The longstanding ambition of developing an inhaled gene therapy for cystic fibrosis has taken a step forward, with the start of a phase I/II trial of a product using a novel pseudotyped viral vector that it is hoped will circumvent problems encountered in previous studies with other vectors.
EG 427 SAS has closed a €27 million (US$28.3 million) series B round, which will fund it to completion of the first clinical trial of the lead gene therapy program, opening the way for its herpes simplex viral-vectored products to be developed in a range of chronic neuro-urology disorders.
Artificial intelligence (AI) technology developer Genesis Therapeutics Inc. has brought in another larger partner to go on a search for the right therapeutic small molecules. The company is getting an up-front $30 million payment from Incyte Corp. and could bring in as much as $295 million per target in development, regulatory and commercial milestones, bringing the deal to about $620 million total.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asklepios, Bayer, Boehringer, Celltrion, Clarity, Doron, Harmony, PTC, Vivozo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: BMI Korea, Brexogen, Epitopea, Immunitybio, Merck, X4.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alzinova, Ascletis, Bristol, Imunon, Karyopharm, Precision, Supernus.
The prospect of U.S. tariffs on pharmaceuticals became more than just speculation this week, with President Donald Trump saying those tariffs likely would begin at 25% and climb over the year. His comments came in response to a question at a Feb. 18 news conference that followed the signing of two unrelated executive orders. Asked about the planned rate for tariffs on semiconductors and pharmaceuticals, Trump responded that it would be 25% and higher and it would “go very substantially higher over [the] course of a year.”
Research seems to be gaining ground in Wilson disease, a rare inherited condition that causes copper levels to accumulate in the liver, brain and eyes. Most people are diagnosed as children or around middle age, but the age spectrum can be wide. Monopar Therapeutics Inc. has drawn Wall Street’s attention in the space.