FDA approves 1st solid tumor cell therapy

Today’s Big News

Aug 2, 2024

Vir gains T-cell engagers from Sanofi, loses 25% of staff in another pipeline switch-up


Vertex lifts sales guidance as launch of gene therapy Casgevy picks up steam


Vertex, beaten by rare disease again, drops 2 assets on growing discard pile


FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor


J&J’s DePuy Synthes nets clearance for Velys spine surgery robot


Potential new antibiotic passes preclinical test against flesh-eating bacteria


After series of patent lawsuits, Novartis doubles down in Entresto defense with FDA complaint


Galapagos pauses CAR-T cell therapy trial over Parkinsonism case

 

Featured

Vir gains T-cell engagers from Sanofi, loses 25% of staff in another pipeline switch-up

The “strategic restructuring” is designed to push more resources into Vir’s hepatitis programs “and focus on the highest near-term value opportunities,” the biotech explained.
 

Top Stories

Vertex lifts sales guidance as launch of gene therapy Casgevy picks up steam

As of mid-July, around 20 patients completed the first step of Casgevy treatment by having their cells collected, up from five patients during the first quarter.

Vertex, beaten by rare disease again, drops 2 assets on growing discard pile

Vertex’s attempt to treat a rare genetic disease has hit another setback. The biotech tossed two more drug candidates onto the discard pile in response to underwhelming data but, following a playbook that has worked in other settings, plans to use the missteps to inform the next wave of preclinical prospects.

FDA signs off on Adaptimmune's Tecelra as the first engineered cell therapy for a solid tumor

Adaptimmune has won accelerated FDA approval for Tecelra (afami-cel), a treatment for metastatic or unresectable synovial sarcoma which becomes the first engineered cell therapy for a solid tumor and the first new treatment in the indication in more than a decade.

J&J's DePuy Synthes nets clearance for Velys spine surgery robot

The DePuy Synthes division’s Velys Spine system is designed to offer what the company describes as active robotic assistance, which tracks patient movements.

Potential new antibiotic passes preclinical test against flesh-eating bacteria

Flesh-eating bacteria sound like something an enterprising science fiction author would dream up, but they are in fact real—and the infections they cause can lead to disfigurement, loss of limbs, and even death.

After series of patent lawsuits, Novartis doubles down in Entresto defense with FDA complaint

Novartis has filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful. The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories. The agency also rejected a Novartis-led Citizen Petition, which asked it to block the entry of generic versions of the blockbuster drug.

Galapagos pauses CAR-T cell therapy trial over Parkinsonism case

Galapagos has paused enrollment in a trial of a BCMA-directed CAR-T cell therapy, pumping the brakes in response to an adverse event also seen in recipients of Bristol Myers Squibb and Johnson & Johnson’s rival drugs.
 
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What 'The Next Berlin Patient' and a PrEP’s 100% efficacy mean for HIV drug development

This week on “The Top Line,” we dive into two studies in HIV research that were presented at the 25th International AIDS Conference in Germany.
 

Resources

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Launching a Product in Europe: Understanding Supply Chain Cost Drivers

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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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