With 100% Accuracy

The likelihood of a favorable outcome for a breast cancer patient is greatly influenced by the stage at which the cancer is diagnosed. Histological examination is the benchmark for diagnosis, but its reliability can be affected by subjective interpretations and the quality of the tissue sample. Inaccuracies in these examinations can lead to incorrect diagnoses. Now, a team of mathematicians has developed a machine learning model that significantly enhances the accuracy of identifying cancer in histological images. The highlight of this model is the incorporation of an additional module that boosts the neural network’s “attention” capability, enabling it to achieve near-perfect accuracy. The mathematicians at RUDN University (Moscow, Russia) conducted tests on several convolutional neural networks and supplemented them with two convolutional attention modules. These modules are crucial for detecting objects within images. The model underwent training and testing using the BreakHis dataset, which comprises nearly 10,000 histological images at ...
- Source: drugdu
- 84
- February 5, 2024
New Method Enables Detection of Lung Cancer through Blood Tests

Lung cancer continues to be a very deadly disease with only 19% of diagnosed patients remaining alive after five years. This makes it important to accurately detect the different forms of lung cancer, each with its own treatment and approach, at an early stage so that patients can be better treated. Currently, there is a gold standard for determining whether someone has lung cancer. If suspected, the first step is a scan, such as CT or PET CT. That gives insight into where the symptoms may be coming from and the location of possible cancer cells or a tumor. The second step is a biopsy in which a ‘morsel’ of tissue is removed and examined under the microscope. However, evidence of tumor cells cannot always be obtained. Additionally, sometimes people are too old or too sick and the biopsy itself is too risky for their health. Also, sometimes people refuse ...
- Source: drugdu
- 86
- February 5, 2024
FDA Issues Warning of Contaminated Copycat Eyedrops

Mike Hollan The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand. Be careful what you put in your eye. FDA has issued a warning for consumers to be on the lookout for copycat eyedrops.1 Specifically, consumers should be wary of purchasing eye drops that are designed to look like Bausch + Lomb’s Lumify brand. While Lumify is approved for redness relief, the noted brands are not approved by FDA. The brands are as follows: South Moon, Rebright, and FivFivGo. The agency’s warning was posted with an image showing how the three brands packaging and branding is designed to look exactly like Lumify. While each brand is clearly marked with its own name, the box’s all use the same color scheme and each feature the same drawing of a women’s eye with a purple tint to it. The drug information is also ...
- Source: drugdu
- 123
- February 5, 2024

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