BioSpace News Archive

FDA

Augmenting the Regulatory Worker: Are We Making Them Better or Worse?

A Discussion with IQVIA’s Michelle Gyzen Sr. Director, Regulatory Affairs and Drug Development Solutions

October 23, 2023
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5 min read
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Lori Ellis
FDA

FDA Approves BioMarin’s Voxzogo for Young Children with Dwarfism

The label for the achondroplasia drug, which promotes endochondral bone growth, now covers children under five years of age with the rare genetic disease causing the most common form of dwarfism.

October 23, 2023
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2 min read
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Tristan Manalac
Drug Development

Novel Immune Modulator Has Potential to Change Treatment Approach in Rheumatoid Arthritis and Ulcerative Colitis

A first-in-class clinical trial will initiate this quarter to determine if a checkpoint agonist can down-regulate activated T cells to help reduce inflammation and tissue damage in patients with moderate-to-severe ulcerative colitis (UC).

October 23, 2023
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4 min read
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AnaptysBio
Business

JLABS @ NYC Celebrates Its 5th Year in the Big Apple

Uniting thought leaders across the life sciences landscape, JLABS @ NYC rejoices in five years of catalyzing startups.

October 23, 2023
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3 min read
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BioSpace Insights
Drug Development

Merck, BMS Score Separate Late-Stage Victories in Bladder Cancer at ESMO

The competitors posted promising survival data for their respective blockbuster PD-1 inhibitors—Keytruda and Opdivo—emphasizing the potential of these therapies in bladder cancer patients.

October 23, 2023
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3 min read
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Tristan Manalac
Deals

Roche Pays $7.1B to Roivant for Rights to Telavant’s IBD Candidate

The Swiss drugmaker gains rights to RVT-3101 in the U.S. and Japan. Telavant was formed in late 2022 by Roivant and Pfizer, which had a 25% stake in the venture and retains rights to the antibody in other countries.

October 23, 2023
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2 min read
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Tristan Manalac
New Data on BerGenBio’s Selective AXL Inhibitor Bemcentinib Released Today at 2023 ESMO Meeting

BerGenBio ASA announced that the full results of its Phase 2 BGBC008 study of bemcentinib and pembrolizumab in second line Non-Small Cell Lung Cancer were presented during the European Society of Clinical Oncologists Annual Meeting 2023.

October 23, 2023
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3 min read
Drug Development

NANOBIOTIX Announces Updated Preliminary Results From Phase 1 Pancreatic Cancer Trial and New Exploratory Analysis From Completed Phase 1 Head and Neck Cancer Trial at ESMO 2023

NANOBIOTIX announced updated data from two presentations at the 2023 Annual Congress of the European Society for Medical Oncology.

October 23, 2023
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11 min read
Drug Development

Hummingbird Bioscience Announces Positive Phase I Clinical Data for HMBD-001 Monotherapy Trial at the European Society for Medical Oncology Congress 2023

Hummingbird Bioscience announced presentation of positive clinical data for the dose escalation part of the HMBD-001 Phase I/IIa trial at the European Society for Medical Oncology Congress 2023.

October 23, 2023
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6 min read
Drug Development

Ryvu Therapeutics Provides an Update on the Progress of RVU120 Phase I Studies in Patients with Solid Tumors and AML/HR-MDS, and Presents the Updated Development Plan for RVU120

Ryvu Therapeutics announced updated clinical Phase I data from RVU120 Phase I/II study in patients with relapsed/refractory metastatic or advanced solid tumors, presented at the European Society for Medical Oncology Congress 2023, taking place October 20-24 in Madrid, Spain.

October 23, 2023
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8 min read