BioSpace News Archive

FDA

Celltrion Wins FDA Approval for First Subcutaneous Version of IBD Drug Infliximab

The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.

October 24, 2023
·
2 min read
·
Tristan Manalac
Policy

Belgium Eyes Short-Term Ban on Novo’s Ozempic for Weight Loss Amid Shortage

The country is considering restricting the use of Novo Nordisk’s Ozempic to just type 2 diabetes and prohibiting its prescription for weight loss as the company struggles with continued supply constraints.

October 24, 2023
·
2 min read
·
Tristan Manalac
Policy

How Companies Can Emerge from Stealth with Their Secrets Intact

The moment of coming out of stealth mode is ripe for biotechs to stumble. Here’s how to get it right.

October 24, 2023
·
5 min read
·
Karen Fischer
Drug Development

AstraZeneca, Daiichi Address Safety Concerns for DXd ADC at ESMO

The companies presented data from two pivotal studies of Dato-DXd, focusing on safety concerns and survival data for the investigational antibody-drug conjugate candidate in lung and breast cancer.

October 24, 2023
·
2 min read
·
Tristan Manalac
Business

Novartis Beats Earnings Estimate in Q3, Raises Full-Year Guidance

The Swiss pharma reported a 12% sales increase and 21% core operating growth for the third quarter on Tuesday, while raising its full-year earnings forecast for the third time.

October 24, 2023
·
2 min read
·
Kate Goodwin
Drug Development

Verve Gets FDA Go-Ahead for First In-Human Base Editing Study in US

The regulator lifted a clinical hold on Verve Therapeutics’ CRISPR-based therapy clearing its Investigational New Drug application and plans to evaluate VERVE-101 in a Phase I heterozygous familial hypercholesterolemia trial.

October 24, 2023
·
2 min read
·
Matt Olszewski
FDA

Medicine’s Hot New Modality, mRNA, Faces Unclear Regulatory Landscape

Even after the runaway success of mRNA vaccines against COVID-19, the pathway to approval for upcoming would-be mRNA therapeutics has yet to be laid out.

October 24, 2023
·
5 min read
·
Kate Goodwin
Drug Development

Novartis Builds Case for Earlier Prostate Cancer Treatment with Phase III Data

Pluvicto improved radiographic progression-free survival in PSMA-positive patients with metastatic castration-resistant prostate cancer who had not been treated with taxane-based chemotherapy.

October 24, 2023
·
3 min read
·
Tristan Manalac
Policy

Syndax to Initiate NDA Submission of Revumenib in Relapsed/Refractory KMT2Ar Acute Leukemia Under FDA’s Real-Time Oncology Review Program

Syndax Pharmaceuticals announced that the Company will submit a New Drug Application for revumenib in relapsed or refractory KMT2Ar acute leukemia, including acute myeloid leukemia and acute lymphoid leukemia, under the U.S. Food and Drug Administration Real-Time Oncology Review program.

October 24, 2023
·
10 min read
Genetown

CervoMed Announces Publications in Major Peer-Reviewed Journals That Inform on Potential of Neflamapimod as a Disease-Modifying Therapy for the Major Dementias

CervoMed Inc., a clinical stage company focused on developing treatments for degenerative diseases of the brain, announced the publication of the following two articles that support advancing neflamapimod as a disease-modifying treatment for Dementia with Lewy Bodies and Alzheimer’s Disease :

October 24, 2023
·
6 min read