Phase III

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.
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.
The announcement for the chikungunya vaccine (VLA1553) comes after the U.S. FDA awarded it with a Breakthrough Designation status. Read more about it here.
Pfizer said that the Phase IIb/III ALLEGRO trial on ritlecitinib was found to be effective against the autoimmune disease, which is characterized by an immune attack on hair follicles.
PRESS RELEASES