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IceCure submits final breast cancer cryoablation data to FDA

BY SEAN WHOOLEYIceCure Medical (Nasdaq:ICCM) announced today that it submitted final data to the FDA requesting marketing authorization for its ProSense system. Caesarea, Israel-based IceCure designed ProSense to deliver cryoablation that treats breast cancer in a 20-40-minute outpatient procedure. It seeks FDA authorization for treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense already holds FDA breakthrough device designation and has clearance in the U.S. for other indications. Those include treating benign tumors of the breast, and tumors in the kidney and liver. However, the FDA in 2022 denied IceCure’s de novo classification request for ProSense to treat patients with early-stage, low-risk breast cancer. In January of this year, the FDA agreed to reopen the de novo file. An affirmative response from the FDA provided IceCure with a potential pathway to clearance. The company submitted a five-year follow-up dataset from the ICE3 study and ...
- Source: drugdu
- 116
- April 22, 2024
UniDoc Brings AI-Powered Health Cube to Alaska

Mike Hollan The Health Cube will increase remote and virtual care options for populations living in remote areas. AI is helping to expand healthcare solutions to rural areas. While people living in or near highly populated areas tend to have more options when it comes to healthcare, the lack of options in rural areas can be a real issue. For patients living in a state like Alaska, getting access to the proper care can involve traveling long distances, delays in obtaining medication, and sometimes being unable to find the proper specialists. One way that the industry is attempting to solve this issue is by bringing more telehealth and virtual options to these areas. New technologies, such as AI, are making this easier, as the algorithms are better able to match patients with the proper care providers through virtual sessions, while also making it easier to find ways to get the ...
- Source: drugdu
- 113
- April 22, 2024
23andMe CEO plans to take company private

Dive Brief 23andMe CEO Anne Wojcicki plans to take the DNA testing company private, according to a Wednesday filing with the U.S. Securities and Exchange Commission. Wojcicki currently owns more than 20% of the firm’s total outstanding shares, and about 49% of voting rights. She plans to acquire all outstanding shares of the company. The CEO wants to maintain control of 23andMe and would not be willing to support any alternative transaction, according to the filing. Dive Insight 23andMe, which makes consumer genetic tests, has been looking at strategic alternatives as its shares have fallen. The firm went public in 2021 through a merger with a special purpose acquisition company valuing 23andMe at $3.5 billion. Its stock has traded below a dollar this year, down from its IPO price of $10 per share. 23andMe has also expanded into drug research by using its database built up through the DNA testing ...
- Source: drugdu
- 90
- April 22, 2024
Boston Scientific recalls blood-blocking agent linked to 2 deaths

Dive Brief Boston Scientific has recalled an agent used to block blood flow to specific vessels due to a safety problem that has been tied to seven injuries and two deaths, the Food and Drug Administration said Wednesday in a recall notice. The company wrote to customers in February to advise against delivering the agent via a commonly used method in some patients because of a risk of reduced blood flow to the bowel. Boston Scientific’s product, Obsidio Conformable Embolic, remains on the market, but the company advised healthcare providers to ensure information on the risk is easily accessible to all users. Dive Insight The solution flows like a liquid when force is applied, and then returns to a soft solid state when the force is removed. As a soft solid, the agent blocks blood vessels. Physicians use the product to block blood supply to tumors with large numbers of ...
- Source: drugdu
- 131
- April 22, 2024
ENTOD Pharma gets CDSCO approval for eye drops to treat presbyopia

ENTOD Pharmaceuticals received approval from CDSCO for PresVu, a treatment for presbyopia, by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). PresVu is a eye drop in India designed to alleviate the need for reading glasses among individuals grappling with presbyopia. Presbyopia, characterised by blurred near vision due to the decreased flexibility of the eye’s natural lens, primarily impacts individuals aged 40 and above. PresVu offers swift relief and temporary correction of vision problems associated with presbyopia. PresVu eye drops adjust rapidly to tear pH, ensuring sustained efficacy and safety for long-term use. The company completed development of these eye drops in late 2022 after which it was subjected to clinical testing in India. Reportedly, Phase 3 clinical trials carried out in India and the US have demonstrated PresVu’s efficacy in enhancing close-up vision within minutes of application, with effects lasting up to six hours. ...
- Source: drugdu
- 144
- April 22, 2024
Biocon signs licensing and supply pact with Biomm S.A for Semaglutide commercialisation in Brazil

Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes Biocon announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialisation of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes. Under the terms of this agreement, Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialization in the Brazilian market. Biomm focuses on developing, manufacturing and commercialising complex biotech and biosimilar drug products at their production facility in Nova Lima. The total addressable market opportunity of Semaglutide in Brazil is approximately $580 million as per the IQVIA MAT Q4 2023. https://www.expresspharma.in/biocon-signs-licensing-and-supply-pact-with-biomm-s-a-for-semaglutide-commercialisation-in-brazil/
- Source: drugdu
- 147
- April 22, 2024
Weekly insulin analogues approaching approval could herald change

Upcoming weekly insulin candidates can reduce the injection burden on patients with diabetes and ease the load on healthcare resources, said Anna Hodgkinson, a specialist diabetes pharmacist at an ongoing diabetes conference in London. Hodgkinson, who works at at the Lambeth Diabetes Intermediate Care Team, called particular attention to Novo Nordisk’s Awiqli (insulin icodec) and Eli Lilly’s LY3209590 (insulin efsitora alfa), both of which are weekly insulin candidates that may be available on the market shortly. She was speaking at a talk at the Diabetes UK conference on 17 April. The conference closes on 19 April. Despite the benefits, Hodgkinson raised questions about whether Awiqli’s long half-life may prolong the time required for insulin clearance. The therapy is still yet to be tested in chronic kidney disease patients, Hodgkinson added. Awiqli is a long-acting basal insulin analogue with a half-life of 196 hours (8.1 days). Its treatment regimen involves three ...
- Source: drugdu
- 133
- April 22, 2024
Chiatai Tianqing Achieves Positive Results in Pivotal Registration Study of Class 1 Innovator Rovadicitinib Tablets

Recently, Chiatai Tianqing Pharmaceutical Group has reached the primary endpoint in the pivotal registration clinical study of Rovadicitinib (TQ05105), a Class 1 innovative drug independently developed by Chiatai Tianqing Pharmaceutical Group, for the treatment of intermediate- to high-risk myelofibrosis (MF). The Company has communicated with the Center for Drug Evaluation (CDE) of the State Drug Administration regarding the marketing application for TQ05105 tablets and has obtained the CDE’s consent to submit a marketing application for this product, which will be submitted in the near future. TQ05105 is a JAK/ROCK inhibitor with a new chemical structure developed by the company. In vitro test results show that TQ05105 can effectively inhibit JAK family kinase activity and ROCK kinase activity, and can significantly inhibit the phosphorylation level of STAT3 and STAT5 in cells, thus inhibiting the JAK/STAT signaling pathway conduction and thus exerting anti-tumor activity. The Company announced data from a Phase I ...
- Source: drugdu
- 96
- April 22, 2024
【EXPERT Q&A】How to apply for a Class III Medical Device Operation License?

Drugdu.com expert’s response: Here are the general steps for obtaining a Class III Medical Device Operation License: 1.Qualification Review: First, ensure that your enterprise meets the conditions specified in the “Measures for the Administration of Medical Device Operation Enterprise Licenses,” such as registered capital, premises, personnel, etc. 2.Prepare Application Materials: Prepare the required application materials, including the enterprise legal person business license, medical device operation enterprise filing certificate, medical device quality management system certification certificate, etc. 3.Submit Application: Submit the prepared application materials to the local provincial-level or above drug supervision and administration department or its authorized drug supervision and administration institution. 4.Acceptance Review: The relevant department will review the submitted application to verify the completeness and accuracy of the materials. 5.On-Site Inspection: In some cases, applicants may need to undergo on-site inspections to confirm that their operating premises meet the relevant requirements. 6.Approval Decision: The relevant department will make ...
- Source: drugdu
- 117
- April 22, 2024
Urine-Based Test Detects Head and Neck Cancer

Human papillomavirus (HPV) is well-known for its role in causing cervical cancer and is also increasingly identified as being responsible for cancers in the mouth, throat, and other areas of the head and neck. Early detection of cancer is essential, as it greatly improves patient outcomes. Now, a new urine-based test that can detect DNA fragments shed by head and neck tumors could potentially enable earlier detection of these cancers, which currently lack effective screening techniques. The research team at the University of Michigan (Ann Arbor, MI, USA) utilized whole genome sequencing to show that cell-free DNA fragments found in urine, which originate from tumor cells and pass from the bloodstream through the kidneys, are predominantly ultra-short, with less than 50 base pairs. Their small size makes detection difficult using traditional urine or blood-based liquid biopsy tests for circulating tumor DNA (ctDNA). Currently in the experimental stage, this mail-in test ...
- Source: drugdu
- 164
- April 20, 2024

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