Apple Watch faces potential sales ban—again

Today’s Big News

Oct 27, 2023

‘We knew it was there’: AbbVie CEO says company favored internal work over potential Daiichi deal


Look out, Eylea: Roche's Vabysmo wins new use in retinal vein occlusion


Apple Watch faces another possible sales ban in Masimo pulse oximetry patent fight


After reaching FDA first, CRISPR-Vertex's gene editing therapy will get 'benign' review by committee


Eli Lilly enters crowded ulcerative colitis market with delayed FDA approval for Omvoh


ResMed’s 2024 fiscal year kicks off with plans to lay off 5% of workers

 

Featured

‘We knew it was there’: AbbVie CEO says company favored internal work over potential Daiichi deal

AbbVie CEO Rich Gonzalez says the company was aware of the potential for an ADC transaction with Daiichi that Merck ultimately pounced on, electing to prioritize internal work instead.
 

Top Stories

Look out, Eylea: Roche's Vabysmo wins new use in retinal vein occlusion

The fast-growing blockbuster previously showed non-inferiority to Regeneron and Bayer's Eylea in the condition. This approval will expand the showdown between the two rival drugs.

Apple Watch faces another possible sales ban in Masimo pulse oximetry patent fight

For the second time in the last year, the U.S. International Trade Commission has determined that Apple violated a competitor’s patents in a health-tracking feature of its popular Apple Watch, setting up the devices for a potential ban in the U.S.

After reaching FDA first, CRISPR-Vertex's gene editing therapy will get 'benign' review by committee

A historic moment in pharmaceuticals will happen next week: an FDA advisory committee is set to review the first-ever CRISPR gene editing-based therapy, Vertex Pharmaceuticals and CRISPR Therapeutics’ exa-cel for sickle cell disease.

Eli Lilly enters crowded ulcerative colitis market with delayed FDA approval for Omvoh

Weight loss contender Mounjaro may be getting Eli Lilly a lot of public attention these days, but the Indiana pharma giant is busy expanding in immunology, too.

ResMed’s 2024 fiscal year kicks off with plans to lay off 5% of workers

As it continues to take advantage of the hole left in the CPAP market by Philips’ ongoing recall, ResMed is still fine-tuning its long-term growth strategy—a process that’s now resulting in short-term shrinkage.

Specialty injectables maker Exela issues recall after particles turn in up in 3 different drugs

Exela is working with the FDA to recall three separate medications—injectable sodium bicarbonate, midazolam and the nutrition additive Elcys—after inspections of leftover samples flagged silicone matter in some vials.

Sanofi reports setbacks to Denali, Kymab and Principia assets, delivering mix of misses and halts

Sanofi has reported setbacks to a trio of candidates bought in by its business development team, halting (PDF) work or posting negative data on assets picked up from Denali Therapeutics, Kymab and Principia Biopharma.

As Imbruvica loses steam, AbbVie takes $2.1B charge and points to CMS price negotiations

Sales of AbbVie and Johnson & Johnson’s leukemia blockbuster Imbruvica are taking a hit from BeiGene’s Brukinsa. But what about the impact of the Inflation Reduction Act? In August, Imbruvica was one of the 10 drugs identified by the CMS that will be subject to price negotiations in 2026. On Friday, as AbbVie presented its third-quarter earnings, the company said that it has recorded a $2.1 billion impairment charge based on estimates about “revised cash flows” for Imbruvica.

TCT: Abbott’s drug-eluting, resorbable implant shows gains in below-the-knee artery disease

In a randomized, late-breaking trial presented at the TCT conference, the Esprit BTK implant bested its primary endpoints compared to standard balloon angioplasty alone.

Santhera, Catalyst score FDA nod for Duchenne drug. Can they gain more indications for Agamree?

Thursday’s FDA approval of Santhera’s Agamree (vamorolone) to treat Duchenne muscular dystrophy is just a start. The Swiss company is anxious to see how many disorders the first-in-class corticosteroid can treat.

Chutes & Ladders—J&J's medtech chief exits after almost 30 years

Johnson & Johnson’s year of transition and restructuring is not slowing down, this time marked by the departure of a longtime key executive.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': A look at the FDA's Aduhelm approval and the potential for regulatory bias

In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.  
 

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