Latest news with #MDS
Qatar Tribune
a day ago
- Health
- Qatar Tribune
HMC successfully performs bariatric surgery using magnetic anastomosis technology
DOHA: In a groundbreaking medical achievement, Hamad Medical Corporation (HMC) has successfully performed a bariatric surgery using magnetic anastomosis technology which uses medical magnets to safely and accurately connect parts of the small intestine without the need for surgical stapling or sutures. This advanced surgery has shown promising initial results in terms of response and improved health for two patients who underwent the surgery, according to HMC's announcement. Both procedures were performed at HMC's Aisha Bint Hamad Al Attiyah Hospital by a specialized surgical team at Hamad Medical Corporation's (HMC) National Bariatric Center, rendering it one of the first of its kind in the Middle East, Asia, and Africa. Both patients, both in their thirties, were given modified magnetic duodenal switches using the Modified Duodenal Switch (MDS) technique. The procedure underscores HMC's commitment to adopting cutting-edge technologies and innovations in bariatric surgery. Director of HMC's National Bariatric Center, Dr Mohamed Al Kuwari said: "The new technique, known as the Magnet Anastomosis System and approved by the U.S. Food and Drug Administration (FDA) reflects HMC's commitment to delivering advanced treatments that meet the highest international standards," adding that the procedure "eliminates the need for permanent metal implants in the body, which contributes to further enhancing patient safety." Dr Al Kuwari pointed out that "Modified duodenal switch surgery is considered one of the most effective procedures for weight loss in patients with a Body Mass Index (BMI) over 50, or in those who did not achieve satisfactory results with other procedures such as sleeve gastrectomy, as well as patients with type 2 diabetes." For his part, Senior Consultant Bariatric and Robotic Surgery at HMC Dr Moataz Basha said: "This innovative technique significantly simplified the surgical procedure, especially during the delicate stage of creating intestinal connections, which is traditionally one of the most complex steps. The new technique uses two small medical magnets, each with a diameter of no more than 4cm. The first magnet is swallowed orally by the patient and monitored via radiographic imaging to confirm its arrival in the small intestine." He added that at a later stage, under anesthesia, the second magnet is introduced with a minor surgical procedure. The two magnets are aligned and connected via imaging, which results in a natural digestive connection being formed without the traditional but more invasive surgical intervention. The magnets naturally exit the body after approximately three weeks, requiring no additional procedures. Dr Basha emphasized that this surgical achievement highlights the expertise of HMC's medical teams and reinforces the Corporation's position as a leading regional center in the field of bariatric surgery.
Borneo Post
2 days ago
- Business
- Borneo Post
RM13.5 mln Bung Sadung project to boost Serian's eco-tourism potential, says council chief
Minos (centre) listens to a briefing during his visit to the site. On his right is Ridu. KUCHING (June 18): A tourism project costing RM13.5 million will be implemented at Bung Sadung, a hill near the well-known Kampung Taee in Serian, according to Serian District Council (MDS) chairman Dato Peter Minos. He said Bung Sadung shares many similarities with the popular Bung Bratak in Bau, including huge trees and natural attractions at the hilltop. 'Personally, I see this as another project similar to Bung Bratak, although Bung Sadung is bigger at scale and slightly different in concept and design,' he said in a statement today. The statement followed his visit to the site of the access road to Bung Sadung, accompanied by Warisan Bung Sadung Serian Association (Pewaris) president Dato Sri Robert Jacob Ridu. Minos believes that once completed, the project will transform Bung Sadung into an iconic tourist attraction for nature lovers, much like Bung Bratak. 'It is a big challenge for MDS, but we can do it – with the cooperation of local communities, particularly the residents of Kampung Taee,' he added. According to Minos, the project is funded by the Greater Kuching Coordinated Coordination Agency (GKCDA), and was requested by Tebedu assemblyman Dr Simon Sinang Bada, with MDS acting as the implementing agency. The Public Works Department (JKR), he added, is tasked to build the access road. 'I think the access road will be ready by June 2026, once agreement is given by all the affected landowners. Then, MDS will start to do its part, but planning is on-going.' Minos also said the project is in line with Premier Datuk Patinggi Tan Sri Abang Johari Tun Openg's vision to turn Serian into an agricultural and tourism hub, or a 'mini New Zealand'. Bung Sadung eco-tourism Peter Minos Serian
Yahoo
3 days ago
- Business
- Yahoo
AbbVie says Phase 3 Verona trial of venetoclax/azacitidine did not meet endpoint
AbbVie (ABBV) announced the global Phase 3 Vevrona trial evaluating venetoclax in combination with azacitidine in the treatment of newly diagnosed higher-risk myelodysplastic syndrome did not meet the primary endpoint of overall survival with a hazard ratio of 0.908; stratified log-rank. No new safety signals were observed. Results from the Verona trial will be available in a future medical congress and/or publication. Any patients who received venetoclax in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician. These data do not impact any current approved indications for venetoclax. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders' Hot Stocks on TipRanks >> Read More on ABBV: Disclaimer & DisclosureReport an Issue AbbVie's Promising Growth: A Buy Rating Backed by Robust R&D and Strategic Advancements Balanced Outlook for AbbVie: Hold Rating Amid Opportunities and Challenges AbbVie announces FDA approval for MAVYRET expanded indication AbbVie call volume above normal and directionally bullish AbbVie's Promising Growth Trajectory: Strong Pipeline, Strategic Investments, and Global Expansion Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
3 days ago
- Business
- Yahoo
CERo Therapeutics Holdings, Inc. Announces FDA Orphan Drug Designation Granted to CER-1236 for the Treatment of Acute Myeloid Leukemia (AML)
SOUTH SAN FRANSCISCO, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- CERo Therapeutics Holdings, Inc., (Nasdaq: CERO) ('CERo' or the 'Company') an innovative immunotherapy company seeking to advance the next generation of engineered T cell therapeutics that deploy phagocytic mechanisms, announces that the U.S. Food and Drug Administration (FDA) has granted CERo's Orphan Drug Designation (ODD) for the company's lead drug candidate CER-1236, for the treatment of acute myeloid leukemia (AML). CER-1236 is an innovative therapy that engineers a cancer patient's own T cell therapeutics that deploy phagocytic (i.e., target-cell eating) mechanisms alongside the array of built-in target cell destroying mechanisms used by T cells. CER-1236 is currently in Phase 1 clinical trials for AML. The first-in-human, multi-center, open label, Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia that is either relapsed/refractory, or in remission with measurable residual disease, or newly diagnosed patients with TP53 mutated MDS/AML or AML. The two-part study has begun with dose escalation to determine highest tolerated dose and recommended dose for Phase 2, followed by an expansion phase to evaluate safety and efficacy. Primary outcome measures include incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose limited toxicities and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcome measures include pharmacokinetics (PK). Chris Ehrlich, CERo CEO, commented, 'Orphan Drug Designation underscores the importance of developing new treatments for AML, and the potential for CER-1236 to provide a new and differentiated approach toward treatment. We believe that we are at the forefront of innovation in immuno-oncology and are grateful for the recognition from FDA. We look forward to providing updates on our trial in the near term.' The FDA's Orphan Drug program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer US patients annually. ODD status is given to medicinal products that represent a significant benefit over existing treatments and are intended for the treatment of a disease that is life-threatening or chronically debilitating. The ODD designation qualifies CERo and CER-1236 for certain incentives, which include FDA assistance in designing clinical trials, access to the FDA Orphan Drug Grants Program, exemption from the drug approval application fee and eligibility for seven years of marketing exclusivity. About CERo Therapeutics Holdings, Inc. CERo is an innovative immunotherapy company advancing the development of next generation engineered T cell therapeutics for the treatment of cancer. Its proprietary approach to T cell engineering, which enables it to integrate certain desirable characteristics of both innate and adaptive immunity into a single therapeutic construct, is designed to engage the body's full immune repertoire to achieve optimized cancer therapy. This novel cellular immunotherapy platform is expected to redirect patient-derived T cells to eliminate tumors by building in engulfment pathways that employ phagocytic mechanisms to destroy cancer cells, creating what CERo refers to as Chimeric Engulfment Receptor T cells ('CER-T'). CERo believes the differentiated activity of CER-T cells will afford them greater therapeutic application than currently approved chimeric antigen receptor ('CAR-T') cell therapy, as the use of CER-T may potentially span both hematological malignancies and solid tumors. CERo has commenced clinical trials for its lead product candidate CER-1236 for hematological malignancies. Forward-Looking Statements This communication contains statements that are forward-looking and as such are not historical facts. This includes, without limitation, statements regarding the financial position, business strategy and the plans and objectives of management for future operations of CERo, as well as statements regarding the Company's plans to regain compliance with Nasdaq listing requirements and the ability for the Company's securities to remain listed on Nasdaq. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this communication, words such as 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'might,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'strive,' 'would' and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. When CERo discusses its strategies or plans, it is making projections, forecasts or forward-looking statements. Such statements are based on the beliefs of, as well as assumptions made by and information currently available to, CERo's management. Actual results could differ from those implied by the forward-looking statements in this communication. Certain risks that could cause actual results to differ are set forth in CERo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and the documents incorporated by reference therein. The risks described in CERo's filings with the Securities and Exchange Commission are not exhaustive. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can CERo assess the impact of all such risk factors on its business, or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not guarantees of performance. You should not put undue reliance on these statements, which speak only as of the date hereof. All forward-looking statements made by CERo or persons acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statements. CERo undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Contact: Chris EhrlichChief Executive Officerchris@ Investors: CORE IRinvestors@
Yahoo
4 days ago
- Business
- Yahoo
Genentech Provides Update on Phase III Verona Study
SOUTH SAN FRANCISCO, Calif., June 16, 2025--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and AbbVie announced today the outcome from the Phase III VERONA study (NCT04401748) investigating Venclexta® (venetoclax) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The study did not meet the primary endpoint of overall survival at the final analysis. The safety profile of the Venclexta combination was consistent with the known risk of the individual study medicines and no unexpected safety signals were observed. Full data will be presented at an upcoming medical meeting in 2025. VERONA is a global, AbbVie-led, Phase III, multicenter, randomized, double-blind study evaluating Venclexta in combination with azacitidine compared to placebo plus azacitidine in treatment-naïve patients with higher-risk MDS. The study includes approximately 500 patients across 220 sites globally who were randomly assigned to either Venclexta plus azacitidine or placebo plus azacitidine. Patients who received Venclexta in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician. The results of the VERONA study have no impact on the approved indications for Venclexta or any ongoing studies. About Venclexta® (venetoclax) Venclexta is a first-in-class targeted medicine designed to bind selectively and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis. Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers. Venclexta® (venetoclax) U.S. Indication Venclexta is a prescription medicine used: to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who: are 75 years of age or older, or have other medical conditions that prevent the use of standard chemotherapy. It is not known if Venclexta is safe and effective in children. Important Safety Information What is the most important information patients should know about Venclexta? Venclexta can cause serious side effects, including: Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient's doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein. The patient's doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS. Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased. The patient's doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient's doctor may again check for the risk of TLS and change the patient's dose. What patients should not take Venclexta? Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS. Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects. Patients must not start new medicines during treatment with Venclexta without first talking with their doctor. Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they: Have kidney or liver problems. Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium. Have a history of high uric acid levels in the blood or gout. Are scheduled to receive a vaccine. Patients should not receive a "live vaccine" before, during, or after treatment with Venclexta, until the patient's doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta. Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient's doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away. Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient's breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose. What to avoid while taking Venclexta: Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient's blood. What are the possible side effects of Venclexta? Venclexta can cause serious side effects, including: Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient's doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing. Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient's doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta. Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta. The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet. The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure. Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility. These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or You may also report side effects to Genentech at (888) 835-2555. Please see the Venclexta full Prescribing Information, including the Medication Guide, for additional Important Safety Information. About Genentech in Hematology For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit About Genentech Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit View source version on Contacts Media Contact:Kristen Ingram, (650) 467-6800 Advocacy Contact:Catherine Creme Henry, (202) 745-5210 Investor Contacts:Loren Kalm, (650) 225-3217Bruno Eschli, +41 61 687 5284 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
