BioSpace News Archive

Drug Development

Black Diamond Therapeutics Announces First Patients Dosed in Phase 1 Clinical Trial Expansion Cohorts Evaluating BDTX-1535 in Patients with Intrinsic Driver and Acquired Resistance EGFR Mutation Positive Non-Small Cell Lung Cancer

Black Diamond Therapeutics, Inc. today announced the first patients dosed in mutation matched expansion cohorts of non-small cell lung cancer in the ongoing Phase 1 clinical study evaluating BDTX-1535.

September 11, 2023

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6 min read

Bio NC

Results From Mayo Clinic Clinical Study of Humacyte’s Human Acellular Vessel™ (HAV™) in Treatment of Patients with Chronic Limb Ischemia Presented at Midwestern Vascular Conference

Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced the presentation of results from a Food and Drug Administration -regulated, investigator-sponsored clinical study conducted at the Mayo Clinic.

September 11, 2023

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7 min read

MediWound’s NexoBrid® Highlighted in 20 Oral and Poster Presentations at the 20th European Burns Association Congress

MediWound Ltd. announced its successful participation at the recently concluded 20th European Burns Association Congress held in Nantes, France on September 6-9, 2023.

September 11, 2023

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7 min read

Genetown

Ardelyx Showcased Encouraging Data on Treatment Satisfaction and Efficacy of IBSRELA® (tenapanor) for IBS-C at GHAPP 2023

Ardelyx, Inc. shared encouraging data on IBSRELA ® (tenapanor) via two poster presentations presented at the 2023 Gastroenterology & Hepatology Advanced Practice Providers (GHAPP) Annual Conference currently being held in National Harbor, Maryland September 7-9.

September 11, 2023

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7 min read

Pharm Country

A Retrospective Comparative Study of Chemosat and SIRT Presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting

Delcath Systems, Inc. (Nasdaq: DCTH) today announced the details of an oral presentation by independent investigators on September 9, 2023 at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) Annual Meeting held in Copenhagen, Denmark.

September 11, 2023

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7 min read

FDA

Limaca Medical Receives FDA 510(k) Clearance for its Breakthrough Precision GI™ Endoscopic Biopsy Device

Limaca Medical (“Limaca”) announced today that its Precision GI™ Endoscopic Ultrasound (EUS) Biopsy Device received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”). This follows Limaca’s receipt of FDA Breakthrough Device Designation for its Precision GI™.

September 11, 2023

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2 min read

FDA

OnPoint Surgical Receives 510(k) Clearance for the OnPoint Augmented Reality Spine System

OnPoint Surgical, Inc. today announced that the US Food and Drug Administration (FDA) has given clearance for the use of its OnPoint Augmented Reality Spine System.

September 11, 2023

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3 min read

Business

DermTech Appoints Mark Aguillard as Chief Commercial Officer

DermTech, Inc., a leader in precision dermatology enabled by a non-invasive skin genomics technology, announced the appointment of Mark Aguillard as chief commercial officer effective September 19, 2023.

September 11, 2023

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5 min read

Biotech Beach

Lassen Therapeutics Presents New Data on LASN01 for the Treatment of Idiopathic Pulmonary Fibrosis and Thyroid Eye Disease at the European Respiratory Society (ERS) and European Thyroid Association (ETA) Annual Meetings

Lassen Therapeutics today announced new clinical and preclinical data generated with LASN01 at the 2023 European Respiratory Society (ERS) International Congress and the 45th Annual Meeting of the European Thyroid Association (ETA).

September 11, 2023

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3 min read

Deals

Bausch Health’s Bausch + Lomb Announces Launch of Proposed Financing for Acquisition of XIIDRA(R)

Bausch + Lomb Corporation announced today that, in connection with the financing of its pending acquisition of XIIDRA and certain other ophthalmology assets, Bausch + Lomb Escrow Corp. launched an offering of $1.4 billion aggregate principal amount of new senior secured notes due 2028.

September 11, 2023

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5 min read