Mesoblast makes 3rd FDA attempt

Today’s Big News

Sep 21, 2023

Novo Nordisk Foundation pumps $136M into new clinical cell therapy manufacturing 'hub' in Denmark


Inventiva, Kezar sell Asian rights to NASH and autoimmune assets, netting $17M between them


Take 3: Mesoblast plots path to market for twice-rejected cell therapy


Fierce Biotech M&A Tracker 2023: Applied Molecular Transport finds a buyer; Atriva, Biocure ink reverse takeover


Different roads, same destination: Study shows COVID variants evolve to suppress immunity

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

Novo Nordisk Foundation pumps $136M into new clinical cell therapy manufacturing 'hub' in Denmark

Looking to establish a “hub” in the cell therapy ecosystem, the Novo Nordisk Foundation is pumping 950 million Danish kroner (about $136 million) into a new clinical production site at the Technical University of Denmark (DTU) in Lyngby.
 

Top Stories

Inventiva, Kezar sell Asian rights to NASH and autoimmune assets, netting $17M between them

Inventiva and Kezar Life Sciences have found buyers for Asian rights to their lead candidates, collectively bringing in $17 million upfront in return for the chance to develop and sell assets in certain territories.

Take 3: Mesoblast plots path to market for twice-rejected cell therapy

Mesoblast has plotted a path toward its third attempt to win approval of its off-the-shelf therapy, exiting a meeting with the FDA convinced that new potency assay data and a single-arm trial can finally get the candidate to market.

Health Equity: IHI and Genentech on the Need for an Industry-Wide Approach

Two leaders supporting the Rise to Health Coalition discuss the need for coordinated and collective action across sectors to advance health equity

Fierce Biotech M&A Tracker 2023: Applied Molecular Transport finds a buyer; Atriva, Biocure ink reverse takeover

Fierce Biotech's M&A Tracker, your one-stop shop for dealmaking in the biopharma universe.

Different roads, same destination: Study shows COVID variants evolve to suppress immunity

In the world of COVID variants, many mutations seem to lead to the same goal: Evade innate immunity. By pinpointing key proteins that make this "convergent evolution" possible, researchers are on the way to finding new targets for therapies.

Pharma's reputation hits record low in US as Republicans shun industry: Gallup

Americans' perception of the pharmaceutical industry is at its lowest point this century, especially among Republican voters, as the initial support for COVID-related efforts has turned into disillusionment.

Ypsomed inks deal to manufacture GLP-1 autoinjectors for Novo Nordisk

Joining Novo Nordisk's GLP-1 assembly line is Ypsomed, which has signed on to produce “large quantities of autoinjectors” for the Danish drugmaker.

Roche again found guilty of most serious marketing breach, this time for omitting safety information

Roche has received a dressing-down for omitting important safety information from a cancer drug dosing webpage. A U.K. self-regulatory body concluded Roche brought discredit upon, and reduced confidence in, the pharmaceutical industry by failing to provide information that is important to patient safety.

OutCare Health partners with Veda to deliver LGBTQ+ affirming provider list to payers

OutCare Health is known for its OutList, an extensive directory of LBGTQ+ affirming providers. Data automation company Veda will ingest that information and offer it to payer clients.
 
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This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage

 

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