Helixgate

Helixgate

Uncategorized

FDA, Moderna appear aligned on mRNA flu shot heading into adcomm

Published

on

The Vaccines and Related Biological Products Advisory Committee will meet June 18 to discuss Moderna’s seasonal flu vaccine mRNA-1010 after the FDA initially refused to accept the application in February.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Uncategorized

Edgewise slides as cardiomyopathy challenger to BMS, Cytokinetics falls short

Edgewise slides as cardiomyopathy challenger to BMS, Cytokinetics falls short

Published

on

Although Edgewise Therapeutics’ hypertrophic cardiomyopathy asset missed expectations, Truist Securities called the data “excellent,” leaning on a safety profile that could eliminate the need for risk evaluation and mitigation strategies.​ ​Read More

Continue Reading

Uncategorized

Moderna’s FDA adcomm, IPO mania, biopharma layoffs, more

Published

on

Moderna appears to have aligned with the FDA ahead of an advisory committee meeting for its mRNA-based flu vaccine, which the regulator initially turned away in February; biotech IPOs are going gangbusters, including two new records raises in as many weeks; layoffs continue across biopharma; plus much more.

Continue Reading

Uncategorized

PwC declares biopharma ecosystem ‘back to full health’ as M&A buoys sector

Published

on

Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.

Continue Reading
Advertisement

Trending