Guardant hit with $83M patent verdict

Today’s Big News

Nov 15, 2023

Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity


Gilead hands Arcellx $285M to expand BCMA cell therapy deal, sparking fresh push for congested market


Guardant Health hit with $83M verdict in TwinStrand DNA sequencing patent lawsuit


Organon CEO: ‘We are definitely going to be involved’ with White House women’s health initiative 


Catalent aims to push through COVID slog with gene therapy, GLP-1 hype


Cardinal Health earns FDA Class I tag for warning against 32M+ Monoject syringes 

 

Featured

Novo Nordisk fights back at Lilly with Wegovy combo trial against Zepbound in obesity

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.
 

Top Stories

Gilead hands Arcellx $285M to expand BCMA cell therapy deal, sparking fresh push for congested market

Gilead’s Kite is paying Arcellx $285 million to inject a SparX into its pursuit of BCMA. In return for the outlay, $200 million of which is being invested in Arcellx, Kite has secured rights to an early-phase BCMA CAR-T candidate and expanded its existing midphase cell therapy collaboration to cover lymphomas. 

Guardant Health hit with $83M verdict in TwinStrand DNA sequencing patent lawsuit

The nucleus of the case involves DNA sequencing patents developed by TwinStrand’s former CEO while he was a medical student at the University of Washington.

Organon CEO: 'We are definitely going to be involved' with White House women's health initiative

Organon CEO Kevin Ali says that while it wasn't involved in the recent women's health initiative announced by the White House, it plans to be moving forward.

Catalent aims to push through COVID slog with gene therapy, GLP-1 hype

The CDMO reaffirmed its full year 2024 revenue guidance range of $4.3 billion to $4.5 billion, despite once high COVID revenue continuing to plunge. Now, Catalent is relying on contracts from Sarepta's DMD gene therapy and GLP-1 products.

Cardinal Health earns FDA Class I tag for warning against certain uses of Monoject syringes

The FDA has doled out its most serious classification to a recall of some 32 million of Cardinal Health's medical supplies.

CorMedix gains hard-fought approval for combo drug that reduces risk of catheter infection during dialysis

CorMedix went through a lot to secure its FDA approval for DefenCath. There was a reorganization, a CEO change, an exit from Europe, two complete response letters and a switch of manufacturers and suppliers. And it took a novel pathway for the approval to finally come through on Wednesday.

Regeneron stays out of ADC deal fray as in-house scientists tinker

Regeneron is pretty good at making antibodies. It’s kind of its thing. But while the industry has gone crazy for antibody-drug conjugates, the company has stayed out of the limelight.

PET-guided radiotherapy green light in hand, RefleXion raises $105M for commercial push

After winning an FDA clearance earlier this year for its image-guided radiation treatment for cancer, RefleXion Medical has raised $105 million to boost commercialization efforts as well as develop new applications for its approach.

2seventy suffers sales slump on high production charges for BMS-partnered CAR-T med Abecma

After reporting a sizable revenue decline for its BMS-parntered multiple myeloma cell therapy in 2023’s third quarter, 2seventy stands out as a prime example of the dangers of scaling up a process before suffering lower-than-expected demand, one group of analysts contends.

Pencils down for Graphite, as gene editing biotech merges into vision-loss-focused Lenz

Lenz Therapeutics is absorbing sickle-cell-focused Graphite Bio in a reverse merger that will see the combined company reemerge with a focus on vision loss and $225 million in cash on hand at close.
 
Fierce podcasts

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'Podnosis': A deep dive into Q3 earnings, and key takeaways from the Fierce Health Payer Summit

In this week’s episode of "Podnosis," you'll hear from two journalists from the Fierce Healthcare team: Paige Minemyer, senior editor of Fierce Health Payer, and Dave Muoio, a staff writer for Fierce Healthcare. Together, they guide you through their key insights from the inaugural Fierce Health Payer Summit in Austin and dive into the latest earnings updates from the largest health plans and health systems.
 

Resources

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This paper explores AI’s potential impact on healthcare and on Medical Affairs (MA) more specifically. It also outlines what MA teams can do now to proactively leverage AI to improve service to their stakeholders.
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An Introduction to Organ-on-a-Chip Technology

Emulate in vivo biology with next-generation in vitro technology.
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Accelerate drug discovery with high-performance computing powered by the cloud

Accelerate drug discovery with high-performance computing (HPC) powered by the cloud
 

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