BioSpace News Archive

Drug Development

Pfizer, Moderna Target Emerging Variants with Updated COVID-19 Shots

The companies contend that their updated COVID-19 vaccines for the fall vaccination season can elicit strong immune responses against the virus’ currently dominant and emerging subvariants.

August 18, 2023
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2 min read
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Tristan Manalac
Business

Kodiak CMO Steps Down After Phase III Flops for Eye Therapy

After the company’s investigational eye therapy recently failed two late-stage studies, Kodiak Sciences’ Chief Medical Officer and Chief Development Officer Jason Ehrlich has resigned from his roles.

August 18, 2023
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2 min read
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Tristan Manalac
Drug Development

Genethon’s Gene Therapy for Rare Liver Disease Shows Promising Early-Stage Results

In a European Phase I/II clinical trial, the experimental drug for treating Crigler-Najjar syndrome reduced bilirubin below toxic threshold in the liver with a single intravenous injection.

August 18, 2023
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2 min read
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Connor Lynch
Drug Development

Merck’s Welireg Clears Phase III Primary Endpoint in Renal Cell Carcinoma

The company is continuing its renal cell carcinoma push for its oral HIF-2α inhibitor Welireg with promising Phase III data showing significant progression-free survival improvements in patients.

August 18, 2023
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2 min read
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Tristan Manalac
Drug Development

Week in Review: Obesity Drug Race, Ipsen Therapy Finally Gets Approval and More

Boehringer Ingelheim will launch three Phase III studies for its obesity drug candidate; third time is a charm for Ipsen as it gets FDA approval; and Pfizer takes multiple myeloma battle to J&J.

August 18, 2023
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2 min read
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Greg Slabodkin
FDA

Regeneron’s Antibody Gets FDA Approval for Ultra-Rare Hereditary Disease

The regulator’s greenlight on Friday for Regeneron Pharmaceuticals’ monoclonal antibody Veopoz (pozelimab) makes it the first and only treatment indicated for children and adults with CHAPLE disease.

August 18, 2023
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2 min read
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Connor Lynch
Business

Medivir AB - Interim Report January - June 2023

Continued strong momentum and promising signs of patient benefit in the combination study with fostrox and Lenvima®.

August 18, 2023
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5 min read
Policy

FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy

Calliditas Therapeutics AB, announced that the U.S. Food and Drug Administration has accepted the submission for the supplemental New Drug Application for TARPEYO® delayed release capsules and granted Priority Review.

August 18, 2023
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11 min read
Business

United Imaging Healthcare delivers its 2023 Half-Year report, with revenue growth of 26.35% in the first half of 2023

United Imaging Healthcare, a global innovator in cutting-edge medical imaging and radiotherapy equipment, has unveiled its highly anticipated 2023 half-year report, revealing robust growth.

August 18, 2023
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2 min read
Drug Development

Merck Announces WELIREG® (belzutifan) Phase 3 LITESPARK-005 Trial Met Primary Endpoint of Progression-Free Survival in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma

Merck, known as MSD outside of the United States and Canada, announced topline results from LITESPARK-005, the first positive Phase 3 trial investigating WELIREG, Merck’s oral hypoxia-inducible factor-2 alpha inhibitor.

August 18, 2023
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12 min read