Iona Everson

Zymeworks, a biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics, has entered into a definitive agreement to acquire Theravance Biopharma, a biopharmaceutical company. This proposed acquisition adds Yupelri to Zymeworks’ partnered portfolio.

Launch excellence has long been positioned as the culmination of clinical development, but it’s a view that’s increasingly outdated. Today, success is defined by the ability to anticipate regulatory, payer and patient needs much earlier in the life cycle. In reality, successful launches begin in early clinical development. The target product profile (TPP) defines what success looks like, aligning clinical ambition with the needs of prescribers, patients and payers.

Roche’s Enspryng (satralizumab), a thyroid eye disease (TED) treatment, has been accepted by the FDA and given priority review for a supplemental Biologics License Application (sBLA). The filing acceptance is based on results from the two randomised, placebo-controlled global phase 3 SatraGO studies assessing the safety and efficacy of Enspryng in patients with moderate to severe TED.