News

In a significant move, CoreRx, Societal CDMO, and Bend Bioscience have announced their unification under the Bend Bioscience brand. This merger brings together three highly respected organizations, each with a unique legacy and distinct strengths, to form a comprehensive contract development and manufacturing organization (CDMO) that offers an end-to-end suite of services.

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.

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.

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.

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.

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.

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.

Aker BioMarine has signed a commercial agreement to develop several medical foods products based on the existing Lysoveta, with Trofi Nutritionals.

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.

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...

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...

First Dedicated Device to Enable Coronary Access and Prevent Coronary Obstruction During TAVR.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

L.E.K.’s CEO Stuart Jackson, discusses PharMEDium's extraordinary growth trajectory.