BioSpace News Archive

Drug Development

REGENXBIO Announces Dose Escalation in AFFINITY DUCHENNE® Trial

REGENXBIO Inc. today announced that the first patient received RGX-202 at dose level 2 in the Phase I/II AFFINITY DUCHENNE® trial.

November 29, 2023
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7 min read
Business

Gossamer Bio Announces Appointment of John Quisel, J.D., Ph.D., to its Board of Directors

Gossamer Bio, Inc. today announced the appointment of John Quisel, J.D., Ph.D., President and CEO of Disc Medicine, to its Board of Directors.

November 29, 2023
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2 min read
Pharm Country

KORU Medical Systems to Participate in Piper Sandler’s 35th Annual Healthcare Conference

KORU Medical Systems today announced that the Company will participate in Piper Sandler’s 35th Annual Healthcare Conference on November 29, 2023.

November 29, 2023
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1 min read
Lone Star Bio

Orthofix Announces Publication in The Spine Journal of Five-Year Data for the M6-C Artificial Cervical Disc

Orthofix Medical Inc today announced the publication of the five-year results from the U.S. clinical study comparing the M6-C ™ artificial cervical disc with anterior cervical discectomy and fusion (ACDF).

November 29, 2023
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6 min read
Genetown

Deciphera Pharmaceuticals to Present at the JMP Securities Hematology and Oncology Summit

Deciphera Pharmaceuticals, Inc. today announced that members of the management team will participate in a virtual fireside chat at the JMP Securities Hematology and Oncology Summit on Wednesday, December 6, 2023 at 1:30 PM ET.

November 29, 2023
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1 min read
FDA

Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea

Vivos Therapeutics, Inc. today announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for treating severe obstructive sleep apnea (OSA) in adults using the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances.

November 29, 2023
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7 min read
Business

FluoGuide A/S Publishes Interim Report for the Period January - September 2023

FluoGuide A/S releases its results for the period 1 January - 30 September 2023.

November 29, 2023
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3 min read
Deals

Promore Pharma AB intends to carry out a reverse acquisition of PMD Device Solutions AB

Promore Pharma AB intends to acquire all the shares in PMD Device Solutions AB by making payment in the form of newly issued shares in the Company.

November 29, 2023
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12 min read
Drug Development

Valo Therapeutics Announces Regulatory Approval to Expand Phase I Immuno-oncology Trial into Sarcoma

Valo Therapeutics Oy, the developer of novel, adaptable immunotherapies for cancer, announces it has received approval from Germany’s PEI to extend the tumor types to be treated in the company’s current Phase I trial into two subtypes of sarcoma.

November 29, 2023
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3 min read
Drug Development

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

BiomX Inc. today announced positive safety and efficacy results from Part 2 of the Phase 1b/2a trial evaluating the Company’s novel phage cocktail, BX004, for the treatment of chronic pulmonary infections caused by Pseudomonas aeruginosa (or P. aeruginosa) in patients with cystic fibrosis (“CF”).

November 29, 2023
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10 min read