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Enterprise Therapeutics Doses First Person with Cystic Fibrosis in Phase 2 Trial for Novel Therapy ETD001

Enterprise Therapeutics Ltd (Enterprise), a biopharmaceutical company dedicated to the discovery and development of novel therapies to improve the lives of those suffering from respiratory disease, today announced dosing of the first person with cystic fibrosis (pwCF) in its Phase 2a trial of ETD001.

ETD001, a low molecular weight compound with first-in-class potential, targets the epithelial sodium channel (ENaC) in the airway epithelium to increase the hydration and clearance of mucus. The Phase 2a trial aims to deliver clinical proof-of-concept and to assess the safety profile of ETD001 in the 10% of pwCF with the highest unmet medical need. The study will be performed at sites located in UK, Germany, France and Italy and will assess lung function (FEV1) in pwCF who are either ineligible for or are not receiving CFTR modulators.

CF is estimated to affect over 100,000 people worldwide, with an average life expectancy of only 50 years. Failed mucociliary clearance and mucus congestion in the lungs of pwCF leads to cycles of infection and inflammation and an ongoing decline in lung function. Increasing fluid volume in the lung by inhibiting ENaC with ETD001 will hydrate mucus, improve clearance, reduce mucus congestion, and is expected to drive substantial improvements in lung function. ETD001 has previously demonstrated a strong safety profile in healthy participants in a Phase 1 trial and has been shown to be long-acting in pre-clinical studies.

Dr John Ford, CEO, Enterprise Therapeutics, said:

“The dosing of the first person with CF in our Phase 2a trial of ETD001 represents an incredible milestone, testament to Enterprise’s dedication to advancing a novel approach to treating pwCF with the highest unmet medical need. ETD001 has already demonstrated an excellent safety profile in healthy participants, as well as a pharmacokinetic (PK) profile consistent with a long lung residency. We look forward to progressing ETD001 through Phase 2 trials and beyond.”

Paul Russell, Head of Development, Enterprise Therapeutics, commented: “By targeting the underlying mechanisms of mucus congestion in the lungs through ENaC inhibition, ETD001 has the potential to be a transformative respiratory therapeutic. This is not only for the ~10% of pwCF who are not genetically suited to, or do not benefit from CFTR modulators, but also those suffering from other muco-obstructive lung diseases such as COPD and asthma. The commencement of our Phase 2a trial brings us an exciting step closer to realising that potential.”

Dr Renu Gupta, CMO, Enterprise Therapeutics, said: “We are grateful to the pwCF participating in our Phase 2 study of ETD001, and to the clinical investigators for achieving this major milestone. We are hopeful that our steadfast commitment to advancing this innovative ENaC targeting molecule, along with our partnerships with the CF community, will lead to a treatment that will vastly improve the lives of people living with CF.”

Biolyst Scientific Announces New Brand Name to Encompass EMS and Azer | Will Deepen Offerings to Clinical and Research Lab Customers

Biolyst Scientific today announced its new brand name, reflecting the integration of Electron Microscopy Sciences (EMS) and Azer Scientific. The combined company blends extensive industry knowledge with an uncommon passion to make a difference – creating clinical, research, economic, and relationship value every day.

“This is an incredibly exciting day for Biolyst Scientific, our talented team, and our long-term customers and partners,” said Rajan Kapadia, President & CEO of Biolyst Scientific, who leads the combined entity. “New frontiers in Life Sciences are creating a need for accurate data acquisition and speed of discovery – we don’t just deliver products on time, but elevate the customer experience by providing unparalleled reliability, precision, and a relentless focus on surfacing genuine solutions for the needs of the lab.”

The new name, ‘Biolyst,’ reflects the essential part the company plays in the Life Sciences discoveries that make life better for all. ‘Bio’ signals where impact is felt – in enhancing and extending life – and ‘lyst’ signifies its role as catalyst in helping clinical and research labs pursue breakthroughs with accuracy and efficiency. The EMS and Azer brand names will continue to exist as ‘power brands’ within the product portfolio.

While its broader solutions portfolio amplifies Biolyst Scientific’s impact, the company will maintain its uniquely collaborative relationship style and personalized focus to continue helping clinicians and researchers expand their discovery efforts cost-efficiently. This blend of scale and personal touch positions Biolyst as a significant partner to the most innovative clinical and research laboratories.

Since the merger was announced in August 2023, the company prioritized commercial integration to ensure customers of today and tomorrow have a seamless sales and service experience that meets their needs, tracks their growth, and promotes new discoveries. Yet – to maximize customer experience continuity – the company plans to maintain EMS and Azer websites, ERP systems, and other key touchpoints.

Biolyst Scientific is backed by private investment firm Inverness Graham.

Paige Reports 3 UK-Based Hospital Systems Exploring the Power of their AI for Diagnosing Prostate Cancer in Live Clinical Settings

Paige

In a collaborative project led by the University of Oxford, Paige, a global leader in clinical AI applications that assist in diagnosing cancer, today announced that the Articulate Pro study has achieved live, multisite clinical use study involving three hospital systems across England: North Bristol Trust Southmead Hospital, University Hospitals Coventry and Warwickshire, and Oxford University NHS Foundation Trust.

Each hospital uses different digital pathology scanners and information systems and serves distinct patient populations —but are all adding Paige’s powerful artificial intelligence (AI) technology to their standard of care to determine the potential to improve patient outcomes against a background of rising instances of prostate cancer.

The Paige Prostate Suite is a system of diagnostic AI applications designed to help pathologists detect, grade and measure tumours in prostate biopsies and tissue samples. Pathologists at these three hospital systems are assessing how Paige Prostate Suite impacts their clinical decision-making, pathology service delivery, and use of resources in a real-world setting.

With this use across multiple hospitals, pathologists can assess the ways Paige’s AI technology can best serve patients, histopathologists, and hospital systems for prostate cancer diagnosis. This development is the latest achievement of the ARTICULATE PRO study, funded by the Accelerated Access Collaborative (AAC) Artificial Intelligence in Health and Care Award, overseen by the Department of Health and Social Care.

“The central focus of ARTICULATE PRO is patients. We are striving towards our goal to safely and effectively ensure they benefit the most from powerful AI technology,” said Professor Clare Verrill, OUH Cellular Pathology Consultant, Associate Professor and Principal Investigator of ARTICULATE PRO. “With the multisite live use of The Paige Prostate Suite, we can systematically study benefits to patients in clinical settings.”

Dr. Jon Oxley, uropathologist and Bristol lead of ARTICULATE PRO, added, “I have studied the disease and progression of prostate cancer in clinical research for over 25 years, it is a significant advancement that Paige’s AI applications have achieved a level of validation and performance that allows safe and effective live clinical use. Using Paige Prostate Suite alongside our standard of care has the promise to increase efficiency and improve reproducibility of results for patients.”

Dr. Bidisa Sinha, uropathologist at University Hospitals Coventry and Warwickshire, agreed, “We believe AI can help to improve the accuracy and consistency of grading cancer and assist in detection of small areas of cancer which are easy to miss. This is world-leading research being carried out at UHCW. We are proud to be a global leader in the field of digital and computational pathology.”

Wolters Kluwer Health Launches ClinicalPulse™ | A Simplified Continuing Education Solution for Nurse Practitioners

Wolters Kluwer Health today announced the launch of ClinicalPulse™, a simplified continuing education (CE) solution for Nurse Practitioners (NPs). This innovative offering provides an efficient, personalized learning experience that meets the requirements of national and state certification boards.

CE built by Nurse Practitioners, for Nurse Practitioners

The ClinicalPulse app is powered by content from leading industry conferences and medical institutions, and is the first NP product curated by NPs to offer time-based learning that combines multiple modes including audio, visual, and text. The high-quality content includes personally curated episodes by Jamesetta A. Newland, PhD, FNP-BC, FAANP, DPNAP, FAAN and Editor-in-Chief of Nurse Practitioner, that are specifically selected for its relevance to NPs.

“As a staunch believer in lifelong learning, I am honored to be a collaborator in creating ClinicalPulse for nurse practitioners,” said Jamesetta A. Newland, Editor-in-Chief of Nurse Practitioner. “An exceptional team of innovators driven by the need to keep pace with advances in healthcare stand behind ClinicalPulse. I am excited about this new option to access evidence-based information to promote best practices.”

Keeping busy Nurse Practitioners current without breaking their stride

“Nurse Practitioners bring a comprehensive perspective and compassion to healthcare, blending clinical expertise in diagnosing and treating health conditions with an emphasis on disease prevention and health management,” said Rafael Sidi, Senior Vice President & General Manager of Health Research, Wolters Kluwer Health. “In the current healthcare landscape, NPs are facing demanding workloads paired with staying current on the latest medical evidence to ensure care is meeting the needs of their patients. ClinicalPulse provides critical, high-quality learning tailor-made for NPs in a format that is convenient and easy to use.”

ClinicalPulse builds on Wolters Kluwer’s portfolio of delivering world-class, quality continuing education content for medical professionals through the AudioDigest platform. NPs can easily track all their AANP- and ANCC-accredited CE and Pharmacology Contact Hours. The streamlined submission process for CE progress earned in the app is brief and hassle-free, connecting users with the appropriate accrediting body. Using the app saves time and money compared to attending live conferences, enduring lengthy lectures and presentations, reading articles, as well as completing pre-and post-test requirements.

You can download the ClinicalPulse app through the Apple App Store or on Google Play.

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution

Rapid Medical
DRIVEWIRE 24 redefines interventional access by providing an active deflectable tip that controls and steers a range of catheters directly to the target vessels. Whereas conventional access devices are reactive and rely on external forces to reach their target, DRIVEWIRE's active technology selects turns on-demand and handles the complexity of navigating the vascular highway with ease.

Rapid Medical, a leading developer of advanced endovascular devices, announces the first procedures in the USA with the breakthrough deflectable access platform DRIVEWIRE 24 at the 2024 Society of NeuroInterventional Surgery’s (SNIS) 21st Annual Meeting. With active technology, DRIVEWIRE articulates a wide range of catheters for direct access to endovascular locations.

“DRIVEWIRE addresses a major unmet need in the endovascular space,” exclaims Dr. Shahram Majidi of Mount Sinai Health System in New York City, NY. “It transforms access across a range of procedures, from aneurysms to strokes and more. We’re always looking for devices to make procedures faster, safer, less expensive. My first experience with DRIVEWIRE suggests it could do all of these.”

In the 2 cases completed by Dr. Majidi, DRIVEWIRE 24 navigated the aspiration catheter directly to the M2 arterial occlusion for first-pass excellent reperfusion. In the second case, DRIVEWIRE navigated complex turns to place 2 flow diverters in a large, multilobed aneurysm.

DRIVEWIRE provides high-performance intravascular steering. Physicians control the direction and shape of the guidewire tip in real time, eliminating the need to remove the wire to reshape it. The device also features variable support to articulate a wide range of micro and intermediate catheters without advanced forerun or additional support devices. This results in precise navigation via the most direct route through the neuro and peripheral vasculature.

“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”

Avenacy Announces Launch of Palonosetron Hydrochloride Injection, USP in the U.S. Market

Palonosetron Hydrochloride Injection

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Palonosetron Hydrochloride Injection, USP in the United States as a therapeutic generic equivalent for Aloxi® as approved by the U.S. Food and Drug Administration. Palonosetron Hydrochloride Injection, USP is indicated as an antiemetic.

Avenacy’s Palonosetron Hydrochloride Injection, USP is available in 0.25 mg/5 mL (0.05 mg per mL) single-dose vials. In line with Avenacy’s mission to champion patient safety and streamline patient care, Palonosetron Hydrochloride Injection, USP will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection.

Avenacy will begin shipping Palonosetron Hydrochloride Injection, USP to wholesale partners this week. The Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP-standards.

Palonosetron Hydrochloride Injection, USP had U.S. sales of approximately $20 million for the twelve months ending in June 2023.1

Approved Indications:

For Adult Use

Palonosetron hydrochloride injection is indicated in adults for prevention of:

  • Acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC),
  • Acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC),
  • Postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.

As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, palonosetron hydrochloride injection is recommended even where the incidence of postoperative nausea and/or vomiting is low.

For Pediatric Use

Palonosetron hydrochloride injection is indicated in pediatric patients 1 month to less than 17 years of age for prevention of:

  • Acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.

Please see link for Full Prescribing Information including the Boxed Warning.

Aloxi® is a registered trademark of Eisai Inc.

1Source: IQVIA

Agilent Technologies to Acquire North American CDMO BIOVECTRA

Agilent
A BIOVECTRA manufacturing facility.

Agilent Technologies Inc. (NYSE: A) today announced it has signed a definitive agreement to acquire BIOVECTRA, a leading specialized contract development and manufacturing organization, for $925 million.

Based in Canada, BIOVECTRA produces biologics, highly potent active pharmaceutical ingredients, and other molecules for targeted therapeutics.

The acquisition builds on Agilent’s CDMO specialization in oligonucleotides and CRISPR therapeutics in three key areas:

  • Expands portfolio of services. BIOVECTRA offers sterile fill-finish services, pDNA and mRNA capabilities, and lipid nanoparticle (LNP) formulation.
  • Adds rapidly growing modalities. BIOVECTRA brings expertise in fast-growing segments, including antibody drug conjugates (ADCs), highly potent active pharmaceutical ingredients (HPAPIs), and GLP-1.
  • Brings world-class capabilities to support gene editing. BIOVECTRA’s capabilities in biologics combined with Agilent’s expertise in gRNA will provide customers with a single source for gene-editing technology.

Both BIOVECTRA and Agilent Technologies are fully integrated CDMOs with state-of-the-art facilities that follow current Good Manufacturing Practices (cGMP), a high standard for methods, facilities, and controls used in manufacturing, processing, and packaging of active pharmaceutical ingredients.

“We look forward to welcoming BIOVECTRA to Agilent,” said Agilent President and CEO Padraig McDonnell. “The company has an outstanding record of innovation, and its employees share our commitment to providing integrated biopharma solutions that continuously deliver more value to customers.”

McDonnell continued: “Plus, BIOVECTRA’s manufacturing capabilities further expand Agilent’s end-to-end biopharma offerings into new growth vectors, including workflows that seamlessly integrate analytical instrumentation, consumables, and a wide range of lab services.”

BIOVECTRA supports early-stage clinical development to large-scale commercial manufacturing. The company currently serves biotech and pharmaceutical companies in North America and Europe.

“BIOVECTRA is excited to join Agilent, a company whose dedication to people and customers is very much aligned with ours,” said Oliver Technow, CEO of BIOVECTRA. “BIOVECTRA has dedicated nearly 55 years to the relentless pursuit of helping our customers solve complex problems that improve patients’ lives. This synergistic pairing of our capabilities with Agilent’s will further enhance the value we can offer to our customers.”

BIOVECTRA delivered $113 million in revenue during 2023 and expects double-digit revenue growth in 2024. Agilent expects that the acquisition will be $0.05 dilutive to non-GAAP EPS in the first full year after closing. Agilent will fund the transaction using a mix of cash on hand and debt financing.

The transaction is subject to customary closing conditions, including receipt of regulatory approvals, and is expected to close before 2025. Upon close, BIOVECTRA will become part of the Agilent Diagnostics and Genomics Group.

Spryte Medical Receives Breakthrough Device Designation from FDA for Revolutionary neuro Optical Coherence Tomography (nOCT) Technology

Spryte Medical, a pioneering company in advanced medical imaging technologies, proudly announces that its neuro Optical Coherence Tomography (nOCT) technology has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This recognition underscores the transformative potential of nOCT in neurointervention and cerebrovascular treatment.

The FDA’s Breakthrough Device Designation is awarded to innovative technologies that offer significant advantages over existing alternatives in treating or diagnosing life-threatening or irreversibly debilitating diseases. This designation not only recognizes the potential revolutionary impact of nOCT but also expedites its development and review process, supports reimbursement and timely access for patients and healthcare providers.

Spryte Medical is also pleased to be included in the FDA’s new Total Product Life Cycle Advisory Program (TAP), which aims to help speed development of high-quality, safe, effective, and innovative medical devices that are critical to public health. Participation in the TAP program will provide Spryte with valuable feedback and support from the FDA, further accelerating the path to market for nOCT technology.

Neuro Optical Coherence Tomography (nOCT) represents a significant leap forward in neurointervention. Unlike traditional intravascular imaging systems designed primarily for cardiology, nOCT is specifically engineered for cerebrovascular navigation. This advanced intravascular imaging technology allows for detailed visualization of the brain’s vascular anatomy at near histologic levels, to provide improved diagnostic capabilities and enhance treatment precision.

Dr. Demetrius Lopes, a leading expert in neurointervention, commented on the breakthrough designation:
“Neurointervention has had an incredibly positive impact on the treatment of cerebrovascular conditions. nOCT intravascular imaging will allow us to advance the field even further. With this technology we will be able to better visualize disease and devices, guide our decision making and deliver even better patient care. I have followed the development of intravascular imaging in cardiology for many years. I always believed that OCT information could have an even greater impact in neurointervention outcomes and I am excited to bring the benefits of this technology into the brain for the first time ever. Spryte nOCT was developed specifically with neurointervention in mind and has the potential to overcome the many limitations that prevented its use in the neurovasculature previously. The initial nOCT clinical experience demonstrated consistently the ease of use, safety, and imaging quality. This is a dream coming true… our patients will benefit the most.”

“Our engagement with the FDA through the Breakthrough Device and Total Product Life Cycle Advisory Program (TAP), highlights the potential of Spryte Medical’s neuro OCT imaging platform for patients with cerebrovascular disease” said David Kolstad, Chief Executive Officer of Spryte Medical. “We look forward to working collaboratively with the FDA for the benefit of these patients.”

Spryte Medical’s nOCT technology promises to revolutionize the field of neurointervention, offering unparalleled imaging quality, safety, and ease of use. By providing clinicians with detailed, real-time images of the brain’s vascular structures, nOCT is designed to enable more precise interventions, potentially improving patient outcomes and advancing our understanding of cerebrovascular diseases.

TCBP Announces Dosing of 6th Patient in ACHIEVE Study in Patients with Acute Myeloid Leukemia

TC BioPharm (Holdings) PLC (“TC BioPharm” or the “Company”) (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, today announced that on July 16, the sixth patient in ACHIEVE Study (UK) was treated. This is the first patient treated with a higher dose of TCB-008 post the amendment approved by the MHRA on Feb 22, 2024.

The ACHIEVE Study UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB-008 in patients with AML or MDS/AML, with either refractory or relapsed disease. ACHIEVE is comprised of two cohorts representing separate disease states. The protocol allows for either cohort to be advanced as an independent Phase III Pivotal Trial upon completion of the cohort, presuming the primary efficacy endpoints is met.

Cohort A represents relapsed/refractory patients who have been unable to attain remission and are in palliative care as they are unable to tolerate further chemotherapy. Initially, 5 patients were treated at the lower dose. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort A for a total of 24 patients.

Cohort B represents patients who have attained remission following prior treatment, however, continue to have a detectable residual disease. Up to 14 patients may be recruited into this cohort at the higher dose. Pending confirmation of the primary endpoints, a further 10 patients may be recruited into Cohort B for a total of 24 patients.

Interim data review is not reliant on the completion of either Cohort, and consequently the Company is not required to complete investigation of both Cohorts prior to advancing to a Pivotal Phase 3 study in one or both Cohorts simultaneously.

Enrolled patients will be treated with an increased dose of TCB-008, containing up to 230,000,000 cells per dose compared to the previous dose of 35,000,000. The increased dose is commensurate with the proposed medium dose cohort in the Company’s FDA trial in AML. Eligible patients will receive up to three additional infusions of TCB008, starting 14 days after the previous infusion and administered every subsequent 14 days, representing a total of 4 doses of TCB-008 or approximately 1,000,000,000 cells. Details of the ACHIEVE Study can be found at https://www.clinicaltrials.gov/study/NCT05358808

“The dosing and restart of ACHIEVE represents an important milestone in our progress towards Phase 2b efficacy data in AML with an interim data announcement in the next six to nine months, as well as proof in our ability to successfully navigate potentially arduous regulatory and clinical trial environments in both ACHIEVE and ACHIEVE2,” said Bryan Kobel, CEO of TC BioPharm. “In addition to dosing our 6th patient and restarting ACHIEVE, we’ve screened and enrolled additional patients into the trial and expect to dose up to 10 more in 2024 and expect to open at least one additional clinical trial site in Q3. These efforts, combined with additional refinement of TCB-008 over the last 6 months, escalating the dose size in the ACHIEVE trial and existing data, have us poised for inflection points in 2024 and confidence in our ability to continue to execute on our clinical trial plans. Based on the substantial clinical safety and efficacy data to date and encouraging tolerability information generated in the five-patient safety cohort of ACHIEVE, we are excited to realize the potential of TCB-008 as a mono-therapy and continue to pursue partners for combination therapies.”

Grünenthal Acquires US-company Valinor Pharma and Becomes Global Owner of Movantik®

Grünenthal today announced the acquisition of US-based Valinor Pharma, LLC (“Valinor”) and its product Movantik® (naloxegol), with a total deal value of approx. $250 million inclusive of all royalty obligations. Grünenthal will finance the transaction using available liquidity.

Movantik® is indicated for the oral treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. The transaction further expands Grünenthal’s portfolio of established medicines and adds to the company’s growing U.S. business. Gross sales from Movantik® in the United States reached over $200 million in 2023.

“As a pain specialist, Movantik is a perfect fit for Grünenthal with our existing customer base and complementary product portfolio”, says Gabriel Baertschi, CEO, Grünenthal. “The acquisition of Valinor Pharma strengthens our footprint in the United States, the most important growth market for Grünenthal.”

Marv Kelly, President of Grünenthal US, commented: “We are excited to welcome Valinor and expand our portfolio offering to pain specialists with Movantik.”

Grünenthal acquired the product in Europe (branded Moventig® outside of the U.S.) in 2023 as part of a joint venture with Kyowa-Kirin. The acquisition of Valinor makes Grünenthal the worldwide owner of the brand (ex-Canada).

With Movantik®, Grünenthal continues to execute its strategy of acquiring established medicines to expand its portfolio and increase the company’s profitability. Since 2017, Grünenthal has acquired several established medicines, including NebidoTM, the European rights to CrestorTM and NexiumTM, as well as the global rights to VimovoTM (excluding the U.S. and Japan), QutenzaTM and ZomigTM (excluding Japan). In 2023, Grünenthal established Grünenthal Meds, a joint venture with Kyowa Kirin International, which manages a portfolio of 13 brands primarily focused on pain management. Grünenthal has invested more than €2 billion in successful M&A transactions.

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