FDA grants AZ lung cancer nod despite trial concerns

Today’s Big News

Aug 16, 2024

Genentech to shut down cancer immunology research department amid broader R&D rethink


Following rejection and retractions, Lykos caps off chaotic week by cutting 75% of staff


FDA signs off on AZ's Imfinzi in NSCLC despite concerns about trial design


Novo Nordisk plans new $220M raw ingredients plant in Denmark


GI robotics developer Neptune Medical raises $97M, launches Jupiter Endovascular


FDA clears Cresilon’s bloodstopping gel for severe wounds


Pfizer, BioNTech's combo mRNA shot is latest to be defeated by influenza strain B


GSK notches another Zantac win as Florida court tosses expert testimony linking heartburn drug to cancer

 

Featured

Genentech to shut down cancer immunology research department amid broader R&D rethink

Genentech will close its cancer immunology research department to form a single oncology research organization. Unit head and renowned cell biologist Ira Mellman, who has been with the company for 17 years, will depart in the coming months.
 

Top Stories

Following rejection and retractions, Lykos caps off chaotic week by cutting 75% of staff

Lykos Therapeutics is capping off an awful week with a massive reorganization, laying off about 75% of staff in the aftermath of an FDA rejection and the retraction of three research papers on the biotech’s MDMA treatment due to protocol violations at a clinical trial site.

FDA signs off on AZ's Imfinzi in NSCLC despite concerns about trial design

AstraZeneca has scored an FDA approval in the advancement of its high-flying cancer therapy Imfinzi that comes with some controversy. The nod is for Imfinzi to treat patients with resectable non-small cell lung cancer perioperatively.

Novo Nordisk plans new $220M raw ingredients plant in Denmark

Novo Nordisk Pharmatech, a unit that specializes in producing drug ingredients, is spending 1.5 billion Danish kroner ($220 million) to build a plant in Køge, Denmark, that will make raw materials, the company said Friday. The project will result in the creation of 50 new jobs, according to the company. Novo Nordisk Pharmatech expects the plant to be complete by 2027.

GI robotics developer Neptune Medical raises $97M, launches Jupiter Endovascular

The gastrointestinal device developer raised $97 million and debuted a new subsidiary aimed at translating its tech into the cardiovascular sphere.

FDA clears Cresilon’s bloodstopping gel for severe wounds

The FDA has given a green light to a hydrogel applicator that can be quickly deployed to help stem severe, life-threatening bleeding within seconds.

Pfizer, BioNTech's combo mRNA shot is latest to be defeated by influenza strain B

Pfizer and BioNTech may have a strong pedigree in the mRNA vaccine game, but, when it comes to flu, they’ve run up against the same problem as their peers—neutralizing influenza strain B.

GSK notches another Zantac win as Florida court tosses expert testimony linking heartburn drug to cancer

After knocking out multiple personal injury lawsuits this summer, GSK has prevailed on another front in its long-running Zantac litigation, thanks to a decision in Florida that put the kibosh on suspect expert testimony.
 
Fierce podcasts

Don’t miss an episode

The TROP2 race for supremacy

In this week’s episode of “The Top Line,” Fierce executive editor Eric Sagonowsky chats with Angus Liu about his feature story on the three TROP2 front-runners.
 

Resources

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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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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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