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 disease. Branded as Spevigo, it works by inhibiting interleukin-36 and is delivered via intravenous injection. Ingelheim, Germany-based Boehringer Ingelheim is not giving away details about pricing but Carinne Brouillon, a member of the company’s board responsible for human pharma, said Spevigo is “priced similarly to the other biologic therapies used to treat rare dermatologic diseases.” Read More
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. Read More
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. Read More
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. The agency’s December 2021 draft guidance on the use of digital health technologies to assist in the conduct of clinical trials is still in regulatory drydock. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Algo, Anaptysbio, Avacta, Axsome, Coya, Pliant, Reveragen, Santhera, Vaxart, Vyluma, Werewolf. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bridge, Celsion, Ensysce, Helsinn, I-Cordis, Juniper, MC2, Quotient. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Aston, Biontech, Genentech, Immusoft, Moderna, Pfizer, Roche, Sanofi. Read More
