The U.S. FDA has become the first global regulator to approve Boehringer Ingelheim GmbH’s spesolimab, the first treatment specifically approved for generalized pustular psoriasis flares in adults, a rare and potentially fatal form of the disease. Branded as Spevigo, it works by inhibiting interleukin-36 and is delivered via intravenous injection.

Financings tracking with 2019, but down 56% over last year

While biopharma financings are down in value by 55.8% in comparison with last year, and even more in comparison with 2020, amounts raised are very much in line with the pre-pandemic year of 2019. So far this year biopharma companies have raised $38.56 billion through 674 transactions, not too far off from the $37.9 billion raised three years ago through 706 deals completed by the end of August. But it is a far cry from 2021’s $87 billion and 2020’s $90.4 billion during the same timeframe. Even the volume is significantly down by 39.5% from 1,109 transactions in the eight-month period of 2021. There were 1,039 financings through August in 2020.

Trem2 gains ground as brain-disorders target

A recent paper in the Journal of Neuroscience detailing preclinical research from the University of Texas shone new light on triggering receptor expressed on myeloid cells 2 (Trem2), an increasingly popular target in drug discovery that a handful of companies are pursuing in Alzheimer’s disease and adult-onset leukoencephalopathy with axonal spheroids and pigmented glia. Among those in the Trem2 mix are Vigil Neuroscience Inc., Alector Inc., and Denali Therapeutics Inc.

FDA draft for digital tech in clinical trials languishes despite agency’s digital push

The U.S. FDA’s formation of the Digital Health Center of Excellence was heralded as a key enabler of digital health technologies, but the news hasn’t necessarily had the expected effect.

HKEX Biotech Summit 2022 zooms in on biopharma investment trends

Investments in early stage biotech companies were in focus at the Hong Kong Stock Exchange’s (HKEX) Biotech Summit 2022. The virtual event on Sept. 1 saw discussions centered on this investment trend for younger biotech firms, which looks to be where capital is headed in the sector after a cooldown for listings in Chinese stock markets in the first half of 2022.

Holiday notice

BioWorld's offices will be closed in observance of Labor Day in the U.S. No issue will be published Monday, Sept. 5.

Also in the news

Abivax, Algo, Amneal, Anaptysbio, Aston, Avacta, Axsome, Biontech, Bridge, Celsion, Coya, Ensysce, Helsinn, I-Cordis, Immusoft, Mc2, Moderna, Navidea, Neukio, Pfizer, Pliant, Roche, Sanofi, Santhera, Vaxart, Vyluma