Clinical research
The hold is related to a report of a SUSAR of myelodysplastic syndrome in a patient treated with eli-cel, also known as Lenti-D, in a Phase III clinical trial.
Sanofi has announced that the U.S. FDA approved its new treatment for children one year of age or older diagnosed with late-onset Pompe disease.
Called “female Viagra” in the media, Ovoca Bio’s BP-101 (Libicore) nasal spray therapy for low libidos in premenopausal women is undergoing Phase II trials.
The clinical study compared Enhertu to Kadcyla in HER2+ metastatic breast cancer patients who previously received trastuzumab.
The co-head of a Phase III trial reported Johnson & Johnson’s single-shot COVID-19 vaccine was highly effective at preventing severe disease, including among patients infected with the circulating Delta coronavirus variant.
The deal will give EQRx a pre-transaction enterprise value of $3.65 billion and an immediate $1.8 billion in cash that will be used to advance the development of the company’s pipeline.
Aprea faces another disappointment this week in the clinic. The FDA held up a yellow card, and the Boston-based biotech has placed a partial clinical hold on its myeloid malignancy program.
It was a busy week for clinical trial announcements. Take a look.
Top-line results from the Phase II REPAIR trial show a gold nanocrystal suspension, CNM-Au8®, significantly improved brain energetic metabolism in patients with Parkinson’s disease and multiple sclerosis.
The Phase III trial shows that PD-1 inhibitor Libtayo and platinum-doublet chemotherapy significantly improved OS compared with chemotherapy alone with locally advanced NSCLC.
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