Clinical research
The two companies announced data from a Phase III study which showed 100% efficacy and robust antibody responses in patients ages 12 -15 who received the BNT162b2 vaccine.
The first four patients that were administered BS01, Bionic Sight’s investigational gene therapy for advanced retinitis pigmentosa (RP), all reported the ability to detect light and motion. Two of the patients were also able to detect direction.
Disappointing data from two Phase Ib/IIa trials for both lead Huntington’s disease antisense candidates have pushed Wave Life Sciences to shelve the assets and focus on its next generation of therapies.
AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
Lisa Stockman Mauriello was diagnosed with ALS in January and is seeking access to Biogen’s tofersen (BIIB067) through the Right to Try Act. Her case has reinvigorated the ALS community and its fight for expanded access to investigational therapies for this cruel, always fatal disease.
Between the Moderna and Pfizer-BioNTech COVID-19 vaccines, there are two mRNA therapeutics on the market … the only two.
A new readout from a Phase IIb/III trial showed intravenous RLF-100 (aviptadil) met the primary endpoint of improving survival and recovery at 60 days post-treatment for respiratory failure in critically ill patients with COVID-19.
Humanigen, the biotech briefly run by “Pharma Bro” Martin Shkreli under the name KaloBios up until his arrest, is back in the game with an antibody that is keeping COVID-19 patients off of ventilators and improving survival.
Orphazyme announced its Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit both its primary and secondary endpoints.
There was a fair amount of clinical trial news last week. Here’s a look.
PRESS RELEASES