FDA clears new Alzheimer’s prediction AI

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Today’s Big News

Jan 12, 2024

JPM24: Roche's pharma BD chief explains renewed ADC interest but is spoilt for choice 


Appeals court allows unique argument in Gilead's legal battle over HIV meds 


FDA clears AI that predicts Alzheimer’s progression from an MRI scan


JPM24: Roivant’s Matt Gline has ‘pangs of regret’ for letting Telavant go, but he's ready to deal again


Illumina Ventures launches refreshed genomics startup accelerator program 


BioMarin’s commercial chief Jeffrey Ajer hits the exit as new CEO looks to boost launch of Voxzogo, Roctavian 


Editor’s Corner: Driverless cars and doorless planes at JPM 2024 

 

Featured

JPM24: Roche's pharma BD chief explains renewed ADC interest but is spoilt for choice

As one of the first Big Pharmas to embrace antibody-drug conjugates, Roche plans to bet more on the popular cancer modality, Global Head of Pharma Partnering James Sabry, Ph.D., told Fierce. But biotechs looking for a Roche alliance must first meet an invisible bar.
 

Top Stories

Appeals court allows unique argument in Gilead's legal battle over HIV meds

A group of 24,000 users of Gilead's TDF-based HIV meds argue that the company knowingly shelved a safer HIV med to increase its profits. Now, Gilead will have to prove that a manufacturer can't be held liable for its development timeline of an upgraded product.

FDA clears AI that predicts Alzheimer’s progression from an MRI scan

Described as a virtual microscope, the BrainSee program could be used before a PET scan or biopsies of cerebrospinal fluid, according to the developer Darmiyan.

JPM24: Roivant’s Matt Gline has ‘pangs of regret’ for letting Telavant go, but he's ready to deal again

Sometimes, you have to act while the tea is hot. For Roivant CEO Matt Gline, that meant dealing out Telavant to Roche for $7.1 billion last year, even if he wasn’t quite ready to let the vant company go.

Illumina Ventures launches refreshed genomics startup accelerator program

First announced in June 2023, Illumina Ventures said the new genomics-focused funding and mentorship initiative would take over from its previous Accelerator program, while still offering new companies technical guidance and DNA analysis hardware through the sequencing giant.

BioMarin’s commercial chief Jeffrey Ajer hits the exit as new CEO looks to boost launch of Voxzogo, Roctavian

Rare disease specialist BioMarin has a new CEO in Genentech’s former chief Alexander Hardy and he appears to be shaking up his commercial team as its lead Jeffrey Ajer will now leave the company by July.

Editor’s Corner: Driverless cars and doorless planes at JPM24

The biotech industry has a love-hate relationship with the J.P. Morgan Healthcare Conference in San Francisco. Every year, thousands gather on the Golden Gate City and battle rain, hail, floods, what have you, just to make billion-dollar deals.

Novartis reportedly backs out of Cytokinetics deal, denting biotech’s stock

Reuters and The Wall Street Journal have punctured investors’ hopes that Novartis will buy Cytokinetics. The Swiss drugmaker has reportedly backed away from the potential deal late in negotiations, deflating the biotech’s share price.

ResMed’s warning on CPAP magnet interference earns FDA Class I recall tag

ResMed first warned in November that some of the masks used with its CPAP machines contain magnets that could potentially interfere with pacemakers, neurostimulators and other implanted medical devices.

Boehringer Ingelheim pledges €120M to expand Greek plant, add capacity for Jardiance

Even as obesity and diabetes heavyweights Eli Lilly and Novo Nordisk command headlines with their global manufacturing expansions, Boehringer Ingelheim is getting in on the action.

FDA's early review finds no evidence linking Novo, Lilly weight-loss drugs to suicidal thoughts

A preliminary evaluation by the FDA found no evidence that use of popular diabetes and weight-loss drugs from Novo Nordisk and Eli Lilly can cause suicidal thoughts, the U.S. regulator said.
 
Fierce podcasts

Don’t miss an episode

'The Top Line': The year in biotech

This week on "The Top Line," Fierce Biotech staff writer Gabrielle Masson and senior editor Annalee Armstrong look back at the year in biotech, which was defined by massive layoffs across the industry. They also discuss their favorite stories of the year, including an appearance from a popstar whose reputation precedes her.
 

Resources

Whitepaper

Developing and Manufacturing Drugs with HPAPIs

Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient.

eBook

7 “Make or Break” Factors for Emerging Biopharma Companies

This e-book explores 7 factors that are critical to the success of emerging biopharma companies, whether they plan to out-license, partner, or launch & commercialize products.  It’s an essential resource for emerging companies with products in all stages of development.
 

Whitepaper

Digital Health Innovation: From Concept to Commercialization

The road to digital health innovation is exciting but complex and requires thoughtful navigation; this whitepaper serves as your guide through this process.
 

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