Tag: PR

  • Therapeutics

Shorla Oncology Announces FDA Approval of TEPYLUTE® 100mg, First and Only Ready-to-Dilute Multi-Dose Vial of Thiotepa to Treat Breast and Ovarian Cancer and Commercial Launch of TEPYLUTE 15mg and 100mg Vials in the U.S.

TEPYLUTE 100mg is the first multi-dose formulation of thiotepa that is stable for 14 days when properly stored. TEPYLUTE is Shorla Oncology’s fourth launch in the U.S. Market. CAMBRIDGE, Mass.–(BUSINESS WIRE)–Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration has granted approval for 100 mg/10mL multi-dose vial of TEPYLUTE, a ready-to-dilute formulation …
  • Medtech

Perfuze Announces Completion of Enrollment in Pivotal US Clinical Study and Appointment of Joe Rotger as Executive Vice President of Sales

Perfuze, a leader in next-generation catheter-based technology for the treatment of acute ischemic stroke, today announced two significant milestones in its mission to improve stroke care: 1) the completion of patient enrollment in its U.S. pivotal IDE clinical trial, MARRS (Millipede Aspiration for Revascularization in Stroke Study), and 2) the appointment of seasoned medtech executive Joe Rotger as Executive Vice …
  • Medtech

Perfuze Receives FDA 510(k) Clearance for Zipline™ Delivery Assist Catheters and Secures €22M in Additional Funding

Perfuze, a leading medical device company dedicated to advancing stroke treatment, today announced that it has received FDA 510(k) clearance for its Zipline™ Delivery Assist Catheters. This regulatory milestone strengthens Perfuze’s growing portfolio of innovative neurovascular devices, empowering physicians to treat acute ischemic strokes with greater speed, ease, and precision. In addition, Perfuze has secured €22 million in follow-on funding …
  • Therapeutics

Coave Therapeutics Secures €32 Million in Series A Financing to Advance its Next-Generation Genetic Medicines

Coave Therapeutics (‘Coave’), a company pioneering the future of genetic medicines, today announces the successful raising of €32 million ($33 Million) in Series A financing. The financing was co-led by Novo Holdings A/S and Bpifrance, with participation from Invus and UI Investissement, alongside existing investors Seroba Life Sciences, Fund+, Kurma Partners, Omnes Capital and Turenne Capital.   The financing will enable …
  • Therapeutics

Deciphex Secures €31M Series C to Address Global Pathology Shortage

Deciphex, a leader in AI-powered digital pathology, has closed its Series C financing, raising €31 million to address the acute global pathology crisis. Led by Molten Ventures with significant participation from ACT Venture Capital, Seroba, Charles River Laboratories (NYSE: CRL), IRRUS Investments, Medtech Syndicate and Nextsteps Capital, the funding will advance Deciphex’s mission to democratize access to high-quality pathology through …
  • Therapeutics

Complement Therapeutics Appoints Dr Muhammad Ali Memon FRCOphth, as Chief Medical Officer

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the appointment of Dr Muhammad Ali Memon as its Chief Medical Officer, effective 1st January 2025. Dr. Memon is a qualified ophthalmologist and joins CTx from AAVantgarde Bio, where he held the position of Vice President, Clinical Science and Safety. Prior to AAVantgarde, …
  • Medtech

Shorla Oncology Announces FDA Approval of IMKELDI (imatinib) Oral Solution, an Oral Liquid for the Treatment of Certain Forms of Leukemia and Other Cancers

Shorla Oncology, (“Shorla”), a U.S.-Ireland specialty pharmaceutical company, announced today that the FDA has approved IMKELDI (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers. Leveraging Shorla’s novel technology, IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy. IMKELDI can help slow or prevent the growth …
  • Medtech

Quanta Dialysis Technologies closes oversubscribed Series E Funding

Quanta Dialysis Technologies, a leader in transforming kidney care through its award-winning Quanta™ Dialysis System, has successfully closed its oversubscribed Series E Preferred Stock financing round, raising more than $60 million of additional capital. Led by Novo Holdings, Glenview Capital and b2venture, with broad participation by existing shareholders, this latest funding round underscores strong investor confidence in Quanta’s market potential to revolutionize …
  • Therapeutics

Vico Therapeutics Announces Positive Interim Phase 1/2a Clinical Data of VO659 in Treatment of Huntington’s Disease

Vico Therapeutics B.V., a clinical-stage genetic medicines company developing therapies for severe neurological diseases, today announced new positive interim data in Huntington’s disease (HD) from the ongoing Phase 1/2a clinical trial of VO659, an investigational allele-preferential antisense oligonucleotide (ASO) therapy. Results will be highlighted in an oral presentation at the European Huntington’s Disease Network’s EHDN & Enroll-HD 2024 meeting on Friday, …
  • Medtech

ShiraTronics Raises $66 Million in Oversubscribed Series B Financing to Advance Pioneering Treatment for Chronic Migraine

Implantable Neuromodulation System Shows Early Promise in Improving Patient Quality of Life by Reducing Monthly Headache Days and Severity of Migraine Attacks. ShiraTronics, a clinical-stage medical device company developing neurostimulation therapies for chronic migraine patients, today announced the closing of a $66 million Series B financing. The round was led by new investor Norwest Venture Partners, with participation from additional new investors …
  • Medtech

Seroba Announces Its investment in Ryme Medical as Part of Series A Financing

Seroba, a European life sciences venture capital firm headquartered in Dublin, with offices in Paris and Milan, is pleased to announce the addition of Ryme Medical to its portfolio of medtech investments, following the completion of a Series A financing. The funds will be used to reach clinical and regulatory milestones for Ryme’s cutting-edge technology. Investing from its fourth fund, …
  • Medtech

Edward Lifesciences Expands Structural Heart Portfolio With Acquisitions of JenaValve and Endotronix

Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology, a pioneer in the transcatheter treatment of aortic regurgitation (AR), a deadly disease that impacts a significant and growing population …
  • Medtech

Loci Orthopaedics Closes €12.8 Million Series A Financing

Loci Orthopaedics Ltd, an orthopaedic medical device company, today announced the successful closing of an oversubscribed €12.8 million Series A financing. The financing round was led by new investors Seroba, Johnson & Johnson Innovation, JJDC, Inc., (JJDC) and the European Innovation Council (EIC) Fund. Loci Orthopaedics develops novel technologies that target major unmet clinical needs in orthopaedics extremities. The company’s …
  • Non classé

Shorla Oncology Announces FDA Approval for TEPYLUTE, A Novel Formulation to Treat Breast and Ovarian Cancer

TEPYLUTE is a ready-to-dilute formulation of thiotepa that reduces preparation time and enables accurate dosing Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for TEPYLUTE, a ready-to-dilute formulation to treat breast and ovarian cancer in an easier to prepare, injectable product that …
  • Therapeutics

Sibylla’s PPI-FIT technology joins with MD Anderson’s drug development resources and expertise to create protein folding interfering degraders as cancer therapies.

Sibylla Biotech and The University of Texas MD Anderson Cancer Center today announced a strategic collaboration agreement to discover and develop novel small-molecule cancer therapies known as Folding Interfering Degraders (FIDs), which disrupt the proper folding of target proteins and lead to their degradation. Under the agreement, Sibylla and MD Anderson will jointly conduct discovery and development work from target …
  • Medtech

Endotronix Receives FDA Premarket Approval of the Cordella™ PA Sensor System for the Treatment of Heart Failure

Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, today announced Premarket Approval (PMA) from the U.S Food and Drug Administration (FDA) of the company’s Cordella™ Pulmonary Artery (PA) Sensor System for the treatment of New York Heart Failure (NYHA) class III heart failure patients. The …
  • Therapeutics

Seroba and Kurma Partners Announce Complementary Series B Funding for Vico Therapeutics totaling €65.8 million ($70.7 million)              

Seroba, a European life sciences venture capital firm headquartered in Dublin, with offices in Paris and Milan, and Kurma Partners, a key European Venture Capital firm financing innovation in Healthcare and Biotechnology, from pre-seed to growth capital, based in Paris and Munich, announced today the completion of the second closing part of Series B financing round of Vico Therapeutics. Vico …
  • Therapeutics

STORM Therapeutics Presented Interim Phase 1 Clinical Data on its METTL3 RNA Methyltransferase Inhibitor STC-15 at ASCO 2024

STC-15 was well tolerated and clinical activity was observed across the pharmacologically active dose range in advanced cancer patients Primary objectives were achieved to progress STC-15 into combination with checkpoint inhibitor combination studies STORM Therapeutics Ltd. (STORM), the clinical stage company pioneering cellular reprogramming through RNA modifications to treat disease, today announces that interim Phase 1 clinical data from its first-in-class …
  • Therapeutics

Fusion Pharmaceuticals Reports First Quarter 2024 Financial Results and Announces Clinical Program Updates

Fusion Pharmaceuticals Reports First Quarter 2024 Financial Results and Announces Clinical Program Updates Presented interim data from TATCIST trial of FPI-2265 in mCRPC at the 2024 American Association for Cancer Research (AACR) Annual Meeting Signed definitive agreement to be acquired by AstraZeneca for total transaction value of up to $2.4 billion; transaction expected to close in the second quarter of …
  • Medtech

Deciphex Enters into Collaboration Agreement with Novartis to Advance AI in Preclinical Studies

Collaboration Agreement Seeks to engage AI to Transform Non-clinical Pathology Assessments in Drug Discovery and Development Deciphex, a Dublin-based digital pathology company, has entered into a Collaboration Agreement with Novartis to develop artificial intelligence (AI)-based approaches with potential to transform preclinical pathology assessments in drug discovery and development. The collaboration seeks to develop a suite of AI tools that streamline …
  • Therapeutics

Artica Therapeutics appoints Piet Wigerinck to its board of directors

Artica Therapeutics B.V. (Artica), a biotechnology company developing a pipeline of covalent small molecules for autoimmune and inflammatory disorders, today announced that industry veteran Piet Wigerinck PhD is joining the board as an independent non-executive director. Dr Wigerinck is a seasoned executive with over three decades of R&D experience in the pharmaceutical and biotechnology sector and deep expertise in the …
  • Therapeutics

Fusion to be acquired by AstraZeneca for up to $2.4 billion

We are pleased to announce that our portfolio company Fusion Pharmaceuticals Inc., (FUSN), is to be acquired for up to $2.4 billion by AstraZeneca. Fusion, is a clinical-stage biopharmaceutical company, headquartered in Toronto, with an office in Boston, developing next-generation targeted radiopharmaceuticals. These compounds combine the potent cancer cell killing effects of a radioactive agent (actinium-225, alpha-emitter) with a targeting …
  • Therapeutics

Sibylla Biotech enters a strategic drug discovery collaboration with Ono Pharmaceutical in central nervous system disorders

Sibylla Biotech announced today a drug discovery collaboration with Ono Pharmaceutical Co., Ltd. (TSE: 4528) that will access Sibylla’s cutting-edge Pharmacological Protein Inactivation by Folding Intermediates Targeting (PPI-FIT) technology to identify and develop candidates for multiple therapeutic targets in the field of Central Nervous System (CNS) disorders. Under the terms of the collaboration, Sibylla is entitled to a total deal …
  • Medtech

Endotronix presents positive PROACTIVE-HF clinical trial results for its cordella pulmonary artery sensor

Endotronix, Inc., a privately held company dedicated to advancing the treatment of heart failure (HF) at the intersection of digital health and medtech, presented 6-month results from its PROACTIVE-HF pivotal trial.  PROACTIVE-HF evaluated the company’s investigational Cordella Pulmonary Artery (PA) Sensor in New York Heart Association (NYHA) class III HF patients at risk of congestion.  The trial met primary safety …
  • Therapeutics

Shorla FDA Filing to treat breast and ovarian cancer

Shorla FDA Filing to Treat Breast and Ovarian Cancer U.S.-Ireland Specialty Pharmaceutical Company’s ready-to-dilute form of a drug for the treatment of adenocarcinoma of the breast or ovary Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for a novel formulation …
  • Medtech

Endotronix Submits PMA Application for its Cordella Pulmonary Artery Sensor System

Seroba’s portfolio company, Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the submission of a Premarket Approval (PMA) application for its Cordella™ Pulmonary Artery (PA) Sensor System to the U.S. Food and Drug Administration (FDA). Cordella is an innovative HF patient management platform that delivers proactive PA pressure …
  • Medtech

Perfuze® announces FDA clearances for novel neurovascular aspiration and access catheters for stroke treatment

Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, proudly announces FDA clearance for the Millipede 070 Aspiration Catheter and the 2nd generation of the Millipede 088 Access Catheter. The Millipede 070 Aspiration Catheter is built upon a pioneering, distinctive technology that enables physicians to address critical unmet needs in ischemic stroke treatment. …
  • Therapeutics

Shorla Oncology & EVERSANA announce U.S. commercial launch of FDA-Approved JYLAMVO, the first and only oral methotrexate solution approved in the U.S. for adults

Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, and EVERSANA®, a leading provider of commercialization services to the life science industry, today announced the commercial launch of JYLAMVO (methotrexate) oral solution, the first and only oral methotrexate solution approved in the United States for use in adults. JYLAMVO has been shown to have a sweet, palatable taste 1,2*and is approved …
  • Therapeutics

Complement Therapeutics Announces the Establishment of Medical Advisory Board

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the formation of its Medical Advisory Board which will help guide the development of the company’s innovative therapeutic pipeline including its lead investigational product CTx001, a gene therapy for geographic atrophy. The Medical Advisory Board consists of six esteemed members, led by Chair, …
  • Therapeutics

Complement Therapeutics enrols first US participant in the Non-interventional i-GAIN study of people diagnosed with geographic atrophy

Complement Therapeutics GmbH (CTx), a preclinical stage biotechnology company developing novel therapeutics for complement-mediated diseases, today announced the enrolment of their first participant in the United States, an important milestone for the i-GAIN natural history study of people who have been diagnosed with geographic atrophy (GA), secondary to age-related macular degeneration (AMD). The i-GAIN (investigating Geographic Atrophy Insights) study is …
  • Therapeutics

Artica Therapeutics Closes €12M Seed Investment to Develop Covalent Therapeutics for Autoimmune and Inflammatory Disorders

Artica Therapeutics B.V. (Artica), a biotechnology company unlocking the power of medicines with insurmountable binding characteristics, today announced it has raised €12 million in Seed financing. The round was co-led by Thuja Capital and Seroba, with participation from InnovationQuarter and founding investor BGV. Proceeds from the financing will be used to advance Artica’s small molecule pipeline of novel covalent therapies. …
  • Medtech

Perfuze® announces first stroke patient enrolled in the MARRS Pivotal Clinical Trial for the Millipede System

Perfuze, a private medical device company dedicated to developing pioneering technology to treat acute ischemic stroke, announced commencement of enrollment in its pivotal MARRS (Millipede AspiRation for Revascularization in Stroke) clinical study. MARRS is a multi-center trial to evaluate the performance of the Millipede System. The first patient was enrolled at Stony Brook University Hospital in Stony Brook, NY. MARRS …
  • Therapeutics

Shorla Oncology announces US acquisition of Jylamvo, an oncology and autoimmune drug from Therakind

Shorla Oncology (‘Shorla’), a US-Ireland specialty pharmaceutical company, and Therakind Ltd (‘Therakind’), a UK-based speciality pharmaceutical company have entered into an agreement under which Shorla has agreed to acquire Jylamvo, an oncology and autoimmune drug, for the US market. The therapy has been approved by the US Food and Drug Administration (FDA). Jylamvo is an easy-to-administer, sweet tasting oral methotrexate …
  • Medtech

Endotronix Receives IDE Approval for the Market Expanding PROACTIVE-HF 2 Clinical Trial

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), announced it has received Investigational Device Exemption (IDE) approval from the FDA for a subsequent multicenter study, PROACTIVE-HF 2, which will evaluate the company’s Cordella Sensor for pulmonary artery (PA) pressure-guided therapy. The prospective, dual-arm trial aims to expand access to New …
  • Therapeutics

Shorla Oncology Secures $35M Series B Funding Round to Advance its Oncology Product Portfolio

Seroba’s portfolio company, Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, today announced that it has raised $35 million in Series B funding, led by Kurma Partners’ Growth Opportunities Fund, with participation from existing investors Seroba Life Sciences and Irish, U.S. and Canadian based family offices and Enterprise Ireland. The funding will enable Shorla to accelerate the growth of its …
  • Medtech

New expanded indication will increase home hemodialysis device options available to patients with end-stage kidney disease

Seroba’s portfolio company, Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for indication expansion of the Quanta™ Dialysis System, a compact and easy-to-use hemodialysis device. The Quanta Dialysis System is currently indicated for use in chronic …
  • Medtech

Quanta™ Receives FDA 510(k) Clearance for Expanded Indication of Continuous Renal Replacement Therapies

Quanta Dialysis System becomes first-in-class to perform three standard-of-care dialysis modalities in one device. Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of …
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