The 2022 Albert Lasker Basic Medical Research Award has been awarded to Richard Hynes, of the Massachusetts Institute of Technology, Erkki Ruoslahti, of the Sanford Burnham Prebys Medical Discovery Institute, and Timothy Springer, of Harvard Medical School “for discoveries concerning the integrins, key mediators of cell-matrix and cell-cell adhesion in physiology and disease.” Lauren Gardner, of Johns Hopkins University won the 2022 Lasker-Bloomberg Award for Public Health Service “for creating the COVID-19 Dashboard, which set a new standard for disseminating authoritative public health data in real time.” And Yuk Ming Dennis Lo, of the Chinese University of Hong Kong, won the 2022 Lasker-DeBakey Clinical Medical Research Award “for the discovery of fetal DNA in maternal blood, leading to noninvasive prenatal testing for Down syndrome.”
Ventus ventures into Novo Nordisk deal
After two years of talks, privately held Ventus Therapeutics Inc. and Novo Nordisk A/S have signed an exclusive worldwide license deal to commercialize candidates from Ventus’ portfolio of NLR pyrin domain-containing 3 (NLRP3) inhibitors. Ventus will receive an up-front $70 million in cash while Novo provides R&D funding. Ventus could receive another $633 million in clinical, regulatory and commercial milestones plus tiered royalties. Novo Nordisk gets the exclusive worldwide rights to develop and commercialize Ventus’ lead NLRP3 inhibitor program for a range of indications, including nonalcoholic steatohepatitis, chronic kidney disease and other cardiometabolic conditions.
Trefoil’s TTHX-1114 gets the all-clear in corneal dystrophy trial
Trefoil Therapeutics Inc. has reported promising data from a phase II trial suggesting its engineered version of fibroblast growth factor 1, TTHX-1114, may speed and improve recovery of patients with Fuchs endothelial corneal dystrophy who are undergoing a surgical procedure called Descemet stripping only.
UK pharma facing ‘perfect storm’ of economic turmoil and looming 30% rebate hike
The U.K. could be downgraded as a place to research and launch new medicines because of economic shocks and a looming rebate of 30% or more on sales of branded products, according to industry sources. Pharma and biotech are facing the pinch just like every other business and household – but according to industry commentators there is added pressure because of the country’s pricing arrangements, which require heavy rebates from drug firms if the branded medicines bill for the NHS grows beyond pre-agreed limits. Add to this the increase in energy costs and falling value of the pound and the U.K.’s life science sector, which has been championed by successive governments, is facing a series of economic woes that could hinder research and cause big pharma to look elsewhere to make investment decisions.
EMA launches ATMP pilot
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements. Under the pilot, the EMA will provide enhanced regulatory support for up to five ATMPs, such as gene and cell therapies, that address unmet medical needs and that are solely developed by academic and nonprofit sponsors in Europe. Besides guiding the participants through the regulatory process, the EMA will use the pilot to help identify additional regulatory tools that could facilitate future ATMP development.
US OIG looks at accelerated approvals by the numbers
Medicare and Medicaid have spent more than $18 billion over the past few years covering 18 drugs granted accelerated approval that haven’t completed their confirmatory trials even though their completion dates have passed, according to a new report from the U.S. Department of Health and Human Services Office of Inspector General (OIG). Of the 278 drugs given accelerated approval between 1992 and 2021, OIG found that 104 – more than 37% – have incomplete confirmatory trials; 35 of those have trials past their original planned completion date.
The BioWorld Insider Podcast – Psychedelic evolution: Mindset Pharma looks to change mental health treatment
An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Lanthier discussed challenges facing companies developing psychedelic treatments and how to overcome the one-size-fits-all, trial-and-error approach to mental health treatment that often seems stuck in the past.