Henlius has successfully established the safety and preliminary efficacy of its ophthalmology-indicated bevacizumab biosimilar HLX04-O in Phase I/II trials.

While FDA commissioner meets with firms on shortages, senators challenge alternative source of platinum chemotherapies, FDA hinges imports from Sun plant on successful media fill runs, Safe Chain warned on Biktarvy suppliers, and the FDA asks Ipca more questions while setting “Mr. Ye” straight.

Many new drug commercialization decisions need to happen early in the clinical development of a therapy, and cell and gene treatments are no different. As Amerisource Bergen’s Lung-I Cheng tells In Vivo, creating a patient-first blueprint is the best place to start.

As states weigh their options, the history of past settlements will be a factor. One state signed onto the settlement with the distributors but opted out of the deal with J&J, netting it millions more, and with faster payment, than it would have received under the national settlement.