Search Results for “surgical” – Page 19 – media

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
- 83
- February 6, 2024
Globus lays off Nuvasive employees after merger

Globus Medical is laying off staff after the company merged with spine specialist Nuvasive. In California alone, the company is cutting more than 150 positions, according to documents reviewed by MedTech Dive. Nuvasive said it “will be laying off a number of its employees” in San Diego, where it was headquartered, according to a Jan. 3 notice shared with MedTech Dive by the California Employment Development Department. The affected employees were notified in the first week of January, and their last day of employment will be March 5, according to the document. Nuvasive’s San Diego office will remain open. A Globus spokesperson said the company is restructuring but declined to say how many positions were affected. “As part of our ongoing integration, we recently announced some organizational restructuring across the combined company in support of our committed synergy delivery,” the spokesperson wrote in an email. The California notice included a ...
- Source: drugdu
- 101
- January 30, 2024
Merck’s Keytruda extends life for kidney cancer patients after surgery, while Bristol’s Opdivo fails again

Merck’s unique approval for Keytruda as a postsurgical treatment for resectable kidney cancer has gained new backing in the form of data showing the PD-1 inhibitor can extend patients’ lives. Keytruda slashed the risk of death by 38% compared with placebo when used after kidney removal in patients with clear cell renal carcinoma, the most common form of kidney cancer, according to newly released trial results. After four years of treatment, investigators estimated that 91.2% of patients in the Keytruda arm were still alive, versus 86% for the control group. The results, which reached statistical significance, come from an update of the Keynote-564 trial. Previously, disease-free survival results from the same trial supported Keytruda’s 2021 approval as an adjuvant therapy for certain kidney cancer patients at risk of recurrence after surgery. Keytruda’s survival win comes just as Bristol Myers Squibb’s rival PD-1 inhibitor, Opdivo, failed for a second time in ...
- Source: drugdu
- 98
- January 30, 2024
Bladder Cancer Therapies Developer Raises $380M in the First Biotech IPO of 2024

CG Oncology’s upsized IPO will support pivotal testing of cretostimogene, an oncolytic virus for non-muscle invasive bladder cancer. The clinical program spans tests of the engineered virus as a monotherapy and as part of combination treatments. By FRANK VINLUAN CG Oncology, a company that turns viruses into cancer therapies, has raised $380 million to fund clinical development of a therapy that the company believes could become a new first-line treatment for certain bladder cancers. The stock offering marks the first biotech IPO of 2024. CG was able to raise much more than planned. In preliminary financial terms set earlier this week, the company projected selling 17 million shares in the range of $16 to $18 each, which would have raised $289 million at the pricing midpoint. When CG finalized the IPO terms late Thursday, it ended up offering 20 million shares priced at $19 apiece. Those shares will trade on ...
- Source: drugdu
- 89
- January 27, 2024
Eli Lilly Sounds Off as Early Data Show How Gene Therapy Can Restore Hearing

Eli Lilly said its experimental gene therapy restored hearing in a boy born with profound hearing loss. The results for this experimental treatment come three months after Regeneron Pharmaceuticals reported early but encouraging data for its hearing loss gene therapy. By FRANK VINLUAN Gene therapy made its first breakthroughs slowing vision loss from inherited eye disorders. Eli Lilly is making the ear this therapeutic modality’s next proving ground, and the pharmaceutical giant now has some encouraging early clinical trial results showing it can work. An 11-year-old boy with profound hearing loss experienced restored hearing within 30 days of receiving the gene therapy, AK-OTOF, Lilly announced Tuesday. These are results for just one patient—the first in a clinical trial that could enroll up to 150 participants. But this early result is a promising sign for the therapy, which Lilly gained in 2022 through the $487 million acquisition of its developer, Akouos. ...
- Source: drugdu
- 86
- January 26, 2024
World’s First Perioperative Immunization Phase III Study Results in Esophageal Cancer Presented at 2024 ASCO GI

The American Society of Clinical Oncology Gastrointestinal Oncology Symposium (ASCO GI) was held in San Francisco from January 18 to 20, local time. As an academic event in the field of gastrointestinal tumors, ASCO GI showcased several heavyweight and innovative scientific advances in the field, especially the release of the Late-breaking Abstract (LBA) study, which will lead the way to a new direction in clinical treatment. Phase III study (ESCORT-NEO/NCCES01), led by Prof. Li Yin of Cancer Hospital, Chinese Academy of Medical Sciences, with the participation of 24 centers across China, was selected as LBA. Professor Li Yin reported the results of the study, which is the world’s first perioperative immunization Phase III study in esophageal cancer. Neoadjuvant carelizumab in combination with chemotherapy showed a significantly better pCR rate than that of neoadjuvant chemotherapy, achieving the primary endpoint without increasing the risk of surgery and with a manageable safety profile. ...
- Source: drugdu
- 86
- January 23, 2024
Announcement of Tasly Bioharma on the Notification of Approval of Drug Clinical Trial

Tasly Bioharma (hereinafter referred to as the “Company”) has received a Notice of Approval for Drug Clinical Trial from the State Drug Administration (hereinafter referred to as the “SDA”) for the project of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as the “B2278 Injection”), agreeing to carry out the project of Coronary Artery Bypass Grafting (Coronary Artery Bypass Grafting). The Company has received a Notice of Approval for Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection (hereinafter referred to as “B2278 Injection”) from the State Drug Administration (hereinafter referred to as the “SDA”), agreeing to carry out a clinical trial on chronic heart failure caused by chronic ischemic cardiomyopathy with indications of Coronary artery bypass graft (“CABG”). The relevant information is announced as follows: I. Basic information of the drug Drug name: human umbilical cord mesenchymal stem cell injection Dosage form: Injection Specification: 5×107 cells/1 ...
- Source: drugdu
- 111
- January 22, 2024
Brush Biopsy Test Detects Oral Cancer without Surgery

Oral squamous cell carcinoma, the most common type of oral cancer and globally the ninth most prevalent cancer, currently relies on surgical biopsies for diagnosis. This additional referral step poses the risk of losing patients who may not return for follow-up until the cancer has progressed to advanced, more challenging stages. Additionally, surgical biopsies can be problematic as they often collect a mix of cell types, complicating the analysis, and creating the risk of spreading cancerous cells to other parts of the mouth. General blood tests looking for cancer’s genetic signals also have limitations, as they do not specify the tumor’s location, preventing quick initiation of treatment after detection. Now, a new test that allows dentists to screen for oral squamous cell carcinoma with a simple brush could early detection of oral cancer without surgery. The diagnostic kit, created by researchers at the University of Illinois Chicago (Urbana, IL, USA), ...
- Source: drugdu
- 123
- January 20, 2024
FDA rips MiMedx with warning letter for its placental collagen wound-care treatment

The FDA hit MiMedx Group with a warning letter, citing the maker of regenerative biomaterials products for the classification of its placental collagen matrix designed to treat wounds found in surgical settings. In its letter (PDF), the FDA said MiMedx’s Axiofill doesn’t fall under Section 361 of the U.S. Public Health Service (PHS) Act, which allows lower-risk and minimally processed cell- and tissue-based products to be sold under fewer regulatory requirements. Instead, the product should fall under Section 351 of the law, which regulates products such as biologics that require pre-market approval, according to the agency. In essence, the FDA has taken the stance that Axiofill is an unlicensed biological product. “Based upon this information, we have determined that your actions have violated the [Federal Food, Drug, and Cosmetic Act] and the PHS Act,” the regulatory agency said. The FDA issued the letter after visiting two MiMedx sites in Georgia ...
- Source: drugdu
- 110
- January 15, 2024
Merck expects $20B+ in new cancer sales thanks to Daiichi ADC deal, Moderna vaccine

While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
- Source: drugdu
- 100
- January 11, 2024

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