FDA scraps Applied's ad comm

Today’s Big News

Sep 18, 2024

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


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


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


AstraZeneca's Fasenra plays catch-up with GSK's Nucala, gaining FDA nod for rare autoimmune disease


GE HealthCare claims FDA clearance for amyloid imaging software in Alzheimer’s disease


Navigating the AI 'hype cycle': Bayer, Daiichi Sankyo and argenx leaders on implementing AI in biopharma marketing

 

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

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.

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.

AstraZeneca's Fasenra plays catch-up with GSK's Nucala, gaining FDA nod for rare autoimmune disease

Locked in a spirited market battle with GSK's Nucala, AstraZeneca's Fasenra is catching up with its IL-5 inhibitor rival as the FDA signed off on its use to treat the rare autoimmune condition of eosinophilic granulomatosis with polyangiitis.

GE HealthCare claims FDA clearance for amyloid imaging software in Alzheimer’s disease

GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density of amyloid plaque in the brains of people with Alzheimer’s disease.

Navigating the AI 'hype cycle': Bayer, Daiichi Sankyo and argenx leaders on implementing AI in biopharma marketing

Amid all the AI hype, pharma marketers are taking a more cautious approach to implementing the technology.

Theratechnologies warns of Egrifta supply disruption after third-party plant shutdown

Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could soon run short.

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.

Awaiting FDA review, Medtronic details study of adaptive neurostimulation in Parkinson’s disease

A paper on the methods being used in the company’s clinical study, named ADAPT-PD, was published this week in the Nature journal npj Parkinson’s Disease.

GSK touts co-administration data for RSV, shingles vaccines as narrowed CDC guidance threatens sales

In the study, co-administration of GSK's RSV vaccine Arexvy and shingles shot Shingrix elicited non-inferior immune responses compared with separate administration of the vaccines.

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.
 
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