Drug Development
Roche is dropping its investigational AKT inhibitor ipatasertib, which was being assessed in a Phase III trial for castration-resistant prostate cancer, as well as several other candidates.
FEATURED STORIES
Mixed headlines have plagued the cell and gene therapy space of late. We believe that a renewed case of optimism is not only warranted but essential if these therapies are to reach their full potential.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
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Dianthus Therapeutics, Enavate Sciences and CytoTronics were all launched with this recent wave of investor funding. For that and more, continue reading.
Moderna held its 2022 Q1 earnings call this morning announcing $6.1 billion in revenue and robust plans to roll out COVID-19 boosters this fall.
Connect Biopharma Phase II trial on a potential drug for adults with moderate-to-severe ulcerative colitis may have failed to meet its primary endpoint, but the company isn’t giving up yet.
The FDA accepted Bayer’s supplemental New Drug Application for its proposed oral treatment for metastatic hormone-sensitive prostate cancer.
Three long-time FDA officials, Dr. Peter Marks, Dr. Janet Woodcock and Dr. Robert Califf wrote an op-ed in JAMA describing the reality that COVID-19 represents “the new normal.”
Horizon Therapeutics announced its Phase II dazodalibep (HZN-4920) clinical trial has met its primary endpoint. Dazodalibep is a treatment for patients with Rheumatoid Arthritis (RA).
GPH101 is an investigational next-generation gene-edited autologous hematopoietic stem cell (HSC) therapy.
Denali Therapeutics, Inc. has announced that dosing has begun for participants of a Phase II clinical trial that intends to evaluate the potential of SAR443820 (DNL788) in patients with amyotrophic lateral sclerosis (ALS).
Dianthus Therapeutics launched today with $100 million in Series A financing led by 5AM Ventures, Avidity Partners and Fidelity Research and Management. The company plans to tackle severe and rare autoimmune diseases by utilizing antibodies that target complements.
Humacyte’s engineered blood vessels, human acellular vessels, are in a position to take tissue regeneration from a laboratory possibility to a commercial reality.