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Jan 26, 2024

Special Report—2023's top 10 clinical trial flops 


Merck & Co. signs $220M macrocyclic peptide deal after hailing ‘next wave of drug discovery’ 


FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe


Lilly makes waves, says gene therapy restores hearing for child with genetic hearing loss


Former Pfizer statistician found guilty of insider trading on Paxlovid trial results 


Gilead's Trodelvy fails to extend survival in lung cancer study, prompting selloff

 

Featured

2023's top 10 clinical trial flops

Fierce Biotech recounts the top 10 clinical trial failures of 2023 that sent ripples across the industry.
 

Top Stories

Merck & Co. signs $220M macrocyclic peptide deal after hailing ‘next wave of drug discovery’

Months after hailing macrocyclic peptides as the “next wave of drug discovery,” Merck & Co. has pushed further into the space by penning a $220 million biobucks deal with Unnatural Products.

FDA wants classwide boxed warning on all commercial CAR-T therapies amid secondary cancer safety probe

As many have feared, the FDA's investigation into secondary T-cell malignancies following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.

Lilly makes waves, says gene therapy restores hearing for child with genetic hearing loss

Eli Lilly says an investigational gene therapy has restored hearing in one child who has experienced hearing loss since birth.

Former Pfizer statistician found guilty of insider trading on Paxlovid trial results

A federal jury has found a former Pfizer statistician guilty of insider trading after a two-week trial in Manhattan. The jury convicted Amit Dagar, 44, of Hillsborough, N.J., of using advance information on successful trial results for Pfizer’s COVID-19 treatment Paxlovid to make more than $270,000 in stock trades.

Gilead's Trodelvy fails to extend survival in lung cancer study, prompting selloff

The antibody-drug conjugate did not significantly improve survival outcomes compared with a chemotherapy alone in previously treated patients with metastatic non-small cell lung cancer. The trial outcome marks a setback in Gilead's ambition to grow its presence in the oncology sector.

Novo Nordisk puts $255M on the line to bag another obesity asset, turning to EraCal for novel approach

Novo Nordisk has piled yet another obesity program on its plate. Seeking to build on its early lead in the blockbuster market, the Danish drugmaker has agreed to pay EraCal Therapeutics up to 235 million euros ($255 million) to work on a novel mechanism of action for controlling appetite and body weight.

Researchers link immune dysfunction to long COVID, opening door to new treatments

Scientists from the University of Zurich have released a new study that could explain the mechanism behind the condition—a step towards developing new treatments.

FDA chides Novartis for ‘false or misleading’ Kisqali TV spot, dissecting ad claims in an untitled letter

Novartis’ marketing team has received a dressing-down from the FDA. After reviewing an ad for breast cancer drug Kisqali, the agency accused Novartis of making false or misleading representations about the treatment’s efficacy.

Despite Form 483 from FDA, Alvotech says it's in position to win 2 key biosimilar nods

After several inspections and regulatory setbacks, Alvotech still has a manufacturing issue to work through. This time, the FDA flagged just one observation that the Icelandic manufacturer says is "readily addressable."

J&J highlights Abiomed’s first year in 2023 medtech earnings

Worldwide operational sales across J&J’s medical device divisions grew 12.4% in 2023, to top $30.4 billion in total revenue, with Abiomed alone contributing 4.7%, the company said.
 
Fierce podcasts

Don’t miss an episode

'Podnosis': What’s next for health tech investing in 2024?

This week on "Podnosis," Sofia Guerra and Steve Kraus from Bessemer Venture Partners sat down with Fierce Healthcare's Heather Landi to discuss the health tech sector's performance, unraveling the factors that contributed to its current state. They share what it will take to get health tech out of its current market lull and explore whether we’ll see a rebound in IPOs this year. 
 

Resources

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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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

7 Questions You Should Be Asking Your Digital Point-of-Care Media Vendor

Any EHR provider delivering a quality point-of-care marketing solution should be able to answer these seven questions.

 

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