Wellcome Leap has launched its first program, dedicating $50 million to help develop human tissues, organoids and full organs. The Human Organs, Physiology and Engineering (HOPE) program is looking to bring biologists and engineers together to develop both therapeutic organs as well as organs that can be used in vitro to help discover and develop new medications.
LONDON – After a year in the mill, the U.K. National Institute for Health and Care Excellence (NICE) has put proposals for how it intends to evaluate drugs, devices and diagnostics in the future out for consultation.
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.
PERTH, Australia – During the COVID-19 pandemic, 90% of Australia’s clinical trials were put on hold, and the market cap of biotech and medical device companies on the Australian Securities Exchange dropped 5% to AU$11 billion (US$7.78 billion), according to a recent report by Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre.
As with many conferences, the Cleveland Clinic’s 2020 Medical Innovation Summit went virtual this year. Still, the event featured the hotly anticipated top 10 list of innovations for 2021 that saw a range of therapies. Ranked in order of expected importance, the list was led by gene therapy for hemoglobinopathies. The top three innovations, including a novel drug for primary-progressive multiple sclerosis and smartphone-connected pacemaker devices, were highlighted in a special presentation.
LONDON – U.S. chipmaker Nvidia Inc. is investing £40 million (US$51.9 million) in building a supercomputer in Cambridge, U.K., to be dedicated to applying artificial intelligence in drug discovery and in health care.
With only days left before Inovio Pharmaceuticals Inc. planned to initiate a phase II/III trial of its COVID-19 DNA vaccine candidate, INO-4800, and its accompanying delivery device, the FDA placed a partial clinical hold on the company’s study. This is the study’s second delay as the company originally planned to begin in July or August. November is now the earliest potential start date. Inovio told BioWorld that the company and its partners are continuing to prepare for the phase II/III trial “following resolution of the FDA’s partial clinical hold.”
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. has submitted its first new drug application to the FDA for TLX591-CDx, a radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) for imaging prostate cancer using positron emission tomography (PET).
The BioWorld Artificial Intelligence price-weighted index, which includes biopharmaceutical companies, medical devices and health care services companies, has climbed in value and is currently up almost 37% year-to-date.
The FDA came through at last for Athlone, Ireland-based Innocoll Holdings Ltd., greenlighting the drug-device combo Xaracoll (bupivacaine HCl) for acute postsurgical pain relief for up to 24 hours in adults after open inguinal hernia repair.