The FDA’s rejection of Nuplazid cited clinical trial results in subgroups of patients. Acadia Pharmaceuticals said the FDA’s decision goes against all feedback the company previously received and amounts to an incorrect way of evaluating dementia patients.
The Federal Trade Commission is opposing Illumina’s proposed $7.1 billion Grail acquisition, arguing that it will reduce competition for multi-cancer early detection tests. Illumina disagrees with the regulator’s position and will oppose the FTC’s challenge.
Prometheus Biosciences is taking a precision medicine approach to developing drugs and diagnostics for inflammatory bowel disease. The IPO cash will fund support its pipeline of IBD drug candidates for specific patient subpopulations.
As the Biden Administration pushes to offer more over-the-counter Covid-19 tests, the Food and Drug Administration authorized the first molecular Covid-19 test for over-the counter use. The test was developed by San Diego-based startup Cue Health.
Vividion Therapeutics has technology that enables it to develop drugs for “undruggable” disease targets. The Series C financing is a crossover round, an indication a biotech is preparing for an IPO.
Benchtop blood testing startup Truvian raised $105 million in series C funding, which it plans to use to pave the way to submit its device for FDA clearance.
The Neurocrine decision follows a clinical hold placed on the Parkinson’s program in December. It’s Voyager’s second loss of an R&D partner in the past year; AbbVie previously ended an alliance aiming to develop gene therapies for Parkinson’s and Alzheimer’s.
Concert Health, a San Diego-based behavioral health startup that partners with primary care providers, raised $14 million in series A funding.
The San Diego-based biopharma firm has several oncology therapies in development and has partnered in the past with the likes of Astellas, BeiGene and Bristol-Myers Squibb.
San Diego-based diagnostics startup Cue Health won a $481 million from the Department of Health and Human Services and the Department of Defense to produce more coronavirus tests. The company received an emergency use authorization in June for its rapid molecular test.
Earlier this month, Ohio Gov. Mike DeWine received a false-positive result from a rapid antigen test for Covid-19, raising concerns about the tests’ accuracy. The assay’s maker, Quidel, said it is investigating the case.
San Diego-based medical device startup MedCrypt struck a partnership with Blackberry QNX, an operating system developed by Blackberry for embedded systems.
The company is currently running a Phase I study of its lead candidate, the antibody-drug conjugate VLS-101, in patients with lymphomas and leukemias. It has two additional antibody-drug conjugates and a bispecific antibody in preclinical development.