News
Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.
FEATURED STORIES
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
Job Trends
Ginkgo Bioworks, the leading horizontal platform for cell programming, and First Serv, a Qatari investment holding company, announced that they have entered into a non-binding Memorandum of Understanding to develop and implement new biosecurity capabilities in Qatar.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
The agency is investigating reports of secondary blood cancers in patients who have received certain CAR T cell therapies, but experts say the risk is low and is outweighed by the terminal nature of some cancers.
The biopharma giant provided full-year 2024 guidance on Wednesday that fell below Wall Street’s expectations, as it continues a cost-cutting effort now up to $4 billion in total.
This week, we discuss the two major FDA approvals for sickle cell from Vertex/CRISPR and bluebird bio; Axcella and the future of long-covid treatments, Vanda’s $100m purchase and AI regulatory developments in Europe.
Johnson & Johnson and Genmab revealed the first data from a Phase III study of a Darzalex Faspro-based quadruplet therapy in patients with transplant-eligible newly diagnosed multiple myeloma.
The company’s non-opioid painkiller candidate VX-548 decreased Numerical Pain Rating Scale scores by at least two points after 12 weeks in a mid-stage diabetic peripheral neuropathy study.
The year may be coming to a close, but there’s no holiday break for the FDA, which will release five regulatory verdicts over the next two weeks.
Medicines on the list can still be prescribed but will be under tight monitoring by a regulatory network, which can implement measures to prevent shortages and ensure supply chain continuity.
Ahead of an expected surge in regulatory filings, the FDA is establishing the Genetic Metabolic Diseases Advisory Committee to provide advice on treatments for these complex and challenging conditions.
BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation will discuss alternative financing strategies to consider for 2024. Watch now.
In this episode we dive into regulation, real-time management, and AI’s various applications and how it can streamline different processes with guests from Microsoft and IQVIA.