Clinical research
The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies.
Intellia Therapeutics reported early, positive signs from its in vivo gene therapies for both transthyretin (ATTR) amyloidosis and hereditary angioedema Friday.
AstraZeneca’s rare disease subsidiary Alexion posted positive late-stage results from a potential complementary treatment for paroxysmal nocturnal hemoglobinuria.
The U.S. FDA approved Mallinckrodt’s Terlivaz in adults with hepatorenal syndrome and is the only FDA-approved drug for that indication.
BrainStorm Cell Therapeutics announced the publication of peer-reviewed data from a Phase II trial in progressive multiple sclerosis Thursday showing “preliminary evidence of efficacy.”
There’s a new collaboration in the Parkinson’s disease development space, Cardiff Oncology kicks off a mid-phase study in colorectal cancer and Ocugen published a new review of COVAXIN.
After reporting a failed clinical trial of ELX-02 for cystic fibrosis (CF), Eloxx Pharmaceuticals plans to shift its focus and use the drug to treat Alport syndrome, a rare kidney disease.
Pfizer is leveraging its funding and experience with vaccines, developing its meningococcal, flu, and RSV vaccines. It also announced its venture investment in Nimbus Therapeutics.
NSCLC At ESMO: Pollution does indeed cause lung cancer; Tecentriq shows promise in poor prognosis patients, Amgen makes progress in KRAS G12-mutated disease and an update on a Daiichi Sankyo ADC.
Oramed announced positive mid-stage data that showed its investigational drug ORMD-0801 reduced liver fat content in type 2 diabetes patients who have been diagnosed with NASH.
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