BioSpace News Archive

FDA

Ardelyx Nabs FDA Approval for First Phosphate Absorption Blocker in CKD

The company’s resubmission succeeded in getting the greenlight for tenapanor, now to be marketed as Xphozah, to lower serum phosphorus levels in chronic kidney disease patients.

October 18, 2023
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2 min read
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Tristan Manalac
FDA

FDA Approves UCB’s Complement Inhibitor for Generalized Myasthenia Gravis

The complement inhibitor won the FDA’s approval for the treatment of generalized myasthenia gravis, a rare autoimmune disease. The therapy will be sold under the brand name Zilbrysq.

October 18, 2023
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2 min read
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Tristan Manalac
Drug Development

ESMO Abstract Leak Reveals Promising NSCLC Therapies from BMS, BeiGene, J&J, Mirati

The abstracts, made available Tuesday ahead of the European Society for Medical Oncology Congress 2023, show strong efficacy data from some promising non-small cell lung cancer treatments.

October 18, 2023
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4 min read
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Tristan Manalac
Career Advice

Opinion: When Is it Time to Start Looking for Another Role?

My colleagues and I have often been asked, “When is it time to start looking for another role?” This three-level rubric can help.

October 18, 2023
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3 min read
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Bob Broady
Drug Development

Biotech Accelerator Debuts in Houston

The new Rice Biotech Launch Pad aims to harness local resources to grease the skids of innovation, from the lab to the clinic.

October 18, 2023
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3 min read
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Charlotte LoBuono
Drug Development

Opinion: The Potential of Neurofilament Light Chain as a Biomarker in Parkinson’s Disease

While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.

October 18, 2023
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5 min read
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Joanne Taylor
Drug Development

Ultimovacs Rebounds on New Universal Cancer Vaccine Data for Mesothelioma

After failing its primary endpoint of progression-free survival, new data shows UV1 plus Bristol Myers Squibb’s Opdivo and Yervoy reduces risk of death by 27% over the checkpoint inhibitors alone.

October 18, 2023
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2 min read
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Kate Goodwin
Drug Development

Achieving Data Diversity Through AI in Drug Development

AI and machine learning could transform drug discovery, but first, practitioners must overcome ethical challenges en route to medicines for all.

October 18, 2023
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6 min read
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Jill Neimark
Biotech Bay

Genentech’s Alecensa Reduces the Risk of Disease Recurrence or Death by an Unprecedented 76% in People With ALK-Positive Early-Stage Non-Small Cell Lung Cancer

Genentech, a member of the Roche Group, announced results from the primary analysis of the Phase III ALINA study demonstrating a statistically significant and clinically meaningful improvement in disease-free survival.

October 18, 2023
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10 min read
Drug Development

Ivy Brain Tumor Center Announces Results of Phase 0/1 Study in Recurrent Glioblastoma Patients at the European Society for Medical Oncology (ESMO) 2023 Congress

The Ivy Brain Tumor Center at Barrow Neurological Institute announced initial results from a Phase 0/1 clinical trial of the Ataxia telangiectasia mutated kinase inhibitor AZD1390 in recurrent glioblastoma in combination with radiation therapy.

October 18, 2023
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3 min read