BioSpace News Archive

Pharm Country

Largest Integrated Safety Analysis From Five Prospective Clinical Trials for REBYOTA® (fecal microbiota, live – jslm) Published in Therapeutic Advances in Gastroenterology

Ferring Pharmaceuticals today announced that Therapeutic Advances in Gastroenterology has published an integrated safety analysis from five prospective clinical trials for REBYOTA® (fecal microbiota, live – jslm), the first and only single-dose, FDA approved microbiome-based treatment to prevent recurrent C. diff infection after antibiotic treatment.

July 11, 2023
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8 min read
Business

Incyte to Report Second Quarter Financial Results - July 11, 2023

Incyte (Nasdaq:INCY) announced today that it has scheduled its second quarter financial results conference call and webcast for 8:00 a.m. ET on Tuesday, August 1, 2023.

July 11, 2023
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1 min read
Drug Development

Purple Biotech Reports Positive Results of CM24 Dose Escalation in Advanced Pancreatic Cancer Patients

Purple Biotech Ltd. today announced the completion and data maturity of its Phase 1 dose escalation study of CM24, a first-in-class anti-CEACAM1 monoclonal antibody addressing multiple tumor types.

July 11, 2023
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8 min read
Deals

MEI Pharma Provides Final Reminder to Shareholders to Vote Today FOR the Merger With Infinity Pharmaceuticals

MEI Pharma, Inc. (NASDAQ: MEIP) (the “Company”) today reminded shareholders to vote FOR the Company’s pending transaction with Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) (“Infinity”) in connection with the upcoming special meeting on July 14, 2023.

July 11, 2023
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11 min read
FDA

AccurKardia’s AccurECG™ Analysis System Receives FDA 510(k) Clearance

AccurKardia announced today that its flagship product, the AccurECG™ Analysis System (“AccurECG” or the “System”), has been granted FDA 510(k) clearance.

July 11, 2023
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3 min read
BioMidwest

Fresenius Kabi Introduces New Presentation for Fentanyl Citrate Injection, USP in Simplist® Ready-to-Administer Prefilled Syringes

Fresenius Kabi Introduces New Presentation for Fentanyl Citrate Injection, USP in Simplist ® Ready-to-Administer Prefilled Syringes.

July 11, 2023
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7 min read
First U.S. Patients Implanted with Innovative FIRE1 Remote Heart Failure Monitoring System in Early Feasibility Study

FIRE1 today announced that the first U.S. patients have been successfully implanted with its FIRE1™ System for remote heart failure monitoring in an Early Feasibility Study.

July 11, 2023
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3 min read
BioCapital

Adial Provides Business Update Following Favorable Comments from US and EU Regulatory Meetings

Adial Pharmaceuticals, Inc. as well as an update on the Company’s current clinical development plan based on guidance received.

July 11, 2023
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11 min read
Drug Development

Vaxcyte Advances to Second Stage of Ongoing Phase 2 Study Evaluating VAX-24 for the Prevention of Invasive Pneumococcal Disease in Infants

Vaxcyte, Inc. today announced that the ongoing Phase 2 study of VAX-24 in healthy infants is advancing to the second and final stage of the study. The independent Data Safety Monitoring Board approved advancing to the second stage of the study following the review of the safety and tolerability results from the first stage.

July 11, 2023
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9 min read
Drug Development

Salarius Pharmaceuticals Receives FDA Clearance of SP-3164 Investigational New Drug Application to Begin a Phase 1 Clinical Trial in Relapsed/Refractory Non-Hodgkin Lymphoma Patients

Salarius Pharmaceuticals, Inc. announces U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug (IND) application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma (NHL).

July 11, 2023
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7 min read