| 08.14.23 | 2seventy's CD33 CAR-T now formally on FDA hold; Incyte the latest pharma to ax Syros pact

Click here to subscribe to Fiercebiotech.com

1 year ago

Html
Text


A message from Fierce Biotech Summit

Today’s Big News

Aug 14, 2023

FDA puts 2seventy CAR-T trial on hold in wake of patient death

Incyte drops Syros blood cancer partnership, two months after Pfizer does the same in sickle cell

BioXcel halving head count, narrowing R&D as cash runway crumbles

Cash-strapped Fresh Tracks pauses R&D run as search for a buyer continues

FDA, seeking time for phase 4 talks, delays decision on Valneva's chikungunya vaccine by 3 months

Gracell drops 3 CAR-T programs in hopes of speeding more advanced assets to the finish line

Synthetic antibiotic shows 'potent' efficacy against drug-resistant superbugs


A message from Medical Affairs Strategic Summit

Featured

FDA puts 2seventy CAR-T trial on hold in wake of patient death

By James Waldron

The FDA has put an early-phase trial of 2seventy bio’s CD33-targeted CAR-T cell therapy on hold in the wake of a patient death.

11-14Sep

Join us: Digital Pharma EastPhiladelphia, PA

Incyte drops Syros blood cancer partnership 2 months after Pfizer does the same in sickle cell

By Annalee Armstrong

Incyte has ended a five-year collaboration with Syros Pharmaceuticals after seven targets were identified for myeloproliferative neoplasms and none taken back to the lab for further development.

BioXcel halving head count, narrowing R&D as cash runway crumbles

By Nick Paul Taylor

BioXcel Therapeutics is cutting deep to cope with the collapse of its cash runway. With BioXcel unlikely to meet the requirements for an anticipated cash infusion, the biotech is laying off almost 60% of its staff and narrowing its focus to keep going through the middle of next year.

Cash-strapped Fresh Tracks pauses R&D run as search for a buyer continues

By James Waldron

The walls seemed to be closing in on Fresh Tracks Therapeutics when, in March, the company began searching for a potential buyer to overcome its limited resources. But only now has the biotech revealed that its R&D work has been placed on pause to hold onto more cash.


A message from Digital Pharma East

FDA, seeking time for phase 4 talks, delays decision on Valneva's chikungunya vaccine by 3 months

By Nick Paul Taylor

The FDA is making Valneva wait. Two weeks from the original deadline, the agency has pushed back its decision on whether to approve Valneva’s chikungunya virus vaccine candidate by three months.

Gracell drops 3 CAR-T programs in hopes of speeding more advanced assets to the finish line

By Gabrielle Masson

Gracell Biotechnologies is shaving down its CAR-T pipeline, throwing several programs out the window in an effort to speed its most advanced programs to the finish line.

Synthetic antibiotic shows 'potent' efficacy against drug-resistant superbugs

By Helen Floersh

From CRISPR and artificial intelligence to an old, once-rejected drug, the arsenal of potential weapons against antibiotic resistance is, thankfully, growing at last. The latest: a synthetic antibiotic that holds bacteria back by blocking the development of their vital outer membrane.

Another round of layoffs hits BMS, with 100+ people impacted after earnings miss

By Max Bayer

Bristol Myers Squibb has laid off more than 100 employees amid a reconfiguration of expenses that follows disappointing earnings results.

Italian billionaires behind Ferrari, Juventus drop $2.8B to become Phllips' largest single shareholder

By Andrea Park

Though rebuked by shareholders in a vote earlier this year that kept its executives potentially liable for any legal issues related to its recent recall-related troubles, Philips has gotten a major confidence boost from a new investor.

Thermo Fisher lays off 200-plus at clinical-stage cell and gene therapy factory in Florida

By Fraiser Kansteiner

As layoffs continue to roil the biotech industry, bigger drugmakers and manufacturers like Bristol Myers Squibb and Emergent BioSolutions haven’t been immune. Now, Thermo Fisher Scientific is among the latest to plot hundreds of job cuts.

Drug marketing regulator sounds the alarm over Novartis' Entresto podcast claims

By Ben Adams

Novartis has been consistently pushing the boundaries in digital pharma for years. However, the company has now encountered the intricate challenges associated with navigating regulatory guidelines. This has become evident as the Big Pharma has been hit with the U.K.'s most most serious drug marketing breach.

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.

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.