Approvals & Launches

The revenue boost Evusheld has given AstraZeneca over the past year will grind to a halt now that the FDA, as expected, has pulled approval for the antibody combo on the grounds it is ineffective against most SARS-CoV-2 variants circulating in the US.

US president Mark Reisenauer talked to Scrip about the company's next growth drivers, including fezolinetant for vasomotor symptoms and zolbetuximab for gastric cancer.

Executives told Scrip the company is ready to move five programs into Phase III and launch five products this year, including an obesity indication for Mounjaro, but one drug has since received a CRL.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

The BTK inhibitor demonstrated superiority to AbbVie/J&J’s Imbruvica for overall response in relapsed/refractory CLL, in addition to hitting a progression-free survival endpoint versus chemotherapy in the first-line.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Eisai and Biogen’s aducanumab was never approved in the European Union and while lecanemab is generating more confidence, a fast track review has not yet been confirmed.

The US Food and Drug Administration has approved AstraZeneca and Avillion’s respiratory drug Airsupra, making it the only rescue medication cleared for as-needed use to reduce risk of asthma exacerbations.

Daily notebook from the J.P. Morgan Healthcare Conference: Gene therapy Vertex enters pricing negotiations on gene therapy, Sanofi sees opportunity in hemophilia despite new gene therapy, and AbbVie raises guidance ahead of the introduction of Humira biosimilars. Plus ICER's Steven Pearson and former Biogen CEO George Scangos weigh in on Alzheimer's developments. 

The German group has shone a light at the J.P. Morgan Healthcare Conference on its new launched drugs Nubeqa and Kerendia, plus its late-stage candidates asundexian and elinzanetant, as it prepares for life after patent expiries on Xarelto and Eylea.

The management team talked to Scrip at J.P. Morgan about plans for launching the first gene therapy for hemophilia A in Europe and the US, and its unique approach to reimbursement.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.