Nuala Moran

As generic versions of its blockbuster drug Ofev (nintedanib) start to hit the market, Boehringer Ingelheim GmbH looks to have swerved the patent cliff, with European and Japanese regulators both approving a potential replacement, Jascayd (nerandomilast), this week. At its monthly meeting, the EMA's Committee for Medicinal Products for Human Use also recommended Novartis AG's Vijoice (alpelisib) be given conditional approval in the treatment of PIK3CA-related overgrowth spectrum disorders.

Less than two weeks after the outbreak was officially declared, animal studies of a newly designed vaccine against the Bundibugyo Ebola virus are now underway in the U.S. and U.K., and the Serum Institute of India is standing ready to manufacture the vaccine for clinical trials. If the animal tests are positive, the vaccine will be ready for clinical trials in two to three months.

There are initial signs that President Donald Trump's most-favored nation (MFN) policy may be further delaying access to new drugs in Europe, as companies hold off commercializing in these countries to avoid lower European prices being referenced in the U.S.

Infex Therapeutics Ltd. has published positive phase IIa data for its lead program, RESP-X, in the treatment of exacerbations of chronic respiratory infections caused by Pseudomonas aeruginosa and is now laying the ground for phase IIb development, after raising £4.3 million (US$5.8 million) in new capital.

There are real world demonstrations of how autonomous artificial intelligence agents are poised to disrupt biomedical research, according to two papers published May 19 in Nature. Each describes an AI system that assists across the piece, from generating hypotheses to designing experiments, analyzing the data and refining hypotheses in the light of new data.

GSK plc has announced a breakthrough in the treatment of chronic hepatitis B, reporting a functional cure rate of 19% across two phase III trials of its antisense oligonucleotide bepirovirsen.

“I need to be honest with you about something important. Most previous Ebola outbreaks in the Democratic Republic of Congo (DRC) were caused by a virus called Ebola Zaire, for which we have vaccines and treatments. This outbreak is caused by a different virus called Ebola Bundibugyo. There are currently no approved vaccines or treatments for it.” This was the stark message from Tedros Adhanom Ghebreyesus, director general of the World Health Organization (WHO) in an open letter to the people of the DRC, as he traveled to the country on Friday, May 29.

IMU Biosciences Ltd. has closed its series A at £40 million (US$53.9 million), adding £28.5 million to the initial close in January 2024, and bringing the total raised since the company's formation in 2021 to £45 million. Since that first close, IMU has built what is claimed as the world's largest high-definition immune system dataset, with almost 25,000 profiles of healthy volunteers and disease-specific patient cohorts.

There are initial signs that President Donald Trump’s most-favored nation (MFN) policy may be further delaying access to new drugs in Europe, as companies hold off commercializing in these countries to avoid lower European prices being referenced in the U.S.

Extracellular matrix specialist Engitix Ltd. is teaming up with GSK plc to delve into the mechanisms underlying regression of fibrosis after treatment for chronic liver disease, and identify and validate new drug targets involved in this process.