The U.S. FDA signaled during a Type B meeting that existing data could support a BLA filing for Moonlake Immunotherapeutics AG’s sonelokimab to treat the skin disease hidradenitis suppurativa (HS), despite one of two pivotal phase III trials missing the mark.
There are two significant messages for companies developing and profiting from obesity drugs in a meta-analysis of clinical trials examining the extent of weight regain after treatment stops. First, people taking obesity medication regain weight four times faster on average than those who lose weight through behavioral diet and exercise programs; and second, poor tolerability leads to poor adherence.
It doesn’t take a meteorologist to see the storm clouds of uncertainty that will continue to roll in on health care across the globe this year. While the prospects for the medical device industry may be sunnier than for other aspects of health care, some high pressure areas likely will present challenges.
As widely expected, GSK plc and Ionis Pharmaceuticals Inc. reported positive findings from two pivotal trials testing bepirovirsen in chronic hepatitis B, showing the antisense oligonucleotide therapy achieved a statistically and clinically meaningful functional cure rate, indicating a potential transition in CHB treatment beyond the current viral suppression-focused standard of care.
Amgen Inc. has swooped on two European cancer specialists, buying Dark Blue Therapeutics Ltd. for up to $840 million plus royalties, and sealing a $618 million license agreement with Disco Pharmaceuticals GmbH for rights to a novel cancer cell surface target.
It doesn’t take a meteorologist to predict another stormy year for the biopharma sector, not just in the U.S., but also in Europe. Lurking within those storms, though, could be a few silver linings.
Shanx Medtech BV raised €15 million (US$17.5 million) in a seed funding round for its in vitro diagnostic platform for ultra-rapid antimicrobial susceptibility testing. The financing came from a range of sources including equity, grants and a loan, and will be used to accelerate the development, clinical validation, regulatory approval, and commercial launch of the diagnostic platform.
The U.K. National Institute for Health and Care Excellence has offered a thumbs-up for eight digital technologies to help patients with asthma manage their conditions. The sponsors of these products have three years to turn out enough evidence to persuade NICE to fully endorse those products, after which these platforms could have access to a market of more than five million patients.
Securing a second major partnership with Sanofi SA – this time worth a potential $2.56 billion – Earendil Labs will provide its AI-driven discovery platform to find new therapeutics for autoimmune and inflammatory diseases.
After raising $292 million in its Hong Kong IPO, AI discovery and development biotech, Insilico Medicine, signed an R&D collaboration with French pharma Servier SA valued at $888 million to discover and develop innovative oncology therapies by combining Insilico's AI-driven drug discovery platforms with Servier's global expertise in cancer drug development.