The industry is stepping up its campaign to persuade European governments to increase their drugs budgets, in what is described as a landmark report making the case that spending on patented drugs is not a cost to be contained, but an investment in health and the economy.
Decades of research are helping unravel the “black box” of the brain. The second article in BioWorld’s series on the Brain-Computer Interface (BCI) field looks at how simultaneous breakthroughs in AI technology are pushing the BCI field from a theoretical concept to a potential real-world, clinical option for individuals, particularly in China where the National Medical Products Administration greenlighted the world’s first invasive BCI system – Neuracle Medical Technology Co. Ltd.’s Neural Electronic Opportunity – for clinical use in March 2026.
Europe must focus on prevention and innovation to ensure its health care systems are sustainable in the long term, said Olivér Várhelyi, European commissioner for health and animal welfare. With an aging population, rising chronic diseases, a stretched workforce and geopolitical tensions, the universal health coverage that Europeans enjoy is under threat, he told delegates at the HLTH Europe conference in Amsterdam last week.
Bionyra Pharma has emerged with a $165 million oversubscribed series A and a portfolio of three antibodies with extended half-lives that are designed to offer improvements over existing classes of monoclonal antibodies for treating chronic inflammatory diseases.
More and more individuals now have chronically implanted brain-computer interface (BCI) systems in their heads. Devices that can record and stimulate neural signals are increasingly moving from labs to real-world settings to test their potential to treat neurological disorders. At the same time, startups are emerging, investors are pouring money into the space and companies are accelerating their development programs. After decades of clinical research and false starts, are BCI systems finally here?
Three years on from the rebuff of a U.S. FDA complete response letter, F2G Ltd. now has the data needed to resubmit the NDA for the first novel antifungal drug in more than two decades. Along with partner Shionogi & Co. Ltd., F2G has released positive phase III results for orally administered olorofim, showing noninferiority against I.V.-administered Ambisome (amphotericin B, Gilead Sciences Inc.) in patients with refractory aspergillosis infections, or who were unsuitable for mainstay azole therapy.
Shares of Abcellera Biologics Inc. got a modest boost on news of a preclinical research collaboration with Jazz Pharmaceuticals plc aimed at developing next-generation T-cell engaging multispecific antibodies targeting gastrointestinal cancers and other solid tumors.
HMNC Brain Health GmbH has raised $50 million in the first close of a series B, enabling the company to prepare the way for phase III trials of its two lead programs.
In a little more than a month, 17 big biopharma companies will be subject to U.S. President Donald Trump’s long-promised section 232 global biopharma sector tariff. But instead of paying the 100% duty on imported patented drugs and their key ingredients, most of those companies, if not all, will pay much reduced rates or no tariff at all, based on where the imports are coming from, what type of drug is being imported, and whether the companies have signed onshoring and most-favored-nation pricing agreements with the administration.
Another day, another about-face by the U.S. FDA on Uniqure NV’s Huntington’s disease gene therapy. But this latest shift brings good news for the company’s AMT-130, for which the FDA says three-year analysis data from the phase I/II study will be acceptable for an accelerated BLA filing, now expected to be submitted in the third quarter.