Drug Development

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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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Innovent Biologics’ Phase II trial of mazdutide, a potential treatment for type 2 diabetes, showed the drug met its primary endpoint by successfully reducing HbA1c levels.
The FDA has approved Incyte’s Opzelura as the first and only at-home therapy for repigmentation in nonsegmental vitiligo.
The buyout comes on the heels of promising Phase I/II results from GTX-102, an antisense oligonucleotide candidate being developed to treat Angelman syndrome.
In what it is calling a strategic decision, Sesen Bio announced Monday that it has paused development activities of Vicineum, its lead asset, in the United States.
In the latest in Nestlé’s efforts to establish a presence in the gastroenterology space, the company will pay over $40 million upfront to Enterome as part of a new partnership.
MacroGenics’ Phase II trial shuts down after a patient death believed to be related to enoblituzumab combo, while Exelixis’ Cabometyx combo improves PFS in renal cell carcinoma.
Researchers point out that antibodies against amyloid are still considered an essential approach to treating Alzheimer’s, but the leading risk factor for sporadic AD is aging.
As a result of this new data, the company “has improved the statistical analysis of the ALLOB Phase IIb study.” The changes should speed up the overall recruitment and study.
Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate OTX-2002 has been granted by the FDA.
Clene, Inc. released data that shows its add-on treatment, CNM-Au8, significantly improved survival in patients with amyotrophic lateral sclerosis (ALS) by 70%.