Tag Archives: type-industry &amp; policy

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Organogenesis Enrolls First Patient in Pivotal Phase III Clinical Trial of RMAT-Designated ReNu^® for Knee Osteoarthritis

Organogenesis Holdings Inc. announced that the first patient has been enrolled in its pivotal Phase III clinical trial evaluating the safety and efficacy of ReNu^®, a cryopreserved amniotic suspension allograft, for the management of symptoms associated with knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and ECM components.

[Organogenesis, Inc.]

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Histogen Reports FDA Clinical Hold for Planned Phase I/II Trial of HST-003 for Knee Cartilage Regeneration

Histogen Inc. announced that the US FDA has verbally notified the company that it has additional questions about the company’s Investigational New Drug application package for the planned Phase I/II clinical trial of HST-003, which is intended to evaluate the safety and efficacy of human ECM implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure.

[Histogen, Inc.]

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FDA Grants Priority Review to Genentech’s Esbriet (Pirfenidone) for Unclassifiable Interstitial Lung Disease

Genentech announced that the FDA has accepted the company’s supplemental New Drug Application and granted Priority Review for Esbriet^® for the treatment of unclassifiable interstitial lung disease.

[Genentech]

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Lixte Biotechnology and City of Hope to Initiate Phase Ib Clinical Trial of Lixte’s Lead Compound LB-100 to Treat Small Cell Lung Cancer

Lixte Biotechnology Holdings, Inc. announced an agreement on a Phase Ib clinical trial with City of Hope, a world-renowned independent cancer research and treatment center. The trial will assess the combination of Lixte’s first-in-class protein phosphatase inhibitor LB-100 with a standard regimen for untreated, extensive stage-disease small cell lung cancer.

[Lixte Biotechnology Holdings, Inc. (GlobeNewswire, Inc.)]

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CairnSurgical Announces First Patient Treated in Pivotal Clinical Trial of Breast Cancer Locator System

Cairnsurgical, Inc. announced that the first patient has been treated in its US pivotal trial of the Breast Cancer Locator System at Massachusetts General Hospital.

[Cairnsurgical, Inc. (Business Wire, Inc.)]

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EMBO Installation Grants Support Eight Early-Career Scientists to Establish Independent Laboratories

EMBO has announced the award of Installation Grants to eight scientists in the early stages of setting up their independent laboratories in Lithuania, Poland, Portugal and Turkey.

[EMBO]

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ENHERTU^® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer

Daiichi Sankyo Company, Ltd. and AstraZeneca’s ENHERTU^® has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.

[Daiichi Sankyo Company, Ltd.]

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Phathom Pharmaceuticals Announces Completion of Patient Enrollment in Pivotal Phase III Helicobacter pylori (H. pylori) Trial

Phathom Pharmaceuticals, Inc. announced that it has completed patient enrollment in PHALCON-HP, a pivotal Phase III clinical trial of vonoprazan in combination with amoxicillin and vonoprazan in combination with amoxicillin and clarithromycin for the eradication of H. pylori infection.

[Phathom Pharmaceuticals, Inc. (Globe Newswire, Inc.)]

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Precision BioSciences Announces FDA Accepts IND for PBCAR19B, a Next-Generation, Stealth Cell, CD19 Allogeneic CAR T Candidate for Non-Hodgkin Lymphoma

Precision BioSciences, Inc. announced that the FDA has accepted the Investigational New Drug application for PBCAR19B, a next-generation, stealth cell, CD19 product candidate for patients with relapsed/refractory Non-Hodgkin Lymphoma.

[Precision BioSciences, Inc. (Globe Newswire, Inc.)]

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Bone Therapeutics and Rigenerand Sign Partnership For Cell Therapy Process Development

Bone Therapeutics and Rigenerand SRL, the biotech company that both develops and manufactures medicinal products for cell therapy applications, primarily for regenerative medicine and oncology, announced the signing of a first agreement for a process development partnership.

[Bone Therapeutics]