Search Results for “FDA” – Page 103 – media

Boehringer Ingelheim Strikes Regenerative Med R&D Deal Spanning MASH & More Liver Diseases

The first FDA-approved MASH drug doesn’t treat patients with liver cirrhosis. A new Boehringer Ingelheim/Ochre Bio collaboration is researching regenerative medicines that could treat patients in this most advanced stage of the fatty liver disease. By Frank VinluanThe liver is the only organ in the human body capable of regenerating itself. Boehringer Ingelheim has begun a research alliance with a startup to see if its technology can produce new therapies that tap into the liver’s capacity for regeneration and repair. Boehringer is committing to pay Ochre Bio to up to $35 million to begin the partnership, which is focused on identifying, characterizing, and validating multiple novel regenerative targets for chronic liver diseases. Specific targets were not disclosed, but Monday’s announcement describes the deal as a multi-target, multi-year collaboration. Ochre develops RNA medicines for chronic liver diseases. The Oxford, U.K.-based startup hasn’t disclosed details about its internal pipeline, but the company ...
- Source: drugdu
- 87
- April 24, 2024
Low-Cost Point-Of-Care Diagnostic to Expand Access to STI Testing

Gonorrhea ranks as the second most commonly reported bacterial sexually transmitted infection (STI), with around 82 million global cases in 2020. The infection can lead to severe health consequences like pelvic inflammatory disease, chronic pelvic pain, and infertility. Many patients may not show symptoms, leading to underreported cases and highlighting the need for more accessible, accurate, and cost-effective diagnostic solutions. Now, a new point-of-care test aims to expand access to STI testing by providing affordable, accurate, and convenient diagnosis. Scout (Santa Clara, CA, USA) is developing the STI Scout test to identify and distinguish between Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). This new test delivers results in just 30 minutes at a cost expected to be less than half that of current testing methods. STI Scout can use either first void urine samples or vaginal swabs. The test runs on the Scout Hub device and is integrated with the ...
- Source: drugdu
- 81
- April 23, 2024
AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell

Current strategies for matching cancer patients with specific treatments often depend on bulk sequencing of tumor DNA and RNA, which provides an average profile from all cells within a tumor sample. However, tumors are heterogeneous, containing multiple subpopulations of cells, or clones, each potentially responding differently to treatments. This variability may explain why some patients either fail to respond to certain treatments or develop resistance. Single-cell RNA sequencing offers higher-resolution data than bulk sequencing, capturing data at the single-cell level. This approach to identify and target individual clones may lead to more lasting drug responses, although, single-cell gene expression data are more expensive to generate and less accessible in clinical environments. In a proof-of-concept study, researchers at the National Institutes of Health (NIH, Bethesda, MD, US) have developed an artificial intelligence (AI) tool that leverages data from individual tumor cells to predict how well a person’s cancer might respond to ...
- Source: drugdu
- 119
- April 23, 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
- 123
- 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
- 104
- April 22, 2024
Unique Hand-Warming Technology Supports High-Quality Fingertip Blood Sample Collection

Warming the hand is an effective way to facilitate blood collection from a fingertip, yet off-the-shelf solutions often do not fulfill laboratory requirements. Now, a unique hand-warming technology has been specifically designed to enhance the collection of high-quality blood samples from the fingertip. The hand warmer designed to improve the collection of high-quality capillary blood samples has been developed by Babson Diagnostics (Austin, TX, USA) in collaboration with experts in biomedical engineering who study the impact of heat on the human body in the design of therapeutic devices. The Babson Hand Warmer is part of its BetterWay blood testing ecosystem, which combines Babson’s proprietary sample preparation and laboratory technologies with the BD MiniDraw Capillary Collection System. This system is the result of a strategic partnership between Babson and BD (Becton, Dickinson and Company, Franklin Lakes, NJ, USA). Slated for commercial release this year, BetterWay revolutionizes blood testing by requiring just ...
- Source: drugdu
- 121
- April 20, 2024
Glenmark recalls 6,528 bottles of BP drug in US

Glenmark Pharmaceuticals is recalling 6,528 bottles of Diltiazem Hydrochloride extended-release capsules, a medication used to treat high blood pressure in the American market due to failed dissolution specifications, informed USFDA in its latest Enforcement Report. The affected lot has been produced in India and is being recalled for “failed dissolution specifications”, the USFDA said. “Out of Specification (OOS) was reported in a test of dissolution at the 12th month time point in long-term stability study,” it noted. Glenmark initiated Class II recall of the drug across the US on March 26 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. https://www.business-standard.com/companies/news/glenmark-pharma-recalls-6-528-bottles-of-blood-pressure-drug-in-us-124041400116_1.html
- Source: drugdu
- 113
- April 20, 2024
GlobalData

Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
- Source: drugdu
- 119
- April 20, 2024
Chemomab touts study confirming CCL24 link to systemic sclerosis severity

Clinical-stage biotech Chemomab Therapeutics has announced the publication of a study highlighting that high serum CCL24 levels are linked to more severe forms of systemic sclerosis (SSc). SSc is a chronic autoimmune disease characterised by excessive collagen production, leading to thickening and hardening of the skin and various internal organs. Affecting the skin, blood vessels, muscles, and internal organs, the condition causes symptoms like joint pain, skin tightening, and organ dysfunction. The study, published in the Arthritis Care and Research journal and conducted at the University of Leeds in the UK, looked at 200 patients with SSc. It found that a quarter of them had high levels of CCL24 in their blood, even though they were receiving standard treatment. Higher CCL24 levels were linked to more severe forms of the condition, including worse skin problems and lung issues. Scientists identified that high CCL24 levels were predictive of lung problems worsening ...
- Source: drugdu
- 69
- April 20, 2024
Eli Lilly Shows Obesity Drug Zepbound Can Treat Sleep Apnea Too

Eli Lilly drug tirzepatide, marketed as Zepbound for weight management, has results from two Phase 3 studies showing reductions in the breathing problems caused by obstructive sleep apnea. Lilly is now preparing regulatory submissions to add this indication to the drug’s label. By Frank Vinluan Sleep apnea could be the next new indication for an Eli Lilly drug that’s already a blockbuster seller in metabolic indications. The pharmaceutical giant has preliminary Phase 3 data showing that treatment with the drug reduced the breathing interruptions characteristic of the common sleep disorder. With the positive data in hand, Lilly said it is now planning for regulatory submissions seeking to expand the label of tirzepatide, which is marketed as Mounjaro for type 2 diabetes and as Zepbound for weight management. Those submissions are expected in the middle of this year. Obstructive sleep apnea (OSA) is the collapse or partial collapse of the upper ...
- Source: drugdu
- 111
- April 19, 2024

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