Helixgate

Helixgate

Uncategorized

Amenable FDA review bodes well for Moderna’s mRNA flu shot ahead of adcomm grilling

Published

on

With a panel of outside experts set to weigh in Thursday—and with a refusal-to-file fiasco with the FDA just barely in the rearview—Moderna and its contender for the United States’ first mRNA-based influenza vaccine are heading into a critical test this week.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published.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

Uncategorized

STAT+: Pharmalittle: We’re reading about hackers extorting Novo, an FDA about-face, and more

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cup of stimulation. Our choice today is maple bourbon. A shot of salvation, if you will. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. …

A cyber extortion group claimed ​to have stolen more than a terabyte of data from Novo Nordisk and said it is ‌exploring selling parts of the data after unsuccessfully demanding $25 million from the company, Reuters reports. FulcrumSec, a cyber extortion group that emerged in October 2025, said in a long message posted to its website that it spent more than two months in Novo Nordisk’s networks stealing data. It said that data included company source code, proprietary information on ​released and unreleased drugs, trial data, employee, doctor, and patient data, information related to company processing facilities, and internal AI model ​information.

The U.S. Food and Drug Administration reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for UniQure to file for marketing approval, STAT writes. The decision comes after a recent meeting with FDA officials during which the agency agreed that a three-year analysis of an early-stage study that showed a benefit for patients with Huntington’s was “acceptable” to support a marketing application. These are the same data that former FDA officials, most notably Commissioner Marty Makary and Vinay Prasad, the agency’s top regulator of cell and gene therapies, previously concluded were insufficient to support a marketing application. 

Continue to STAT+ to read the full story…

Read More

Published

on

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cup of stimulation. Our choice today is maple bourbon. A shot of salvation, if you will. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. …

A cyber extortion group claimed ​to have stolen more than a terabyte of data from Novo Nordisk and said it is ‌exploring selling parts of the data after unsuccessfully demanding $25 million from the company, Reuters reports. FulcrumSec, a cyber extortion group that emerged in October 2025, said in a long message posted to its website that it spent more than two months in Novo Nordisk’s networks stealing data. It said that data included company source code, proprietary information on ​released and unreleased drugs, trial data, employee, doctor, and patient data, information related to company processing facilities, and internal AI model ​information.

The U.S. Food and Drug Administration reversed its opposition to a closely watched experimental treatment for Huntington’s disease, clearing a path for UniQure to file for marketing approval, STAT writes. The decision comes after a recent meeting with FDA officials during which the agency agreed that a three-year analysis of an early-stage study that showed a benefit for patients with Huntington’s was “acceptable” to support a marketing application. These are the same data that former FDA officials, most notably Commissioner Marty Makary and Vinay Prasad, the agency’s top regulator of cell and gene therapies, previously concluded were insufficient to support a marketing application. 

Continue to STAT+ to read the full story…

Read More

Continue Reading

Uncategorized

Be Bio bins hemophilia B cell therapy trial—the biotech’s lead program

Published

on

Be Biopharma’s terminated trial is the latest setback in the hemophilia space, where companies like Pfizer and BioMarin have opted to pull their respective products from the market after weak traction.

Continue Reading

Uncategorized

STAT+: Is Abridge’s ‘patient centered’ claim a bridge too far?

You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. 

I cried reading about people’s shared moments with strangers at the bottom of last week’s edition of “We’re Here,” the community newsletter from Hank and John Green.

My colleague Eric Boodman’s stories usually make me cry as well, but his recent article about babies being born with congenital syphilis, which is usually totally preventable with penicillin from Pfizer, made me want to tear my hair out.

Continue to STAT+ to read the full story…

Read More

Published

on

You’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. 

I cried reading about people’s shared moments with strangers at the bottom of last week’s edition of “We’re Here,” the community newsletter from Hank and John Green.

My colleague Eric Boodman’s stories usually make me cry as well, but his recent article about babies being born with congenital syphilis, which is usually totally preventable with penicillin from Pfizer, made me want to tear my hair out.

Continue to STAT+ to read the full story…

Read More

Continue Reading
Advertisement

Trending