FDA's device chief Shuren to retire

Today’s Big News

Jul 24, 2024
 

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Biogen, Sage fail midphase essential tremor trial, extending long wait for new option

Sage Therapeutics and Biogen have extended the pharma industry’s multi-decade essential tremor losing streak. Three years after tolerability overshadowed efficacy, the partners have given up on SAGE-324 in the indication after failing to reduce tremors in a phase 2 trial designed to address their earlier problems.
 

Top Stories

Ahead of adcomm, FDA pokes holes in AZ's perioperative lung cancer filing for Imfinzi

An FDA advisory committee will discuss AstraZeneca’s application for Imfinzi in early-stage non-small cell lung cancer. The agency is asking external experts to weigh in on whether a new trial is needed to determine the contributions of the therapy on either end of surgery.

FDA’s device center director, Jeff Shuren, to retire

It’s a decision that comes after 28 years in government, and, according to Shuren, one that's overdue following the COVID-19 pandemic.

Castle Biosciences turns to former ‘Real Housewife’ for melanoma awareness campaign

Castle Biosciences is keeping it “Real.” The diagnostics developer has partnered with Teddi Mellencamp Arroyave, a former cast member on “The Real Housewives of Beverly Hills” and the daughter of musician John Mellencamp, for a new campaign focused on raising awareness of melanoma.

Pfizer’s gene therapy offers alternative to 'burden' of regular infusions, but can it outlast Roctavian?

Three months after scoring FDA approval for its hemophilia B gene therapy, Pfizer has posted phase 3 data suggesting it may be able to pull off the same success with a different candidate in hemophilia A.

BeiGene CEO eyes biologics deals for new US innovation center in New Jersey

A new 42-acre campus in New Jersey gives BeiGene CEO John Oyler hope that the company can strike new partnerships in biologics.

Surge in sales of biosimilars helps Samsung Biologics to a record-setting quarter

Korean CDMO juggernaut Samsung Biologics continued its sales surge in the second quarter, with its biosimilars unit, Samsung Bioepis, doing much of the heavy lifting. For the period, Samsung Bioepis achieved (PDF) sales of 530 South Korean won ($384 million), which was a 107% year-over-year increase and a 75% sequential boost.

Boston Scientific sees electric 125% EP growth after pulsed field ablation launch

Boston Scientific boosted its financial outlook for the remainder of 2024, after seeing a nearly 20% surge in the year-over-year sales of its cardiovascular devices.

JPA Health’s shopping spree continues with Akt Health purchase

Less than a year after announcing its first-ever acquisition, JPA Health has now completed a hat trick of buyouts.

Tourette's biotech Asarina to wind down after outreach to 200 companies fails to produce a partner

After reaching out to more than 200 companies to partner a Tourette syndrome therapy that showed the ability to beat standard of care last year, Asarina Pharma has come up empty and will fold.

Following Lilly's lead, Sanofi pledges discounted insulin in Minnesota after lawsuit

The company agreed to provide its insulin to patients in Minnesota for $35 per month, following a similar settlement the state reached with Eli Lilly.

HCPs embrace podcasts to stay abreast of drug options: survey

Keen to reach the eyes and ears of healthcare professionals? Social media and podcasts could provide a way in, according to a CMI Media Group and Compas report about the media landscape.

Geron losing commercial chief shortly after first FDA approval

Geron’s chief commercial officer is hitting the exit just as the party is getting started. Less than 50 days after the biotech won FDA approval for its first drug, the exec who played a starring role in creating its commercial strategy has announced he is leaving “to pursue other interests.”

The brain regions responsible for the placebo effect have been mapped in mice

When it comes to developing new pain drugs, the placebo effect is a powerful but baffling force. Researchers have successfully mapped the neural circuits responsible for placebo pain relief in mice.
 
Fierce podcasts

Don’t miss an episode

ONC’s Micky Tripathi on creating a connected healthcare system

In this week’s episode of “Podnosis,” Micky Tripathi, Ph.D., National Coordinator for Health Information Technology at HHS, chats with Executive Editor Heather Landi about ONC’s achievements over the past 20 years, the agency’s current top priorities, the rapid adoption of AI in healthcare and more.
 

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2024 Life Sciences Industry Outlook

The definitive report on the state of our industry.  Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.
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The “Best Practice Organization” & Its Importance for Success in Today’s Biopharma Industry

In a complex industry like biopharma, being a “Best Practice Organization” (BPO) is essential to success. But what is a BPO & how do you build one? This eBook provides the answers.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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