Approvals & Launches

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 first ever approval for ultra-rare immunodeficiency disease APDS gives Pharming its second product on the market but patient diagnosis will be a major challenge.

Cidara’s US commercial partner Melinta will launch the novel echinocandin this summer, announcing pricing shortly before rollout. Limited indication follows recommendation of FDA advisory panel.

The US firm’s Zynyz has won accelerated approval for the treatment of first-line Merkel cell carcinoma, bouncing back from a prior regulatory setback, but its third-to-market status leaves it with the crumbs under the table in this orphan indication.

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.

Daybue is the first drug approved to treat the rare neurodevelopmental disorder Rett syndrome, despite high clinical trial incidence of diarrhea. Product labeling includes clinician guidance for the side effect.

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.

Pfizer plans to build on the momentum gained for its oral drug Nurtec ODT, now the leading CGRP inhibitor, with the intranasal Zavzpret, which will be priced in line with the rest of the class. 

The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.

While reproductive medicine and maternal health remains the mainstay for the Swiss group, Ferring president Per Falk says the approvals of the microbiome treatment Rebyota and bladder cancer gene therapy Adstiladrin represent "important avenues for exploration and growth."

WW International’s decision to move into pharmaceutical weight management could build commercial momentum for Novo Nordisk’s Wegovy and Lilly’s Mounjaro.

The company plans to ramp up its commercial infrastructure later this year, ahead of a labeling update based on positive cardiovascular outcomes trial data.