Inflammation

Biocon maintains it doesn’t expect the US to remain an eight to 10 player market for adalimumab biosimilars for long and also outlines expectations for its GLP-1 portfolio, led by liraglutide, seen as a major growth driver in the coming years.

Nine new entries targeting a wide range of unmet medical needs. Several EU marketing approvals and two withdrawals. And an accelerated assessment tool that was seldom used. These were among the activities noted as part of the European Medicines Agency’s priority medicines scheme during the first half of 2024.

After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.    

The drug maker’s next-generation JAK1 inhibitor povorcitinib has an addressable market potentially worth more than $3bn if it wins approval in hidradenitis suppurativa and vitiligo.

An instagram post by Brittany Mahomes, wife of Kansas City Chiefs quarterback Patrick Mahomes, failed to contain any risk information for the epinephrine injector, the FDA’s Office of Prescription Drug Promotion said in an untitled letter.

The US FDA approved Leqselvi for alopecia areata, making it the third drug in the class for the indication after Lilly’s Olumiant and Pfizer’s Litfulo.

Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.

Big biopharma is struggling to find the next generation of cancer immunotherapies, but the sector’s smallest companies might just have the platforms of the future.

Eisai/Biogen could this week learn whether the European Medicines Agency will give the thumbs up to market lecanemab across the EU for early Alzheimer’s disease.

Flush with cash, the controlling stakeholder of Novo Nordisk’s life sciences investment arm is increasing its financing of other biopharma innovators.

The Munich-based firm looks to pioneer the novel iRhom2 mechanism to dial down inflammation while maintaining immune homeostasis.

In Vivo sat down with Benjamin Hadida, CEO of Exeliom, at the 2024 BIO International Convention to discuss how the company is using its first-in-class drug candidate to improve therapeutic responsiveness in immuno-oncology, immuno-inflammation and rare disease. 

The French drugmaker can now boast seven approvals for its huge-earning IL-4/IL-13 inhibitor.

The drug maker is spending $250m to acquire privately held Celsius and its lead candidate, a monoclonal antibody targeting TREM1 in inflammatory bowel disease.

Ensho Therapeutics is raising series A cash to develop Phase II-ready NSHO-101 (EA1080), a third oral ɑ4β7 integrin inhibitor attempting to take on Takeda’s blockbuster injectable Entyvio.

Regeneron, whose blood cancer treatment odronextamab was recently turned down by the US regulator but not for reasons relating to efficacy or safety, could soon learn whether its product will be among the drugs to get the thumbs up from the CHMP, the European Medicines Agency’s human medicines committee.

The US major's blockbuster is already well established as a treatment for Crohn’s disease but the latest thumbs-up from the US FDA means Skyrizi is the first interleukin-23 inhibitor approved for both principal types of inflammatory bowel disease.

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.

CRISPR pioneer Jennifer Doudna recently co-launched an initiative focused on microbial gene editing, but French biotech Eligo has been diligently working on this for 10 years. 

The group says INF904 can make billions in two highly competitive skin diseases, but this looks optimistic.