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Baxter receives FDA clearance for delayed Novum IQ infusion pump

Dive Brief Baxter has received 510(k) clearance for its large volume infusion pump (LVP) Novum IQ, the company said Monday. The clearance follows three years of talks with the Food and Drug Administration, in which time a delay to the authorization drove Baxter to wipe $100 million in sales off its forecast in 2022. A Baxter spokesperson said in an email that the company will update 2024 guidance on its upcoming first-quarter earnings call and expects Novum IQ to be a meaningful contributor to future growth. Evercore ISI analysts said the success of Baxter’s Spectrum pumps and the return of BD’s Alaris to the market means the $100 million annual sales assumption no longer applies. Even so, Evercore and Stifel analysts called the clearance positive for Baxter in notes to investors. Dive Insight The FDA identified an issue with Baxter’s filing for clearance of the LVP version of Novum IQ ...
- Source: drugdu
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- April 5, 2024
Abbott nets FDA approval for Triclip

Dive Brief Abbott said Tuesday it received the Food and Drug Administration’s approval to market a transcatheter device for repairing the tricuspid valve in patients who are unable to withstand open-heart surgery. The go-ahead from the FDA paves the way for Abbott’s Triclip repair system to compete in the U.S. against Edwards Lifesciences’ recently approved transcatheter tricuspid valve replacement device, Evoque. Triclip uses the same clip-based technology to treat tricuspid regurgitation as Abbott’s Mitraclip for mitral valve regurgitation, a device the company has credited with driving double-digit growth in its structural heart business. Dive Insight Valve regurgitation, or leaking, occurs when the heart valve does not close correctly as it opens and shuts to circulate blood. The tricuspid valve controls blood flow from the right atrium to the right ventricle. When the valve isn’t closing properly, blood can flow backward in the heart, forcing it to work harder. Most common ...
- Source: drugdu
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- April 5, 2024
Alebund receives ODD for investigational drug AP303

Alebund Pharmaceuticals has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for its investigational drug AP303. This designation is intended for the treatment of autosomal dominant polycystic kidney disease (ADPKD), a genetic disorder that causes the growth of numerous cysts in the kidneys. AP303 is an internally developed drug candidate that has shown promise in improving renal survival in an ADPKD mice model. The drug has successfully completed a first-in-human study in healthy subjects in Australia and is poised to enter Phase II trials. ADPKD has a prevalence of between one in 400 and one in 1,000 live births and is a significant cause of end-stage kidney disease (ESKD), which often necessitates renal replacement therapy. Alebund co-founder, chairman, and CEO Dr Gavin Xia said: “We are very excited that AP303 has been granted orphan drug designation by the FDA. “It is an important milestone for Alebund ...
- Source: drugdu
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- April 5, 2024
Bavarian Nordic expands access to mpox vaccine in US

Bavarian Nordic has commercially launched its mpox (monkeypox) vaccine Jynneos (Imvanex/Imvamune) in the US, creating more avenues for its procurement, distribution, and reimbursement, and catering to both public and private healthcare providers. Healthcare providers now have the option to request Jynneos via chosen wholesalers and distribution channels, thereby increasing access for vulnerable individuals at nearby pharmacies, doctor’s offices, and public health centres. Mpox is a rare viral disease most commonly found in Central and West Africa. It is similar to smallpox, but less severe and causes fever, rash, and muscle aches and spreads through contact with infected animals or materials. The US Food and Drug Administration (FDA) originally approved Jynneos in 2019 for the prevention of smallpox and mpox. In May 2022, a case of mpox was confirmed in the UK, originating from a British resident who had travelled to Nigeria. Cases then emerged in countries where the disease is ...
- Source: drugdu
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- April 5, 2024
Xilio fires 21% of its workforce and reprioritises pipeline

XIlio Therapeutics has implemented cost-cutting measures which include a 21% workforce reduction and the termination of investments for developing one of its assets, XTX202, as a monotherapy. Xilio expects to incur one-time cost of approximately $1m for reducing its workforce by 15 employees. The company has reported $44.7m in cash reserves, which are expected to fund the company’s activities into Q2 2025. The Waltham, Massachusetts-based company’s market cap currently stands at $42.1m. Following the recent round of layoffs, Xilio joins a list of pharmaceutical companies including Atreca, Candel Therapeutics, Kinnate Bio, and NexImmune that have fired workers to funnel more money into their clinical development pipelines in the last few months. The company plans to not investigate XTX202, a tumour-activated beta-gamma biased interleukin (IL)-2, as a monotherapy and instead will explore partnerships to develop the therapy as a combination treatment. The therapy was evaluated in an open label Phase I/II ...
- Source: drugdu
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- April 5, 2024
Cellenkos links with Mount Sinai to explore CK0804 for myelofibrosis

Cellenkos has signed a sponsored research agreement with the Icahn School of Medicine at Mount Sinai Hospital, New York, US, to investigate the use of CK0804, a T-regulatory cell therapy for myelofibrosis. The collaboration aims to explore the therapeutic potential of CK0804, an allogeneic, cord blood-derived T-regulatory cell product enriched with C-X-C chemokine receptor type 4. The research will be led by Ronald Hoffman, director of the Myeloproliferative Disorders Research Program at the Tisch Cancer Institute, Mount Sinai. CK0804 uses Cellenkos’ CRANE technology to create disease-specific cell therapy products. This approach allows CK0804 cells to preferentially target inflamed bone marrow. Cellenkos chief operating officer Tara Sadeghi stated: “We are very excited by our collaboration with Mount Sinai and eagerly anticipate gaining a deeper understanding of [how] mechanisms of CK0804 Tregs work in myelofibrosis, especially to decrease inflammation. “CK0804 is already in a Phase I clinical trial to examine its safety ...
- Source: drugdu
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- April 5, 2024
Eisai to divest rights for two therapies to Kaken

Eisai has signed an agreement for the divestiture of rights for Merislon and Myonal, two of its long-standing products in Japan, to Kaken Pharmaceutical. The transaction is valued at Y3.8bn ($25.10m). Merislon treats vertigo and equilibrium disturbances and Myonal is a muscle relaxant, which patients have used since their respective launches in 1969 and 1983. The agreement stipulates that Eisai will complete the transfer of marketing capabilities by March 2025, followed by manufacturing and marketing approval transfer. The deal will not impact Eisai’s consolidated financial forecast for 31 March 2024. The company stated: “Eisai has determined that divesting rights for these products to Kaken, which has strengths in the products’ disease areas, is the optimal choice to ensure they continue contributing to a greater number of patients.” Eisai will continue to focus on creating and delivering products to target diseases with higher unmet medical needs such as neurology, oncology and ...
- Source: drugdu
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- April 5, 2024
Zhongde Meilian HuGen 21HS Fluorescent Assay Kit Launched on the Market

Recently, ANKE Bio’s member company, Wuxi Zhongde Meilian HuGen 21HS fluorescence detection kit was launched on the market, which contains 18 new autosomal loci, 1 CODIS locus, 1 sex locus and 1 Y-chromosome locus, and can be used in conjunction with other ANKE Bio kits to detect at least 73 autosomal STR loci, which is able to meet the new requirements of the Technical Specification for Biological Half-Sibling Relationships (SF/T 0131-2023), making the identification of half-sibling relationship more accurate and reliable. It is able to meet the new requirements in the technical specification of biological half-sibling relationship identification (SF/T 0131-2023), which makes the identification of half-sibling relationship more accurate and reliable. The new autosomal loci also have many applications other than half-sibling detection, which can provide new possibilities for kinship identification or other forensic evidence cases. In the field of biology, half-siblings are individuals with multiple offspring having the same ...
- Source: drugdu
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- April 5, 2024
Jazz Pharmaceuticals Completes Biologics License Application for Zanidatamab for HER2-Positive Metastatic Biliary Tract Cancer

Don Tracy, Associate Editor Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States. Jazz Pharmaceuticals announced that it has completed its Biologics License Application (BLA) for zanidatamab, an investigational bispecific antibody treatment targeting HER2-positive metastatic(BTC). Aiming for accelerated approval, zanidatamab has the potential to be the first HER2-targeted therapy indicated for BTC in the United States. According to the company, the BLA was based on findings from the Phase IIb HERIZON-BTC-01 trial for zanidatamab. The primary study endpoint of confirmed objective response rate (cORR) by independent central review (ICR) was deemed a success, as the 80 enrolled patients demonstrated a cORR of 41.3%. The HERIZON-BTC-302 Phase III started recently and is currently in the process of enrollment.1 “This important milestone brings us one step closer to delivering zanidatamab, a targeted treatment option, to patients living with HER2-positive BTC, a type of cancer that is associated ...
- Source: drugdu
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- April 5, 2024
FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside

Don Tracy, Associate Editor The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says. The FDA has approved Abbott’s i-STAT TBI cartridge to use with whole blood for rapid bedside assessment of patients with suspected concussions. The company stated this regulatory action is significant because previously available concussion tests required plasma or serum and lab processing. The device has been found to provide lab-quality results in 15 minutes to evaluate patients over the age of 18 years up to 24 hours after injury. Abbott stated the approval is an important milestone, citing that many individuals may have to wait following an injury to obtain proper treatment for the symptoms of a concussion.1 “Emergency departments can be a busy place. It’s important to be able to triage patients quickly,” Geoffrey Manley, MD, PhD, chief, neurosurgery, Zuckerberg San Francisco General Hospital, ...
- Source: drugdu
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- April 5, 2024

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