Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim data from an ongoing Phase I trial of NTLA-2001 for transthyretin (ATTR) amyloidosis.
Sarepta announced that the FDA has put the Phase II trial for its SRP-5051 (vesleteplirsen) for the treatment of patients with DMD on clinical hold following a serious safety signal.
The genetically-modified heart of a man who died two months after his heart was replaced with that of a pig had nearly doubled in size, autopsy results show.
Positive news continues for COVID-19 vaccine development and distribution, with Sanofi and GSK announcing the success of their candidate against the Omicron variant.
The Roche Accelerator is designed to help companies bridge the gap between idea and proof-of-concept. It is one of several incubators recently founded by Western companies.
Amryt Pharma is filing a formal dispute resolution request (FDRR) with the FDA after receiving a CRL that delays the production of its drug for a rare skin disorder.
Researchers have been able to use machine learning to evaluate MRI scans and diagnose Alzheimer's in a single scan. For that and more research news, continue reading.
With the submission of NDAs and BLAs, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.
The Boston University School of Medicine has unraveled details about a known genetic component for the development of Alzheimer’s disease (AD): the APOE4 gene.
Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm after only 29 people signed up for an expected enrollment of 6,000 patients.
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.
There were multiple leadership changes in the biopharma industry, with several new chief executive officers tapped to guide companies through their next growth phases.
The life science industry is growing rapidly, and many companies have announced expansions and job creation. Still, others have been forced to cut costs and slash jobs. For that and more, continue reading.
GSK plc (LSE/NYSE: GSK) announced an investment of £1bn over ten years to accelerate research and development (R&D) dedicated to infectious diseases that disproportionately impact lower-income countries.
This research will focus on new and disruptive vaccines and medicines to prevent and treat malaria, tuberculosis, HIV (through ViiV Healthcare), neglected tropical diseases (NTDs), and anti-microbial resistance (AMR),
An experimental AstraZeneca drug for Wilson disease hit the mark in a Phase III study in which the drug, ALXN1840, was able to mobilize copper three times greater than standard-of-care.
The WHO will decide whether to declare a public health emergency following the recent outbreaks of monkeypox, and poliovirus has been detected in London water samples.