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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
FDA
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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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.”
BioSpace sat down with Sven Kili, 2022 ISCT Annual Meeting co-chair, to preview the event, which will focus on 4 key subject areas including launch and commercialization of cell and gene therapies.
Over the past several years, The Lone Star State has been growing in significance as a life sciences hub. Now the industry is flocking to Hays County and its Innovation Corridor.
David Sabatini has withdrawn his name for consideration for a faculty post at New York University Langone Health.
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.
Spero is reducing a huge chunk of its staff to minimize expenses and reallocate resources toward more promising projects in anticipation of the FDA’s decision on its NDA for tebipenem HBr.