Drug Development
Fueled by advances in biomarkers, brain mapping, and AI, investment in neuro and CNS innovation shows no signs of slowing, even amid costly setbacks. BioSpace spoke to investors at JPM26 to get their take on recent bets in new therapies and neurotech.
FEATURED STORIES
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
Facing the loss of exclusivity on key products, Pfizer has pulled forward its lead obesity asset into Phase III and targeted a 2028 launch. CEO Albert Bourla explained the pharma’s strategy at J.P. Morgan on Monday.
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Mineralys Therapeutics, a clinical-stage biopharmaceutical company focused on developing a best-in-class, novel therapy for high blood pressure, closed a $118 million Series B investment round.
South San Francisco-based Rigel Pharmaceuticals reported its Phase III Forward trial of fostamatinib did not show statistical significance in warm autoimmune hemolytic anemia
At ENDO 2022, Ascendis will share Phase II and III data showing clinical efficacy for its investigational product candidate for hypoparathyroidism. For this and more, see inside.
Results of the Phase III trial showed that Evusheld protected against progression to severe COVID-19 or death in the early outpatient treatment of mild-to-moderate COVID-19.
Aldeyra Therapeutics reported that its reproxalap hit the mark in the Phase III Tranquility-2 study for dry eye disease. The drug showed statistical superiority for its two primary endpoints.
Ensysce Biosciences is developing solutions that make opioids safer, and virtually impossible to abuse. BioSpace spoke with CEO Lynn Kirkpatrick about the company’s novel technology.
More oncology firms presented positive developments in their respective cancer research programs at the 2022 ASCO annual meeting this week.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
The FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
Moderna announced its Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study.