| 11.04.22 | Galapagos cuts staff in yet another pivot; NextCure turns to its next cure after phase 2 flop

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Today's Big News

Nov 4, 2022

Galapagos lays off 200 staff, drops kidney and fibrosis programs in renewed CAR-T push

NextCure discards antibody after candidate delivers no response in phase 2 cancer trial

‘Full psychedelic experience in just 10 minutes;’ Biomind says hallucinogenic asset meets main trial goals

Akebia is taking the fight to the FDA months after approval rejection

3 is the magic number: Exelixis' 3rd deal in 3 days offers $30M for 3 Catalent programs

Abeona completes metamorphosis as 'butterfly' disease therapy heals wounds in phase 3

New gene therapy for epilepsy hits seizures where they start

‘The Top Line’: Philips' plans to cut costs to come back from its ventilator recalls

Chutes & Ladders—Rubius execs depart as the walls close in


A message from Thermo Fisher Scientific

Featured

Galapagos lays off 200 staff, drops kidney and fibrosis programs in renewed CAR-T push

By James Waldron

Galapagos is not a company lacking a vision—in fact, they’ve just made their second strategic announcement in six months. This one comes with a further pipeline trim and the loss of 200 roles.

NextCure discards antibody after candidate delivers no response in phase 2 cancer trial

By James Waldron

In a third-quarter earnings release, the Maryland-based biotech said that it had made the call to end development of the antibody, dubbed NC318, after reviewing data of the drug as monotherapy, including a phase 2 trial that had produced “no responses.”

‘Full psychedelic experience in 10 minutes.’ Biomind says inhaled DMT meets trial goals

By Gabrielle Masson

Biomind Labs just hit a landmark on its trip that has clinic flagged as the final destination, posting new data that shows its psychedelic candidate aimed at helping patients with depression is safe and tolerable for healthy individuals.

Lindsay Rosenwald’s Fortress Bio ‘Uniquely’ Positioned to Capitalize on Current Long Biotech Winter

Akebia is taking the fight to the FDA months after approval rejection

By Max Bayer

More than six months after Akebia's anemia med was rejected by the FDA, the company is formally disputing the decision. Akebia expects a response back from regulators before the end of the year.

Executive Interviews at Fierce Biotech Summit 2022

3 is the magic number: Exelixis' 3rd deal in 3 days offers $30M for 3 Catalent programs

By Gabrielle Masson

Exelixis has made its third deal in three days, this time paying Catalent Biologics $30 million cash for licensing rights to three of its antibody-drug conjugate candidates.

Abeona completes metamorphosis as 'butterfly' disease therapy heals wounds in phase 3

By Annalee Armstrong

Abeona Therapeutics has overcome an FDA clinical hold to show that its cell therapy can heal wounds in patients with a rare connective tissue disease, teeing up an FDA filing in the new year.

New gene therapy for epilepsy hits seizures where they start

By Helen Floersh

A highly targeted epilepsy gene therapy that impacts only hyperactive neurons and stops when the seizures go away showed promise in mice and human brain organoids.

‘The Top Line’: Philips' plans to cut costs to come back from its ventilator recalls

By Querida Anderson

This week on “The Top Line,” we dig into Philips’ revelation that it is laying off 4,000 workers and planning for even more restructuring.

Chutes & Ladders—Rubius execs depart as the walls close in

By Max Bayer,Gabrielle Masson

A number of Rubius executives are leaving with the company's final days numbered. Ambrx lands new CEO to chart the company through rough clinical seas. Alexion co-founder to help lead new J.P. Morgan investment venture.

Amid launch of Omnipod 5, Insulet clocks 42% US revenue growth rate, its highest 'in at least a decade'

By Andrea Park

For Insulet, this year has been all about the Omnipod 5 insulin pump—and that dedication is already paying off.

Healthcare Twitter influencers beam over Pfizer's RSV shot data: report

By Ben Adams

Move over, COVID: Shots to stop RSV are providing the new must-watch trial data on Twitter as healthcare influencers on the social media platform talk up the latest readout from Pfizer.

Fierce Pharma Asia—Eisai's lecanemab patient death; GSK's China VBP suspension; Daiichi's Enhertu projection

By Angus Liu

A patient death clouds the outlook for Eisai and Biogen's closely watched Alzheimer's disease drug lecanemab. GSK is barred from participating in China's volume-based procurement program for 18 months. Daiichi Sankyo expects AstraZeneca-partnered Enhertu to cross the blockbuster threshold in fiscal year 2022. And more.

Fierce podcasts

Don't miss an episode

‘The Top Line’: Philips' plans to cut costs to come back from its ventilator recalls

This week on “The Top Line,” we dig into Philips’ revelation that it is laying off 4,000 workers and planning for even more restructuring.

'Podnosis': Sizing up data privacy legislation and what you missed from the Digital Pharma East conference

'The Top Line': What went down on Biogen's earnings call, AstraZeneca's prospects after its CTLA-4 approval

Webinar: Health data intelligence: Advancing patient research and care using genetic insights

Tuesday, November 8, 2022 | 12:30pm ET / 9:30am PT

As a partner in the overall health ecosystem, Myriad Genetics is combining de-identified genetic data with indications, phenotypes, and outcomes to power the next generation of precision medicine advancements. Register now.

Resources

Webinar

Webinar: Writing the Future of Antibody Discovery Solutions

Twist Bioscience CSO Dr. Aaron Sato shares how Twist's tools for antibody discovery have been applied to identify antibodies against diverse and challenging targets. See how high-throughput DNA synthesis combined with antibody engineering expertise provides end-to-end antibody discovery solutions.

Presented by: Twist Bioscience

Whitepaper

Scaling life sciences companies: Discover resources to support growth and innovation

Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals.

Optimizing Trial Efficiency with Bayesian Dose Escalation Designs

Learn more about adaptive ascending dose escalation designs and considerations for determining the optimal approach to meet your drug development objectives

Commercializing Gene Therapies – Supply Chain Considerations

This paper outlines how gene therapy supply chains are different from traditional biopharma products, as well as the factors that are essential to success.

Discover why you should choose the Gibco™️ Efficient-Pro™️ system

Revolutionize your monoclonal antibody (mAb) manufacturing process with the Gibco™️ Efficient-Pro™️ Medium and Feed System. Watch our how-to video.

The Most Suitable Dosage Form Technologies for the Oral Delivery of Lipid-Based Formulations

What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations?

Sponsored by: Catalent

Research

Versatility of Softgel Technology - Encapsulation of a Volatile Compound

Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound.

Sponsored by: Catalent

Whitepaper

Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market

How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market?

Sponsored by: Catalent

Whitepaper

Formulation Strategies When Transitioning From Vial to PFS

Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care.

The Faster Path From Pre-Filled Syringe to Auto-Injector

Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar.

Softgel Formulation Enables Oral Delivery of Testosterone

Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy.

Sponsored by: Catalent

Whitepaper