News
September 30, 2024
Pi-Cardia Receives FDA Market Clearance for ShortCut™
First dedicated leaflet modification device to enable TAVR in patients at risk of coronary obstruction
Pi-Cardia Ltd., a global leader in the development of leaflet modification solutions for treating heart valves, announced today that the United States Food and Drug Administration (FDA) provided market clearance for ShortCut™ - the world's first dedicated leaflet modification device, enabling valve-in-valve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.
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July 23, 2024
Magenta Medical Closes $105M Financing Led by Novo Holdings
Funding will support Magenta’s clinical programs in support of FDA approval for Elevate, the world’s smallest heart pump
Magenta Medical, developer of Elevate™, the world's smallest heart pump, has closed a $105M financing round led by global healthcare investment firm Novo Holdings. New investors Viking Global Investors and RA Capital Management, and existing investors OrbiMed, New Enterprise Associates (NEA), JVC Investment Partners, and ALIVE - Israel HealthTech Fund, also participated in this round.
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January 22, 2024
Pi-Cardia Receives FDA Breakthrough Device Designation for ShortCut™
First dedicated leaflet modification device to enable TAVR in patients at risk of coronary obstruction
Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today it received Breakthrough Device Designation from the US Food and Drug Administration for ShortCut™ - the world's first dedicated leaflet modification device facilitating valve-invalve Transcatheter Aortic Valve Replacement (TAVR) procedures in patients at risk of coronary obstruction.
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October 26, 2023
Magenta Medical Reports Positive Results for US Early Feasibility Study of Elevate™ Heart Pump in Providing Temporary Mechanical Circulatory Support During High-Risk PCI Procedures
The US Early Feasibility Study of Magenta Medical's Elevate™ System, designed to provide temporary mechanical circulatory support during high-risk percutaneous coronary intervention (HR-PCI) procedures, has successfully met its objectives. Elevate™ is the smallest and most powerful percutaneous Left Ventricular Assist Device (pLVAD) in the world.
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September 30, 2023
Pi-Cardia Successfully Completes Enrollment in Pivotal Study for ShortCut™
Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based, leaflet modification solutions for treating heart valves, announced today the successful completion of its ShortCut™ Pivotal Study enrollment. ShortCut™ is the world's first dedicated device designed to split the leaflets of pre-existing valves to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk of coronary obstruction.
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August 23, 2023
Trisol announces successful implants of its Transcatheter Tricuspid Valve in the US
The heart teams at the Piedmont Heart Institute in Atlanta, Georgia, USA and the University of Virginia Health System in Charlottesville, VA, USA, successfully performed the first two implantations in the US of the Trisol Transcatheter Tricuspid Valve Replacement as part of a U.S. Food and Drug Administration approved Early Feasibility Study (EFS), led by Principal Investigator Isaac George, MD.
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May 03, 2023
Magenta Medical Closes $55M Funding Round Led by OrbiMed
Magenta Medical, developer of the world's smallest heart pump, announced today a $55M financing round led by global healthcare investment manager OrbiMed, with participation from existing investors New Enterprise Associates (NEA), Pitango VC, and ALIVE - Israel HealthTech Fund. The financing will be used, among other things, to advance the clinical programs of the company's product in the United States towards its first FDA approval.
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December 9, 2022
Arcellx and Kite Announce Strategic Collaboration to Co-Develop and Co-Commercialize Late-Stage Clinical CART-ddBCMA in Multiple Myeloma
Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced a global strategic collaboration to co-develop and co-commercialize Arcellx’s lead late-stage product candidate, CART-ddBCMA, for the treatment of patients with relapsed or refractory multiple myeloma. Multiple myeloma is an incurable disease for most patients and the need remains for effective, safe, and broadly accessible therapies.
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November 30, 2022
Ferring Receives U.S. FDA Approval for REBYOTA™ (fecal microbiota, live-jslm) – A Novel First-in-Class Microbiota-Based Live Biotherapeutic
Ferring Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approved REBYOTA™ (fecal microbiota, live-jslm), a novel first-in-class microbiota-based live biotherapeutic indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
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November 23, 2022
NewAmsterdam Pharma Debuts as Publicly Traded Company Focused on Developing Obicetrapib, a Low-Dose, Once-Daily Oral LDL-Lowering Agent with Promising Safety and Efficacy Clinical Data, as a Potential Preferred Therapy for High Risk Cardiovascular Disease Patients
NewAmsterdam Pharma Company N.V. (Nasdaq:NAMS or “NewAmsterdam” or the “Company”), a clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, today announced the closing of its business combination with Frazier Lifesciences Acquisition Corporation (Nasdaq:FLAC), a special purpose acquisition company sponsored by an affiliate of Frazier Healthcare Partners.
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September 2, 2022
Aker BioMarine enters Lysoveta agreement with Trofi Nutritionals
Aker BioMarine has signed a commercial agreement to develop several medical foods products based on the existing Lysoveta, with Trofi Nutritionals.
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July 26, 2022
Pi-Cardia Receives FDA IDE Approval for Pivotal Study with ShortCut(TM) Device
Pi-Cardia Ltd., a global leader in the development of non-implant, catheter-based solutions for treating heart valves, announced today it received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to commence the ShortCut™ Pivotal Study, which will assess the safety and effectiveness of the ShortCut™ device.
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July 25, 2022
NewAmsterdam Pharma Holding B.V. and Frazier Lifesciences Acquisition Corporation Announce Merger Agreement to Create Publicly Listed Company Focused on Transformative Oral Therapies for Major Cardiometabolic Diseases
NewAmsterdam Pharma Holding B.V. (“Company”), a late clinical-stage company focused on the research and development of transformative oral therapies for major cardiometabolic diseases, and Frazier Lifesciences Acquisition Corporation (“FLAC”), a special purpose acquisition company sponsored by an affiliate of Frazier Healthcare Partners...
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February 8, 2021
Arcellx Announces Closing Of Initial Public Offering And Exercise In Full Of The Underwriters’ Option To Purchase Additional Shares
Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced the closing of its initial public offering of 9,487,500 shares of its common stock...
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December 20, 2021
Pi-Cardia ShortCut™ Device Successfully Treats First Patients in Europe
First Dedicated Device to Enable Coronary Access and Prevent Coronary Obstruction During TAVR.
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April 3, 2021
Arcellx Closes $115 Million Series C Financing to Advance its Pipeline of Adaptive and Controllable Cell Therapies
Arcellx, a privately held clinical-stage biopharmaceutical company, today announced that it raised $115 million in a Series C financing to advance its pipeline of adaptive and controllable cell therapies. The proceeds will support the company’s development of CART-ddBCMA, a BCMA-specific CAR-modified T-cell therapy currently in Phase 1 and anticipated to begin a pivotal trial in 2022.
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January 14, 2021
NewAmsterdam Pharma Completes $196M (€160M) Series A Funding for Comprehensive Phase 3 Development Program
Naarden, the Netherlands, January 14, 2021 – NewAmsterdam Pharma (NAP), a clinical stage company focused on the research and development of transformative therapies for cardio-metabolic diseases, today announced completion of a $196M (€160M) Series A funding round.
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August 18, 2020
ImmPACT Bio USA Inc. Raises $18 Million In Series A Financing
ImmPACT Bio USA, Inc., a company founded in the FutuRx incubator located in Ness Ziona, Israel, developing novel cell therapies for treating cancer, today announced the closing of a US$ 18 million equity financing round. The financing included OrbiMed, Johnson & Johnson Innovation – JJDC, Inc., Takeda Ventures, Inc., RM Global Partners (RMGP) BioPharma Investment Fund, Novartis Venture Fund, Bukwang Pharmaceutical, Hayan Health Networks, Inc., and JVC Investment Partners.
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May 18, 2020
UChicago Medicine gets $10 Million for Cancer Research
The gift from longtime health care executive David Jonas aims to improve emerging treatments that use the body's own immune system to fight the disease.
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April 20, 2020
Pi-Cardia Closes a $27 Million Financing led by Sofinnova Partners
Pi-Cardia Ltd., a global leader in the development of non-implant catheter-based solutions for treating heart valve calcification, announced today it has closed a $27 million round of financing, led by Sofinnova Partners, a leading European life sciences venture capital firm, and joined by Professor Jacques Séguin, Chairman of the company, with further participation from existing investors.
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October 3, 2019
Arcellx Raises $85 Million in a Series B Financing to Advance its Intelligent Cell Therapy Program
Arcellx, a privately-held biopharmaceutical company, today announced that it has raised $85 million in an oversubscribed Series B financing. Proceeds will be used to advance the Company’s ARC-T + sparX programs, including clinical development of a bivalent BCMA-targeted cell therapy in multiple myeloma, and a CD123-targeted therapy in acute myeloid leukemia.
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July 29, 2019
Magenta Medical Closes Funding Round Led by NEA In Its First-Ever Life Sciences Investment in Israel
Magenta Medical, the developer of heart failure solutions based on proprietary miniaturized blood pump technology, today announced a financing round led by global venture capital firm New Enterprise Associates (NEA), with participation from existing investors, including Pitango Venture Capital, JVC Investment Partners and a group of private investors led by Prof. Jacques Seguin (CoreValve, ReCor).
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April 13, 2018
Novartis-AveXis Deal Could Be Game-Changer for Chicago
Chicago scored a major win April 9, but it barely registered with most local business leaders. The triumph was Novartis' eye-popping $8.7 billion buyout of a largely unknown startup called AveXis. It was far and away the biggest acquisition yet of a Chicago-area biotech company, more than three times the size of the next largest deal—the 2015 sale of Lake Forest-based PharMEDium to AmerisourceBergen for $2.58 billion.
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April 5, 2018
Ferring Acquires Innovative Biotechnology Company and Microbiome Pioneer Rebiotix Inc.
Chicago scored a major win April 9, but it barely registered with most local business leaders. The triumph was Novartis' eye-popping $8.7 billion buyout of a largely unknown startup called AveXis. It was far and away the biggest acquisition yet of a Chicago-area biotech company, more than three times the size of the next largest deal—the 2015 sale of Lake Forest-based PharMEDium to AmerisourceBergen for $2.58 billion.
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November 21, 2015
AmerisourceBergen to Buy PharMEDium for $2.58 Billion
David Jonas doesn't like to sit idle. He plays tennis, not golf. He's an early riser, often starting his day with a run of 4 to 5 miles on an empty stomach. When he retired from Baxter International after 25 years, he started a new company. It just sold for $2.58 billion.
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PharMEDium - LEK Consulting
L.E.K.’s CEO Stuart Jackson, discusses PharMEDium's extraordinary growth trajectory.
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