| 08.15.23 | Good day for Gilead as CAR-T hold lifted, research collab inked; Galecto gallops toward liver after bucking IPF work

Click here to subscribe to Fiercebiotech.com

1 year ago

Html
Text


A message from Fierce Biotech Summit

Today’s Big News

Aug 15, 2023

FDA lifts clinical hold on Gilead's CAR-T as Arcellx sheds light on reason for patient death

Galecto cans lung fibrosis work after phase 2 fail, with all eyes now on liver cirrhosis med

Gritstone goes back to Genevant to boost power of infectious disease vaccine programs

Gilead inks $66M+ deal with Tentarix in oncology, inflammatory diseases

Houston biotech winds down sole clinical-stage trial, cuts 60% of its staff

AgeX keeps defying time, coming through another quarter despite multiyear cash crunch

Design Therapeutics goes back to the drawing board, causing delay and steep stock drop

Are 'living fillings' the future of teeth restoration? Enamel-growing organoids could open up regenerative dentistry


A message from Medical Affairs Strategic Summit

Featured

FDA lifts clinical hold on Gilead's CAR-T as Arcellx sheds light on reason for patient death

By James Waldron

Gilead Sciences' $225 million bet on Arcellx’s CAR-T cell therapy is back in play after the FDA lifted a clinical hold instigated in the wake of a patient death.

11-14Sep

Join us: Digital Pharma EastPhiladelphia, PA

Galecto cans lung fibrosis work after phase 2 fail, with all eyes now on liver cirrhosis med

By Max Bayer

Galecto's idiopathic pulmonary fibrosis therapy was ineffective in a phase 2 study compared to placebo and recorded a higher rate of serious side effects. The company has discontinued further development, electing to prioritize a clinical-stage treatment for severe liver disease.

Gritstone goes back to Genevant to boost power of infectious disease vaccine programs

By James Waldron

As part of its efforts to develop self-amplifying RNA-based vaccines against a range of infectious diseases, Gritstone bio has tapped regular collaborator Genevant Sciences to again use its lipid nanoparticle tech.

Gilead inks $66M+ deal with Tentarix in oncology, inflammatory diseases

By Annalee Armstrong

Tentarix Biotherapeutics is emerging from its den to ink a multi-pronged deal with Gilead Sciences to work on therapies for oncology and inflammatory diseases worth $66 million upfront, including an equity payment.


A message from Digital Pharma East

Houston biotech winds down sole clinical-stage trial, cuts 60% of staff

By Max Bayer

Alaunos Therapeutics is cutting loose its sole clinical-stage asset and letting 60% of staff go less than two years after rebranding and refocusing on TCR-T cell therapies.

AgeX keeps defying time, coming through another quarter despite multiyear cash crunch

By Nick Paul Taylor

If Juvenescence is as adept at extending the life spans of humans as biotechs, we might all live forever. AgeX Therapeutics, a biotech backed by the longevity specialist, continues to defy Father Time, ending yet another quarter with less than $1 million in the bank and repeating its well-worn going concern warning.

Design Therapeutics goes back to the drawing board, causing delay and steep stock drop

By Nick Paul Taylor

Design Therapeutics is living up to its name. After seeing adverse events in its phase 1 rare disease trial, the biotech has redesigned the formulation to counter the problem—but the developments have set the program back years and triggered a 48% stock drop.

Are 'living fillings' the future of teeth restoration? Enamel-growing organoids could open up regenerative dentistry

By Helen Floersh

It’s one of life’s hard truths: Once tooth enamel is gone, you can’t get it back. And while tooth tech has come a long way since the days of wooden dentures, there’s no regrowing lost teeth. But with the help of enamel-producing organoids, that may not be the case forever.

How Biogen outbid a rival 'large-cap' pharma to claim Reata for $7.3B

By Fraiser Kansteiner

Biogen’s $7.3 billion buyout of Skyclarys-maker Reata Pharmaceuticals surprised some industry watchers last month. But it turns out Biogen wasn’t the only drugmaker jockeying for the Texas-based rare disease outfit, a new securities filing shows.

After patient death, Philips recalls another 120K ventilators due to dust and dirt buildup

By Andrea Park

Just as remediation efforts in Philips' massive 2021 respiratory device recall wind down, the company is now facing yet another Class I recall of some of its ventilators.

As former biotech leader Vivek Ramaswamy jumps in the presidential polls, what does he say for the life sciences brand?

By Ben Adams

For those of us old enough to remember Vivek Ramaswamy as the founder of Roivant and its continuously expanding group of biotech subsidiaries, his presidential campaign at the age of 38 came as a significant shift in his career trajectory.

Amazon Pharmacy's latest move aims to ease access to affordable insulin

By Heather Landi

Amazon Pharmacy will automatically apply drug manufacturer-sponsored coupons on more than 15 insulin and diabetes care brands during online check-out. With the coupons, many insulin brands are available to eligible customers starting at $35 a month with free delivery.

Obesity, diabetes drugs push Novo Nordisk and Eli Lilly to top of pharma's growth pack in Q2

By Kevin Dunleavy

Thanks to sales of their metabolism drugs, Novo Nordisk and Eli Lilly posted the biopharma industry’s largest revenue gains in the second quarter—by far. Meanwhile, only six of the industry’s top 20 firms experienced revenue decreases, with Pfizer's sales dropping a whopping 54%.

Fierce podcasts

Don’t miss an episode

'The Top Line': How left-handedness impacts brain research

This week on "The Top Line," we discuss left-handedness and its significance in neurodevelopmental and psychiatric disorder research.

'Podnosis': A close look at intersectionality and intersexuality

'The Top Line': Addressing drug shortages, plus this week's news

New Product Planning Summit

October 16-17 | Boston, MA

Examine the ways the IRA has impacted the drug pricing and access landscape and review business implications for affordability and evaluate strategies for engaging with stakeholders.

Secure your spot today and save $400 on registration. Savings end August 21st!

Resources

Whitepaper

Plan for success with your process liquid and buffer preparation

Learn how process liquids and buffers impact your total cost of ownership (TCO) and how outsourcing can revolutionize your approach, ensuring quality standards and improving productivity.

Sponsored by: Thermo Fisher Scientific Process Liquid Preparation Services

Whitepaper

Key Drivers of Sales Force Strategy in Oncology

In oncology, traditional methods for determining sales force size & structure are no longer appropriate. This paper describes the multiple drivers of sales strategy in oncology markets today.

Sponsored by: Blue Matter, strategic consultants in the life sciences

Whitepaper

Five ways to get the most from your lab and manufacturing facilities

Learn more about how you can improve the productivity of your research and manufacturing operations and accelerate the journey from laboratory to saving lives.

Reduce chemical lead times with just-in-time delivery

Learn how the right chemical inventory strategy helped save a mid-size CDMO millions of dollars while securing a stable supply of products with just-in-time delivery.

Sponsored by: Thermo Fisher Scientific Production Chemicals and Services

Webinar

Novel Antibodies for the Characterization of CAR-T Cells

Download this webinar to learn how to avoid pitfalls when characterizing CAR-T cells in your development workflow, how to save time by using one antibody to examine your entire panel of CARs, and more.