Food and Drug Administration (FDA)
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The Phase I randomized, double-blind, placebo-controlled, single ascending dose study will assess the tolerability and safety of the compound PDC-APB when delivered via intramuscular injection.
FDA approved Incyte’s Opzelura (ruxolitinib) cream for atopic dermatitis (AD) for the short-term and non-continuous chronic treatment of mild to moderate AD.
As of September 11, slightly over 100 Alzheimer’s patients had received the drug, reported to be dramatically below Biogen’s internal projections and Wall Street expectations.
Nektar collaborates with Pfizer and Merck KGaA, Darmstadt, Germany, to assess NKTR-255 in combination with Bavencio in patients with bladder cancer.
It earned the FDA’s green light after its Phase II innovaTV 204 clinical trial delivered stellar results in terms of tumor response and durability of the response.
The FDA did not identify any deficiencies related to the manufacturing of the asset. However, the agency did identify deficiencies at the facility of a CMO Verrica is working with.
The Phase III COSMIC-311 trial for CABOMETYX delivered favorable final results in terms of objective response rate, progression-free survival, median overall survival, and safety.
The company announced Friday that clinical studies have been placed on hold following the development of tumors in mice in a non-clinical study.
The Phase II/III trial showed a favorable safety profile and “robust” neutralizing antibody responses in children five to 11 years old who received two 10 µg doses of the vaccine at 21 days apart.
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