FDA drops AdComm for Applied's rare disease drug

Today’s Big News

Sep 18, 2024

Novo Nordisk bets $600M biobucks on NanoVation's ability to take genetic medicines beyond the liver


ESMO: Innovent links cytokine fusion protein to responses in colorectal cancer 


FDA scraps adcomm for Applied's rare disease drug ahead of November decision


Capricor sells Europe rights to DMD therapy for $35M as FDA application approaches


Drug based on anti-nausea agent reduces Alzheimer's-advancing astrocytes in mice, biotech says


Trispecific antibody from Ichnos Glenmark Innovation beats J&J's Tecvayli at treating multiple myeloma in mice

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Featured

Novo Nordisk bets $600M biobucks on NanoVation's ability to take genetic medicines beyond the liver

Novo Nordisk is continuing its push into genetic medicines, agreeing to pay NanoVation Therapeutics up to $600 million to collaborate on up to seven programs built on technology for targeting cells outside the liver.
 

Top Stories

ESMO: Innovent links cytokine fusion protein to responses in colorectal cancer

Innovent Biologics has made the case that its checkpoint inhibitor-cytokine fusion protein has a future in colorectal cancer. A phase 1 trial that combined the drug candidate with bevacizumab reported a 21.9% response rate, including signs of efficacy in patients with liver metastases and prior immunotherapy use.

FDA scraps adcomm for Applied's rare disease drug ahead of November decision

After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided that a planned advisory committee meeting won’t be required.

Beyond data: Humanizing clinical research with Avacare

With intricate protocols and shifting regulatory demands, it’s more difficult than ever to find and keep participants, as well as gather reliable data.

Capricor sells Europe rights to DMD therapy for $35M as FDA application approaches

Having already scooped up the U.S. rights to Capricor Therapeutics’ late-stage Duchenne muscular dystrophy therapy, Japan’s Nippon Shinyaku has signed off on $35 million in cash and a stock purchase to secure the same deal in Europe.

Drug based on anti-nausea agent reduces Alzheimer's-advancing astrocytes in mice, biotech says

A drug candidate based on aprepitant was reported to reduce the brain area of astrocytes and improve cognitive function in a mouse model. Hoth Therapeutics reported the preclinical findings.

Trispecific antibody from Ichnos Glenmark Innovation beats J&J's Tecvayli at treating multiple myeloma in mice

For Ichnos Glenmark Innovation, good things come in threes. The alliance between Ichnos Sciences and Glenmark Pharmaceuticals has developed a trispecific, T-cell activating antibody that shrank multiple myeloma tumors in mice and killed cancer cells in human tissue more effectively than Janssen’s Tecvayli.

Organon pays up to $1.2B to acquire Dermavant and its steroid-free skin cream Vtama

Organon is set to acquire Roivant’s immuno-dermatology subsidiary Dermavant for up to $1.2 billion, the companies announced Wednesday. The crown jewel of the deal is undoubtedly Vtama, Dermavant’s steroid-free cream for plaque psoriasis, which is looking at a major expansion opportunity in eczema.

Noom to offer compounded GLP-1 drug to rival pricey branded weight loss meds

Noom is the latest digital health company to jump into the off-label weight loss drug market to make medications more accessible to consumers.

FDA elevates recall as Zimmer Biomet phases out hip replacement implant

The FDA is getting the word out regarding a recall effort from Zimmer Biomet, related to its discontinued CPT hip implant and its potential link to fractures of the thigh bone after placement.

Novartis heaps pressure on Lilly with broad FDA approval for Kisqali in early breast cancer

An FDA approval has officially lifted the curtain on a blockbuster market showdown between Novartis' Kisqali and Eli Lilly's Verzenio in early breast cancer.
 
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We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
 

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